Cleaning Protocols and Equipment - APIC MT€¦ · Identify AAMI recommended cleaning protocols to...

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3/13/2019 1 Keeping Ophthalmic Instruments Safe Nancy Chobin, RN, AAS, ACSP, CSPM, CFER CEO Sterile Processing University Lebanon, NJ Copyright 2019 Objectives Identify AAMI recommended cleaning protocols to prevent TASS Review the AAMI preparation recommendations for instruments and sets Review care and handling of ophthalmic instruments Background Time to perform a cataract procedure has decreased15-20 minutes. The cost for a set of instruments can range from $6,000 to $8,000 or more Urgency to turn the instruments around for the next case. Instruments come in contact with the eye and thus body fluids. They are considered contaminated and must receive the entire cleaning and sterilization process between patients. Manufacturer’s Instructions Instrument manufacturer should: specify the pH of detergent (e.g. neutral pH) may recommend a pre-soak in an enzymatic cleaner to help remove protein soils (e.g. body fluids) specify if any special cleaning implements are needed (e.g. to clean out lumens). Specify water quality for cleaning and rinsing However, need to reconcile this information with AAMI and ASORN, AORN, ASCRS and the CDC. Manufacturer’s Instructions Also known as Instructions for Use (IFUs) Keep on file - readily available to processing personnel. Ensure IFUs followed each and every time the instrument is processed. Employee training should complement the AAMI guidelines as well as manufacturers’ instructions Eye instrumentation is extremely delicate and as such requires very special handling and processing to prevent damage. All personnel handling eye instrumentation should ensure careful handling. Example of Steam Sterilization IFU Prevacuum High Temperature Autoclave: 274˚F (134˚C) for 3 minutes; wrapped. NOTE: As per ANSI/AAMI ST79:2010 and A1:2010 270˚F (132˚C) for 4 minutes and 275˚F (135˚C) for 3 minutes are acceptable minimum cycle times for dynamic-air- removal steam sterilization cycles. Standard Gravity Autoclave: 250˚F (121˚C) for 30 minutes; wrapped. High Speed (Flash) Autoclave: 270˚F (132˚C) for 10 minutes; unwrapped. 1 2 3 4 5 6

Transcript of Cleaning Protocols and Equipment - APIC MT€¦ · Identify AAMI recommended cleaning protocols to...

Page 1: Cleaning Protocols and Equipment - APIC MT€¦ · Identify AAMI recommended cleaning protocols to prevent TASS Review the AAMI preparation recommendations for instruments and sets

3/13/2019

1

Keeping Ophthalmic Instruments Safe

Nancy Chobin, RN, AAS, ACSP, CSPM, CFER

CEO Sterile Processing University

Lebanon, NJ

Copyright 2019

Objectives

Identify AAMI recommended cleaning protocols to prevent TASS

Review the AAMI preparation recommendations for instruments and sets

Review care and handling of ophthalmic instruments

Background

Time to perform a cataract procedure has decreased15-20 minutes.

The cost for a set of instruments can range from $6,000 to $8,000 or more

Urgency to turn the instruments around for the next case.

Instruments come in contact with the eye and thus body fluids.

They are considered contaminated and must receive the entire cleaning and sterilization process between patients.

Manufacturer’s Instructions

Instrument manufacturer should:

specify the pH of detergent (e.g. neutral pH)

may recommend a pre-soak in an enzymatic cleaner to help remove protein soils (e.g. body fluids)

specify if any special cleaning implements are needed (e.g. to clean out lumens).

Specify water quality for cleaning and rinsing

However, need to reconcile this information with AAMI and ASORN, AORN, ASCRS and the CDC.

Manufacturer’s Instructions

Also known as Instructions for Use (IFUs)

Keep on file - readily available to processing personnel.

Ensure IFUs followed each and every time the instrument is processed.

Employee training should complement the AAMI guidelines as well as manufacturers’ instructions

Eye instrumentation is extremely delicate and as such requires very special handling and processing to prevent damage. All personnel handling eye instrumentation should ensure careful handling.

Example of Steam Sterilization IFU

Prevacuum High Temperature Autoclave: 274˚F (134˚C) for 3 minutes; wrapped.

NOTE: As per ANSI/AAMI ST79:2010 and A1:2010 270˚F (132˚C) for 4 minutes and 275˚F (135˚C) for 3 minutes are acceptable minimum cycle times for dynamic-air-removal steam sterilization cycles.

Standard Gravity Autoclave: 250˚F (121˚C) for 30 minutes; wrapped.

High Speed (Flash) Autoclave: 270˚F (132˚C) for 10 minutes; unwrapped.

Training and Competencies

Employee competencies should be verified in the processing protocols for processing ophthalmic instruments

Competencies should be verified initially and annually

Utilize resources such as ophthalmic instrument company's educational materials

Reconcile with national standards

Cleaning

Removal of contamination from an item to the extent necessary for further processing or for the intended use.

Involves the use of detergent and water, of adherent visible soil (i.e. blood, pus, protein) from the surfaces, crevices, serrations, jaws and lumens of instruments, devices and equipment, by a manual or mechanical process.

Due to their design, eye instrument challenging to clean

Very small lumens, very delicate tips, can easily break/damage

Pre-Cleaning in Room

Treat with demineralized water to prevent drying of bioburden.

Saline, disinfectants, and chlorinated solutions can cause pitting

and corrosion and should never be used for soaking instruments

Instruments should not remain in water for lengthy periods of time.

–– Biofilms may form, particularly within lumens.

Decontamination

According to OSHA, “the use of physical or chemical means to remove, inactivate, or destroy blood-borne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, use, or disposal.” [29 CFR 1910.1030]

NOTE—Generally used in health care facilities to refer to all pathogenic organisms, not just those transmitted by blood

First and most critical step in breaking the chain of disease transmission

Why Is Cleaning Important?

Process of disinfection or sterilization dependent upon direct contact of the sterilant or disinfectant with the surface of the item

Protein left on items can be “baked on” in the sterilizer

Why are some facilities only “wiping off” the instruments? “Cleaning with water? Alcohol?

TASS – Focus

Toxic Anterior Segment Syndrome (TASS) – main focus by AAMI and AORN

TASS - an acute inflammatory response of the anterior chamber of the eye.

May lead to severe visual impairment if it is not recognized and treated in a timely manner.

Many causes including detergents, water quality, steam quality, instruments, etc.

Major concern is when endotoxins form

Causes of TASS (ASCRS)*

Detergent residues (in general)

Endotoxins

Preservatives

Residues from sterilization processing

Residues of detergents inside a reusable cannula or instrument

Cement sealant on bags of irrigating solution which has leached out

All can induce TASS and cause severe damage to ocular tissue

* American Society of Cataract and Refractive Surgeons

TASS

Particular care must be taken in the processing of intraocular surgical instruments to help ensure that foreign substances or materials associated with the instruments will not be introduced into the anterior chamber of the eye during surgery.

TASS

Outbreaks of TASS have often been linked to the failure to follow the processing procedures recommended by the instrument manufacturer

Specific instrument cleaning and sterilization recommendations intended to diminish the risk of TASS associated with intraocular surgical instruments have been published by the American Society for Cataract and Refractive Surgery (ASCRS, 2006).

Also in AAMI ST-79 as an Annex

ASCRS Recommendations

An adequate inventory of the necessary intraocular surgical instruments should be maintained in order to allow for the timely processing of instruments between cases.

Major issue in surgery centers

Insufficient inventory of instruments leads to short cuts in cleaning

ASCRS Recommendations

Adequate time must be allowed for processing instruments according to the manufacturer’s instructions; otherwise, the cleaning and sterilization of the instruments will be ineffective.

ASCRS Recommendations

A designated cleaning area and equipment specific to the cleaning of intraocular surgical instruments should be identified.

Whenever possible, intraocular surgical instruments should be processed separately from general surgical instruments and equipment in order to reduce the potential for cross-contamination by material or residue from the general surgical instruments

ASCRS Recommendations

Instruments should be pre-cleaned immediately following use.

Gross debris should be removed, and instrument lumens should be flushed with sterile distilled water or another suitable agent as recommended in the room at the end of the procedure

ASCRS Recommendations

Only cleaning agents that have been recommended by the manufacturer should be used.

Particular attention should be paid to the specified concentration of cleaning agent and to the recommended water quality.

ASCRS Recommendations

Final rinsing of the instrument should be performed with sterile, distilled, or deionized water, unless otherwise specified by the manufacturer.

The water used to clean or rinse instruments should be discarded after each use.

ASCRS Recommendations

If an ultrasonic cleaner is used to process the instruments, it should be emptied, cleaned, rinsed, and dried at least daily or, preferably, after each use.

Brushes and other cleaning tools should be cleaned and sterilized as recommended by the manufacturer at least daily or, preferably, after each use.

ASCRS Recommendations

Cleaning and sterilization equipment should be properly maintained.

Foreign materials such as endotoxin or heavy metals may be deposited onto the instruments during processing and induce TASS

Water Quality

Water used to for the final rinse of the device should have a low endotoxin content to avoid pyrogens on processed

devices.

Can lead to pyrogenic reactions (i.e., fever) in patients.

Adequate cleaning and rinsing should result in low bioburden

Essential to the effectiveness of terminal sterilization and to the protection of patients from pyrogens.

Physical Area

Separate area – dedicated to cleaning of ophthalmic instruments

Away from any other type of surgical instruments

Temp 60-65oF

Humidity 30-60%

Air exchanges 10/hour negative

Monitor temperature and humidity daily and document

FIRST STEP

Must have manufacturer’s instructions for cleaning of all devices; method, implements and chemicals recommended

Steps in the Cleaning Process

Pre-Cleaning in room

Contain contaminated items at the point of use

Transport to Decontamination (confined and contained)

Sort

Soak

Wash

Rinse/Dry

Pre-Cleaning - Transport

Instruments should be pre-cleaned immediately following use

Remove gross debris and flush lumens with sterile distilled water (or other agent as recommended by the instrument manufacturer)

Keep instruments moist to avoid drying of soils

Many now recommend cleaning immediately or within 30 minutes of use

Transport in closed container (confine/contain)

Container should be labeled as biohazard (OSHA)

Soaking

Can pre-soak with a detergent

Use of enzyme detergents preferred – but only if recommended by the instrument manufacturer

Assists in the loosening of soils to facilitate cleaning

Do NOT soak in fluids for prolonged periods of time - biofilms can form

Generally form on any surface that is exposed to non-sterile water or other liquids and is consistently found in many environments including industrial and medical systems

use enzymatic gels or foam

Biofiolms

Are produced by microorganisms and consist of a sticky rigid structure of organic contaminates

Slime layer anchored firmly to a surface and provides a protective environment for microorganisms to grow

Cleaning

Need to take special precautions with eye instruments due to

Delicate nature of the design

Sensitivity of eye tissue

Cleaning becomes a challenge

Manual cleaning may be only validated method

Manual cleaning is not as controlled (standardized) as mechanical cleaning

Dilemma

Some eye instrument manufacturer’s do not recommend ANY detergent

Source of confusion for end user

Need to challenge manufacturers

Enzymatic Cleaners

Organic substances which assist in the breakdown of soils

Facilitate the removal of blood and protein soils

Excellent for devices with lumens

Effectiveness dependent upon concentration, use temperature and contact time

Enzymatic Cleaners

Sold as liquid concentrates or powder

Generally more effective in warm water (110-140oF)

Enzyme activity can be inactivated above certain maximum temperatures (140oF)

Follow manufacturer’s directions

Use a thermometer – monitor water temperature

Principles of Cleaning

Must have manufacturer’s written instructions for cleaning of all devices processed

Follow all recommended steps using equipment recommended

Must wear PPE

Impervious gown, head cover, shoe covers, cuffed gloves, face shield

Manual Cleaning Process

May be the only cleaning process available

Items should be submerged, disassembled

Preferable to use 3-sink method; wash, rinse, rinse

Can also be used to remove deposits which were not removed during the pre-soak

Brush all serrations, crevices, tips, handles, and hinges.

Brushing should be done under the surface of the water to prevent aerosolization of contaminants.

Manual Cleaning – General Instructions

Handle instruments one at a time or in small numbers to avoid damage

Open hinged instruments

Disassemble multi-part instruments – keep parts together for easy reassembly after cleaning

Brush and flush all lumened devices

Clean all surfaces

Specialty Items

Cannulas, irrigation cannulas,irrigation/aspiration (I/A) handpieces, suction tips, cystotomes.

Use a brush of the appropriate size to clean the lumen; hold instrument and brush below the water surface

Manual Cleaning Detergents

Usually used for manual cleaning and as a pre-soak

Range from low foam to high foam products

Generally have neutral pH of 7 to 9

Sold as concentrates

Free rinsing

Always measure and dilute the detergent as specified by the detergent manufacturer

Water used to clean instruments should be discarded after each use

Manual Cleaning Implements

Soft bristle brushes, various sizes and lengths (no metal brushes)

Soft cloths

No abrasive items

No sponges

No materials which are permeable; i.e.. Wood

Implements used to clean instruments should be cleaned according to the manufacturer or at least daily, preferably after each use

Mechanical Cleaners

Do not put microsurgical instruments into a washer decontaminator unless it has a delicate cycle.

Can result in damage to instruments

Specialty Cleaner

Specialty cleaning and rinsing system for lumened devices such as Phaco and OZIL handpieces

Effectively cleans and rinses lumens

Must disinfect according to IFUs and document

Diamond Knives

The diamond knife is designed to make precision atraumatic cuts

The diamond knife has the sharpest cutting edge possible

Cost can range from $800 - $2,500 or more

Diamond Blade Knives

Cleaning: Immediately after using a diamond knife, the blade must be rinsed with demineralized water, preventing cell particles or viscoelastic materials from sticking to the blade.

Generally. ultrasonically clean holding the knife and suspending only the blade into the fluid.

The blade should not touch any other instruments or the sides of the cleaner.

Diamond Blade Knives

Never completely submerge a diamond knife in an ultrasonic cleaner.

At all time, (except cleaning) the blade should be in the retracted position to prevent damage.

Inspect with microscope.

Ultrasonic Cleaning

Uses sound waves transmitted through a solution

Sound waves produce tiny bubbles which implode - results in scouring action that cleans

Mechanical process = cavitation

Ultrasonic Cleaning

Effective to remove soils in hard-to-reach areas (box locks, mouth teeth, etc..)

Generally can only use detergents specifically formulated for ultrasonic cleaners - low foaming

Water temperatures usually 100 - 140 o F.

Can be used after manual cleaning

Ultrasonic Cleaning

Solution should be changed at least daily preferably after each use

Outbreaks of TASS have been associated with contaminated sonic baths

Unit should have a cover to contain aerosols

Items should not be stacked

Need to “de-gas” water

Ultrasonic Cleaning

Containers/baskets should have perforations; should be all metal mesh; no plastic

Should be located in Decontamination Area

cleaning process

more efficient than manual cleaning

Test the sonic for efficacy (daily???)

Testing Sonic

Rinsing

The most important part of the cleaning process

Essential to remove loosened debris

Should be performed with the volume and quality (sterile, distilled, or deionized water (if manual cleaning)

Water used to rinse instruments should be discarded after each use

Sterile distilled water recommended for final rinse to prevent mineral deposits and TASS

Lubrication

The use of instrument milk is beneficial to instruments to prevent corrosion and to keep moving parts from getting stiff.

However, not all instruments should be lubricated. The instrument manufacturer will indicate if this process is recommended.

Principles of Inspection/Assembly

All items should be prepared according to the device manufacturer’s written instructions (i.e. must the device be disassembled for sterilization?)

All hinged instruments should be in the open position to permit the sterilant to contact all surfaces of the jaws, blades, etc.

Items must be checked for cleanliness – the use of a lighted magnifying lamp is recommended to visualize defects such as cracked box locks, soils or missing tips.

Inspection

Best method is to use a microscope

Principles of Inspection/Assembly

All parts are present and functional

Use perforated or mesh bottom trays

All scissors should be tested for sharpness each time they are processed

Test that ratchets hold on clamps

Inspect hand held forceps that tips approximate

Test needle holders; ratchets hold and tips hold suture needle

Principles of Inspection/Assembly

Inspect that joints are not stiff

Use a lighted magnifying lamp or microscope to inspect

Inspect for rust, pitting, cracked box lock, etc.

Demagnetization of eye instruments may be needed

Separate delicate, sharp items

Use non-linting surgical towels, or paper sterilization bags to separate items inside set; not peel pack material

Refer to manufacturer’s IFUs regarding flushing of all lumened devices (AAMI states only for gravity cycles). Use sterile, distilled water

Ophthalmic Instruments

Look for defects:

Rusting common (especially if IUSS frequently used

Corrosion

Damage to tips/ teeth

Cords

Lumens (e.g. Phaco handpieces)

Stiffness

Sharpness

Spotting – Staining - Rust

Delicate Tips Require Protection

Can use small containers with silicone mat for individual instruments to provide protection.

General Guidelines for Packaging

Instrument Sets

Use specialty containers to keep delicate instruments in place and prevent damage in transport and cleaning.

The single most effective means to prevent damage to eye instruments is to place them in specialty protective containers

The basket or container of the correct size to prevent instrument damage

Handling Eye Instruments

Place instruments in the tray so that they do not touch each other.

Locate each instrument in the tray to prevent movement and possible damage during handling.

Always keep delicate tips protected with a tip guard when the instrument is not in use.

Protective Container - Cataract Set

Finger Mats May Not Provide Adequate Protection

Paper Plastic Pouches

Widely used because of the visibility of the contents.

However, according to AAMI and AORN pouches should be used for 1-2, light weight instruments.

If packaging instruments separately, select the correct size pouch.

Allow approximately 1” distance from the device and the pouch edges.

Must ensure instruments packaged to protect from damage

General Guidelines for Packaging

Individual Instruments/Small Items

Use correct size packaging

Do not use rubber bands to secure instruments

Paper Plastic Pouches

Double pouching is not required (AORN, AAMI)

May be used for small items which would be difficult to keep together

If double pouching, do not fold over the edges of inside pouch

Inside pouch must lay flat

Tip Protectors

Obtain the manufacturer’s instructions for use.

Some can “catch” onto the instruments – can result in damage

You can use any tip protector that has been approved for use in a sterilization system; foam sleeves, plastic; paper/plastic.

Make sure device can be held open with protector on (e.g. scissors, clamps).

Must have manufacturer’s data that sterilant will penetrate through the tip protector.

Chemical Indicators (Types)

External (Type I) – used to distinguish an item that has been in a sterilizer from an item that has not

Internal chemical indicators (Type 3-4-5)

Should be used inside and outside each package. For wrapped sets, the internal chemical indicator should be located in the center of the pack, not the top.

Type 3 – responds to one parameter

Type 4 – responds to 2 or more parameters

Should use at least a Type 4 CI

Chemical Indicators

Type 5 – integrating indicators – correlate to the action of a biological test

Cannot substitute for a BI test

Type 6 – emulating indicators that respond to a specific cycle type, temperature and exposure time

Labeling Packages

Use a marking pen containing non-toxic, permanent ink and approved for the intended process (e.g., steam sterilization cycles).

Need documentation that marker is non-toxic.

Packages - label on the indicator tape used to close the package, never on the wrapping material itself.

Paper–plastic pouches - label only on the plastic side or on sterilization tape.

If a package is labeled directly on the packaging material, the

marker could damage the packaging material.

Exception is the plastic side of paper plastic pouches.

Table Top Sterilizers

Many ASCs use table top sterilizers

A table-top sterilizer is a ”compact steam sterilizer that has a chamber volume of not more than two cubic feet and that generates its own steam when distilled or deionized water is added by the user” (ANSI/AAMI ST79).

Table-top sterilizers -commonly found in smaller surgery centers where a high volume of sterilization processing does not take place.

Also found in doctors’ and dental offices.

Cycles

The device manufacturer’s sterilization instructions should always be followed

If the cycles provided by the sterilizer cannot be adjusted to conform to the device manufacturer’s instructions, the device should not be processed in that sterilizer.

Conventional Steam Sterilizers

Read the IFUs for exposure time, temperature and cycle time

Many have CJD cycles ONLY

Many have European temperatures only (e.g. 273oF)

Must reconcile IFU information

May have to separate sets to meet IFUs

E.g. some instruments require 10 minutes exposure

Water Quality

Water quality is just as important for table-top units as for sterilizers that use boiler-generated steam.

Distilled or deionized water is recommended to prevent the buildup of minerals in the reservoir and on processed devices.

Each day, before the sterilizer is used for the first time, the reservoir should be checked to ensure that there is enough water for the number of loads to be processed.

Maintenance

Perform all the recommended maintenance of the tabletop sterilizer

Document all maintenance (e.g. reservoir cleaned, gaskets cleaned, etc.

Documentation

All cycles run should be documented

All items processed must be documented

Specific name of device/tray

Quantity

All items must be identified with a lot control number (to facilitate recall)

Must include date sterilized, sterilizer #, load number

Expiration date or event related statement

Traceability to the patient if posterior eye tissue surgery (CJD)

Summary

Best practices for processing ophthalmic instruments requires knowledge of the standards and recommendations to prevent TASS

Manufacturers IFUs

Effective cleaning

Correct packaging methods and materials

Effective sterilization –

Processing equipment in good condition

Proper handling after sterilization

Monitoring of staff compliance with all stated policies and manufacturers’ instructions

Training and competencies for staff

Conclusion - The End

Successful patient outcomes require we develop effective policies, train staff and monitor for compliance

Careful handling of ophthalmic instruments will keep patients safe and reduce costs.

References

AAMI. Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. ST-79, 2017.

AORN. Standards and Recommended Practices. “Selection and Use of Packaging Systems”, AORN.

Centers for Disease Control (Hospital Infection Control Guidelines) 2008

American Society of Cataract & Refractive Surgeons. White Paper on TASS (2006).

The Basics of Sterile Processing textbook, 6th edition, Sterile Processing University, 2016.

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Page 2: Cleaning Protocols and Equipment - APIC MT€¦ · Identify AAMI recommended cleaning protocols to prevent TASS Review the AAMI preparation recommendations for instruments and sets

3/13/2019

2

Keeping Ophthalmic Instruments Safe

Nancy Chobin, RN, AAS, ACSP, CSPM, CFER

CEO Sterile Processing University

Lebanon, NJ

Copyright 2019

Objectives

Identify AAMI recommended cleaning protocols to prevent TASS

Review the AAMI preparation recommendations for instruments and sets

Review care and handling of ophthalmic instruments

Background

Time to perform a cataract procedure has decreased15-20 minutes.

The cost for a set of instruments can range from $6,000 to $8,000 or more

Urgency to turn the instruments around for the next case.

Instruments come in contact with the eye and thus body fluids.

They are considered contaminated and must receive the entire cleaning and sterilization process between patients.

Manufacturer’s Instructions

Instrument manufacturer should:

specify the pH of detergent (e.g. neutral pH)

may recommend a pre-soak in an enzymatic cleaner to help remove protein soils (e.g. body fluids)

specify if any special cleaning implements are needed (e.g. to clean out lumens).

Specify water quality for cleaning and rinsing

However, need to reconcile this information with AAMI and ASORN, AORN, ASCRS and the CDC.

Manufacturer’s Instructions

Also known as Instructions for Use (IFUs)

Keep on file - readily available to processing personnel.

Ensure IFUs followed each and every time the instrument is processed.

Employee training should complement the AAMI guidelines as well as manufacturers’ instructions

Eye instrumentation is extremely delicate and as such requires very special handling and processing to prevent damage. All personnel handling eye instrumentation should ensure careful handling.

Example of Steam Sterilization IFU

Prevacuum High Temperature Autoclave: 274˚F (134˚C) for 3 minutes; wrapped.

NOTE: As per ANSI/AAMI ST79:2010 and A1:2010 270˚F (132˚C) for 4 minutes and 275˚F (135˚C) for 3 minutes are acceptable minimum cycle times for dynamic-air-removal steam sterilization cycles.

Standard Gravity Autoclave: 250˚F (121˚C) for 30 minutes; wrapped.

High Speed (Flash) Autoclave: 270˚F (132˚C) for 10 minutes; unwrapped.

Training and Competencies

Employee competencies should be verified in the processing protocols for processing ophthalmic instruments

Competencies should be verified initially and annually

Utilize resources such as ophthalmic instrument company's educational materials

Reconcile with national standards

Cleaning

Removal of contamination from an item to the extent necessary for further processing or for the intended use.

Involves the use of detergent and water, of adherent visible soil (i.e. blood, pus, protein) from the surfaces, crevices, serrations, jaws and lumens of instruments, devices and equipment, by a manual or mechanical process.

Due to their design, eye instrument challenging to clean

Very small lumens, very delicate tips, can easily break/damage

Pre-Cleaning in Room

Treat with demineralized water to prevent drying of bioburden.

Saline, disinfectants, and chlorinated solutions can cause pitting

and corrosion and should never be used for soaking instruments

Instruments should not remain in water for lengthy periods of time.

–– Biofilms may form, particularly within lumens.

Decontamination

According to OSHA, “the use of physical or chemical means to remove, inactivate, or destroy blood-borne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, use, or disposal.” [29 CFR 1910.1030]

NOTE—Generally used in health care facilities to refer to all pathogenic organisms, not just those transmitted by blood

First and most critical step in breaking the chain of disease transmission

Why Is Cleaning Important?

Process of disinfection or sterilization dependent upon direct contact of the sterilant or disinfectant with the surface of the item

Protein left on items can be “baked on” in the sterilizer

Why are some facilities only “wiping off” the instruments? “Cleaning with water? Alcohol?

TASS – Focus

Toxic Anterior Segment Syndrome (TASS) – main focus by AAMI and AORN

TASS - an acute inflammatory response of the anterior chamber of the eye.

May lead to severe visual impairment if it is not recognized and treated in a timely manner.

Many causes including detergents, water quality, steam quality, instruments, etc.

Major concern is when endotoxins form

Causes of TASS (ASCRS)*

Detergent residues (in general)

Endotoxins

Preservatives

Residues from sterilization processing

Residues of detergents inside a reusable cannula or instrument

Cement sealant on bags of irrigating solution which has leached out

All can induce TASS and cause severe damage to ocular tissue

* American Society of Cataract and Refractive Surgeons

TASS

Particular care must be taken in the processing of intraocular surgical instruments to help ensure that foreign substances or materials associated with the instruments will not be introduced into the anterior chamber of the eye during surgery.

TASS

Outbreaks of TASS have often been linked to the failure to follow the processing procedures recommended by the instrument manufacturer

Specific instrument cleaning and sterilization recommendations intended to diminish the risk of TASS associated with intraocular surgical instruments have been published by the American Society for Cataract and Refractive Surgery (ASCRS, 2006).

Also in AAMI ST-79 as an Annex

ASCRS Recommendations

An adequate inventory of the necessary intraocular surgical instruments should be maintained in order to allow for the timely processing of instruments between cases.

Major issue in surgery centers

Insufficient inventory of instruments leads to short cuts in cleaning

ASCRS Recommendations

Adequate time must be allowed for processing instruments according to the manufacturer’s instructions; otherwise, the cleaning and sterilization of the instruments will be ineffective.

ASCRS Recommendations

A designated cleaning area and equipment specific to the cleaning of intraocular surgical instruments should be identified.

Whenever possible, intraocular surgical instruments should be processed separately from general surgical instruments and equipment in order to reduce the potential for cross-contamination by material or residue from the general surgical instruments

ASCRS Recommendations

Instruments should be pre-cleaned immediately following use.

Gross debris should be removed, and instrument lumens should be flushed with sterile distilled water or another suitable agent as recommended in the room at the end of the procedure

ASCRS Recommendations

Only cleaning agents that have been recommended by the manufacturer should be used.

Particular attention should be paid to the specified concentration of cleaning agent and to the recommended water quality.

ASCRS Recommendations

Final rinsing of the instrument should be performed with sterile, distilled, or deionized water, unless otherwise specified by the manufacturer.

The water used to clean or rinse instruments should be discarded after each use.

ASCRS Recommendations

If an ultrasonic cleaner is used to process the instruments, it should be emptied, cleaned, rinsed, and dried at least daily or, preferably, after each use.

Brushes and other cleaning tools should be cleaned and sterilized as recommended by the manufacturer at least daily or, preferably, after each use.

ASCRS Recommendations

Cleaning and sterilization equipment should be properly maintained.

Foreign materials such as endotoxin or heavy metals may be deposited onto the instruments during processing and induce TASS

Water Quality

Water used to for the final rinse of the device should have a low endotoxin content to avoid pyrogens on processed

devices.

Can lead to pyrogenic reactions (i.e., fever) in patients.

Adequate cleaning and rinsing should result in low bioburden

Essential to the effectiveness of terminal sterilization and to the protection of patients from pyrogens.

Physical Area

Separate area – dedicated to cleaning of ophthalmic instruments

Away from any other type of surgical instruments

Temp 60-65oF

Humidity 30-60%

Air exchanges 10/hour negative

Monitor temperature and humidity daily and document

FIRST STEP

Must have manufacturer’s instructions for cleaning of all devices; method, implements and chemicals recommended

Steps in the Cleaning Process

Pre-Cleaning in room

Contain contaminated items at the point of use

Transport to Decontamination (confined and contained)

Sort

Soak

Wash

Rinse/Dry

Pre-Cleaning - Transport

Instruments should be pre-cleaned immediately following use

Remove gross debris and flush lumens with sterile distilled water (or other agent as recommended by the instrument manufacturer)

Keep instruments moist to avoid drying of soils

Many now recommend cleaning immediately or within 30 minutes of use

Transport in closed container (confine/contain)

Container should be labeled as biohazard (OSHA)

Soaking

Can pre-soak with a detergent

Use of enzyme detergents preferred – but only if recommended by the instrument manufacturer

Assists in the loosening of soils to facilitate cleaning

Do NOT soak in fluids for prolonged periods of time - biofilms can form

Generally form on any surface that is exposed to non-sterile water or other liquids and is consistently found in many environments including industrial and medical systems

use enzymatic gels or foam

Biofiolms

Are produced by microorganisms and consist of a sticky rigid structure of organic contaminates

Slime layer anchored firmly to a surface and provides a protective environment for microorganisms to grow

Cleaning

Need to take special precautions with eye instruments due to

Delicate nature of the design

Sensitivity of eye tissue

Cleaning becomes a challenge

Manual cleaning may be only validated method

Manual cleaning is not as controlled (standardized) as mechanical cleaning

Dilemma

Some eye instrument manufacturer’s do not recommend ANY detergent

Source of confusion for end user

Need to challenge manufacturers

Enzymatic Cleaners

Organic substances which assist in the breakdown of soils

Facilitate the removal of blood and protein soils

Excellent for devices with lumens

Effectiveness dependent upon concentration, use temperature and contact time

Enzymatic Cleaners

Sold as liquid concentrates or powder

Generally more effective in warm water (110-140oF)

Enzyme activity can be inactivated above certain maximum temperatures (140oF)

Follow manufacturer’s directions

Use a thermometer – monitor water temperature

Principles of Cleaning

Must have manufacturer’s written instructions for cleaning of all devices processed

Follow all recommended steps using equipment recommended

Must wear PPE

Impervious gown, head cover, shoe covers, cuffed gloves, face shield

Manual Cleaning Process

May be the only cleaning process available

Items should be submerged, disassembled

Preferable to use 3-sink method; wash, rinse, rinse

Can also be used to remove deposits which were not removed during the pre-soak

Brush all serrations, crevices, tips, handles, and hinges.

Brushing should be done under the surface of the water to prevent aerosolization of contaminants.

Manual Cleaning – General Instructions

Handle instruments one at a time or in small numbers to avoid damage

Open hinged instruments

Disassemble multi-part instruments – keep parts together for easy reassembly after cleaning

Brush and flush all lumened devices

Clean all surfaces

Specialty Items

Cannulas, irrigation cannulas,irrigation/aspiration (I/A) handpieces, suction tips, cystotomes.

Use a brush of the appropriate size to clean the lumen; hold instrument and brush below the water surface

Manual Cleaning Detergents

Usually used for manual cleaning and as a pre-soak

Range from low foam to high foam products

Generally have neutral pH of 7 to 9

Sold as concentrates

Free rinsing

Always measure and dilute the detergent as specified by the detergent manufacturer

Water used to clean instruments should be discarded after each use

Manual Cleaning Implements

Soft bristle brushes, various sizes and lengths (no metal brushes)

Soft cloths

No abrasive items

No sponges

No materials which are permeable; i.e.. Wood

Implements used to clean instruments should be cleaned according to the manufacturer or at least daily, preferably after each use

Mechanical Cleaners

Do not put microsurgical instruments into a washer decontaminator unless it has a delicate cycle.

Can result in damage to instruments

Specialty Cleaner

Specialty cleaning and rinsing system for lumened devices such as Phaco and OZIL handpieces

Effectively cleans and rinses lumens

Must disinfect according to IFUs and document

Diamond Knives

The diamond knife is designed to make precision atraumatic cuts

The diamond knife has the sharpest cutting edge possible

Cost can range from $800 - $2,500 or more

Diamond Blade Knives

Cleaning: Immediately after using a diamond knife, the blade must be rinsed with demineralized water, preventing cell particles or viscoelastic materials from sticking to the blade.

Generally. ultrasonically clean holding the knife and suspending only the blade into the fluid.

The blade should not touch any other instruments or the sides of the cleaner.

Diamond Blade Knives

Never completely submerge a diamond knife in an ultrasonic cleaner.

At all time, (except cleaning) the blade should be in the retracted position to prevent damage.

Inspect with microscope.

Ultrasonic Cleaning

Uses sound waves transmitted through a solution

Sound waves produce tiny bubbles which implode - results in scouring action that cleans

Mechanical process = cavitation

Ultrasonic Cleaning

Effective to remove soils in hard-to-reach areas (box locks, mouth teeth, etc..)

Generally can only use detergents specifically formulated for ultrasonic cleaners - low foaming

Water temperatures usually 100 - 140 o F.

Can be used after manual cleaning

Ultrasonic Cleaning

Solution should be changed at least daily preferably after each use

Outbreaks of TASS have been associated with contaminated sonic baths

Unit should have a cover to contain aerosols

Items should not be stacked

Need to “de-gas” water

Ultrasonic Cleaning

Containers/baskets should have perforations; should be all metal mesh; no plastic

Should be located in Decontamination Area

cleaning process

more efficient than manual cleaning

Test the sonic for efficacy (daily???)

Testing Sonic

Rinsing

The most important part of the cleaning process

Essential to remove loosened debris

Should be performed with the volume and quality (sterile, distilled, or deionized water (if manual cleaning)

Water used to rinse instruments should be discarded after each use

Sterile distilled water recommended for final rinse to prevent mineral deposits and TASS

Lubrication

The use of instrument milk is beneficial to instruments to prevent corrosion and to keep moving parts from getting stiff.

However, not all instruments should be lubricated. The instrument manufacturer will indicate if this process is recommended.

Principles of Inspection/Assembly

All items should be prepared according to the device manufacturer’s written instructions (i.e. must the device be disassembled for sterilization?)

All hinged instruments should be in the open position to permit the sterilant to contact all surfaces of the jaws, blades, etc.

Items must be checked for cleanliness – the use of a lighted magnifying lamp is recommended to visualize defects such as cracked box locks, soils or missing tips.

Inspection

Best method is to use a microscope

Principles of Inspection/Assembly

All parts are present and functional

Use perforated or mesh bottom trays

All scissors should be tested for sharpness each time they are processed

Test that ratchets hold on clamps

Inspect hand held forceps that tips approximate

Test needle holders; ratchets hold and tips hold suture needle

Principles of Inspection/Assembly

Inspect that joints are not stiff

Use a lighted magnifying lamp or microscope to inspect

Inspect for rust, pitting, cracked box lock, etc.

Demagnetization of eye instruments may be needed

Separate delicate, sharp items

Use non-linting surgical towels, or paper sterilization bags to separate items inside set; not peel pack material

Refer to manufacturer’s IFUs regarding flushing of all lumened devices (AAMI states only for gravity cycles). Use sterile, distilled water

Ophthalmic Instruments

Look for defects:

Rusting common (especially if IUSS frequently used

Corrosion

Damage to tips/ teeth

Cords

Lumens (e.g. Phaco handpieces)

Stiffness

Sharpness

Spotting – Staining - Rust

Delicate Tips Require Protection

Can use small containers with silicone mat for individual instruments to provide protection.

General Guidelines for Packaging

Instrument Sets

Use specialty containers to keep delicate instruments in place and prevent damage in transport and cleaning.

The single most effective means to prevent damage to eye instruments is to place them in specialty protective containers

The basket or container of the correct size to prevent instrument damage

Handling Eye Instruments

Place instruments in the tray so that they do not touch each other.

Locate each instrument in the tray to prevent movement and possible damage during handling.

Always keep delicate tips protected with a tip guard when the instrument is not in use.

Protective Container - Cataract Set

Finger Mats May Not Provide Adequate Protection

Paper Plastic Pouches

Widely used because of the visibility of the contents.

However, according to AAMI and AORN pouches should be used for 1-2, light weight instruments.

If packaging instruments separately, select the correct size pouch.

Allow approximately 1” distance from the device and the pouch edges.

Must ensure instruments packaged to protect from damage

General Guidelines for Packaging

Individual Instruments/Small Items

Use correct size packaging

Do not use rubber bands to secure instruments

Paper Plastic Pouches

Double pouching is not required (AORN, AAMI)

May be used for small items which would be difficult to keep together

If double pouching, do not fold over the edges of inside pouch

Inside pouch must lay flat

Tip Protectors

Obtain the manufacturer’s instructions for use.

Some can “catch” onto the instruments – can result in damage

You can use any tip protector that has been approved for use in a sterilization system; foam sleeves, plastic; paper/plastic.

Make sure device can be held open with protector on (e.g. scissors, clamps).

Must have manufacturer’s data that sterilant will penetrate through the tip protector.

Chemical Indicators (Types)

External (Type I) – used to distinguish an item that has been in a sterilizer from an item that has not

Internal chemical indicators (Type 3-4-5)

Should be used inside and outside each package. For wrapped sets, the internal chemical indicator should be located in the center of the pack, not the top.

Type 3 – responds to one parameter

Type 4 – responds to 2 or more parameters

Should use at least a Type 4 CI

Chemical Indicators

Type 5 – integrating indicators – correlate to the action of a biological test

Cannot substitute for a BI test

Type 6 – emulating indicators that respond to a specific cycle type, temperature and exposure time

Labeling Packages

Use a marking pen containing non-toxic, permanent ink and approved for the intended process (e.g., steam sterilization cycles).

Need documentation that marker is non-toxic.

Packages - label on the indicator tape used to close the package, never on the wrapping material itself.

Paper–plastic pouches - label only on the plastic side or on sterilization tape.

If a package is labeled directly on the packaging material, the

marker could damage the packaging material.

Exception is the plastic side of paper plastic pouches.

Table Top Sterilizers

Many ASCs use table top sterilizers

A table-top sterilizer is a ”compact steam sterilizer that has a chamber volume of not more than two cubic feet and that generates its own steam when distilled or deionized water is added by the user” (ANSI/AAMI ST79).

Table-top sterilizers -commonly found in smaller surgery centers where a high volume of sterilization processing does not take place.

Also found in doctors’ and dental offices.

Cycles

The device manufacturer’s sterilization instructions should always be followed

If the cycles provided by the sterilizer cannot be adjusted to conform to the device manufacturer’s instructions, the device should not be processed in that sterilizer.

Conventional Steam Sterilizers

Read the IFUs for exposure time, temperature and cycle time

Many have CJD cycles ONLY

Many have European temperatures only (e.g. 273oF)

Must reconcile IFU information

May have to separate sets to meet IFUs

E.g. some instruments require 10 minutes exposure

Water Quality

Water quality is just as important for table-top units as for sterilizers that use boiler-generated steam.

Distilled or deionized water is recommended to prevent the buildup of minerals in the reservoir and on processed devices.

Each day, before the sterilizer is used for the first time, the reservoir should be checked to ensure that there is enough water for the number of loads to be processed.

Maintenance

Perform all the recommended maintenance of the tabletop sterilizer

Document all maintenance (e.g. reservoir cleaned, gaskets cleaned, etc.

Documentation

All cycles run should be documented

All items processed must be documented

Specific name of device/tray

Quantity

All items must be identified with a lot control number (to facilitate recall)

Must include date sterilized, sterilizer #, load number

Expiration date or event related statement

Traceability to the patient if posterior eye tissue surgery (CJD)

Summary

Best practices for processing ophthalmic instruments requires knowledge of the standards and recommendations to prevent TASS

Manufacturers IFUs

Effective cleaning

Correct packaging methods and materials

Effective sterilization –

Processing equipment in good condition

Proper handling after sterilization

Monitoring of staff compliance with all stated policies and manufacturers’ instructions

Training and competencies for staff

Conclusion - The End

Successful patient outcomes require we develop effective policies, train staff and monitor for compliance

Careful handling of ophthalmic instruments will keep patients safe and reduce costs.

References

AAMI. Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. ST-79, 2017.

AORN. Standards and Recommended Practices. “Selection and Use of Packaging Systems”, AORN.

Centers for Disease Control (Hospital Infection Control Guidelines) 2008

American Society of Cataract & Refractive Surgeons. White Paper on TASS (2006).

The Basics of Sterile Processing textbook, 6th edition, Sterile Processing University, 2016.

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Page 3: Cleaning Protocols and Equipment - APIC MT€¦ · Identify AAMI recommended cleaning protocols to prevent TASS Review the AAMI preparation recommendations for instruments and sets

3/13/2019

3

Keeping Ophthalmic Instruments Safe

Nancy Chobin, RN, AAS, ACSP, CSPM, CFER

CEO Sterile Processing University

Lebanon, NJ

Copyright 2019

Objectives

Identify AAMI recommended cleaning protocols to prevent TASS

Review the AAMI preparation recommendations for instruments and sets

Review care and handling of ophthalmic instruments

Background

Time to perform a cataract procedure has decreased15-20 minutes.

The cost for a set of instruments can range from $6,000 to $8,000 or more

Urgency to turn the instruments around for the next case.

Instruments come in contact with the eye and thus body fluids.

They are considered contaminated and must receive the entire cleaning and sterilization process between patients.

Manufacturer’s Instructions

Instrument manufacturer should:

specify the pH of detergent (e.g. neutral pH)

may recommend a pre-soak in an enzymatic cleaner to help remove protein soils (e.g. body fluids)

specify if any special cleaning implements are needed (e.g. to clean out lumens).

Specify water quality for cleaning and rinsing

However, need to reconcile this information with AAMI and ASORN, AORN, ASCRS and the CDC.

Manufacturer’s Instructions

Also known as Instructions for Use (IFUs)

Keep on file - readily available to processing personnel.

Ensure IFUs followed each and every time the instrument is processed.

Employee training should complement the AAMI guidelines as well as manufacturers’ instructions

Eye instrumentation is extremely delicate and as such requires very special handling and processing to prevent damage. All personnel handling eye instrumentation should ensure careful handling.

Example of Steam Sterilization IFU

Prevacuum High Temperature Autoclave: 274˚F (134˚C) for 3 minutes; wrapped.

NOTE: As per ANSI/AAMI ST79:2010 and A1:2010 270˚F (132˚C) for 4 minutes and 275˚F (135˚C) for 3 minutes are acceptable minimum cycle times for dynamic-air-removal steam sterilization cycles.

Standard Gravity Autoclave: 250˚F (121˚C) for 30 minutes; wrapped.

High Speed (Flash) Autoclave: 270˚F (132˚C) for 10 minutes; unwrapped.

Training and Competencies

Employee competencies should be verified in the processing protocols for processing ophthalmic instruments

Competencies should be verified initially and annually

Utilize resources such as ophthalmic instrument company's educational materials

Reconcile with national standards

Cleaning

Removal of contamination from an item to the extent necessary for further processing or for the intended use.

Involves the use of detergent and water, of adherent visible soil (i.e. blood, pus, protein) from the surfaces, crevices, serrations, jaws and lumens of instruments, devices and equipment, by a manual or mechanical process.

Due to their design, eye instrument challenging to clean

Very small lumens, very delicate tips, can easily break/damage

Pre-Cleaning in Room

Treat with demineralized water to prevent drying of bioburden.

Saline, disinfectants, and chlorinated solutions can cause pitting

and corrosion and should never be used for soaking instruments

Instruments should not remain in water for lengthy periods of time.

–– Biofilms may form, particularly within lumens.

Decontamination

According to OSHA, “the use of physical or chemical means to remove, inactivate, or destroy blood-borne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, use, or disposal.” [29 CFR 1910.1030]

NOTE—Generally used in health care facilities to refer to all pathogenic organisms, not just those transmitted by blood

First and most critical step in breaking the chain of disease transmission

Why Is Cleaning Important?

Process of disinfection or sterilization dependent upon direct contact of the sterilant or disinfectant with the surface of the item

Protein left on items can be “baked on” in the sterilizer

Why are some facilities only “wiping off” the instruments? “Cleaning with water? Alcohol?

TASS – Focus

Toxic Anterior Segment Syndrome (TASS) – main focus by AAMI and AORN

TASS - an acute inflammatory response of the anterior chamber of the eye.

May lead to severe visual impairment if it is not recognized and treated in a timely manner.

Many causes including detergents, water quality, steam quality, instruments, etc.

Major concern is when endotoxins form

Causes of TASS (ASCRS)*

Detergent residues (in general)

Endotoxins

Preservatives

Residues from sterilization processing

Residues of detergents inside a reusable cannula or instrument

Cement sealant on bags of irrigating solution which has leached out

All can induce TASS and cause severe damage to ocular tissue

* American Society of Cataract and Refractive Surgeons

TASS

Particular care must be taken in the processing of intraocular surgical instruments to help ensure that foreign substances or materials associated with the instruments will not be introduced into the anterior chamber of the eye during surgery.

TASS

Outbreaks of TASS have often been linked to the failure to follow the processing procedures recommended by the instrument manufacturer

Specific instrument cleaning and sterilization recommendations intended to diminish the risk of TASS associated with intraocular surgical instruments have been published by the American Society for Cataract and Refractive Surgery (ASCRS, 2006).

Also in AAMI ST-79 as an Annex

ASCRS Recommendations

An adequate inventory of the necessary intraocular surgical instruments should be maintained in order to allow for the timely processing of instruments between cases.

Major issue in surgery centers

Insufficient inventory of instruments leads to short cuts in cleaning

ASCRS Recommendations

Adequate time must be allowed for processing instruments according to the manufacturer’s instructions; otherwise, the cleaning and sterilization of the instruments will be ineffective.

ASCRS Recommendations

A designated cleaning area and equipment specific to the cleaning of intraocular surgical instruments should be identified.

Whenever possible, intraocular surgical instruments should be processed separately from general surgical instruments and equipment in order to reduce the potential for cross-contamination by material or residue from the general surgical instruments

ASCRS Recommendations

Instruments should be pre-cleaned immediately following use.

Gross debris should be removed, and instrument lumens should be flushed with sterile distilled water or another suitable agent as recommended in the room at the end of the procedure

ASCRS Recommendations

Only cleaning agents that have been recommended by the manufacturer should be used.

Particular attention should be paid to the specified concentration of cleaning agent and to the recommended water quality.

ASCRS Recommendations

Final rinsing of the instrument should be performed with sterile, distilled, or deionized water, unless otherwise specified by the manufacturer.

The water used to clean or rinse instruments should be discarded after each use.

ASCRS Recommendations

If an ultrasonic cleaner is used to process the instruments, it should be emptied, cleaned, rinsed, and dried at least daily or, preferably, after each use.

Brushes and other cleaning tools should be cleaned and sterilized as recommended by the manufacturer at least daily or, preferably, after each use.

ASCRS Recommendations

Cleaning and sterilization equipment should be properly maintained.

Foreign materials such as endotoxin or heavy metals may be deposited onto the instruments during processing and induce TASS

Water Quality

Water used to for the final rinse of the device should have a low endotoxin content to avoid pyrogens on processed

devices.

Can lead to pyrogenic reactions (i.e., fever) in patients.

Adequate cleaning and rinsing should result in low bioburden

Essential to the effectiveness of terminal sterilization and to the protection of patients from pyrogens.

Physical Area

Separate area – dedicated to cleaning of ophthalmic instruments

Away from any other type of surgical instruments

Temp 60-65oF

Humidity 30-60%

Air exchanges 10/hour negative

Monitor temperature and humidity daily and document

FIRST STEP

Must have manufacturer’s instructions for cleaning of all devices; method, implements and chemicals recommended

Steps in the Cleaning Process

Pre-Cleaning in room

Contain contaminated items at the point of use

Transport to Decontamination (confined and contained)

Sort

Soak

Wash

Rinse/Dry

Pre-Cleaning - Transport

Instruments should be pre-cleaned immediately following use

Remove gross debris and flush lumens with sterile distilled water (or other agent as recommended by the instrument manufacturer)

Keep instruments moist to avoid drying of soils

Many now recommend cleaning immediately or within 30 minutes of use

Transport in closed container (confine/contain)

Container should be labeled as biohazard (OSHA)

Soaking

Can pre-soak with a detergent

Use of enzyme detergents preferred – but only if recommended by the instrument manufacturer

Assists in the loosening of soils to facilitate cleaning

Do NOT soak in fluids for prolonged periods of time - biofilms can form

Generally form on any surface that is exposed to non-sterile water or other liquids and is consistently found in many environments including industrial and medical systems

use enzymatic gels or foam

Biofiolms

Are produced by microorganisms and consist of a sticky rigid structure of organic contaminates

Slime layer anchored firmly to a surface and provides a protective environment for microorganisms to grow

Cleaning

Need to take special precautions with eye instruments due to

Delicate nature of the design

Sensitivity of eye tissue

Cleaning becomes a challenge

Manual cleaning may be only validated method

Manual cleaning is not as controlled (standardized) as mechanical cleaning

Dilemma

Some eye instrument manufacturer’s do not recommend ANY detergent

Source of confusion for end user

Need to challenge manufacturers

Enzymatic Cleaners

Organic substances which assist in the breakdown of soils

Facilitate the removal of blood and protein soils

Excellent for devices with lumens

Effectiveness dependent upon concentration, use temperature and contact time

Enzymatic Cleaners

Sold as liquid concentrates or powder

Generally more effective in warm water (110-140oF)

Enzyme activity can be inactivated above certain maximum temperatures (140oF)

Follow manufacturer’s directions

Use a thermometer – monitor water temperature

Principles of Cleaning

Must have manufacturer’s written instructions for cleaning of all devices processed

Follow all recommended steps using equipment recommended

Must wear PPE

Impervious gown, head cover, shoe covers, cuffed gloves, face shield

Manual Cleaning Process

May be the only cleaning process available

Items should be submerged, disassembled

Preferable to use 3-sink method; wash, rinse, rinse

Can also be used to remove deposits which were not removed during the pre-soak

Brush all serrations, crevices, tips, handles, and hinges.

Brushing should be done under the surface of the water to prevent aerosolization of contaminants.

Manual Cleaning – General Instructions

Handle instruments one at a time or in small numbers to avoid damage

Open hinged instruments

Disassemble multi-part instruments – keep parts together for easy reassembly after cleaning

Brush and flush all lumened devices

Clean all surfaces

Specialty Items

Cannulas, irrigation cannulas,irrigation/aspiration (I/A) handpieces, suction tips, cystotomes.

Use a brush of the appropriate size to clean the lumen; hold instrument and brush below the water surface

Manual Cleaning Detergents

Usually used for manual cleaning and as a pre-soak

Range from low foam to high foam products

Generally have neutral pH of 7 to 9

Sold as concentrates

Free rinsing

Always measure and dilute the detergent as specified by the detergent manufacturer

Water used to clean instruments should be discarded after each use

Manual Cleaning Implements

Soft bristle brushes, various sizes and lengths (no metal brushes)

Soft cloths

No abrasive items

No sponges

No materials which are permeable; i.e.. Wood

Implements used to clean instruments should be cleaned according to the manufacturer or at least daily, preferably after each use

Mechanical Cleaners

Do not put microsurgical instruments into a washer decontaminator unless it has a delicate cycle.

Can result in damage to instruments

Specialty Cleaner

Specialty cleaning and rinsing system for lumened devices such as Phaco and OZIL handpieces

Effectively cleans and rinses lumens

Must disinfect according to IFUs and document

Diamond Knives

The diamond knife is designed to make precision atraumatic cuts

The diamond knife has the sharpest cutting edge possible

Cost can range from $800 - $2,500 or more

Diamond Blade Knives

Cleaning: Immediately after using a diamond knife, the blade must be rinsed with demineralized water, preventing cell particles or viscoelastic materials from sticking to the blade.

Generally. ultrasonically clean holding the knife and suspending only the blade into the fluid.

The blade should not touch any other instruments or the sides of the cleaner.

Diamond Blade Knives

Never completely submerge a diamond knife in an ultrasonic cleaner.

At all time, (except cleaning) the blade should be in the retracted position to prevent damage.

Inspect with microscope.

Ultrasonic Cleaning

Uses sound waves transmitted through a solution

Sound waves produce tiny bubbles which implode - results in scouring action that cleans

Mechanical process = cavitation

Ultrasonic Cleaning

Effective to remove soils in hard-to-reach areas (box locks, mouth teeth, etc..)

Generally can only use detergents specifically formulated for ultrasonic cleaners - low foaming

Water temperatures usually 100 - 140 o F.

Can be used after manual cleaning

Ultrasonic Cleaning

Solution should be changed at least daily preferably after each use

Outbreaks of TASS have been associated with contaminated sonic baths

Unit should have a cover to contain aerosols

Items should not be stacked

Need to “de-gas” water

Ultrasonic Cleaning

Containers/baskets should have perforations; should be all metal mesh; no plastic

Should be located in Decontamination Area

cleaning process

more efficient than manual cleaning

Test the sonic for efficacy (daily???)

Testing Sonic

Rinsing

The most important part of the cleaning process

Essential to remove loosened debris

Should be performed with the volume and quality (sterile, distilled, or deionized water (if manual cleaning)

Water used to rinse instruments should be discarded after each use

Sterile distilled water recommended for final rinse to prevent mineral deposits and TASS

Lubrication

The use of instrument milk is beneficial to instruments to prevent corrosion and to keep moving parts from getting stiff.

However, not all instruments should be lubricated. The instrument manufacturer will indicate if this process is recommended.

Principles of Inspection/Assembly

All items should be prepared according to the device manufacturer’s written instructions (i.e. must the device be disassembled for sterilization?)

All hinged instruments should be in the open position to permit the sterilant to contact all surfaces of the jaws, blades, etc.

Items must be checked for cleanliness – the use of a lighted magnifying lamp is recommended to visualize defects such as cracked box locks, soils or missing tips.

Inspection

Best method is to use a microscope

Principles of Inspection/Assembly

All parts are present and functional

Use perforated or mesh bottom trays

All scissors should be tested for sharpness each time they are processed

Test that ratchets hold on clamps

Inspect hand held forceps that tips approximate

Test needle holders; ratchets hold and tips hold suture needle

Principles of Inspection/Assembly

Inspect that joints are not stiff

Use a lighted magnifying lamp or microscope to inspect

Inspect for rust, pitting, cracked box lock, etc.

Demagnetization of eye instruments may be needed

Separate delicate, sharp items

Use non-linting surgical towels, or paper sterilization bags to separate items inside set; not peel pack material

Refer to manufacturer’s IFUs regarding flushing of all lumened devices (AAMI states only for gravity cycles). Use sterile, distilled water

Ophthalmic Instruments

Look for defects:

Rusting common (especially if IUSS frequently used

Corrosion

Damage to tips/ teeth

Cords

Lumens (e.g. Phaco handpieces)

Stiffness

Sharpness

Spotting – Staining - Rust

Delicate Tips Require Protection

Can use small containers with silicone mat for individual instruments to provide protection.

General Guidelines for Packaging

Instrument Sets

Use specialty containers to keep delicate instruments in place and prevent damage in transport and cleaning.

The single most effective means to prevent damage to eye instruments is to place them in specialty protective containers

The basket or container of the correct size to prevent instrument damage

Handling Eye Instruments

Place instruments in the tray so that they do not touch each other.

Locate each instrument in the tray to prevent movement and possible damage during handling.

Always keep delicate tips protected with a tip guard when the instrument is not in use.

Protective Container - Cataract Set

Finger Mats May Not Provide Adequate Protection

Paper Plastic Pouches

Widely used because of the visibility of the contents.

However, according to AAMI and AORN pouches should be used for 1-2, light weight instruments.

If packaging instruments separately, select the correct size pouch.

Allow approximately 1” distance from the device and the pouch edges.

Must ensure instruments packaged to protect from damage

General Guidelines for Packaging

Individual Instruments/Small Items

Use correct size packaging

Do not use rubber bands to secure instruments

Paper Plastic Pouches

Double pouching is not required (AORN, AAMI)

May be used for small items which would be difficult to keep together

If double pouching, do not fold over the edges of inside pouch

Inside pouch must lay flat

Tip Protectors

Obtain the manufacturer’s instructions for use.

Some can “catch” onto the instruments – can result in damage

You can use any tip protector that has been approved for use in a sterilization system; foam sleeves, plastic; paper/plastic.

Make sure device can be held open with protector on (e.g. scissors, clamps).

Must have manufacturer’s data that sterilant will penetrate through the tip protector.

Chemical Indicators (Types)

External (Type I) – used to distinguish an item that has been in a sterilizer from an item that has not

Internal chemical indicators (Type 3-4-5)

Should be used inside and outside each package. For wrapped sets, the internal chemical indicator should be located in the center of the pack, not the top.

Type 3 – responds to one parameter

Type 4 – responds to 2 or more parameters

Should use at least a Type 4 CI

Chemical Indicators

Type 5 – integrating indicators – correlate to the action of a biological test

Cannot substitute for a BI test

Type 6 – emulating indicators that respond to a specific cycle type, temperature and exposure time

Labeling Packages

Use a marking pen containing non-toxic, permanent ink and approved for the intended process (e.g., steam sterilization cycles).

Need documentation that marker is non-toxic.

Packages - label on the indicator tape used to close the package, never on the wrapping material itself.

Paper–plastic pouches - label only on the plastic side or on sterilization tape.

If a package is labeled directly on the packaging material, the

marker could damage the packaging material.

Exception is the plastic side of paper plastic pouches.

Table Top Sterilizers

Many ASCs use table top sterilizers

A table-top sterilizer is a ”compact steam sterilizer that has a chamber volume of not more than two cubic feet and that generates its own steam when distilled or deionized water is added by the user” (ANSI/AAMI ST79).

Table-top sterilizers -commonly found in smaller surgery centers where a high volume of sterilization processing does not take place.

Also found in doctors’ and dental offices.

Cycles

The device manufacturer’s sterilization instructions should always be followed

If the cycles provided by the sterilizer cannot be adjusted to conform to the device manufacturer’s instructions, the device should not be processed in that sterilizer.

Conventional Steam Sterilizers

Read the IFUs for exposure time, temperature and cycle time

Many have CJD cycles ONLY

Many have European temperatures only (e.g. 273oF)

Must reconcile IFU information

May have to separate sets to meet IFUs

E.g. some instruments require 10 minutes exposure

Water Quality

Water quality is just as important for table-top units as for sterilizers that use boiler-generated steam.

Distilled or deionized water is recommended to prevent the buildup of minerals in the reservoir and on processed devices.

Each day, before the sterilizer is used for the first time, the reservoir should be checked to ensure that there is enough water for the number of loads to be processed.

Maintenance

Perform all the recommended maintenance of the tabletop sterilizer

Document all maintenance (e.g. reservoir cleaned, gaskets cleaned, etc.

Documentation

All cycles run should be documented

All items processed must be documented

Specific name of device/tray

Quantity

All items must be identified with a lot control number (to facilitate recall)

Must include date sterilized, sterilizer #, load number

Expiration date or event related statement

Traceability to the patient if posterior eye tissue surgery (CJD)

Summary

Best practices for processing ophthalmic instruments requires knowledge of the standards and recommendations to prevent TASS

Manufacturers IFUs

Effective cleaning

Correct packaging methods and materials

Effective sterilization –

Processing equipment in good condition

Proper handling after sterilization

Monitoring of staff compliance with all stated policies and manufacturers’ instructions

Training and competencies for staff

Conclusion - The End

Successful patient outcomes require we develop effective policies, train staff and monitor for compliance

Careful handling of ophthalmic instruments will keep patients safe and reduce costs.

References

AAMI. Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. ST-79, 2017.

AORN. Standards and Recommended Practices. “Selection and Use of Packaging Systems”, AORN.

Centers for Disease Control (Hospital Infection Control Guidelines) 2008

American Society of Cataract & Refractive Surgeons. White Paper on TASS (2006).

The Basics of Sterile Processing textbook, 6th edition, Sterile Processing University, 2016.

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Page 4: Cleaning Protocols and Equipment - APIC MT€¦ · Identify AAMI recommended cleaning protocols to prevent TASS Review the AAMI preparation recommendations for instruments and sets

3/13/2019

4

Keeping Ophthalmic Instruments Safe

Nancy Chobin, RN, AAS, ACSP, CSPM, CFER

CEO Sterile Processing University

Lebanon, NJ

Copyright 2019

Objectives

Identify AAMI recommended cleaning protocols to prevent TASS

Review the AAMI preparation recommendations for instruments and sets

Review care and handling of ophthalmic instruments

Background

Time to perform a cataract procedure has decreased15-20 minutes.

The cost for a set of instruments can range from $6,000 to $8,000 or more

Urgency to turn the instruments around for the next case.

Instruments come in contact with the eye and thus body fluids.

They are considered contaminated and must receive the entire cleaning and sterilization process between patients.

Manufacturer’s Instructions

Instrument manufacturer should:

specify the pH of detergent (e.g. neutral pH)

may recommend a pre-soak in an enzymatic cleaner to help remove protein soils (e.g. body fluids)

specify if any special cleaning implements are needed (e.g. to clean out lumens).

Specify water quality for cleaning and rinsing

However, need to reconcile this information with AAMI and ASORN, AORN, ASCRS and the CDC.

Manufacturer’s Instructions

Also known as Instructions for Use (IFUs)

Keep on file - readily available to processing personnel.

Ensure IFUs followed each and every time the instrument is processed.

Employee training should complement the AAMI guidelines as well as manufacturers’ instructions

Eye instrumentation is extremely delicate and as such requires very special handling and processing to prevent damage. All personnel handling eye instrumentation should ensure careful handling.

Example of Steam Sterilization IFU

Prevacuum High Temperature Autoclave: 274˚F (134˚C) for 3 minutes; wrapped.

NOTE: As per ANSI/AAMI ST79:2010 and A1:2010 270˚F (132˚C) for 4 minutes and 275˚F (135˚C) for 3 minutes are acceptable minimum cycle times for dynamic-air-removal steam sterilization cycles.

Standard Gravity Autoclave: 250˚F (121˚C) for 30 minutes; wrapped.

High Speed (Flash) Autoclave: 270˚F (132˚C) for 10 minutes; unwrapped.

Training and Competencies

Employee competencies should be verified in the processing protocols for processing ophthalmic instruments

Competencies should be verified initially and annually

Utilize resources such as ophthalmic instrument company's educational materials

Reconcile with national standards

Cleaning

Removal of contamination from an item to the extent necessary for further processing or for the intended use.

Involves the use of detergent and water, of adherent visible soil (i.e. blood, pus, protein) from the surfaces, crevices, serrations, jaws and lumens of instruments, devices and equipment, by a manual or mechanical process.

Due to their design, eye instrument challenging to clean

Very small lumens, very delicate tips, can easily break/damage

Pre-Cleaning in Room

Treat with demineralized water to prevent drying of bioburden.

Saline, disinfectants, and chlorinated solutions can cause pitting

and corrosion and should never be used for soaking instruments

Instruments should not remain in water for lengthy periods of time.

–– Biofilms may form, particularly within lumens.

Decontamination

According to OSHA, “the use of physical or chemical means to remove, inactivate, or destroy blood-borne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, use, or disposal.” [29 CFR 1910.1030]

NOTE—Generally used in health care facilities to refer to all pathogenic organisms, not just those transmitted by blood

First and most critical step in breaking the chain of disease transmission

Why Is Cleaning Important?

Process of disinfection or sterilization dependent upon direct contact of the sterilant or disinfectant with the surface of the item

Protein left on items can be “baked on” in the sterilizer

Why are some facilities only “wiping off” the instruments? “Cleaning with water? Alcohol?

TASS – Focus

Toxic Anterior Segment Syndrome (TASS) – main focus by AAMI and AORN

TASS - an acute inflammatory response of the anterior chamber of the eye.

May lead to severe visual impairment if it is not recognized and treated in a timely manner.

Many causes including detergents, water quality, steam quality, instruments, etc.

Major concern is when endotoxins form

Causes of TASS (ASCRS)*

Detergent residues (in general)

Endotoxins

Preservatives

Residues from sterilization processing

Residues of detergents inside a reusable cannula or instrument

Cement sealant on bags of irrigating solution which has leached out

All can induce TASS and cause severe damage to ocular tissue

* American Society of Cataract and Refractive Surgeons

TASS

Particular care must be taken in the processing of intraocular surgical instruments to help ensure that foreign substances or materials associated with the instruments will not be introduced into the anterior chamber of the eye during surgery.

TASS

Outbreaks of TASS have often been linked to the failure to follow the processing procedures recommended by the instrument manufacturer

Specific instrument cleaning and sterilization recommendations intended to diminish the risk of TASS associated with intraocular surgical instruments have been published by the American Society for Cataract and Refractive Surgery (ASCRS, 2006).

Also in AAMI ST-79 as an Annex

ASCRS Recommendations

An adequate inventory of the necessary intraocular surgical instruments should be maintained in order to allow for the timely processing of instruments between cases.

Major issue in surgery centers

Insufficient inventory of instruments leads to short cuts in cleaning

ASCRS Recommendations

Adequate time must be allowed for processing instruments according to the manufacturer’s instructions; otherwise, the cleaning and sterilization of the instruments will be ineffective.

ASCRS Recommendations

A designated cleaning area and equipment specific to the cleaning of intraocular surgical instruments should be identified.

Whenever possible, intraocular surgical instruments should be processed separately from general surgical instruments and equipment in order to reduce the potential for cross-contamination by material or residue from the general surgical instruments

ASCRS Recommendations

Instruments should be pre-cleaned immediately following use.

Gross debris should be removed, and instrument lumens should be flushed with sterile distilled water or another suitable agent as recommended in the room at the end of the procedure

ASCRS Recommendations

Only cleaning agents that have been recommended by the manufacturer should be used.

Particular attention should be paid to the specified concentration of cleaning agent and to the recommended water quality.

ASCRS Recommendations

Final rinsing of the instrument should be performed with sterile, distilled, or deionized water, unless otherwise specified by the manufacturer.

The water used to clean or rinse instruments should be discarded after each use.

ASCRS Recommendations

If an ultrasonic cleaner is used to process the instruments, it should be emptied, cleaned, rinsed, and dried at least daily or, preferably, after each use.

Brushes and other cleaning tools should be cleaned and sterilized as recommended by the manufacturer at least daily or, preferably, after each use.

ASCRS Recommendations

Cleaning and sterilization equipment should be properly maintained.

Foreign materials such as endotoxin or heavy metals may be deposited onto the instruments during processing and induce TASS

Water Quality

Water used to for the final rinse of the device should have a low endotoxin content to avoid pyrogens on processed

devices.

Can lead to pyrogenic reactions (i.e., fever) in patients.

Adequate cleaning and rinsing should result in low bioburden

Essential to the effectiveness of terminal sterilization and to the protection of patients from pyrogens.

Physical Area

Separate area – dedicated to cleaning of ophthalmic instruments

Away from any other type of surgical instruments

Temp 60-65oF

Humidity 30-60%

Air exchanges 10/hour negative

Monitor temperature and humidity daily and document

FIRST STEP

Must have manufacturer’s instructions for cleaning of all devices; method, implements and chemicals recommended

Steps in the Cleaning Process

Pre-Cleaning in room

Contain contaminated items at the point of use

Transport to Decontamination (confined and contained)

Sort

Soak

Wash

Rinse/Dry

Pre-Cleaning - Transport

Instruments should be pre-cleaned immediately following use

Remove gross debris and flush lumens with sterile distilled water (or other agent as recommended by the instrument manufacturer)

Keep instruments moist to avoid drying of soils

Many now recommend cleaning immediately or within 30 minutes of use

Transport in closed container (confine/contain)

Container should be labeled as biohazard (OSHA)

Soaking

Can pre-soak with a detergent

Use of enzyme detergents preferred – but only if recommended by the instrument manufacturer

Assists in the loosening of soils to facilitate cleaning

Do NOT soak in fluids for prolonged periods of time - biofilms can form

Generally form on any surface that is exposed to non-sterile water or other liquids and is consistently found in many environments including industrial and medical systems

use enzymatic gels or foam

Biofiolms

Are produced by microorganisms and consist of a sticky rigid structure of organic contaminates

Slime layer anchored firmly to a surface and provides a protective environment for microorganisms to grow

Cleaning

Need to take special precautions with eye instruments due to

Delicate nature of the design

Sensitivity of eye tissue

Cleaning becomes a challenge

Manual cleaning may be only validated method

Manual cleaning is not as controlled (standardized) as mechanical cleaning

Dilemma

Some eye instrument manufacturer’s do not recommend ANY detergent

Source of confusion for end user

Need to challenge manufacturers

Enzymatic Cleaners

Organic substances which assist in the breakdown of soils

Facilitate the removal of blood and protein soils

Excellent for devices with lumens

Effectiveness dependent upon concentration, use temperature and contact time

Enzymatic Cleaners

Sold as liquid concentrates or powder

Generally more effective in warm water (110-140oF)

Enzyme activity can be inactivated above certain maximum temperatures (140oF)

Follow manufacturer’s directions

Use a thermometer – monitor water temperature

Principles of Cleaning

Must have manufacturer’s written instructions for cleaning of all devices processed

Follow all recommended steps using equipment recommended

Must wear PPE

Impervious gown, head cover, shoe covers, cuffed gloves, face shield

Manual Cleaning Process

May be the only cleaning process available

Items should be submerged, disassembled

Preferable to use 3-sink method; wash, rinse, rinse

Can also be used to remove deposits which were not removed during the pre-soak

Brush all serrations, crevices, tips, handles, and hinges.

Brushing should be done under the surface of the water to prevent aerosolization of contaminants.

Manual Cleaning – General Instructions

Handle instruments one at a time or in small numbers to avoid damage

Open hinged instruments

Disassemble multi-part instruments – keep parts together for easy reassembly after cleaning

Brush and flush all lumened devices

Clean all surfaces

Specialty Items

Cannulas, irrigation cannulas,irrigation/aspiration (I/A) handpieces, suction tips, cystotomes.

Use a brush of the appropriate size to clean the lumen; hold instrument and brush below the water surface

Manual Cleaning Detergents

Usually used for manual cleaning and as a pre-soak

Range from low foam to high foam products

Generally have neutral pH of 7 to 9

Sold as concentrates

Free rinsing

Always measure and dilute the detergent as specified by the detergent manufacturer

Water used to clean instruments should be discarded after each use

Manual Cleaning Implements

Soft bristle brushes, various sizes and lengths (no metal brushes)

Soft cloths

No abrasive items

No sponges

No materials which are permeable; i.e.. Wood

Implements used to clean instruments should be cleaned according to the manufacturer or at least daily, preferably after each use

Mechanical Cleaners

Do not put microsurgical instruments into a washer decontaminator unless it has a delicate cycle.

Can result in damage to instruments

Specialty Cleaner

Specialty cleaning and rinsing system for lumened devices such as Phaco and OZIL handpieces

Effectively cleans and rinses lumens

Must disinfect according to IFUs and document

Diamond Knives

The diamond knife is designed to make precision atraumatic cuts

The diamond knife has the sharpest cutting edge possible

Cost can range from $800 - $2,500 or more

Diamond Blade Knives

Cleaning: Immediately after using a diamond knife, the blade must be rinsed with demineralized water, preventing cell particles or viscoelastic materials from sticking to the blade.

Generally. ultrasonically clean holding the knife and suspending only the blade into the fluid.

The blade should not touch any other instruments or the sides of the cleaner.

Diamond Blade Knives

Never completely submerge a diamond knife in an ultrasonic cleaner.

At all time, (except cleaning) the blade should be in the retracted position to prevent damage.

Inspect with microscope.

Ultrasonic Cleaning

Uses sound waves transmitted through a solution

Sound waves produce tiny bubbles which implode - results in scouring action that cleans

Mechanical process = cavitation

Ultrasonic Cleaning

Effective to remove soils in hard-to-reach areas (box locks, mouth teeth, etc..)

Generally can only use detergents specifically formulated for ultrasonic cleaners - low foaming

Water temperatures usually 100 - 140 o F.

Can be used after manual cleaning

Ultrasonic Cleaning

Solution should be changed at least daily preferably after each use

Outbreaks of TASS have been associated with contaminated sonic baths

Unit should have a cover to contain aerosols

Items should not be stacked

Need to “de-gas” water

Ultrasonic Cleaning

Containers/baskets should have perforations; should be all metal mesh; no plastic

Should be located in Decontamination Area

cleaning process

more efficient than manual cleaning

Test the sonic for efficacy (daily???)

Testing Sonic

Rinsing

The most important part of the cleaning process

Essential to remove loosened debris

Should be performed with the volume and quality (sterile, distilled, or deionized water (if manual cleaning)

Water used to rinse instruments should be discarded after each use

Sterile distilled water recommended for final rinse to prevent mineral deposits and TASS

Lubrication

The use of instrument milk is beneficial to instruments to prevent corrosion and to keep moving parts from getting stiff.

However, not all instruments should be lubricated. The instrument manufacturer will indicate if this process is recommended.

Principles of Inspection/Assembly

All items should be prepared according to the device manufacturer’s written instructions (i.e. must the device be disassembled for sterilization?)

All hinged instruments should be in the open position to permit the sterilant to contact all surfaces of the jaws, blades, etc.

Items must be checked for cleanliness – the use of a lighted magnifying lamp is recommended to visualize defects such as cracked box locks, soils or missing tips.

Inspection

Best method is to use a microscope

Principles of Inspection/Assembly

All parts are present and functional

Use perforated or mesh bottom trays

All scissors should be tested for sharpness each time they are processed

Test that ratchets hold on clamps

Inspect hand held forceps that tips approximate

Test needle holders; ratchets hold and tips hold suture needle

Principles of Inspection/Assembly

Inspect that joints are not stiff

Use a lighted magnifying lamp or microscope to inspect

Inspect for rust, pitting, cracked box lock, etc.

Demagnetization of eye instruments may be needed

Separate delicate, sharp items

Use non-linting surgical towels, or paper sterilization bags to separate items inside set; not peel pack material

Refer to manufacturer’s IFUs regarding flushing of all lumened devices (AAMI states only for gravity cycles). Use sterile, distilled water

Ophthalmic Instruments

Look for defects:

Rusting common (especially if IUSS frequently used

Corrosion

Damage to tips/ teeth

Cords

Lumens (e.g. Phaco handpieces)

Stiffness

Sharpness

Spotting – Staining - Rust

Delicate Tips Require Protection

Can use small containers with silicone mat for individual instruments to provide protection.

General Guidelines for Packaging

Instrument Sets

Use specialty containers to keep delicate instruments in place and prevent damage in transport and cleaning.

The single most effective means to prevent damage to eye instruments is to place them in specialty protective containers

The basket or container of the correct size to prevent instrument damage

Handling Eye Instruments

Place instruments in the tray so that they do not touch each other.

Locate each instrument in the tray to prevent movement and possible damage during handling.

Always keep delicate tips protected with a tip guard when the instrument is not in use.

Protective Container - Cataract Set

Finger Mats May Not Provide Adequate Protection

Paper Plastic Pouches

Widely used because of the visibility of the contents.

However, according to AAMI and AORN pouches should be used for 1-2, light weight instruments.

If packaging instruments separately, select the correct size pouch.

Allow approximately 1” distance from the device and the pouch edges.

Must ensure instruments packaged to protect from damage

General Guidelines for Packaging

Individual Instruments/Small Items

Use correct size packaging

Do not use rubber bands to secure instruments

Paper Plastic Pouches

Double pouching is not required (AORN, AAMI)

May be used for small items which would be difficult to keep together

If double pouching, do not fold over the edges of inside pouch

Inside pouch must lay flat

Tip Protectors

Obtain the manufacturer’s instructions for use.

Some can “catch” onto the instruments – can result in damage

You can use any tip protector that has been approved for use in a sterilization system; foam sleeves, plastic; paper/plastic.

Make sure device can be held open with protector on (e.g. scissors, clamps).

Must have manufacturer’s data that sterilant will penetrate through the tip protector.

Chemical Indicators (Types)

External (Type I) – used to distinguish an item that has been in a sterilizer from an item that has not

Internal chemical indicators (Type 3-4-5)

Should be used inside and outside each package. For wrapped sets, the internal chemical indicator should be located in the center of the pack, not the top.

Type 3 – responds to one parameter

Type 4 – responds to 2 or more parameters

Should use at least a Type 4 CI

Chemical Indicators

Type 5 – integrating indicators – correlate to the action of a biological test

Cannot substitute for a BI test

Type 6 – emulating indicators that respond to a specific cycle type, temperature and exposure time

Labeling Packages

Use a marking pen containing non-toxic, permanent ink and approved for the intended process (e.g., steam sterilization cycles).

Need documentation that marker is non-toxic.

Packages - label on the indicator tape used to close the package, never on the wrapping material itself.

Paper–plastic pouches - label only on the plastic side or on sterilization tape.

If a package is labeled directly on the packaging material, the

marker could damage the packaging material.

Exception is the plastic side of paper plastic pouches.

Table Top Sterilizers

Many ASCs use table top sterilizers

A table-top sterilizer is a ”compact steam sterilizer that has a chamber volume of not more than two cubic feet and that generates its own steam when distilled or deionized water is added by the user” (ANSI/AAMI ST79).

Table-top sterilizers -commonly found in smaller surgery centers where a high volume of sterilization processing does not take place.

Also found in doctors’ and dental offices.

Cycles

The device manufacturer’s sterilization instructions should always be followed

If the cycles provided by the sterilizer cannot be adjusted to conform to the device manufacturer’s instructions, the device should not be processed in that sterilizer.

Conventional Steam Sterilizers

Read the IFUs for exposure time, temperature and cycle time

Many have CJD cycles ONLY

Many have European temperatures only (e.g. 273oF)

Must reconcile IFU information

May have to separate sets to meet IFUs

E.g. some instruments require 10 minutes exposure

Water Quality

Water quality is just as important for table-top units as for sterilizers that use boiler-generated steam.

Distilled or deionized water is recommended to prevent the buildup of minerals in the reservoir and on processed devices.

Each day, before the sterilizer is used for the first time, the reservoir should be checked to ensure that there is enough water for the number of loads to be processed.

Maintenance

Perform all the recommended maintenance of the tabletop sterilizer

Document all maintenance (e.g. reservoir cleaned, gaskets cleaned, etc.

Documentation

All cycles run should be documented

All items processed must be documented

Specific name of device/tray

Quantity

All items must be identified with a lot control number (to facilitate recall)

Must include date sterilized, sterilizer #, load number

Expiration date or event related statement

Traceability to the patient if posterior eye tissue surgery (CJD)

Summary

Best practices for processing ophthalmic instruments requires knowledge of the standards and recommendations to prevent TASS

Manufacturers IFUs

Effective cleaning

Correct packaging methods and materials

Effective sterilization –

Processing equipment in good condition

Proper handling after sterilization

Monitoring of staff compliance with all stated policies and manufacturers’ instructions

Training and competencies for staff

Conclusion - The End

Successful patient outcomes require we develop effective policies, train staff and monitor for compliance

Careful handling of ophthalmic instruments will keep patients safe and reduce costs.

References

AAMI. Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. ST-79, 2017.

AORN. Standards and Recommended Practices. “Selection and Use of Packaging Systems”, AORN.

Centers for Disease Control (Hospital Infection Control Guidelines) 2008

American Society of Cataract & Refractive Surgeons. White Paper on TASS (2006).

The Basics of Sterile Processing textbook, 6th edition, Sterile Processing University, 2016.

Questions??????

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5

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Page 5: Cleaning Protocols and Equipment - APIC MT€¦ · Identify AAMI recommended cleaning protocols to prevent TASS Review the AAMI preparation recommendations for instruments and sets

3/13/2019

5

Keeping Ophthalmic Instruments Safe

Nancy Chobin, RN, AAS, ACSP, CSPM, CFER

CEO Sterile Processing University

Lebanon, NJ

Copyright 2019

Objectives

Identify AAMI recommended cleaning protocols to prevent TASS

Review the AAMI preparation recommendations for instruments and sets

Review care and handling of ophthalmic instruments

Background

Time to perform a cataract procedure has decreased15-20 minutes.

The cost for a set of instruments can range from $6,000 to $8,000 or more

Urgency to turn the instruments around for the next case.

Instruments come in contact with the eye and thus body fluids.

They are considered contaminated and must receive the entire cleaning and sterilization process between patients.

Manufacturer’s Instructions

Instrument manufacturer should:

specify the pH of detergent (e.g. neutral pH)

may recommend a pre-soak in an enzymatic cleaner to help remove protein soils (e.g. body fluids)

specify if any special cleaning implements are needed (e.g. to clean out lumens).

Specify water quality for cleaning and rinsing

However, need to reconcile this information with AAMI and ASORN, AORN, ASCRS and the CDC.

Manufacturer’s Instructions

Also known as Instructions for Use (IFUs)

Keep on file - readily available to processing personnel.

Ensure IFUs followed each and every time the instrument is processed.

Employee training should complement the AAMI guidelines as well as manufacturers’ instructions

Eye instrumentation is extremely delicate and as such requires very special handling and processing to prevent damage. All personnel handling eye instrumentation should ensure careful handling.

Example of Steam Sterilization IFU

Prevacuum High Temperature Autoclave: 274˚F (134˚C) for 3 minutes; wrapped.

NOTE: As per ANSI/AAMI ST79:2010 and A1:2010 270˚F (132˚C) for 4 minutes and 275˚F (135˚C) for 3 minutes are acceptable minimum cycle times for dynamic-air-removal steam sterilization cycles.

Standard Gravity Autoclave: 250˚F (121˚C) for 30 minutes; wrapped.

High Speed (Flash) Autoclave: 270˚F (132˚C) for 10 minutes; unwrapped.

Training and Competencies

Employee competencies should be verified in the processing protocols for processing ophthalmic instruments

Competencies should be verified initially and annually

Utilize resources such as ophthalmic instrument company's educational materials

Reconcile with national standards

Cleaning

Removal of contamination from an item to the extent necessary for further processing or for the intended use.

Involves the use of detergent and water, of adherent visible soil (i.e. blood, pus, protein) from the surfaces, crevices, serrations, jaws and lumens of instruments, devices and equipment, by a manual or mechanical process.

Due to their design, eye instrument challenging to clean

Very small lumens, very delicate tips, can easily break/damage

Pre-Cleaning in Room

Treat with demineralized water to prevent drying of bioburden.

Saline, disinfectants, and chlorinated solutions can cause pitting

and corrosion and should never be used for soaking instruments

Instruments should not remain in water for lengthy periods of time.

–– Biofilms may form, particularly within lumens.

Decontamination

According to OSHA, “the use of physical or chemical means to remove, inactivate, or destroy blood-borne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, use, or disposal.” [29 CFR 1910.1030]

NOTE—Generally used in health care facilities to refer to all pathogenic organisms, not just those transmitted by blood

First and most critical step in breaking the chain of disease transmission

Why Is Cleaning Important?

Process of disinfection or sterilization dependent upon direct contact of the sterilant or disinfectant with the surface of the item

Protein left on items can be “baked on” in the sterilizer

Why are some facilities only “wiping off” the instruments? “Cleaning with water? Alcohol?

TASS – Focus

Toxic Anterior Segment Syndrome (TASS) – main focus by AAMI and AORN

TASS - an acute inflammatory response of the anterior chamber of the eye.

May lead to severe visual impairment if it is not recognized and treated in a timely manner.

Many causes including detergents, water quality, steam quality, instruments, etc.

Major concern is when endotoxins form

Causes of TASS (ASCRS)*

Detergent residues (in general)

Endotoxins

Preservatives

Residues from sterilization processing

Residues of detergents inside a reusable cannula or instrument

Cement sealant on bags of irrigating solution which has leached out

All can induce TASS and cause severe damage to ocular tissue

* American Society of Cataract and Refractive Surgeons

TASS

Particular care must be taken in the processing of intraocular surgical instruments to help ensure that foreign substances or materials associated with the instruments will not be introduced into the anterior chamber of the eye during surgery.

TASS

Outbreaks of TASS have often been linked to the failure to follow the processing procedures recommended by the instrument manufacturer

Specific instrument cleaning and sterilization recommendations intended to diminish the risk of TASS associated with intraocular surgical instruments have been published by the American Society for Cataract and Refractive Surgery (ASCRS, 2006).

Also in AAMI ST-79 as an Annex

ASCRS Recommendations

An adequate inventory of the necessary intraocular surgical instruments should be maintained in order to allow for the timely processing of instruments between cases.

Major issue in surgery centers

Insufficient inventory of instruments leads to short cuts in cleaning

ASCRS Recommendations

Adequate time must be allowed for processing instruments according to the manufacturer’s instructions; otherwise, the cleaning and sterilization of the instruments will be ineffective.

ASCRS Recommendations

A designated cleaning area and equipment specific to the cleaning of intraocular surgical instruments should be identified.

Whenever possible, intraocular surgical instruments should be processed separately from general surgical instruments and equipment in order to reduce the potential for cross-contamination by material or residue from the general surgical instruments

ASCRS Recommendations

Instruments should be pre-cleaned immediately following use.

Gross debris should be removed, and instrument lumens should be flushed with sterile distilled water or another suitable agent as recommended in the room at the end of the procedure

ASCRS Recommendations

Only cleaning agents that have been recommended by the manufacturer should be used.

Particular attention should be paid to the specified concentration of cleaning agent and to the recommended water quality.

ASCRS Recommendations

Final rinsing of the instrument should be performed with sterile, distilled, or deionized water, unless otherwise specified by the manufacturer.

The water used to clean or rinse instruments should be discarded after each use.

ASCRS Recommendations

If an ultrasonic cleaner is used to process the instruments, it should be emptied, cleaned, rinsed, and dried at least daily or, preferably, after each use.

Brushes and other cleaning tools should be cleaned and sterilized as recommended by the manufacturer at least daily or, preferably, after each use.

ASCRS Recommendations

Cleaning and sterilization equipment should be properly maintained.

Foreign materials such as endotoxin or heavy metals may be deposited onto the instruments during processing and induce TASS

Water Quality

Water used to for the final rinse of the device should have a low endotoxin content to avoid pyrogens on processed

devices.

Can lead to pyrogenic reactions (i.e., fever) in patients.

Adequate cleaning and rinsing should result in low bioburden

Essential to the effectiveness of terminal sterilization and to the protection of patients from pyrogens.

Physical Area

Separate area – dedicated to cleaning of ophthalmic instruments

Away from any other type of surgical instruments

Temp 60-65oF

Humidity 30-60%

Air exchanges 10/hour negative

Monitor temperature and humidity daily and document

FIRST STEP

Must have manufacturer’s instructions for cleaning of all devices; method, implements and chemicals recommended

Steps in the Cleaning Process

Pre-Cleaning in room

Contain contaminated items at the point of use

Transport to Decontamination (confined and contained)

Sort

Soak

Wash

Rinse/Dry

Pre-Cleaning - Transport

Instruments should be pre-cleaned immediately following use

Remove gross debris and flush lumens with sterile distilled water (or other agent as recommended by the instrument manufacturer)

Keep instruments moist to avoid drying of soils

Many now recommend cleaning immediately or within 30 minutes of use

Transport in closed container (confine/contain)

Container should be labeled as biohazard (OSHA)

Soaking

Can pre-soak with a detergent

Use of enzyme detergents preferred – but only if recommended by the instrument manufacturer

Assists in the loosening of soils to facilitate cleaning

Do NOT soak in fluids for prolonged periods of time - biofilms can form

Generally form on any surface that is exposed to non-sterile water or other liquids and is consistently found in many environments including industrial and medical systems

use enzymatic gels or foam

Biofiolms

Are produced by microorganisms and consist of a sticky rigid structure of organic contaminates

Slime layer anchored firmly to a surface and provides a protective environment for microorganisms to grow

Cleaning

Need to take special precautions with eye instruments due to

Delicate nature of the design

Sensitivity of eye tissue

Cleaning becomes a challenge

Manual cleaning may be only validated method

Manual cleaning is not as controlled (standardized) as mechanical cleaning

Dilemma

Some eye instrument manufacturer’s do not recommend ANY detergent

Source of confusion for end user

Need to challenge manufacturers

Enzymatic Cleaners

Organic substances which assist in the breakdown of soils

Facilitate the removal of blood and protein soils

Excellent for devices with lumens

Effectiveness dependent upon concentration, use temperature and contact time

Enzymatic Cleaners

Sold as liquid concentrates or powder

Generally more effective in warm water (110-140oF)

Enzyme activity can be inactivated above certain maximum temperatures (140oF)

Follow manufacturer’s directions

Use a thermometer – monitor water temperature

Principles of Cleaning

Must have manufacturer’s written instructions for cleaning of all devices processed

Follow all recommended steps using equipment recommended

Must wear PPE

Impervious gown, head cover, shoe covers, cuffed gloves, face shield

Manual Cleaning Process

May be the only cleaning process available

Items should be submerged, disassembled

Preferable to use 3-sink method; wash, rinse, rinse

Can also be used to remove deposits which were not removed during the pre-soak

Brush all serrations, crevices, tips, handles, and hinges.

Brushing should be done under the surface of the water to prevent aerosolization of contaminants.

Manual Cleaning – General Instructions

Handle instruments one at a time or in small numbers to avoid damage

Open hinged instruments

Disassemble multi-part instruments – keep parts together for easy reassembly after cleaning

Brush and flush all lumened devices

Clean all surfaces

Specialty Items

Cannulas, irrigation cannulas,irrigation/aspiration (I/A) handpieces, suction tips, cystotomes.

Use a brush of the appropriate size to clean the lumen; hold instrument and brush below the water surface

Manual Cleaning Detergents

Usually used for manual cleaning and as a pre-soak

Range from low foam to high foam products

Generally have neutral pH of 7 to 9

Sold as concentrates

Free rinsing

Always measure and dilute the detergent as specified by the detergent manufacturer

Water used to clean instruments should be discarded after each use

Manual Cleaning Implements

Soft bristle brushes, various sizes and lengths (no metal brushes)

Soft cloths

No abrasive items

No sponges

No materials which are permeable; i.e.. Wood

Implements used to clean instruments should be cleaned according to the manufacturer or at least daily, preferably after each use

Mechanical Cleaners

Do not put microsurgical instruments into a washer decontaminator unless it has a delicate cycle.

Can result in damage to instruments

Specialty Cleaner

Specialty cleaning and rinsing system for lumened devices such as Phaco and OZIL handpieces

Effectively cleans and rinses lumens

Must disinfect according to IFUs and document

Diamond Knives

The diamond knife is designed to make precision atraumatic cuts

The diamond knife has the sharpest cutting edge possible

Cost can range from $800 - $2,500 or more

Diamond Blade Knives

Cleaning: Immediately after using a diamond knife, the blade must be rinsed with demineralized water, preventing cell particles or viscoelastic materials from sticking to the blade.

Generally. ultrasonically clean holding the knife and suspending only the blade into the fluid.

The blade should not touch any other instruments or the sides of the cleaner.

Diamond Blade Knives

Never completely submerge a diamond knife in an ultrasonic cleaner.

At all time, (except cleaning) the blade should be in the retracted position to prevent damage.

Inspect with microscope.

Ultrasonic Cleaning

Uses sound waves transmitted through a solution

Sound waves produce tiny bubbles which implode - results in scouring action that cleans

Mechanical process = cavitation

Ultrasonic Cleaning

Effective to remove soils in hard-to-reach areas (box locks, mouth teeth, etc..)

Generally can only use detergents specifically formulated for ultrasonic cleaners - low foaming

Water temperatures usually 100 - 140 o F.

Can be used after manual cleaning

Ultrasonic Cleaning

Solution should be changed at least daily preferably after each use

Outbreaks of TASS have been associated with contaminated sonic baths

Unit should have a cover to contain aerosols

Items should not be stacked

Need to “de-gas” water

Ultrasonic Cleaning

Containers/baskets should have perforations; should be all metal mesh; no plastic

Should be located in Decontamination Area

cleaning process

more efficient than manual cleaning

Test the sonic for efficacy (daily???)

Testing Sonic

Rinsing

The most important part of the cleaning process

Essential to remove loosened debris

Should be performed with the volume and quality (sterile, distilled, or deionized water (if manual cleaning)

Water used to rinse instruments should be discarded after each use

Sterile distilled water recommended for final rinse to prevent mineral deposits and TASS

Lubrication

The use of instrument milk is beneficial to instruments to prevent corrosion and to keep moving parts from getting stiff.

However, not all instruments should be lubricated. The instrument manufacturer will indicate if this process is recommended.

Principles of Inspection/Assembly

All items should be prepared according to the device manufacturer’s written instructions (i.e. must the device be disassembled for sterilization?)

All hinged instruments should be in the open position to permit the sterilant to contact all surfaces of the jaws, blades, etc.

Items must be checked for cleanliness – the use of a lighted magnifying lamp is recommended to visualize defects such as cracked box locks, soils or missing tips.

Inspection

Best method is to use a microscope

Principles of Inspection/Assembly

All parts are present and functional

Use perforated or mesh bottom trays

All scissors should be tested for sharpness each time they are processed

Test that ratchets hold on clamps

Inspect hand held forceps that tips approximate

Test needle holders; ratchets hold and tips hold suture needle

Principles of Inspection/Assembly

Inspect that joints are not stiff

Use a lighted magnifying lamp or microscope to inspect

Inspect for rust, pitting, cracked box lock, etc.

Demagnetization of eye instruments may be needed

Separate delicate, sharp items

Use non-linting surgical towels, or paper sterilization bags to separate items inside set; not peel pack material

Refer to manufacturer’s IFUs regarding flushing of all lumened devices (AAMI states only for gravity cycles). Use sterile, distilled water

Ophthalmic Instruments

Look for defects:

Rusting common (especially if IUSS frequently used

Corrosion

Damage to tips/ teeth

Cords

Lumens (e.g. Phaco handpieces)

Stiffness

Sharpness

Spotting – Staining - Rust

Delicate Tips Require Protection

Can use small containers with silicone mat for individual instruments to provide protection.

General Guidelines for Packaging

Instrument Sets

Use specialty containers to keep delicate instruments in place and prevent damage in transport and cleaning.

The single most effective means to prevent damage to eye instruments is to place them in specialty protective containers

The basket or container of the correct size to prevent instrument damage

Handling Eye Instruments

Place instruments in the tray so that they do not touch each other.

Locate each instrument in the tray to prevent movement and possible damage during handling.

Always keep delicate tips protected with a tip guard when the instrument is not in use.

Protective Container - Cataract Set

Finger Mats May Not Provide Adequate Protection

Paper Plastic Pouches

Widely used because of the visibility of the contents.

However, according to AAMI and AORN pouches should be used for 1-2, light weight instruments.

If packaging instruments separately, select the correct size pouch.

Allow approximately 1” distance from the device and the pouch edges.

Must ensure instruments packaged to protect from damage

General Guidelines for Packaging

Individual Instruments/Small Items

Use correct size packaging

Do not use rubber bands to secure instruments

Paper Plastic Pouches

Double pouching is not required (AORN, AAMI)

May be used for small items which would be difficult to keep together

If double pouching, do not fold over the edges of inside pouch

Inside pouch must lay flat

Tip Protectors

Obtain the manufacturer’s instructions for use.

Some can “catch” onto the instruments – can result in damage

You can use any tip protector that has been approved for use in a sterilization system; foam sleeves, plastic; paper/plastic.

Make sure device can be held open with protector on (e.g. scissors, clamps).

Must have manufacturer’s data that sterilant will penetrate through the tip protector.

Chemical Indicators (Types)

External (Type I) – used to distinguish an item that has been in a sterilizer from an item that has not

Internal chemical indicators (Type 3-4-5)

Should be used inside and outside each package. For wrapped sets, the internal chemical indicator should be located in the center of the pack, not the top.

Type 3 – responds to one parameter

Type 4 – responds to 2 or more parameters

Should use at least a Type 4 CI

Chemical Indicators

Type 5 – integrating indicators – correlate to the action of a biological test

Cannot substitute for a BI test

Type 6 – emulating indicators that respond to a specific cycle type, temperature and exposure time

Labeling Packages

Use a marking pen containing non-toxic, permanent ink and approved for the intended process (e.g., steam sterilization cycles).

Need documentation that marker is non-toxic.

Packages - label on the indicator tape used to close the package, never on the wrapping material itself.

Paper–plastic pouches - label only on the plastic side or on sterilization tape.

If a package is labeled directly on the packaging material, the

marker could damage the packaging material.

Exception is the plastic side of paper plastic pouches.

Table Top Sterilizers

Many ASCs use table top sterilizers

A table-top sterilizer is a ”compact steam sterilizer that has a chamber volume of not more than two cubic feet and that generates its own steam when distilled or deionized water is added by the user” (ANSI/AAMI ST79).

Table-top sterilizers -commonly found in smaller surgery centers where a high volume of sterilization processing does not take place.

Also found in doctors’ and dental offices.

Cycles

The device manufacturer’s sterilization instructions should always be followed

If the cycles provided by the sterilizer cannot be adjusted to conform to the device manufacturer’s instructions, the device should not be processed in that sterilizer.

Conventional Steam Sterilizers

Read the IFUs for exposure time, temperature and cycle time

Many have CJD cycles ONLY

Many have European temperatures only (e.g. 273oF)

Must reconcile IFU information

May have to separate sets to meet IFUs

E.g. some instruments require 10 minutes exposure

Water Quality

Water quality is just as important for table-top units as for sterilizers that use boiler-generated steam.

Distilled or deionized water is recommended to prevent the buildup of minerals in the reservoir and on processed devices.

Each day, before the sterilizer is used for the first time, the reservoir should be checked to ensure that there is enough water for the number of loads to be processed.

Maintenance

Perform all the recommended maintenance of the tabletop sterilizer

Document all maintenance (e.g. reservoir cleaned, gaskets cleaned, etc.

Documentation

All cycles run should be documented

All items processed must be documented

Specific name of device/tray

Quantity

All items must be identified with a lot control number (to facilitate recall)

Must include date sterilized, sterilizer #, load number

Expiration date or event related statement

Traceability to the patient if posterior eye tissue surgery (CJD)

Summary

Best practices for processing ophthalmic instruments requires knowledge of the standards and recommendations to prevent TASS

Manufacturers IFUs

Effective cleaning

Correct packaging methods and materials

Effective sterilization –

Processing equipment in good condition

Proper handling after sterilization

Monitoring of staff compliance with all stated policies and manufacturers’ instructions

Training and competencies for staff

Conclusion - The End

Successful patient outcomes require we develop effective policies, train staff and monitor for compliance

Careful handling of ophthalmic instruments will keep patients safe and reduce costs.

References

AAMI. Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. ST-79, 2017.

AORN. Standards and Recommended Practices. “Selection and Use of Packaging Systems”, AORN.

Centers for Disease Control (Hospital Infection Control Guidelines) 2008

American Society of Cataract & Refractive Surgeons. White Paper on TASS (2006).

The Basics of Sterile Processing textbook, 6th edition, Sterile Processing University, 2016.

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Page 6: Cleaning Protocols and Equipment - APIC MT€¦ · Identify AAMI recommended cleaning protocols to prevent TASS Review the AAMI preparation recommendations for instruments and sets

3/13/2019

6

Keeping Ophthalmic Instruments Safe

Nancy Chobin, RN, AAS, ACSP, CSPM, CFER

CEO Sterile Processing University

Lebanon, NJ

Copyright 2019

Objectives

Identify AAMI recommended cleaning protocols to prevent TASS

Review the AAMI preparation recommendations for instruments and sets

Review care and handling of ophthalmic instruments

Background

Time to perform a cataract procedure has decreased15-20 minutes.

The cost for a set of instruments can range from $6,000 to $8,000 or more

Urgency to turn the instruments around for the next case.

Instruments come in contact with the eye and thus body fluids.

They are considered contaminated and must receive the entire cleaning and sterilization process between patients.

Manufacturer’s Instructions

Instrument manufacturer should:

specify the pH of detergent (e.g. neutral pH)

may recommend a pre-soak in an enzymatic cleaner to help remove protein soils (e.g. body fluids)

specify if any special cleaning implements are needed (e.g. to clean out lumens).

Specify water quality for cleaning and rinsing

However, need to reconcile this information with AAMI and ASORN, AORN, ASCRS and the CDC.

Manufacturer’s Instructions

Also known as Instructions for Use (IFUs)

Keep on file - readily available to processing personnel.

Ensure IFUs followed each and every time the instrument is processed.

Employee training should complement the AAMI guidelines as well as manufacturers’ instructions

Eye instrumentation is extremely delicate and as such requires very special handling and processing to prevent damage. All personnel handling eye instrumentation should ensure careful handling.

Example of Steam Sterilization IFU

Prevacuum High Temperature Autoclave: 274˚F (134˚C) for 3 minutes; wrapped.

NOTE: As per ANSI/AAMI ST79:2010 and A1:2010 270˚F (132˚C) for 4 minutes and 275˚F (135˚C) for 3 minutes are acceptable minimum cycle times for dynamic-air-removal steam sterilization cycles.

Standard Gravity Autoclave: 250˚F (121˚C) for 30 minutes; wrapped.

High Speed (Flash) Autoclave: 270˚F (132˚C) for 10 minutes; unwrapped.

Training and Competencies

Employee competencies should be verified in the processing protocols for processing ophthalmic instruments

Competencies should be verified initially and annually

Utilize resources such as ophthalmic instrument company's educational materials

Reconcile with national standards

Cleaning

Removal of contamination from an item to the extent necessary for further processing or for the intended use.

Involves the use of detergent and water, of adherent visible soil (i.e. blood, pus, protein) from the surfaces, crevices, serrations, jaws and lumens of instruments, devices and equipment, by a manual or mechanical process.

Due to their design, eye instrument challenging to clean

Very small lumens, very delicate tips, can easily break/damage

Pre-Cleaning in Room

Treat with demineralized water to prevent drying of bioburden.

Saline, disinfectants, and chlorinated solutions can cause pitting

and corrosion and should never be used for soaking instruments

Instruments should not remain in water for lengthy periods of time.

–– Biofilms may form, particularly within lumens.

Decontamination

According to OSHA, “the use of physical or chemical means to remove, inactivate, or destroy blood-borne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, use, or disposal.” [29 CFR 1910.1030]

NOTE—Generally used in health care facilities to refer to all pathogenic organisms, not just those transmitted by blood

First and most critical step in breaking the chain of disease transmission

Why Is Cleaning Important?

Process of disinfection or sterilization dependent upon direct contact of the sterilant or disinfectant with the surface of the item

Protein left on items can be “baked on” in the sterilizer

Why are some facilities only “wiping off” the instruments? “Cleaning with water? Alcohol?

TASS – Focus

Toxic Anterior Segment Syndrome (TASS) – main focus by AAMI and AORN

TASS - an acute inflammatory response of the anterior chamber of the eye.

May lead to severe visual impairment if it is not recognized and treated in a timely manner.

Many causes including detergents, water quality, steam quality, instruments, etc.

Major concern is when endotoxins form

Causes of TASS (ASCRS)*

Detergent residues (in general)

Endotoxins

Preservatives

Residues from sterilization processing

Residues of detergents inside a reusable cannula or instrument

Cement sealant on bags of irrigating solution which has leached out

All can induce TASS and cause severe damage to ocular tissue

* American Society of Cataract and Refractive Surgeons

TASS

Particular care must be taken in the processing of intraocular surgical instruments to help ensure that foreign substances or materials associated with the instruments will not be introduced into the anterior chamber of the eye during surgery.

TASS

Outbreaks of TASS have often been linked to the failure to follow the processing procedures recommended by the instrument manufacturer

Specific instrument cleaning and sterilization recommendations intended to diminish the risk of TASS associated with intraocular surgical instruments have been published by the American Society for Cataract and Refractive Surgery (ASCRS, 2006).

Also in AAMI ST-79 as an Annex

ASCRS Recommendations

An adequate inventory of the necessary intraocular surgical instruments should be maintained in order to allow for the timely processing of instruments between cases.

Major issue in surgery centers

Insufficient inventory of instruments leads to short cuts in cleaning

ASCRS Recommendations

Adequate time must be allowed for processing instruments according to the manufacturer’s instructions; otherwise, the cleaning and sterilization of the instruments will be ineffective.

ASCRS Recommendations

A designated cleaning area and equipment specific to the cleaning of intraocular surgical instruments should be identified.

Whenever possible, intraocular surgical instruments should be processed separately from general surgical instruments and equipment in order to reduce the potential for cross-contamination by material or residue from the general surgical instruments

ASCRS Recommendations

Instruments should be pre-cleaned immediately following use.

Gross debris should be removed, and instrument lumens should be flushed with sterile distilled water or another suitable agent as recommended in the room at the end of the procedure

ASCRS Recommendations

Only cleaning agents that have been recommended by the manufacturer should be used.

Particular attention should be paid to the specified concentration of cleaning agent and to the recommended water quality.

ASCRS Recommendations

Final rinsing of the instrument should be performed with sterile, distilled, or deionized water, unless otherwise specified by the manufacturer.

The water used to clean or rinse instruments should be discarded after each use.

ASCRS Recommendations

If an ultrasonic cleaner is used to process the instruments, it should be emptied, cleaned, rinsed, and dried at least daily or, preferably, after each use.

Brushes and other cleaning tools should be cleaned and sterilized as recommended by the manufacturer at least daily or, preferably, after each use.

ASCRS Recommendations

Cleaning and sterilization equipment should be properly maintained.

Foreign materials such as endotoxin or heavy metals may be deposited onto the instruments during processing and induce TASS

Water Quality

Water used to for the final rinse of the device should have a low endotoxin content to avoid pyrogens on processed

devices.

Can lead to pyrogenic reactions (i.e., fever) in patients.

Adequate cleaning and rinsing should result in low bioburden

Essential to the effectiveness of terminal sterilization and to the protection of patients from pyrogens.

Physical Area

Separate area – dedicated to cleaning of ophthalmic instruments

Away from any other type of surgical instruments

Temp 60-65oF

Humidity 30-60%

Air exchanges 10/hour negative

Monitor temperature and humidity daily and document

FIRST STEP

Must have manufacturer’s instructions for cleaning of all devices; method, implements and chemicals recommended

Steps in the Cleaning Process

Pre-Cleaning in room

Contain contaminated items at the point of use

Transport to Decontamination (confined and contained)

Sort

Soak

Wash

Rinse/Dry

Pre-Cleaning - Transport

Instruments should be pre-cleaned immediately following use

Remove gross debris and flush lumens with sterile distilled water (or other agent as recommended by the instrument manufacturer)

Keep instruments moist to avoid drying of soils

Many now recommend cleaning immediately or within 30 minutes of use

Transport in closed container (confine/contain)

Container should be labeled as biohazard (OSHA)

Soaking

Can pre-soak with a detergent

Use of enzyme detergents preferred – but only if recommended by the instrument manufacturer

Assists in the loosening of soils to facilitate cleaning

Do NOT soak in fluids for prolonged periods of time - biofilms can form

Generally form on any surface that is exposed to non-sterile water or other liquids and is consistently found in many environments including industrial and medical systems

use enzymatic gels or foam

Biofiolms

Are produced by microorganisms and consist of a sticky rigid structure of organic contaminates

Slime layer anchored firmly to a surface and provides a protective environment for microorganisms to grow

Cleaning

Need to take special precautions with eye instruments due to

Delicate nature of the design

Sensitivity of eye tissue

Cleaning becomes a challenge

Manual cleaning may be only validated method

Manual cleaning is not as controlled (standardized) as mechanical cleaning

Dilemma

Some eye instrument manufacturer’s do not recommend ANY detergent

Source of confusion for end user

Need to challenge manufacturers

Enzymatic Cleaners

Organic substances which assist in the breakdown of soils

Facilitate the removal of blood and protein soils

Excellent for devices with lumens

Effectiveness dependent upon concentration, use temperature and contact time

Enzymatic Cleaners

Sold as liquid concentrates or powder

Generally more effective in warm water (110-140oF)

Enzyme activity can be inactivated above certain maximum temperatures (140oF)

Follow manufacturer’s directions

Use a thermometer – monitor water temperature

Principles of Cleaning

Must have manufacturer’s written instructions for cleaning of all devices processed

Follow all recommended steps using equipment recommended

Must wear PPE

Impervious gown, head cover, shoe covers, cuffed gloves, face shield

Manual Cleaning Process

May be the only cleaning process available

Items should be submerged, disassembled

Preferable to use 3-sink method; wash, rinse, rinse

Can also be used to remove deposits which were not removed during the pre-soak

Brush all serrations, crevices, tips, handles, and hinges.

Brushing should be done under the surface of the water to prevent aerosolization of contaminants.

Manual Cleaning – General Instructions

Handle instruments one at a time or in small numbers to avoid damage

Open hinged instruments

Disassemble multi-part instruments – keep parts together for easy reassembly after cleaning

Brush and flush all lumened devices

Clean all surfaces

Specialty Items

Cannulas, irrigation cannulas,irrigation/aspiration (I/A) handpieces, suction tips, cystotomes.

Use a brush of the appropriate size to clean the lumen; hold instrument and brush below the water surface

Manual Cleaning Detergents

Usually used for manual cleaning and as a pre-soak

Range from low foam to high foam products

Generally have neutral pH of 7 to 9

Sold as concentrates

Free rinsing

Always measure and dilute the detergent as specified by the detergent manufacturer

Water used to clean instruments should be discarded after each use

Manual Cleaning Implements

Soft bristle brushes, various sizes and lengths (no metal brushes)

Soft cloths

No abrasive items

No sponges

No materials which are permeable; i.e.. Wood

Implements used to clean instruments should be cleaned according to the manufacturer or at least daily, preferably after each use

Mechanical Cleaners

Do not put microsurgical instruments into a washer decontaminator unless it has a delicate cycle.

Can result in damage to instruments

Specialty Cleaner

Specialty cleaning and rinsing system for lumened devices such as Phaco and OZIL handpieces

Effectively cleans and rinses lumens

Must disinfect according to IFUs and document

Diamond Knives

The diamond knife is designed to make precision atraumatic cuts

The diamond knife has the sharpest cutting edge possible

Cost can range from $800 - $2,500 or more

Diamond Blade Knives

Cleaning: Immediately after using a diamond knife, the blade must be rinsed with demineralized water, preventing cell particles or viscoelastic materials from sticking to the blade.

Generally. ultrasonically clean holding the knife and suspending only the blade into the fluid.

The blade should not touch any other instruments or the sides of the cleaner.

Diamond Blade Knives

Never completely submerge a diamond knife in an ultrasonic cleaner.

At all time, (except cleaning) the blade should be in the retracted position to prevent damage.

Inspect with microscope.

Ultrasonic Cleaning

Uses sound waves transmitted through a solution

Sound waves produce tiny bubbles which implode - results in scouring action that cleans

Mechanical process = cavitation

Ultrasonic Cleaning

Effective to remove soils in hard-to-reach areas (box locks, mouth teeth, etc..)

Generally can only use detergents specifically formulated for ultrasonic cleaners - low foaming

Water temperatures usually 100 - 140 o F.

Can be used after manual cleaning

Ultrasonic Cleaning

Solution should be changed at least daily preferably after each use

Outbreaks of TASS have been associated with contaminated sonic baths

Unit should have a cover to contain aerosols

Items should not be stacked

Need to “de-gas” water

Ultrasonic Cleaning

Containers/baskets should have perforations; should be all metal mesh; no plastic

Should be located in Decontamination Area

cleaning process

more efficient than manual cleaning

Test the sonic for efficacy (daily???)

Testing Sonic

Rinsing

The most important part of the cleaning process

Essential to remove loosened debris

Should be performed with the volume and quality (sterile, distilled, or deionized water (if manual cleaning)

Water used to rinse instruments should be discarded after each use

Sterile distilled water recommended for final rinse to prevent mineral deposits and TASS

Lubrication

The use of instrument milk is beneficial to instruments to prevent corrosion and to keep moving parts from getting stiff.

However, not all instruments should be lubricated. The instrument manufacturer will indicate if this process is recommended.

Principles of Inspection/Assembly

All items should be prepared according to the device manufacturer’s written instructions (i.e. must the device be disassembled for sterilization?)

All hinged instruments should be in the open position to permit the sterilant to contact all surfaces of the jaws, blades, etc.

Items must be checked for cleanliness – the use of a lighted magnifying lamp is recommended to visualize defects such as cracked box locks, soils or missing tips.

Inspection

Best method is to use a microscope

Principles of Inspection/Assembly

All parts are present and functional

Use perforated or mesh bottom trays

All scissors should be tested for sharpness each time they are processed

Test that ratchets hold on clamps

Inspect hand held forceps that tips approximate

Test needle holders; ratchets hold and tips hold suture needle

Principles of Inspection/Assembly

Inspect that joints are not stiff

Use a lighted magnifying lamp or microscope to inspect

Inspect for rust, pitting, cracked box lock, etc.

Demagnetization of eye instruments may be needed

Separate delicate, sharp items

Use non-linting surgical towels, or paper sterilization bags to separate items inside set; not peel pack material

Refer to manufacturer’s IFUs regarding flushing of all lumened devices (AAMI states only for gravity cycles). Use sterile, distilled water

Ophthalmic Instruments

Look for defects:

Rusting common (especially if IUSS frequently used

Corrosion

Damage to tips/ teeth

Cords

Lumens (e.g. Phaco handpieces)

Stiffness

Sharpness

Spotting – Staining - Rust

Delicate Tips Require Protection

Can use small containers with silicone mat for individual instruments to provide protection.

General Guidelines for Packaging

Instrument Sets

Use specialty containers to keep delicate instruments in place and prevent damage in transport and cleaning.

The single most effective means to prevent damage to eye instruments is to place them in specialty protective containers

The basket or container of the correct size to prevent instrument damage

Handling Eye Instruments

Place instruments in the tray so that they do not touch each other.

Locate each instrument in the tray to prevent movement and possible damage during handling.

Always keep delicate tips protected with a tip guard when the instrument is not in use.

Protective Container - Cataract Set

Finger Mats May Not Provide Adequate Protection

Paper Plastic Pouches

Widely used because of the visibility of the contents.

However, according to AAMI and AORN pouches should be used for 1-2, light weight instruments.

If packaging instruments separately, select the correct size pouch.

Allow approximately 1” distance from the device and the pouch edges.

Must ensure instruments packaged to protect from damage

General Guidelines for Packaging

Individual Instruments/Small Items

Use correct size packaging

Do not use rubber bands to secure instruments

Paper Plastic Pouches

Double pouching is not required (AORN, AAMI)

May be used for small items which would be difficult to keep together

If double pouching, do not fold over the edges of inside pouch

Inside pouch must lay flat

Tip Protectors

Obtain the manufacturer’s instructions for use.

Some can “catch” onto the instruments – can result in damage

You can use any tip protector that has been approved for use in a sterilization system; foam sleeves, plastic; paper/plastic.

Make sure device can be held open with protector on (e.g. scissors, clamps).

Must have manufacturer’s data that sterilant will penetrate through the tip protector.

Chemical Indicators (Types)

External (Type I) – used to distinguish an item that has been in a sterilizer from an item that has not

Internal chemical indicators (Type 3-4-5)

Should be used inside and outside each package. For wrapped sets, the internal chemical indicator should be located in the center of the pack, not the top.

Type 3 – responds to one parameter

Type 4 – responds to 2 or more parameters

Should use at least a Type 4 CI

Chemical Indicators

Type 5 – integrating indicators – correlate to the action of a biological test

Cannot substitute for a BI test

Type 6 – emulating indicators that respond to a specific cycle type, temperature and exposure time

Labeling Packages

Use a marking pen containing non-toxic, permanent ink and approved for the intended process (e.g., steam sterilization cycles).

Need documentation that marker is non-toxic.

Packages - label on the indicator tape used to close the package, never on the wrapping material itself.

Paper–plastic pouches - label only on the plastic side or on sterilization tape.

If a package is labeled directly on the packaging material, the

marker could damage the packaging material.

Exception is the plastic side of paper plastic pouches.

Table Top Sterilizers

Many ASCs use table top sterilizers

A table-top sterilizer is a ”compact steam sterilizer that has a chamber volume of not more than two cubic feet and that generates its own steam when distilled or deionized water is added by the user” (ANSI/AAMI ST79).

Table-top sterilizers -commonly found in smaller surgery centers where a high volume of sterilization processing does not take place.

Also found in doctors’ and dental offices.

Cycles

The device manufacturer’s sterilization instructions should always be followed

If the cycles provided by the sterilizer cannot be adjusted to conform to the device manufacturer’s instructions, the device should not be processed in that sterilizer.

Conventional Steam Sterilizers

Read the IFUs for exposure time, temperature and cycle time

Many have CJD cycles ONLY

Many have European temperatures only (e.g. 273oF)

Must reconcile IFU information

May have to separate sets to meet IFUs

E.g. some instruments require 10 minutes exposure

Water Quality

Water quality is just as important for table-top units as for sterilizers that use boiler-generated steam.

Distilled or deionized water is recommended to prevent the buildup of minerals in the reservoir and on processed devices.

Each day, before the sterilizer is used for the first time, the reservoir should be checked to ensure that there is enough water for the number of loads to be processed.

Maintenance

Perform all the recommended maintenance of the tabletop sterilizer

Document all maintenance (e.g. reservoir cleaned, gaskets cleaned, etc.

Documentation

All cycles run should be documented

All items processed must be documented

Specific name of device/tray

Quantity

All items must be identified with a lot control number (to facilitate recall)

Must include date sterilized, sterilizer #, load number

Expiration date or event related statement

Traceability to the patient if posterior eye tissue surgery (CJD)

Summary

Best practices for processing ophthalmic instruments requires knowledge of the standards and recommendations to prevent TASS

Manufacturers IFUs

Effective cleaning

Correct packaging methods and materials

Effective sterilization –

Processing equipment in good condition

Proper handling after sterilization

Monitoring of staff compliance with all stated policies and manufacturers’ instructions

Training and competencies for staff

Conclusion - The End

Successful patient outcomes require we develop effective policies, train staff and monitor for compliance

Careful handling of ophthalmic instruments will keep patients safe and reduce costs.

References

AAMI. Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. ST-79, 2017.

AORN. Standards and Recommended Practices. “Selection and Use of Packaging Systems”, AORN.

Centers for Disease Control (Hospital Infection Control Guidelines) 2008

American Society of Cataract & Refractive Surgeons. White Paper on TASS (2006).

The Basics of Sterile Processing textbook, 6th edition, Sterile Processing University, 2016.

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Page 7: Cleaning Protocols and Equipment - APIC MT€¦ · Identify AAMI recommended cleaning protocols to prevent TASS Review the AAMI preparation recommendations for instruments and sets

3/13/2019

7

Keeping Ophthalmic Instruments Safe

Nancy Chobin, RN, AAS, ACSP, CSPM, CFER

CEO Sterile Processing University

Lebanon, NJ

Copyright 2019

Objectives

Identify AAMI recommended cleaning protocols to prevent TASS

Review the AAMI preparation recommendations for instruments and sets

Review care and handling of ophthalmic instruments

Background

Time to perform a cataract procedure has decreased15-20 minutes.

The cost for a set of instruments can range from $6,000 to $8,000 or more

Urgency to turn the instruments around for the next case.

Instruments come in contact with the eye and thus body fluids.

They are considered contaminated and must receive the entire cleaning and sterilization process between patients.

Manufacturer’s Instructions

Instrument manufacturer should:

specify the pH of detergent (e.g. neutral pH)

may recommend a pre-soak in an enzymatic cleaner to help remove protein soils (e.g. body fluids)

specify if any special cleaning implements are needed (e.g. to clean out lumens).

Specify water quality for cleaning and rinsing

However, need to reconcile this information with AAMI and ASORN, AORN, ASCRS and the CDC.

Manufacturer’s Instructions

Also known as Instructions for Use (IFUs)

Keep on file - readily available to processing personnel.

Ensure IFUs followed each and every time the instrument is processed.

Employee training should complement the AAMI guidelines as well as manufacturers’ instructions

Eye instrumentation is extremely delicate and as such requires very special handling and processing to prevent damage. All personnel handling eye instrumentation should ensure careful handling.

Example of Steam Sterilization IFU

Prevacuum High Temperature Autoclave: 274˚F (134˚C) for 3 minutes; wrapped.

NOTE: As per ANSI/AAMI ST79:2010 and A1:2010 270˚F (132˚C) for 4 minutes and 275˚F (135˚C) for 3 minutes are acceptable minimum cycle times for dynamic-air-removal steam sterilization cycles.

Standard Gravity Autoclave: 250˚F (121˚C) for 30 minutes; wrapped.

High Speed (Flash) Autoclave: 270˚F (132˚C) for 10 minutes; unwrapped.

Training and Competencies

Employee competencies should be verified in the processing protocols for processing ophthalmic instruments

Competencies should be verified initially and annually

Utilize resources such as ophthalmic instrument company's educational materials

Reconcile with national standards

Cleaning

Removal of contamination from an item to the extent necessary for further processing or for the intended use.

Involves the use of detergent and water, of adherent visible soil (i.e. blood, pus, protein) from the surfaces, crevices, serrations, jaws and lumens of instruments, devices and equipment, by a manual or mechanical process.

Due to their design, eye instrument challenging to clean

Very small lumens, very delicate tips, can easily break/damage

Pre-Cleaning in Room

Treat with demineralized water to prevent drying of bioburden.

Saline, disinfectants, and chlorinated solutions can cause pitting

and corrosion and should never be used for soaking instruments

Instruments should not remain in water for lengthy periods of time.

–– Biofilms may form, particularly within lumens.

Decontamination

According to OSHA, “the use of physical or chemical means to remove, inactivate, or destroy blood-borne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, use, or disposal.” [29 CFR 1910.1030]

NOTE—Generally used in health care facilities to refer to all pathogenic organisms, not just those transmitted by blood

First and most critical step in breaking the chain of disease transmission

Why Is Cleaning Important?

Process of disinfection or sterilization dependent upon direct contact of the sterilant or disinfectant with the surface of the item

Protein left on items can be “baked on” in the sterilizer

Why are some facilities only “wiping off” the instruments? “Cleaning with water? Alcohol?

TASS – Focus

Toxic Anterior Segment Syndrome (TASS) – main focus by AAMI and AORN

TASS - an acute inflammatory response of the anterior chamber of the eye.

May lead to severe visual impairment if it is not recognized and treated in a timely manner.

Many causes including detergents, water quality, steam quality, instruments, etc.

Major concern is when endotoxins form

Causes of TASS (ASCRS)*

Detergent residues (in general)

Endotoxins

Preservatives

Residues from sterilization processing

Residues of detergents inside a reusable cannula or instrument

Cement sealant on bags of irrigating solution which has leached out

All can induce TASS and cause severe damage to ocular tissue

* American Society of Cataract and Refractive Surgeons

TASS

Particular care must be taken in the processing of intraocular surgical instruments to help ensure that foreign substances or materials associated with the instruments will not be introduced into the anterior chamber of the eye during surgery.

TASS

Outbreaks of TASS have often been linked to the failure to follow the processing procedures recommended by the instrument manufacturer

Specific instrument cleaning and sterilization recommendations intended to diminish the risk of TASS associated with intraocular surgical instruments have been published by the American Society for Cataract and Refractive Surgery (ASCRS, 2006).

Also in AAMI ST-79 as an Annex

ASCRS Recommendations

An adequate inventory of the necessary intraocular surgical instruments should be maintained in order to allow for the timely processing of instruments between cases.

Major issue in surgery centers

Insufficient inventory of instruments leads to short cuts in cleaning

ASCRS Recommendations

Adequate time must be allowed for processing instruments according to the manufacturer’s instructions; otherwise, the cleaning and sterilization of the instruments will be ineffective.

ASCRS Recommendations

A designated cleaning area and equipment specific to the cleaning of intraocular surgical instruments should be identified.

Whenever possible, intraocular surgical instruments should be processed separately from general surgical instruments and equipment in order to reduce the potential for cross-contamination by material or residue from the general surgical instruments

ASCRS Recommendations

Instruments should be pre-cleaned immediately following use.

Gross debris should be removed, and instrument lumens should be flushed with sterile distilled water or another suitable agent as recommended in the room at the end of the procedure

ASCRS Recommendations

Only cleaning agents that have been recommended by the manufacturer should be used.

Particular attention should be paid to the specified concentration of cleaning agent and to the recommended water quality.

ASCRS Recommendations

Final rinsing of the instrument should be performed with sterile, distilled, or deionized water, unless otherwise specified by the manufacturer.

The water used to clean or rinse instruments should be discarded after each use.

ASCRS Recommendations

If an ultrasonic cleaner is used to process the instruments, it should be emptied, cleaned, rinsed, and dried at least daily or, preferably, after each use.

Brushes and other cleaning tools should be cleaned and sterilized as recommended by the manufacturer at least daily or, preferably, after each use.

ASCRS Recommendations

Cleaning and sterilization equipment should be properly maintained.

Foreign materials such as endotoxin or heavy metals may be deposited onto the instruments during processing and induce TASS

Water Quality

Water used to for the final rinse of the device should have a low endotoxin content to avoid pyrogens on processed

devices.

Can lead to pyrogenic reactions (i.e., fever) in patients.

Adequate cleaning and rinsing should result in low bioburden

Essential to the effectiveness of terminal sterilization and to the protection of patients from pyrogens.

Physical Area

Separate area – dedicated to cleaning of ophthalmic instruments

Away from any other type of surgical instruments

Temp 60-65oF

Humidity 30-60%

Air exchanges 10/hour negative

Monitor temperature and humidity daily and document

FIRST STEP

Must have manufacturer’s instructions for cleaning of all devices; method, implements and chemicals recommended

Steps in the Cleaning Process

Pre-Cleaning in room

Contain contaminated items at the point of use

Transport to Decontamination (confined and contained)

Sort

Soak

Wash

Rinse/Dry

Pre-Cleaning - Transport

Instruments should be pre-cleaned immediately following use

Remove gross debris and flush lumens with sterile distilled water (or other agent as recommended by the instrument manufacturer)

Keep instruments moist to avoid drying of soils

Many now recommend cleaning immediately or within 30 minutes of use

Transport in closed container (confine/contain)

Container should be labeled as biohazard (OSHA)

Soaking

Can pre-soak with a detergent

Use of enzyme detergents preferred – but only if recommended by the instrument manufacturer

Assists in the loosening of soils to facilitate cleaning

Do NOT soak in fluids for prolonged periods of time - biofilms can form

Generally form on any surface that is exposed to non-sterile water or other liquids and is consistently found in many environments including industrial and medical systems

use enzymatic gels or foam

Biofiolms

Are produced by microorganisms and consist of a sticky rigid structure of organic contaminates

Slime layer anchored firmly to a surface and provides a protective environment for microorganisms to grow

Cleaning

Need to take special precautions with eye instruments due to

Delicate nature of the design

Sensitivity of eye tissue

Cleaning becomes a challenge

Manual cleaning may be only validated method

Manual cleaning is not as controlled (standardized) as mechanical cleaning

Dilemma

Some eye instrument manufacturer’s do not recommend ANY detergent

Source of confusion for end user

Need to challenge manufacturers

Enzymatic Cleaners

Organic substances which assist in the breakdown of soils

Facilitate the removal of blood and protein soils

Excellent for devices with lumens

Effectiveness dependent upon concentration, use temperature and contact time

Enzymatic Cleaners

Sold as liquid concentrates or powder

Generally more effective in warm water (110-140oF)

Enzyme activity can be inactivated above certain maximum temperatures (140oF)

Follow manufacturer’s directions

Use a thermometer – monitor water temperature

Principles of Cleaning

Must have manufacturer’s written instructions for cleaning of all devices processed

Follow all recommended steps using equipment recommended

Must wear PPE

Impervious gown, head cover, shoe covers, cuffed gloves, face shield

Manual Cleaning Process

May be the only cleaning process available

Items should be submerged, disassembled

Preferable to use 3-sink method; wash, rinse, rinse

Can also be used to remove deposits which were not removed during the pre-soak

Brush all serrations, crevices, tips, handles, and hinges.

Brushing should be done under the surface of the water to prevent aerosolization of contaminants.

Manual Cleaning – General Instructions

Handle instruments one at a time or in small numbers to avoid damage

Open hinged instruments

Disassemble multi-part instruments – keep parts together for easy reassembly after cleaning

Brush and flush all lumened devices

Clean all surfaces

Specialty Items

Cannulas, irrigation cannulas,irrigation/aspiration (I/A) handpieces, suction tips, cystotomes.

Use a brush of the appropriate size to clean the lumen; hold instrument and brush below the water surface

Manual Cleaning Detergents

Usually used for manual cleaning and as a pre-soak

Range from low foam to high foam products

Generally have neutral pH of 7 to 9

Sold as concentrates

Free rinsing

Always measure and dilute the detergent as specified by the detergent manufacturer

Water used to clean instruments should be discarded after each use

Manual Cleaning Implements

Soft bristle brushes, various sizes and lengths (no metal brushes)

Soft cloths

No abrasive items

No sponges

No materials which are permeable; i.e.. Wood

Implements used to clean instruments should be cleaned according to the manufacturer or at least daily, preferably after each use

Mechanical Cleaners

Do not put microsurgical instruments into a washer decontaminator unless it has a delicate cycle.

Can result in damage to instruments

Specialty Cleaner

Specialty cleaning and rinsing system for lumened devices such as Phaco and OZIL handpieces

Effectively cleans and rinses lumens

Must disinfect according to IFUs and document

Diamond Knives

The diamond knife is designed to make precision atraumatic cuts

The diamond knife has the sharpest cutting edge possible

Cost can range from $800 - $2,500 or more

Diamond Blade Knives

Cleaning: Immediately after using a diamond knife, the blade must be rinsed with demineralized water, preventing cell particles or viscoelastic materials from sticking to the blade.

Generally. ultrasonically clean holding the knife and suspending only the blade into the fluid.

The blade should not touch any other instruments or the sides of the cleaner.

Diamond Blade Knives

Never completely submerge a diamond knife in an ultrasonic cleaner.

At all time, (except cleaning) the blade should be in the retracted position to prevent damage.

Inspect with microscope.

Ultrasonic Cleaning

Uses sound waves transmitted through a solution

Sound waves produce tiny bubbles which implode - results in scouring action that cleans

Mechanical process = cavitation

Ultrasonic Cleaning

Effective to remove soils in hard-to-reach areas (box locks, mouth teeth, etc..)

Generally can only use detergents specifically formulated for ultrasonic cleaners - low foaming

Water temperatures usually 100 - 140 o F.

Can be used after manual cleaning

Ultrasonic Cleaning

Solution should be changed at least daily preferably after each use

Outbreaks of TASS have been associated with contaminated sonic baths

Unit should have a cover to contain aerosols

Items should not be stacked

Need to “de-gas” water

Ultrasonic Cleaning

Containers/baskets should have perforations; should be all metal mesh; no plastic

Should be located in Decontamination Area

cleaning process

more efficient than manual cleaning

Test the sonic for efficacy (daily???)

Testing Sonic

Rinsing

The most important part of the cleaning process

Essential to remove loosened debris

Should be performed with the volume and quality (sterile, distilled, or deionized water (if manual cleaning)

Water used to rinse instruments should be discarded after each use

Sterile distilled water recommended for final rinse to prevent mineral deposits and TASS

Lubrication

The use of instrument milk is beneficial to instruments to prevent corrosion and to keep moving parts from getting stiff.

However, not all instruments should be lubricated. The instrument manufacturer will indicate if this process is recommended.

Principles of Inspection/Assembly

All items should be prepared according to the device manufacturer’s written instructions (i.e. must the device be disassembled for sterilization?)

All hinged instruments should be in the open position to permit the sterilant to contact all surfaces of the jaws, blades, etc.

Items must be checked for cleanliness – the use of a lighted magnifying lamp is recommended to visualize defects such as cracked box locks, soils or missing tips.

Inspection

Best method is to use a microscope

Principles of Inspection/Assembly

All parts are present and functional

Use perforated or mesh bottom trays

All scissors should be tested for sharpness each time they are processed

Test that ratchets hold on clamps

Inspect hand held forceps that tips approximate

Test needle holders; ratchets hold and tips hold suture needle

Principles of Inspection/Assembly

Inspect that joints are not stiff

Use a lighted magnifying lamp or microscope to inspect

Inspect for rust, pitting, cracked box lock, etc.

Demagnetization of eye instruments may be needed

Separate delicate, sharp items

Use non-linting surgical towels, or paper sterilization bags to separate items inside set; not peel pack material

Refer to manufacturer’s IFUs regarding flushing of all lumened devices (AAMI states only for gravity cycles). Use sterile, distilled water

Ophthalmic Instruments

Look for defects:

Rusting common (especially if IUSS frequently used

Corrosion

Damage to tips/ teeth

Cords

Lumens (e.g. Phaco handpieces)

Stiffness

Sharpness

Spotting – Staining - Rust

Delicate Tips Require Protection

Can use small containers with silicone mat for individual instruments to provide protection.

General Guidelines for Packaging

Instrument Sets

Use specialty containers to keep delicate instruments in place and prevent damage in transport and cleaning.

The single most effective means to prevent damage to eye instruments is to place them in specialty protective containers

The basket or container of the correct size to prevent instrument damage

Handling Eye Instruments

Place instruments in the tray so that they do not touch each other.

Locate each instrument in the tray to prevent movement and possible damage during handling.

Always keep delicate tips protected with a tip guard when the instrument is not in use.

Protective Container - Cataract Set

Finger Mats May Not Provide Adequate Protection

Paper Plastic Pouches

Widely used because of the visibility of the contents.

However, according to AAMI and AORN pouches should be used for 1-2, light weight instruments.

If packaging instruments separately, select the correct size pouch.

Allow approximately 1” distance from the device and the pouch edges.

Must ensure instruments packaged to protect from damage

General Guidelines for Packaging

Individual Instruments/Small Items

Use correct size packaging

Do not use rubber bands to secure instruments

Paper Plastic Pouches

Double pouching is not required (AORN, AAMI)

May be used for small items which would be difficult to keep together

If double pouching, do not fold over the edges of inside pouch

Inside pouch must lay flat

Tip Protectors

Obtain the manufacturer’s instructions for use.

Some can “catch” onto the instruments – can result in damage

You can use any tip protector that has been approved for use in a sterilization system; foam sleeves, plastic; paper/plastic.

Make sure device can be held open with protector on (e.g. scissors, clamps).

Must have manufacturer’s data that sterilant will penetrate through the tip protector.

Chemical Indicators (Types)

External (Type I) – used to distinguish an item that has been in a sterilizer from an item that has not

Internal chemical indicators (Type 3-4-5)

Should be used inside and outside each package. For wrapped sets, the internal chemical indicator should be located in the center of the pack, not the top.

Type 3 – responds to one parameter

Type 4 – responds to 2 or more parameters

Should use at least a Type 4 CI

Chemical Indicators

Type 5 – integrating indicators – correlate to the action of a biological test

Cannot substitute for a BI test

Type 6 – emulating indicators that respond to a specific cycle type, temperature and exposure time

Labeling Packages

Use a marking pen containing non-toxic, permanent ink and approved for the intended process (e.g., steam sterilization cycles).

Need documentation that marker is non-toxic.

Packages - label on the indicator tape used to close the package, never on the wrapping material itself.

Paper–plastic pouches - label only on the plastic side or on sterilization tape.

If a package is labeled directly on the packaging material, the

marker could damage the packaging material.

Exception is the plastic side of paper plastic pouches.

Table Top Sterilizers

Many ASCs use table top sterilizers

A table-top sterilizer is a ”compact steam sterilizer that has a chamber volume of not more than two cubic feet and that generates its own steam when distilled or deionized water is added by the user” (ANSI/AAMI ST79).

Table-top sterilizers -commonly found in smaller surgery centers where a high volume of sterilization processing does not take place.

Also found in doctors’ and dental offices.

Cycles

The device manufacturer’s sterilization instructions should always be followed

If the cycles provided by the sterilizer cannot be adjusted to conform to the device manufacturer’s instructions, the device should not be processed in that sterilizer.

Conventional Steam Sterilizers

Read the IFUs for exposure time, temperature and cycle time

Many have CJD cycles ONLY

Many have European temperatures only (e.g. 273oF)

Must reconcile IFU information

May have to separate sets to meet IFUs

E.g. some instruments require 10 minutes exposure

Water Quality

Water quality is just as important for table-top units as for sterilizers that use boiler-generated steam.

Distilled or deionized water is recommended to prevent the buildup of minerals in the reservoir and on processed devices.

Each day, before the sterilizer is used for the first time, the reservoir should be checked to ensure that there is enough water for the number of loads to be processed.

Maintenance

Perform all the recommended maintenance of the tabletop sterilizer

Document all maintenance (e.g. reservoir cleaned, gaskets cleaned, etc.

Documentation

All cycles run should be documented

All items processed must be documented

Specific name of device/tray

Quantity

All items must be identified with a lot control number (to facilitate recall)

Must include date sterilized, sterilizer #, load number

Expiration date or event related statement

Traceability to the patient if posterior eye tissue surgery (CJD)

Summary

Best practices for processing ophthalmic instruments requires knowledge of the standards and recommendations to prevent TASS

Manufacturers IFUs

Effective cleaning

Correct packaging methods and materials

Effective sterilization –

Processing equipment in good condition

Proper handling after sterilization

Monitoring of staff compliance with all stated policies and manufacturers’ instructions

Training and competencies for staff

Conclusion - The End

Successful patient outcomes require we develop effective policies, train staff and monitor for compliance

Careful handling of ophthalmic instruments will keep patients safe and reduce costs.

References

AAMI. Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. ST-79, 2017.

AORN. Standards and Recommended Practices. “Selection and Use of Packaging Systems”, AORN.

Centers for Disease Control (Hospital Infection Control Guidelines) 2008

American Society of Cataract & Refractive Surgeons. White Paper on TASS (2006).

The Basics of Sterile Processing textbook, 6th edition, Sterile Processing University, 2016.

Questions??????

1

2

3

4

5

6

7

8

9

10

11

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Page 8: Cleaning Protocols and Equipment - APIC MT€¦ · Identify AAMI recommended cleaning protocols to prevent TASS Review the AAMI preparation recommendations for instruments and sets

3/13/2019

8

Keeping Ophthalmic Instruments Safe

Nancy Chobin, RN, AAS, ACSP, CSPM, CFER

CEO Sterile Processing University

Lebanon, NJ

Copyright 2019

Objectives

Identify AAMI recommended cleaning protocols to prevent TASS

Review the AAMI preparation recommendations for instruments and sets

Review care and handling of ophthalmic instruments

Background

Time to perform a cataract procedure has decreased15-20 minutes.

The cost for a set of instruments can range from $6,000 to $8,000 or more

Urgency to turn the instruments around for the next case.

Instruments come in contact with the eye and thus body fluids.

They are considered contaminated and must receive the entire cleaning and sterilization process between patients.

Manufacturer’s Instructions

Instrument manufacturer should:

specify the pH of detergent (e.g. neutral pH)

may recommend a pre-soak in an enzymatic cleaner to help remove protein soils (e.g. body fluids)

specify if any special cleaning implements are needed (e.g. to clean out lumens).

Specify water quality for cleaning and rinsing

However, need to reconcile this information with AAMI and ASORN, AORN, ASCRS and the CDC.

Manufacturer’s Instructions

Also known as Instructions for Use (IFUs)

Keep on file - readily available to processing personnel.

Ensure IFUs followed each and every time the instrument is processed.

Employee training should complement the AAMI guidelines as well as manufacturers’ instructions

Eye instrumentation is extremely delicate and as such requires very special handling and processing to prevent damage. All personnel handling eye instrumentation should ensure careful handling.

Example of Steam Sterilization IFU

Prevacuum High Temperature Autoclave: 274˚F (134˚C) for 3 minutes; wrapped.

NOTE: As per ANSI/AAMI ST79:2010 and A1:2010 270˚F (132˚C) for 4 minutes and 275˚F (135˚C) for 3 minutes are acceptable minimum cycle times for dynamic-air-removal steam sterilization cycles.

Standard Gravity Autoclave: 250˚F (121˚C) for 30 minutes; wrapped.

High Speed (Flash) Autoclave: 270˚F (132˚C) for 10 minutes; unwrapped.

Training and Competencies

Employee competencies should be verified in the processing protocols for processing ophthalmic instruments

Competencies should be verified initially and annually

Utilize resources such as ophthalmic instrument company's educational materials

Reconcile with national standards

Cleaning

Removal of contamination from an item to the extent necessary for further processing or for the intended use.

Involves the use of detergent and water, of adherent visible soil (i.e. blood, pus, protein) from the surfaces, crevices, serrations, jaws and lumens of instruments, devices and equipment, by a manual or mechanical process.

Due to their design, eye instrument challenging to clean

Very small lumens, very delicate tips, can easily break/damage

Pre-Cleaning in Room

Treat with demineralized water to prevent drying of bioburden.

Saline, disinfectants, and chlorinated solutions can cause pitting

and corrosion and should never be used for soaking instruments

Instruments should not remain in water for lengthy periods of time.

–– Biofilms may form, particularly within lumens.

Decontamination

According to OSHA, “the use of physical or chemical means to remove, inactivate, or destroy blood-borne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, use, or disposal.” [29 CFR 1910.1030]

NOTE—Generally used in health care facilities to refer to all pathogenic organisms, not just those transmitted by blood

First and most critical step in breaking the chain of disease transmission

Why Is Cleaning Important?

Process of disinfection or sterilization dependent upon direct contact of the sterilant or disinfectant with the surface of the item

Protein left on items can be “baked on” in the sterilizer

Why are some facilities only “wiping off” the instruments? “Cleaning with water? Alcohol?

TASS – Focus

Toxic Anterior Segment Syndrome (TASS) – main focus by AAMI and AORN

TASS - an acute inflammatory response of the anterior chamber of the eye.

May lead to severe visual impairment if it is not recognized and treated in a timely manner.

Many causes including detergents, water quality, steam quality, instruments, etc.

Major concern is when endotoxins form

Causes of TASS (ASCRS)*

Detergent residues (in general)

Endotoxins

Preservatives

Residues from sterilization processing

Residues of detergents inside a reusable cannula or instrument

Cement sealant on bags of irrigating solution which has leached out

All can induce TASS and cause severe damage to ocular tissue

* American Society of Cataract and Refractive Surgeons

TASS

Particular care must be taken in the processing of intraocular surgical instruments to help ensure that foreign substances or materials associated with the instruments will not be introduced into the anterior chamber of the eye during surgery.

TASS

Outbreaks of TASS have often been linked to the failure to follow the processing procedures recommended by the instrument manufacturer

Specific instrument cleaning and sterilization recommendations intended to diminish the risk of TASS associated with intraocular surgical instruments have been published by the American Society for Cataract and Refractive Surgery (ASCRS, 2006).

Also in AAMI ST-79 as an Annex

ASCRS Recommendations

An adequate inventory of the necessary intraocular surgical instruments should be maintained in order to allow for the timely processing of instruments between cases.

Major issue in surgery centers

Insufficient inventory of instruments leads to short cuts in cleaning

ASCRS Recommendations

Adequate time must be allowed for processing instruments according to the manufacturer’s instructions; otherwise, the cleaning and sterilization of the instruments will be ineffective.

ASCRS Recommendations

A designated cleaning area and equipment specific to the cleaning of intraocular surgical instruments should be identified.

Whenever possible, intraocular surgical instruments should be processed separately from general surgical instruments and equipment in order to reduce the potential for cross-contamination by material or residue from the general surgical instruments

ASCRS Recommendations

Instruments should be pre-cleaned immediately following use.

Gross debris should be removed, and instrument lumens should be flushed with sterile distilled water or another suitable agent as recommended in the room at the end of the procedure

ASCRS Recommendations

Only cleaning agents that have been recommended by the manufacturer should be used.

Particular attention should be paid to the specified concentration of cleaning agent and to the recommended water quality.

ASCRS Recommendations

Final rinsing of the instrument should be performed with sterile, distilled, or deionized water, unless otherwise specified by the manufacturer.

The water used to clean or rinse instruments should be discarded after each use.

ASCRS Recommendations

If an ultrasonic cleaner is used to process the instruments, it should be emptied, cleaned, rinsed, and dried at least daily or, preferably, after each use.

Brushes and other cleaning tools should be cleaned and sterilized as recommended by the manufacturer at least daily or, preferably, after each use.

ASCRS Recommendations

Cleaning and sterilization equipment should be properly maintained.

Foreign materials such as endotoxin or heavy metals may be deposited onto the instruments during processing and induce TASS

Water Quality

Water used to for the final rinse of the device should have a low endotoxin content to avoid pyrogens on processed

devices.

Can lead to pyrogenic reactions (i.e., fever) in patients.

Adequate cleaning and rinsing should result in low bioburden

Essential to the effectiveness of terminal sterilization and to the protection of patients from pyrogens.

Physical Area

Separate area – dedicated to cleaning of ophthalmic instruments

Away from any other type of surgical instruments

Temp 60-65oF

Humidity 30-60%

Air exchanges 10/hour negative

Monitor temperature and humidity daily and document

FIRST STEP

Must have manufacturer’s instructions for cleaning of all devices; method, implements and chemicals recommended

Steps in the Cleaning Process

Pre-Cleaning in room

Contain contaminated items at the point of use

Transport to Decontamination (confined and contained)

Sort

Soak

Wash

Rinse/Dry

Pre-Cleaning - Transport

Instruments should be pre-cleaned immediately following use

Remove gross debris and flush lumens with sterile distilled water (or other agent as recommended by the instrument manufacturer)

Keep instruments moist to avoid drying of soils

Many now recommend cleaning immediately or within 30 minutes of use

Transport in closed container (confine/contain)

Container should be labeled as biohazard (OSHA)

Soaking

Can pre-soak with a detergent

Use of enzyme detergents preferred – but only if recommended by the instrument manufacturer

Assists in the loosening of soils to facilitate cleaning

Do NOT soak in fluids for prolonged periods of time - biofilms can form

Generally form on any surface that is exposed to non-sterile water or other liquids and is consistently found in many environments including industrial and medical systems

use enzymatic gels or foam

Biofiolms

Are produced by microorganisms and consist of a sticky rigid structure of organic contaminates

Slime layer anchored firmly to a surface and provides a protective environment for microorganisms to grow

Cleaning

Need to take special precautions with eye instruments due to

Delicate nature of the design

Sensitivity of eye tissue

Cleaning becomes a challenge

Manual cleaning may be only validated method

Manual cleaning is not as controlled (standardized) as mechanical cleaning

Dilemma

Some eye instrument manufacturer’s do not recommend ANY detergent

Source of confusion for end user

Need to challenge manufacturers

Enzymatic Cleaners

Organic substances which assist in the breakdown of soils

Facilitate the removal of blood and protein soils

Excellent for devices with lumens

Effectiveness dependent upon concentration, use temperature and contact time

Enzymatic Cleaners

Sold as liquid concentrates or powder

Generally more effective in warm water (110-140oF)

Enzyme activity can be inactivated above certain maximum temperatures (140oF)

Follow manufacturer’s directions

Use a thermometer – monitor water temperature

Principles of Cleaning

Must have manufacturer’s written instructions for cleaning of all devices processed

Follow all recommended steps using equipment recommended

Must wear PPE

Impervious gown, head cover, shoe covers, cuffed gloves, face shield

Manual Cleaning Process

May be the only cleaning process available

Items should be submerged, disassembled

Preferable to use 3-sink method; wash, rinse, rinse

Can also be used to remove deposits which were not removed during the pre-soak

Brush all serrations, crevices, tips, handles, and hinges.

Brushing should be done under the surface of the water to prevent aerosolization of contaminants.

Manual Cleaning – General Instructions

Handle instruments one at a time or in small numbers to avoid damage

Open hinged instruments

Disassemble multi-part instruments – keep parts together for easy reassembly after cleaning

Brush and flush all lumened devices

Clean all surfaces

Specialty Items

Cannulas, irrigation cannulas,irrigation/aspiration (I/A) handpieces, suction tips, cystotomes.

Use a brush of the appropriate size to clean the lumen; hold instrument and brush below the water surface

Manual Cleaning Detergents

Usually used for manual cleaning and as a pre-soak

Range from low foam to high foam products

Generally have neutral pH of 7 to 9

Sold as concentrates

Free rinsing

Always measure and dilute the detergent as specified by the detergent manufacturer

Water used to clean instruments should be discarded after each use

Manual Cleaning Implements

Soft bristle brushes, various sizes and lengths (no metal brushes)

Soft cloths

No abrasive items

No sponges

No materials which are permeable; i.e.. Wood

Implements used to clean instruments should be cleaned according to the manufacturer or at least daily, preferably after each use

Mechanical Cleaners

Do not put microsurgical instruments into a washer decontaminator unless it has a delicate cycle.

Can result in damage to instruments

Specialty Cleaner

Specialty cleaning and rinsing system for lumened devices such as Phaco and OZIL handpieces

Effectively cleans and rinses lumens

Must disinfect according to IFUs and document

Diamond Knives

The diamond knife is designed to make precision atraumatic cuts

The diamond knife has the sharpest cutting edge possible

Cost can range from $800 - $2,500 or more

Diamond Blade Knives

Cleaning: Immediately after using a diamond knife, the blade must be rinsed with demineralized water, preventing cell particles or viscoelastic materials from sticking to the blade.

Generally. ultrasonically clean holding the knife and suspending only the blade into the fluid.

The blade should not touch any other instruments or the sides of the cleaner.

Diamond Blade Knives

Never completely submerge a diamond knife in an ultrasonic cleaner.

At all time, (except cleaning) the blade should be in the retracted position to prevent damage.

Inspect with microscope.

Ultrasonic Cleaning

Uses sound waves transmitted through a solution

Sound waves produce tiny bubbles which implode - results in scouring action that cleans

Mechanical process = cavitation

Ultrasonic Cleaning

Effective to remove soils in hard-to-reach areas (box locks, mouth teeth, etc..)

Generally can only use detergents specifically formulated for ultrasonic cleaners - low foaming

Water temperatures usually 100 - 140 o F.

Can be used after manual cleaning

Ultrasonic Cleaning

Solution should be changed at least daily preferably after each use

Outbreaks of TASS have been associated with contaminated sonic baths

Unit should have a cover to contain aerosols

Items should not be stacked

Need to “de-gas” water

Ultrasonic Cleaning

Containers/baskets should have perforations; should be all metal mesh; no plastic

Should be located in Decontamination Area

cleaning process

more efficient than manual cleaning

Test the sonic for efficacy (daily???)

Testing Sonic

Rinsing

The most important part of the cleaning process

Essential to remove loosened debris

Should be performed with the volume and quality (sterile, distilled, or deionized water (if manual cleaning)

Water used to rinse instruments should be discarded after each use

Sterile distilled water recommended for final rinse to prevent mineral deposits and TASS

Lubrication

The use of instrument milk is beneficial to instruments to prevent corrosion and to keep moving parts from getting stiff.

However, not all instruments should be lubricated. The instrument manufacturer will indicate if this process is recommended.

Principles of Inspection/Assembly

All items should be prepared according to the device manufacturer’s written instructions (i.e. must the device be disassembled for sterilization?)

All hinged instruments should be in the open position to permit the sterilant to contact all surfaces of the jaws, blades, etc.

Items must be checked for cleanliness – the use of a lighted magnifying lamp is recommended to visualize defects such as cracked box locks, soils or missing tips.

Inspection

Best method is to use a microscope

Principles of Inspection/Assembly

All parts are present and functional

Use perforated or mesh bottom trays

All scissors should be tested for sharpness each time they are processed

Test that ratchets hold on clamps

Inspect hand held forceps that tips approximate

Test needle holders; ratchets hold and tips hold suture needle

Principles of Inspection/Assembly

Inspect that joints are not stiff

Use a lighted magnifying lamp or microscope to inspect

Inspect for rust, pitting, cracked box lock, etc.

Demagnetization of eye instruments may be needed

Separate delicate, sharp items

Use non-linting surgical towels, or paper sterilization bags to separate items inside set; not peel pack material

Refer to manufacturer’s IFUs regarding flushing of all lumened devices (AAMI states only for gravity cycles). Use sterile, distilled water

Ophthalmic Instruments

Look for defects:

Rusting common (especially if IUSS frequently used

Corrosion

Damage to tips/ teeth

Cords

Lumens (e.g. Phaco handpieces)

Stiffness

Sharpness

Spotting – Staining - Rust

Delicate Tips Require Protection

Can use small containers with silicone mat for individual instruments to provide protection.

General Guidelines for Packaging

Instrument Sets

Use specialty containers to keep delicate instruments in place and prevent damage in transport and cleaning.

The single most effective means to prevent damage to eye instruments is to place them in specialty protective containers

The basket or container of the correct size to prevent instrument damage

Handling Eye Instruments

Place instruments in the tray so that they do not touch each other.

Locate each instrument in the tray to prevent movement and possible damage during handling.

Always keep delicate tips protected with a tip guard when the instrument is not in use.

Protective Container - Cataract Set

Finger Mats May Not Provide Adequate Protection

Paper Plastic Pouches

Widely used because of the visibility of the contents.

However, according to AAMI and AORN pouches should be used for 1-2, light weight instruments.

If packaging instruments separately, select the correct size pouch.

Allow approximately 1” distance from the device and the pouch edges.

Must ensure instruments packaged to protect from damage

General Guidelines for Packaging

Individual Instruments/Small Items

Use correct size packaging

Do not use rubber bands to secure instruments

Paper Plastic Pouches

Double pouching is not required (AORN, AAMI)

May be used for small items which would be difficult to keep together

If double pouching, do not fold over the edges of inside pouch

Inside pouch must lay flat

Tip Protectors

Obtain the manufacturer’s instructions for use.

Some can “catch” onto the instruments – can result in damage

You can use any tip protector that has been approved for use in a sterilization system; foam sleeves, plastic; paper/plastic.

Make sure device can be held open with protector on (e.g. scissors, clamps).

Must have manufacturer’s data that sterilant will penetrate through the tip protector.

Chemical Indicators (Types)

External (Type I) – used to distinguish an item that has been in a sterilizer from an item that has not

Internal chemical indicators (Type 3-4-5)

Should be used inside and outside each package. For wrapped sets, the internal chemical indicator should be located in the center of the pack, not the top.

Type 3 – responds to one parameter

Type 4 – responds to 2 or more parameters

Should use at least a Type 4 CI

Chemical Indicators

Type 5 – integrating indicators – correlate to the action of a biological test

Cannot substitute for a BI test

Type 6 – emulating indicators that respond to a specific cycle type, temperature and exposure time

Labeling Packages

Use a marking pen containing non-toxic, permanent ink and approved for the intended process (e.g., steam sterilization cycles).

Need documentation that marker is non-toxic.

Packages - label on the indicator tape used to close the package, never on the wrapping material itself.

Paper–plastic pouches - label only on the plastic side or on sterilization tape.

If a package is labeled directly on the packaging material, the

marker could damage the packaging material.

Exception is the plastic side of paper plastic pouches.

Table Top Sterilizers

Many ASCs use table top sterilizers

A table-top sterilizer is a ”compact steam sterilizer that has a chamber volume of not more than two cubic feet and that generates its own steam when distilled or deionized water is added by the user” (ANSI/AAMI ST79).

Table-top sterilizers -commonly found in smaller surgery centers where a high volume of sterilization processing does not take place.

Also found in doctors’ and dental offices.

Cycles

The device manufacturer’s sterilization instructions should always be followed

If the cycles provided by the sterilizer cannot be adjusted to conform to the device manufacturer’s instructions, the device should not be processed in that sterilizer.

Conventional Steam Sterilizers

Read the IFUs for exposure time, temperature and cycle time

Many have CJD cycles ONLY

Many have European temperatures only (e.g. 273oF)

Must reconcile IFU information

May have to separate sets to meet IFUs

E.g. some instruments require 10 minutes exposure

Water Quality

Water quality is just as important for table-top units as for sterilizers that use boiler-generated steam.

Distilled or deionized water is recommended to prevent the buildup of minerals in the reservoir and on processed devices.

Each day, before the sterilizer is used for the first time, the reservoir should be checked to ensure that there is enough water for the number of loads to be processed.

Maintenance

Perform all the recommended maintenance of the tabletop sterilizer

Document all maintenance (e.g. reservoir cleaned, gaskets cleaned, etc.

Documentation

All cycles run should be documented

All items processed must be documented

Specific name of device/tray

Quantity

All items must be identified with a lot control number (to facilitate recall)

Must include date sterilized, sterilizer #, load number

Expiration date or event related statement

Traceability to the patient if posterior eye tissue surgery (CJD)

Summary

Best practices for processing ophthalmic instruments requires knowledge of the standards and recommendations to prevent TASS

Manufacturers IFUs

Effective cleaning

Correct packaging methods and materials

Effective sterilization –

Processing equipment in good condition

Proper handling after sterilization

Monitoring of staff compliance with all stated policies and manufacturers’ instructions

Training and competencies for staff

Conclusion - The End

Successful patient outcomes require we develop effective policies, train staff and monitor for compliance

Careful handling of ophthalmic instruments will keep patients safe and reduce costs.

References

AAMI. Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. ST-79, 2017.

AORN. Standards and Recommended Practices. “Selection and Use of Packaging Systems”, AORN.

Centers for Disease Control (Hospital Infection Control Guidelines) 2008

American Society of Cataract & Refractive Surgeons. White Paper on TASS (2006).

The Basics of Sterile Processing textbook, 6th edition, Sterile Processing University, 2016.

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Page 9: Cleaning Protocols and Equipment - APIC MT€¦ · Identify AAMI recommended cleaning protocols to prevent TASS Review the AAMI preparation recommendations for instruments and sets

3/13/2019

9

Keeping Ophthalmic Instruments Safe

Nancy Chobin, RN, AAS, ACSP, CSPM, CFER

CEO Sterile Processing University

Lebanon, NJ

Copyright 2019

Objectives

Identify AAMI recommended cleaning protocols to prevent TASS

Review the AAMI preparation recommendations for instruments and sets

Review care and handling of ophthalmic instruments

Background

Time to perform a cataract procedure has decreased15-20 minutes.

The cost for a set of instruments can range from $6,000 to $8,000 or more

Urgency to turn the instruments around for the next case.

Instruments come in contact with the eye and thus body fluids.

They are considered contaminated and must receive the entire cleaning and sterilization process between patients.

Manufacturer’s Instructions

Instrument manufacturer should:

specify the pH of detergent (e.g. neutral pH)

may recommend a pre-soak in an enzymatic cleaner to help remove protein soils (e.g. body fluids)

specify if any special cleaning implements are needed (e.g. to clean out lumens).

Specify water quality for cleaning and rinsing

However, need to reconcile this information with AAMI and ASORN, AORN, ASCRS and the CDC.

Manufacturer’s Instructions

Also known as Instructions for Use (IFUs)

Keep on file - readily available to processing personnel.

Ensure IFUs followed each and every time the instrument is processed.

Employee training should complement the AAMI guidelines as well as manufacturers’ instructions

Eye instrumentation is extremely delicate and as such requires very special handling and processing to prevent damage. All personnel handling eye instrumentation should ensure careful handling.

Example of Steam Sterilization IFU

Prevacuum High Temperature Autoclave: 274˚F (134˚C) for 3 minutes; wrapped.

NOTE: As per ANSI/AAMI ST79:2010 and A1:2010 270˚F (132˚C) for 4 minutes and 275˚F (135˚C) for 3 minutes are acceptable minimum cycle times for dynamic-air-removal steam sterilization cycles.

Standard Gravity Autoclave: 250˚F (121˚C) for 30 minutes; wrapped.

High Speed (Flash) Autoclave: 270˚F (132˚C) for 10 minutes; unwrapped.

Training and Competencies

Employee competencies should be verified in the processing protocols for processing ophthalmic instruments

Competencies should be verified initially and annually

Utilize resources such as ophthalmic instrument company's educational materials

Reconcile with national standards

Cleaning

Removal of contamination from an item to the extent necessary for further processing or for the intended use.

Involves the use of detergent and water, of adherent visible soil (i.e. blood, pus, protein) from the surfaces, crevices, serrations, jaws and lumens of instruments, devices and equipment, by a manual or mechanical process.

Due to their design, eye instrument challenging to clean

Very small lumens, very delicate tips, can easily break/damage

Pre-Cleaning in Room

Treat with demineralized water to prevent drying of bioburden.

Saline, disinfectants, and chlorinated solutions can cause pitting

and corrosion and should never be used for soaking instruments

Instruments should not remain in water for lengthy periods of time.

–– Biofilms may form, particularly within lumens.

Decontamination

According to OSHA, “the use of physical or chemical means to remove, inactivate, or destroy blood-borne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, use, or disposal.” [29 CFR 1910.1030]

NOTE—Generally used in health care facilities to refer to all pathogenic organisms, not just those transmitted by blood

First and most critical step in breaking the chain of disease transmission

Why Is Cleaning Important?

Process of disinfection or sterilization dependent upon direct contact of the sterilant or disinfectant with the surface of the item

Protein left on items can be “baked on” in the sterilizer

Why are some facilities only “wiping off” the instruments? “Cleaning with water? Alcohol?

TASS – Focus

Toxic Anterior Segment Syndrome (TASS) – main focus by AAMI and AORN

TASS - an acute inflammatory response of the anterior chamber of the eye.

May lead to severe visual impairment if it is not recognized and treated in a timely manner.

Many causes including detergents, water quality, steam quality, instruments, etc.

Major concern is when endotoxins form

Causes of TASS (ASCRS)*

Detergent residues (in general)

Endotoxins

Preservatives

Residues from sterilization processing

Residues of detergents inside a reusable cannula or instrument

Cement sealant on bags of irrigating solution which has leached out

All can induce TASS and cause severe damage to ocular tissue

* American Society of Cataract and Refractive Surgeons

TASS

Particular care must be taken in the processing of intraocular surgical instruments to help ensure that foreign substances or materials associated with the instruments will not be introduced into the anterior chamber of the eye during surgery.

TASS

Outbreaks of TASS have often been linked to the failure to follow the processing procedures recommended by the instrument manufacturer

Specific instrument cleaning and sterilization recommendations intended to diminish the risk of TASS associated with intraocular surgical instruments have been published by the American Society for Cataract and Refractive Surgery (ASCRS, 2006).

Also in AAMI ST-79 as an Annex

ASCRS Recommendations

An adequate inventory of the necessary intraocular surgical instruments should be maintained in order to allow for the timely processing of instruments between cases.

Major issue in surgery centers

Insufficient inventory of instruments leads to short cuts in cleaning

ASCRS Recommendations

Adequate time must be allowed for processing instruments according to the manufacturer’s instructions; otherwise, the cleaning and sterilization of the instruments will be ineffective.

ASCRS Recommendations

A designated cleaning area and equipment specific to the cleaning of intraocular surgical instruments should be identified.

Whenever possible, intraocular surgical instruments should be processed separately from general surgical instruments and equipment in order to reduce the potential for cross-contamination by material or residue from the general surgical instruments

ASCRS Recommendations

Instruments should be pre-cleaned immediately following use.

Gross debris should be removed, and instrument lumens should be flushed with sterile distilled water or another suitable agent as recommended in the room at the end of the procedure

ASCRS Recommendations

Only cleaning agents that have been recommended by the manufacturer should be used.

Particular attention should be paid to the specified concentration of cleaning agent and to the recommended water quality.

ASCRS Recommendations

Final rinsing of the instrument should be performed with sterile, distilled, or deionized water, unless otherwise specified by the manufacturer.

The water used to clean or rinse instruments should be discarded after each use.

ASCRS Recommendations

If an ultrasonic cleaner is used to process the instruments, it should be emptied, cleaned, rinsed, and dried at least daily or, preferably, after each use.

Brushes and other cleaning tools should be cleaned and sterilized as recommended by the manufacturer at least daily or, preferably, after each use.

ASCRS Recommendations

Cleaning and sterilization equipment should be properly maintained.

Foreign materials such as endotoxin or heavy metals may be deposited onto the instruments during processing and induce TASS

Water Quality

Water used to for the final rinse of the device should have a low endotoxin content to avoid pyrogens on processed

devices.

Can lead to pyrogenic reactions (i.e., fever) in patients.

Adequate cleaning and rinsing should result in low bioburden

Essential to the effectiveness of terminal sterilization and to the protection of patients from pyrogens.

Physical Area

Separate area – dedicated to cleaning of ophthalmic instruments

Away from any other type of surgical instruments

Temp 60-65oF

Humidity 30-60%

Air exchanges 10/hour negative

Monitor temperature and humidity daily and document

FIRST STEP

Must have manufacturer’s instructions for cleaning of all devices; method, implements and chemicals recommended

Steps in the Cleaning Process

Pre-Cleaning in room

Contain contaminated items at the point of use

Transport to Decontamination (confined and contained)

Sort

Soak

Wash

Rinse/Dry

Pre-Cleaning - Transport

Instruments should be pre-cleaned immediately following use

Remove gross debris and flush lumens with sterile distilled water (or other agent as recommended by the instrument manufacturer)

Keep instruments moist to avoid drying of soils

Many now recommend cleaning immediately or within 30 minutes of use

Transport in closed container (confine/contain)

Container should be labeled as biohazard (OSHA)

Soaking

Can pre-soak with a detergent

Use of enzyme detergents preferred – but only if recommended by the instrument manufacturer

Assists in the loosening of soils to facilitate cleaning

Do NOT soak in fluids for prolonged periods of time - biofilms can form

Generally form on any surface that is exposed to non-sterile water or other liquids and is consistently found in many environments including industrial and medical systems

use enzymatic gels or foam

Biofiolms

Are produced by microorganisms and consist of a sticky rigid structure of organic contaminates

Slime layer anchored firmly to a surface and provides a protective environment for microorganisms to grow

Cleaning

Need to take special precautions with eye instruments due to

Delicate nature of the design

Sensitivity of eye tissue

Cleaning becomes a challenge

Manual cleaning may be only validated method

Manual cleaning is not as controlled (standardized) as mechanical cleaning

Dilemma

Some eye instrument manufacturer’s do not recommend ANY detergent

Source of confusion for end user

Need to challenge manufacturers

Enzymatic Cleaners

Organic substances which assist in the breakdown of soils

Facilitate the removal of blood and protein soils

Excellent for devices with lumens

Effectiveness dependent upon concentration, use temperature and contact time

Enzymatic Cleaners

Sold as liquid concentrates or powder

Generally more effective in warm water (110-140oF)

Enzyme activity can be inactivated above certain maximum temperatures (140oF)

Follow manufacturer’s directions

Use a thermometer – monitor water temperature

Principles of Cleaning

Must have manufacturer’s written instructions for cleaning of all devices processed

Follow all recommended steps using equipment recommended

Must wear PPE

Impervious gown, head cover, shoe covers, cuffed gloves, face shield

Manual Cleaning Process

May be the only cleaning process available

Items should be submerged, disassembled

Preferable to use 3-sink method; wash, rinse, rinse

Can also be used to remove deposits which were not removed during the pre-soak

Brush all serrations, crevices, tips, handles, and hinges.

Brushing should be done under the surface of the water to prevent aerosolization of contaminants.

Manual Cleaning – General Instructions

Handle instruments one at a time or in small numbers to avoid damage

Open hinged instruments

Disassemble multi-part instruments – keep parts together for easy reassembly after cleaning

Brush and flush all lumened devices

Clean all surfaces

Specialty Items

Cannulas, irrigation cannulas,irrigation/aspiration (I/A) handpieces, suction tips, cystotomes.

Use a brush of the appropriate size to clean the lumen; hold instrument and brush below the water surface

Manual Cleaning Detergents

Usually used for manual cleaning and as a pre-soak

Range from low foam to high foam products

Generally have neutral pH of 7 to 9

Sold as concentrates

Free rinsing

Always measure and dilute the detergent as specified by the detergent manufacturer

Water used to clean instruments should be discarded after each use

Manual Cleaning Implements

Soft bristle brushes, various sizes and lengths (no metal brushes)

Soft cloths

No abrasive items

No sponges

No materials which are permeable; i.e.. Wood

Implements used to clean instruments should be cleaned according to the manufacturer or at least daily, preferably after each use

Mechanical Cleaners

Do not put microsurgical instruments into a washer decontaminator unless it has a delicate cycle.

Can result in damage to instruments

Specialty Cleaner

Specialty cleaning and rinsing system for lumened devices such as Phaco and OZIL handpieces

Effectively cleans and rinses lumens

Must disinfect according to IFUs and document

Diamond Knives

The diamond knife is designed to make precision atraumatic cuts

The diamond knife has the sharpest cutting edge possible

Cost can range from $800 - $2,500 or more

Diamond Blade Knives

Cleaning: Immediately after using a diamond knife, the blade must be rinsed with demineralized water, preventing cell particles or viscoelastic materials from sticking to the blade.

Generally. ultrasonically clean holding the knife and suspending only the blade into the fluid.

The blade should not touch any other instruments or the sides of the cleaner.

Diamond Blade Knives

Never completely submerge a diamond knife in an ultrasonic cleaner.

At all time, (except cleaning) the blade should be in the retracted position to prevent damage.

Inspect with microscope.

Ultrasonic Cleaning

Uses sound waves transmitted through a solution

Sound waves produce tiny bubbles which implode - results in scouring action that cleans

Mechanical process = cavitation

Ultrasonic Cleaning

Effective to remove soils in hard-to-reach areas (box locks, mouth teeth, etc..)

Generally can only use detergents specifically formulated for ultrasonic cleaners - low foaming

Water temperatures usually 100 - 140 o F.

Can be used after manual cleaning

Ultrasonic Cleaning

Solution should be changed at least daily preferably after each use

Outbreaks of TASS have been associated with contaminated sonic baths

Unit should have a cover to contain aerosols

Items should not be stacked

Need to “de-gas” water

Ultrasonic Cleaning

Containers/baskets should have perforations; should be all metal mesh; no plastic

Should be located in Decontamination Area

cleaning process

more efficient than manual cleaning

Test the sonic for efficacy (daily???)

Testing Sonic

Rinsing

The most important part of the cleaning process

Essential to remove loosened debris

Should be performed with the volume and quality (sterile, distilled, or deionized water (if manual cleaning)

Water used to rinse instruments should be discarded after each use

Sterile distilled water recommended for final rinse to prevent mineral deposits and TASS

Lubrication

The use of instrument milk is beneficial to instruments to prevent corrosion and to keep moving parts from getting stiff.

However, not all instruments should be lubricated. The instrument manufacturer will indicate if this process is recommended.

Principles of Inspection/Assembly

All items should be prepared according to the device manufacturer’s written instructions (i.e. must the device be disassembled for sterilization?)

All hinged instruments should be in the open position to permit the sterilant to contact all surfaces of the jaws, blades, etc.

Items must be checked for cleanliness – the use of a lighted magnifying lamp is recommended to visualize defects such as cracked box locks, soils or missing tips.

Inspection

Best method is to use a microscope

Principles of Inspection/Assembly

All parts are present and functional

Use perforated or mesh bottom trays

All scissors should be tested for sharpness each time they are processed

Test that ratchets hold on clamps

Inspect hand held forceps that tips approximate

Test needle holders; ratchets hold and tips hold suture needle

Principles of Inspection/Assembly

Inspect that joints are not stiff

Use a lighted magnifying lamp or microscope to inspect

Inspect for rust, pitting, cracked box lock, etc.

Demagnetization of eye instruments may be needed

Separate delicate, sharp items

Use non-linting surgical towels, or paper sterilization bags to separate items inside set; not peel pack material

Refer to manufacturer’s IFUs regarding flushing of all lumened devices (AAMI states only for gravity cycles). Use sterile, distilled water

Ophthalmic Instruments

Look for defects:

Rusting common (especially if IUSS frequently used

Corrosion

Damage to tips/ teeth

Cords

Lumens (e.g. Phaco handpieces)

Stiffness

Sharpness

Spotting – Staining - Rust

Delicate Tips Require Protection

Can use small containers with silicone mat for individual instruments to provide protection.

General Guidelines for Packaging

Instrument Sets

Use specialty containers to keep delicate instruments in place and prevent damage in transport and cleaning.

The single most effective means to prevent damage to eye instruments is to place them in specialty protective containers

The basket or container of the correct size to prevent instrument damage

Handling Eye Instruments

Place instruments in the tray so that they do not touch each other.

Locate each instrument in the tray to prevent movement and possible damage during handling.

Always keep delicate tips protected with a tip guard when the instrument is not in use.

Protective Container - Cataract Set

Finger Mats May Not Provide Adequate Protection

Paper Plastic Pouches

Widely used because of the visibility of the contents.

However, according to AAMI and AORN pouches should be used for 1-2, light weight instruments.

If packaging instruments separately, select the correct size pouch.

Allow approximately 1” distance from the device and the pouch edges.

Must ensure instruments packaged to protect from damage

General Guidelines for Packaging

Individual Instruments/Small Items

Use correct size packaging

Do not use rubber bands to secure instruments

Paper Plastic Pouches

Double pouching is not required (AORN, AAMI)

May be used for small items which would be difficult to keep together

If double pouching, do not fold over the edges of inside pouch

Inside pouch must lay flat

Tip Protectors

Obtain the manufacturer’s instructions for use.

Some can “catch” onto the instruments – can result in damage

You can use any tip protector that has been approved for use in a sterilization system; foam sleeves, plastic; paper/plastic.

Make sure device can be held open with protector on (e.g. scissors, clamps).

Must have manufacturer’s data that sterilant will penetrate through the tip protector.

Chemical Indicators (Types)

External (Type I) – used to distinguish an item that has been in a sterilizer from an item that has not

Internal chemical indicators (Type 3-4-5)

Should be used inside and outside each package. For wrapped sets, the internal chemical indicator should be located in the center of the pack, not the top.

Type 3 – responds to one parameter

Type 4 – responds to 2 or more parameters

Should use at least a Type 4 CI

Chemical Indicators

Type 5 – integrating indicators – correlate to the action of a biological test

Cannot substitute for a BI test

Type 6 – emulating indicators that respond to a specific cycle type, temperature and exposure time

Labeling Packages

Use a marking pen containing non-toxic, permanent ink and approved for the intended process (e.g., steam sterilization cycles).

Need documentation that marker is non-toxic.

Packages - label on the indicator tape used to close the package, never on the wrapping material itself.

Paper–plastic pouches - label only on the plastic side or on sterilization tape.

If a package is labeled directly on the packaging material, the

marker could damage the packaging material.

Exception is the plastic side of paper plastic pouches.

Table Top Sterilizers

Many ASCs use table top sterilizers

A table-top sterilizer is a ”compact steam sterilizer that has a chamber volume of not more than two cubic feet and that generates its own steam when distilled or deionized water is added by the user” (ANSI/AAMI ST79).

Table-top sterilizers -commonly found in smaller surgery centers where a high volume of sterilization processing does not take place.

Also found in doctors’ and dental offices.

Cycles

The device manufacturer’s sterilization instructions should always be followed

If the cycles provided by the sterilizer cannot be adjusted to conform to the device manufacturer’s instructions, the device should not be processed in that sterilizer.

Conventional Steam Sterilizers

Read the IFUs for exposure time, temperature and cycle time

Many have CJD cycles ONLY

Many have European temperatures only (e.g. 273oF)

Must reconcile IFU information

May have to separate sets to meet IFUs

E.g. some instruments require 10 minutes exposure

Water Quality

Water quality is just as important for table-top units as for sterilizers that use boiler-generated steam.

Distilled or deionized water is recommended to prevent the buildup of minerals in the reservoir and on processed devices.

Each day, before the sterilizer is used for the first time, the reservoir should be checked to ensure that there is enough water for the number of loads to be processed.

Maintenance

Perform all the recommended maintenance of the tabletop sterilizer

Document all maintenance (e.g. reservoir cleaned, gaskets cleaned, etc.

Documentation

All cycles run should be documented

All items processed must be documented

Specific name of device/tray

Quantity

All items must be identified with a lot control number (to facilitate recall)

Must include date sterilized, sterilizer #, load number

Expiration date or event related statement

Traceability to the patient if posterior eye tissue surgery (CJD)

Summary

Best practices for processing ophthalmic instruments requires knowledge of the standards and recommendations to prevent TASS

Manufacturers IFUs

Effective cleaning

Correct packaging methods and materials

Effective sterilization –

Processing equipment in good condition

Proper handling after sterilization

Monitoring of staff compliance with all stated policies and manufacturers’ instructions

Training and competencies for staff

Conclusion - The End

Successful patient outcomes require we develop effective policies, train staff and monitor for compliance

Careful handling of ophthalmic instruments will keep patients safe and reduce costs.

References

AAMI. Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. ST-79, 2017.

AORN. Standards and Recommended Practices. “Selection and Use of Packaging Systems”, AORN.

Centers for Disease Control (Hospital Infection Control Guidelines) 2008

American Society of Cataract & Refractive Surgeons. White Paper on TASS (2006).

The Basics of Sterile Processing textbook, 6th edition, Sterile Processing University, 2016.

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Page 10: Cleaning Protocols and Equipment - APIC MT€¦ · Identify AAMI recommended cleaning protocols to prevent TASS Review the AAMI preparation recommendations for instruments and sets

3/13/2019

10

Keeping Ophthalmic Instruments Safe

Nancy Chobin, RN, AAS, ACSP, CSPM, CFER

CEO Sterile Processing University

Lebanon, NJ

Copyright 2019

Objectives

Identify AAMI recommended cleaning protocols to prevent TASS

Review the AAMI preparation recommendations for instruments and sets

Review care and handling of ophthalmic instruments

Background

Time to perform a cataract procedure has decreased15-20 minutes.

The cost for a set of instruments can range from $6,000 to $8,000 or more

Urgency to turn the instruments around for the next case.

Instruments come in contact with the eye and thus body fluids.

They are considered contaminated and must receive the entire cleaning and sterilization process between patients.

Manufacturer’s Instructions

Instrument manufacturer should:

specify the pH of detergent (e.g. neutral pH)

may recommend a pre-soak in an enzymatic cleaner to help remove protein soils (e.g. body fluids)

specify if any special cleaning implements are needed (e.g. to clean out lumens).

Specify water quality for cleaning and rinsing

However, need to reconcile this information with AAMI and ASORN, AORN, ASCRS and the CDC.

Manufacturer’s Instructions

Also known as Instructions for Use (IFUs)

Keep on file - readily available to processing personnel.

Ensure IFUs followed each and every time the instrument is processed.

Employee training should complement the AAMI guidelines as well as manufacturers’ instructions

Eye instrumentation is extremely delicate and as such requires very special handling and processing to prevent damage. All personnel handling eye instrumentation should ensure careful handling.

Example of Steam Sterilization IFU

Prevacuum High Temperature Autoclave: 274˚F (134˚C) for 3 minutes; wrapped.

NOTE: As per ANSI/AAMI ST79:2010 and A1:2010 270˚F (132˚C) for 4 minutes and 275˚F (135˚C) for 3 minutes are acceptable minimum cycle times for dynamic-air-removal steam sterilization cycles.

Standard Gravity Autoclave: 250˚F (121˚C) for 30 minutes; wrapped.

High Speed (Flash) Autoclave: 270˚F (132˚C) for 10 minutes; unwrapped.

Training and Competencies

Employee competencies should be verified in the processing protocols for processing ophthalmic instruments

Competencies should be verified initially and annually

Utilize resources such as ophthalmic instrument company's educational materials

Reconcile with national standards

Cleaning

Removal of contamination from an item to the extent necessary for further processing or for the intended use.

Involves the use of detergent and water, of adherent visible soil (i.e. blood, pus, protein) from the surfaces, crevices, serrations, jaws and lumens of instruments, devices and equipment, by a manual or mechanical process.

Due to their design, eye instrument challenging to clean

Very small lumens, very delicate tips, can easily break/damage

Pre-Cleaning in Room

Treat with demineralized water to prevent drying of bioburden.

Saline, disinfectants, and chlorinated solutions can cause pitting

and corrosion and should never be used for soaking instruments

Instruments should not remain in water for lengthy periods of time.

–– Biofilms may form, particularly within lumens.

Decontamination

According to OSHA, “the use of physical or chemical means to remove, inactivate, or destroy blood-borne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, use, or disposal.” [29 CFR 1910.1030]

NOTE—Generally used in health care facilities to refer to all pathogenic organisms, not just those transmitted by blood

First and most critical step in breaking the chain of disease transmission

Why Is Cleaning Important?

Process of disinfection or sterilization dependent upon direct contact of the sterilant or disinfectant with the surface of the item

Protein left on items can be “baked on” in the sterilizer

Why are some facilities only “wiping off” the instruments? “Cleaning with water? Alcohol?

TASS – Focus

Toxic Anterior Segment Syndrome (TASS) – main focus by AAMI and AORN

TASS - an acute inflammatory response of the anterior chamber of the eye.

May lead to severe visual impairment if it is not recognized and treated in a timely manner.

Many causes including detergents, water quality, steam quality, instruments, etc.

Major concern is when endotoxins form

Causes of TASS (ASCRS)*

Detergent residues (in general)

Endotoxins

Preservatives

Residues from sterilization processing

Residues of detergents inside a reusable cannula or instrument

Cement sealant on bags of irrigating solution which has leached out

All can induce TASS and cause severe damage to ocular tissue

* American Society of Cataract and Refractive Surgeons

TASS

Particular care must be taken in the processing of intraocular surgical instruments to help ensure that foreign substances or materials associated with the instruments will not be introduced into the anterior chamber of the eye during surgery.

TASS

Outbreaks of TASS have often been linked to the failure to follow the processing procedures recommended by the instrument manufacturer

Specific instrument cleaning and sterilization recommendations intended to diminish the risk of TASS associated with intraocular surgical instruments have been published by the American Society for Cataract and Refractive Surgery (ASCRS, 2006).

Also in AAMI ST-79 as an Annex

ASCRS Recommendations

An adequate inventory of the necessary intraocular surgical instruments should be maintained in order to allow for the timely processing of instruments between cases.

Major issue in surgery centers

Insufficient inventory of instruments leads to short cuts in cleaning

ASCRS Recommendations

Adequate time must be allowed for processing instruments according to the manufacturer’s instructions; otherwise, the cleaning and sterilization of the instruments will be ineffective.

ASCRS Recommendations

A designated cleaning area and equipment specific to the cleaning of intraocular surgical instruments should be identified.

Whenever possible, intraocular surgical instruments should be processed separately from general surgical instruments and equipment in order to reduce the potential for cross-contamination by material or residue from the general surgical instruments

ASCRS Recommendations

Instruments should be pre-cleaned immediately following use.

Gross debris should be removed, and instrument lumens should be flushed with sterile distilled water or another suitable agent as recommended in the room at the end of the procedure

ASCRS Recommendations

Only cleaning agents that have been recommended by the manufacturer should be used.

Particular attention should be paid to the specified concentration of cleaning agent and to the recommended water quality.

ASCRS Recommendations

Final rinsing of the instrument should be performed with sterile, distilled, or deionized water, unless otherwise specified by the manufacturer.

The water used to clean or rinse instruments should be discarded after each use.

ASCRS Recommendations

If an ultrasonic cleaner is used to process the instruments, it should be emptied, cleaned, rinsed, and dried at least daily or, preferably, after each use.

Brushes and other cleaning tools should be cleaned and sterilized as recommended by the manufacturer at least daily or, preferably, after each use.

ASCRS Recommendations

Cleaning and sterilization equipment should be properly maintained.

Foreign materials such as endotoxin or heavy metals may be deposited onto the instruments during processing and induce TASS

Water Quality

Water used to for the final rinse of the device should have a low endotoxin content to avoid pyrogens on processed

devices.

Can lead to pyrogenic reactions (i.e., fever) in patients.

Adequate cleaning and rinsing should result in low bioburden

Essential to the effectiveness of terminal sterilization and to the protection of patients from pyrogens.

Physical Area

Separate area – dedicated to cleaning of ophthalmic instruments

Away from any other type of surgical instruments

Temp 60-65oF

Humidity 30-60%

Air exchanges 10/hour negative

Monitor temperature and humidity daily and document

FIRST STEP

Must have manufacturer’s instructions for cleaning of all devices; method, implements and chemicals recommended

Steps in the Cleaning Process

Pre-Cleaning in room

Contain contaminated items at the point of use

Transport to Decontamination (confined and contained)

Sort

Soak

Wash

Rinse/Dry

Pre-Cleaning - Transport

Instruments should be pre-cleaned immediately following use

Remove gross debris and flush lumens with sterile distilled water (or other agent as recommended by the instrument manufacturer)

Keep instruments moist to avoid drying of soils

Many now recommend cleaning immediately or within 30 minutes of use

Transport in closed container (confine/contain)

Container should be labeled as biohazard (OSHA)

Soaking

Can pre-soak with a detergent

Use of enzyme detergents preferred – but only if recommended by the instrument manufacturer

Assists in the loosening of soils to facilitate cleaning

Do NOT soak in fluids for prolonged periods of time - biofilms can form

Generally form on any surface that is exposed to non-sterile water or other liquids and is consistently found in many environments including industrial and medical systems

use enzymatic gels or foam

Biofiolms

Are produced by microorganisms and consist of a sticky rigid structure of organic contaminates

Slime layer anchored firmly to a surface and provides a protective environment for microorganisms to grow

Cleaning

Need to take special precautions with eye instruments due to

Delicate nature of the design

Sensitivity of eye tissue

Cleaning becomes a challenge

Manual cleaning may be only validated method

Manual cleaning is not as controlled (standardized) as mechanical cleaning

Dilemma

Some eye instrument manufacturer’s do not recommend ANY detergent

Source of confusion for end user

Need to challenge manufacturers

Enzymatic Cleaners

Organic substances which assist in the breakdown of soils

Facilitate the removal of blood and protein soils

Excellent for devices with lumens

Effectiveness dependent upon concentration, use temperature and contact time

Enzymatic Cleaners

Sold as liquid concentrates or powder

Generally more effective in warm water (110-140oF)

Enzyme activity can be inactivated above certain maximum temperatures (140oF)

Follow manufacturer’s directions

Use a thermometer – monitor water temperature

Principles of Cleaning

Must have manufacturer’s written instructions for cleaning of all devices processed

Follow all recommended steps using equipment recommended

Must wear PPE

Impervious gown, head cover, shoe covers, cuffed gloves, face shield

Manual Cleaning Process

May be the only cleaning process available

Items should be submerged, disassembled

Preferable to use 3-sink method; wash, rinse, rinse

Can also be used to remove deposits which were not removed during the pre-soak

Brush all serrations, crevices, tips, handles, and hinges.

Brushing should be done under the surface of the water to prevent aerosolization of contaminants.

Manual Cleaning – General Instructions

Handle instruments one at a time or in small numbers to avoid damage

Open hinged instruments

Disassemble multi-part instruments – keep parts together for easy reassembly after cleaning

Brush and flush all lumened devices

Clean all surfaces

Specialty Items

Cannulas, irrigation cannulas,irrigation/aspiration (I/A) handpieces, suction tips, cystotomes.

Use a brush of the appropriate size to clean the lumen; hold instrument and brush below the water surface

Manual Cleaning Detergents

Usually used for manual cleaning and as a pre-soak

Range from low foam to high foam products

Generally have neutral pH of 7 to 9

Sold as concentrates

Free rinsing

Always measure and dilute the detergent as specified by the detergent manufacturer

Water used to clean instruments should be discarded after each use

Manual Cleaning Implements

Soft bristle brushes, various sizes and lengths (no metal brushes)

Soft cloths

No abrasive items

No sponges

No materials which are permeable; i.e.. Wood

Implements used to clean instruments should be cleaned according to the manufacturer or at least daily, preferably after each use

Mechanical Cleaners

Do not put microsurgical instruments into a washer decontaminator unless it has a delicate cycle.

Can result in damage to instruments

Specialty Cleaner

Specialty cleaning and rinsing system for lumened devices such as Phaco and OZIL handpieces

Effectively cleans and rinses lumens

Must disinfect according to IFUs and document

Diamond Knives

The diamond knife is designed to make precision atraumatic cuts

The diamond knife has the sharpest cutting edge possible

Cost can range from $800 - $2,500 or more

Diamond Blade Knives

Cleaning: Immediately after using a diamond knife, the blade must be rinsed with demineralized water, preventing cell particles or viscoelastic materials from sticking to the blade.

Generally. ultrasonically clean holding the knife and suspending only the blade into the fluid.

The blade should not touch any other instruments or the sides of the cleaner.

Diamond Blade Knives

Never completely submerge a diamond knife in an ultrasonic cleaner.

At all time, (except cleaning) the blade should be in the retracted position to prevent damage.

Inspect with microscope.

Ultrasonic Cleaning

Uses sound waves transmitted through a solution

Sound waves produce tiny bubbles which implode - results in scouring action that cleans

Mechanical process = cavitation

Ultrasonic Cleaning

Effective to remove soils in hard-to-reach areas (box locks, mouth teeth, etc..)

Generally can only use detergents specifically formulated for ultrasonic cleaners - low foaming

Water temperatures usually 100 - 140 o F.

Can be used after manual cleaning

Ultrasonic Cleaning

Solution should be changed at least daily preferably after each use

Outbreaks of TASS have been associated with contaminated sonic baths

Unit should have a cover to contain aerosols

Items should not be stacked

Need to “de-gas” water

Ultrasonic Cleaning

Containers/baskets should have perforations; should be all metal mesh; no plastic

Should be located in Decontamination Area

cleaning process

more efficient than manual cleaning

Test the sonic for efficacy (daily???)

Testing Sonic

Rinsing

The most important part of the cleaning process

Essential to remove loosened debris

Should be performed with the volume and quality (sterile, distilled, or deionized water (if manual cleaning)

Water used to rinse instruments should be discarded after each use

Sterile distilled water recommended for final rinse to prevent mineral deposits and TASS

Lubrication

The use of instrument milk is beneficial to instruments to prevent corrosion and to keep moving parts from getting stiff.

However, not all instruments should be lubricated. The instrument manufacturer will indicate if this process is recommended.

Principles of Inspection/Assembly

All items should be prepared according to the device manufacturer’s written instructions (i.e. must the device be disassembled for sterilization?)

All hinged instruments should be in the open position to permit the sterilant to contact all surfaces of the jaws, blades, etc.

Items must be checked for cleanliness – the use of a lighted magnifying lamp is recommended to visualize defects such as cracked box locks, soils or missing tips.

Inspection

Best method is to use a microscope

Principles of Inspection/Assembly

All parts are present and functional

Use perforated or mesh bottom trays

All scissors should be tested for sharpness each time they are processed

Test that ratchets hold on clamps

Inspect hand held forceps that tips approximate

Test needle holders; ratchets hold and tips hold suture needle

Principles of Inspection/Assembly

Inspect that joints are not stiff

Use a lighted magnifying lamp or microscope to inspect

Inspect for rust, pitting, cracked box lock, etc.

Demagnetization of eye instruments may be needed

Separate delicate, sharp items

Use non-linting surgical towels, or paper sterilization bags to separate items inside set; not peel pack material

Refer to manufacturer’s IFUs regarding flushing of all lumened devices (AAMI states only for gravity cycles). Use sterile, distilled water

Ophthalmic Instruments

Look for defects:

Rusting common (especially if IUSS frequently used

Corrosion

Damage to tips/ teeth

Cords

Lumens (e.g. Phaco handpieces)

Stiffness

Sharpness

Spotting – Staining - Rust

Delicate Tips Require Protection

Can use small containers with silicone mat for individual instruments to provide protection.

General Guidelines for Packaging

Instrument Sets

Use specialty containers to keep delicate instruments in place and prevent damage in transport and cleaning.

The single most effective means to prevent damage to eye instruments is to place them in specialty protective containers

The basket or container of the correct size to prevent instrument damage

Handling Eye Instruments

Place instruments in the tray so that they do not touch each other.

Locate each instrument in the tray to prevent movement and possible damage during handling.

Always keep delicate tips protected with a tip guard when the instrument is not in use.

Protective Container - Cataract Set

Finger Mats May Not Provide Adequate Protection

Paper Plastic Pouches

Widely used because of the visibility of the contents.

However, according to AAMI and AORN pouches should be used for 1-2, light weight instruments.

If packaging instruments separately, select the correct size pouch.

Allow approximately 1” distance from the device and the pouch edges.

Must ensure instruments packaged to protect from damage

General Guidelines for Packaging

Individual Instruments/Small Items

Use correct size packaging

Do not use rubber bands to secure instruments

Paper Plastic Pouches

Double pouching is not required (AORN, AAMI)

May be used for small items which would be difficult to keep together

If double pouching, do not fold over the edges of inside pouch

Inside pouch must lay flat

Tip Protectors

Obtain the manufacturer’s instructions for use.

Some can “catch” onto the instruments – can result in damage

You can use any tip protector that has been approved for use in a sterilization system; foam sleeves, plastic; paper/plastic.

Make sure device can be held open with protector on (e.g. scissors, clamps).

Must have manufacturer’s data that sterilant will penetrate through the tip protector.

Chemical Indicators (Types)

External (Type I) – used to distinguish an item that has been in a sterilizer from an item that has not

Internal chemical indicators (Type 3-4-5)

Should be used inside and outside each package. For wrapped sets, the internal chemical indicator should be located in the center of the pack, not the top.

Type 3 – responds to one parameter

Type 4 – responds to 2 or more parameters

Should use at least a Type 4 CI

Chemical Indicators

Type 5 – integrating indicators – correlate to the action of a biological test

Cannot substitute for a BI test

Type 6 – emulating indicators that respond to a specific cycle type, temperature and exposure time

Labeling Packages

Use a marking pen containing non-toxic, permanent ink and approved for the intended process (e.g., steam sterilization cycles).

Need documentation that marker is non-toxic.

Packages - label on the indicator tape used to close the package, never on the wrapping material itself.

Paper–plastic pouches - label only on the plastic side or on sterilization tape.

If a package is labeled directly on the packaging material, the

marker could damage the packaging material.

Exception is the plastic side of paper plastic pouches.

Table Top Sterilizers

Many ASCs use table top sterilizers

A table-top sterilizer is a ”compact steam sterilizer that has a chamber volume of not more than two cubic feet and that generates its own steam when distilled or deionized water is added by the user” (ANSI/AAMI ST79).

Table-top sterilizers -commonly found in smaller surgery centers where a high volume of sterilization processing does not take place.

Also found in doctors’ and dental offices.

Cycles

The device manufacturer’s sterilization instructions should always be followed

If the cycles provided by the sterilizer cannot be adjusted to conform to the device manufacturer’s instructions, the device should not be processed in that sterilizer.

Conventional Steam Sterilizers

Read the IFUs for exposure time, temperature and cycle time

Many have CJD cycles ONLY

Many have European temperatures only (e.g. 273oF)

Must reconcile IFU information

May have to separate sets to meet IFUs

E.g. some instruments require 10 minutes exposure

Water Quality

Water quality is just as important for table-top units as for sterilizers that use boiler-generated steam.

Distilled or deionized water is recommended to prevent the buildup of minerals in the reservoir and on processed devices.

Each day, before the sterilizer is used for the first time, the reservoir should be checked to ensure that there is enough water for the number of loads to be processed.

Maintenance

Perform all the recommended maintenance of the tabletop sterilizer

Document all maintenance (e.g. reservoir cleaned, gaskets cleaned, etc.

Documentation

All cycles run should be documented

All items processed must be documented

Specific name of device/tray

Quantity

All items must be identified with a lot control number (to facilitate recall)

Must include date sterilized, sterilizer #, load number

Expiration date or event related statement

Traceability to the patient if posterior eye tissue surgery (CJD)

Summary

Best practices for processing ophthalmic instruments requires knowledge of the standards and recommendations to prevent TASS

Manufacturers IFUs

Effective cleaning

Correct packaging methods and materials

Effective sterilization –

Processing equipment in good condition

Proper handling after sterilization

Monitoring of staff compliance with all stated policies and manufacturers’ instructions

Training and competencies for staff

Conclusion - The End

Successful patient outcomes require we develop effective policies, train staff and monitor for compliance

Careful handling of ophthalmic instruments will keep patients safe and reduce costs.

References

AAMI. Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. ST-79, 2017.

AORN. Standards and Recommended Practices. “Selection and Use of Packaging Systems”, AORN.

Centers for Disease Control (Hospital Infection Control Guidelines) 2008

American Society of Cataract & Refractive Surgeons. White Paper on TASS (2006).

The Basics of Sterile Processing textbook, 6th edition, Sterile Processing University, 2016.

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Page 11: Cleaning Protocols and Equipment - APIC MT€¦ · Identify AAMI recommended cleaning protocols to prevent TASS Review the AAMI preparation recommendations for instruments and sets

3/13/2019

11

Keeping Ophthalmic Instruments Safe

Nancy Chobin, RN, AAS, ACSP, CSPM, CFER

CEO Sterile Processing University

Lebanon, NJ

Copyright 2019

Objectives

Identify AAMI recommended cleaning protocols to prevent TASS

Review the AAMI preparation recommendations for instruments and sets

Review care and handling of ophthalmic instruments

Background

Time to perform a cataract procedure has decreased15-20 minutes.

The cost for a set of instruments can range from $6,000 to $8,000 or more

Urgency to turn the instruments around for the next case.

Instruments come in contact with the eye and thus body fluids.

They are considered contaminated and must receive the entire cleaning and sterilization process between patients.

Manufacturer’s Instructions

Instrument manufacturer should:

specify the pH of detergent (e.g. neutral pH)

may recommend a pre-soak in an enzymatic cleaner to help remove protein soils (e.g. body fluids)

specify if any special cleaning implements are needed (e.g. to clean out lumens).

Specify water quality for cleaning and rinsing

However, need to reconcile this information with AAMI and ASORN, AORN, ASCRS and the CDC.

Manufacturer’s Instructions

Also known as Instructions for Use (IFUs)

Keep on file - readily available to processing personnel.

Ensure IFUs followed each and every time the instrument is processed.

Employee training should complement the AAMI guidelines as well as manufacturers’ instructions

Eye instrumentation is extremely delicate and as such requires very special handling and processing to prevent damage. All personnel handling eye instrumentation should ensure careful handling.

Example of Steam Sterilization IFU

Prevacuum High Temperature Autoclave: 274˚F (134˚C) for 3 minutes; wrapped.

NOTE: As per ANSI/AAMI ST79:2010 and A1:2010 270˚F (132˚C) for 4 minutes and 275˚F (135˚C) for 3 minutes are acceptable minimum cycle times for dynamic-air-removal steam sterilization cycles.

Standard Gravity Autoclave: 250˚F (121˚C) for 30 minutes; wrapped.

High Speed (Flash) Autoclave: 270˚F (132˚C) for 10 minutes; unwrapped.

Training and Competencies

Employee competencies should be verified in the processing protocols for processing ophthalmic instruments

Competencies should be verified initially and annually

Utilize resources such as ophthalmic instrument company's educational materials

Reconcile with national standards

Cleaning

Removal of contamination from an item to the extent necessary for further processing or for the intended use.

Involves the use of detergent and water, of adherent visible soil (i.e. blood, pus, protein) from the surfaces, crevices, serrations, jaws and lumens of instruments, devices and equipment, by a manual or mechanical process.

Due to their design, eye instrument challenging to clean

Very small lumens, very delicate tips, can easily break/damage

Pre-Cleaning in Room

Treat with demineralized water to prevent drying of bioburden.

Saline, disinfectants, and chlorinated solutions can cause pitting

and corrosion and should never be used for soaking instruments

Instruments should not remain in water for lengthy periods of time.

–– Biofilms may form, particularly within lumens.

Decontamination

According to OSHA, “the use of physical or chemical means to remove, inactivate, or destroy blood-borne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, use, or disposal.” [29 CFR 1910.1030]

NOTE—Generally used in health care facilities to refer to all pathogenic organisms, not just those transmitted by blood

First and most critical step in breaking the chain of disease transmission

Why Is Cleaning Important?

Process of disinfection or sterilization dependent upon direct contact of the sterilant or disinfectant with the surface of the item

Protein left on items can be “baked on” in the sterilizer

Why are some facilities only “wiping off” the instruments? “Cleaning with water? Alcohol?

TASS – Focus

Toxic Anterior Segment Syndrome (TASS) – main focus by AAMI and AORN

TASS - an acute inflammatory response of the anterior chamber of the eye.

May lead to severe visual impairment if it is not recognized and treated in a timely manner.

Many causes including detergents, water quality, steam quality, instruments, etc.

Major concern is when endotoxins form

Causes of TASS (ASCRS)*

Detergent residues (in general)

Endotoxins

Preservatives

Residues from sterilization processing

Residues of detergents inside a reusable cannula or instrument

Cement sealant on bags of irrigating solution which has leached out

All can induce TASS and cause severe damage to ocular tissue

* American Society of Cataract and Refractive Surgeons

TASS

Particular care must be taken in the processing of intraocular surgical instruments to help ensure that foreign substances or materials associated with the instruments will not be introduced into the anterior chamber of the eye during surgery.

TASS

Outbreaks of TASS have often been linked to the failure to follow the processing procedures recommended by the instrument manufacturer

Specific instrument cleaning and sterilization recommendations intended to diminish the risk of TASS associated with intraocular surgical instruments have been published by the American Society for Cataract and Refractive Surgery (ASCRS, 2006).

Also in AAMI ST-79 as an Annex

ASCRS Recommendations

An adequate inventory of the necessary intraocular surgical instruments should be maintained in order to allow for the timely processing of instruments between cases.

Major issue in surgery centers

Insufficient inventory of instruments leads to short cuts in cleaning

ASCRS Recommendations

Adequate time must be allowed for processing instruments according to the manufacturer’s instructions; otherwise, the cleaning and sterilization of the instruments will be ineffective.

ASCRS Recommendations

A designated cleaning area and equipment specific to the cleaning of intraocular surgical instruments should be identified.

Whenever possible, intraocular surgical instruments should be processed separately from general surgical instruments and equipment in order to reduce the potential for cross-contamination by material or residue from the general surgical instruments

ASCRS Recommendations

Instruments should be pre-cleaned immediately following use.

Gross debris should be removed, and instrument lumens should be flushed with sterile distilled water or another suitable agent as recommended in the room at the end of the procedure

ASCRS Recommendations

Only cleaning agents that have been recommended by the manufacturer should be used.

Particular attention should be paid to the specified concentration of cleaning agent and to the recommended water quality.

ASCRS Recommendations

Final rinsing of the instrument should be performed with sterile, distilled, or deionized water, unless otherwise specified by the manufacturer.

The water used to clean or rinse instruments should be discarded after each use.

ASCRS Recommendations

If an ultrasonic cleaner is used to process the instruments, it should be emptied, cleaned, rinsed, and dried at least daily or, preferably, after each use.

Brushes and other cleaning tools should be cleaned and sterilized as recommended by the manufacturer at least daily or, preferably, after each use.

ASCRS Recommendations

Cleaning and sterilization equipment should be properly maintained.

Foreign materials such as endotoxin or heavy metals may be deposited onto the instruments during processing and induce TASS

Water Quality

Water used to for the final rinse of the device should have a low endotoxin content to avoid pyrogens on processed

devices.

Can lead to pyrogenic reactions (i.e., fever) in patients.

Adequate cleaning and rinsing should result in low bioburden

Essential to the effectiveness of terminal sterilization and to the protection of patients from pyrogens.

Physical Area

Separate area – dedicated to cleaning of ophthalmic instruments

Away from any other type of surgical instruments

Temp 60-65oF

Humidity 30-60%

Air exchanges 10/hour negative

Monitor temperature and humidity daily and document

FIRST STEP

Must have manufacturer’s instructions for cleaning of all devices; method, implements and chemicals recommended

Steps in the Cleaning Process

Pre-Cleaning in room

Contain contaminated items at the point of use

Transport to Decontamination (confined and contained)

Sort

Soak

Wash

Rinse/Dry

Pre-Cleaning - Transport

Instruments should be pre-cleaned immediately following use

Remove gross debris and flush lumens with sterile distilled water (or other agent as recommended by the instrument manufacturer)

Keep instruments moist to avoid drying of soils

Many now recommend cleaning immediately or within 30 minutes of use

Transport in closed container (confine/contain)

Container should be labeled as biohazard (OSHA)

Soaking

Can pre-soak with a detergent

Use of enzyme detergents preferred – but only if recommended by the instrument manufacturer

Assists in the loosening of soils to facilitate cleaning

Do NOT soak in fluids for prolonged periods of time - biofilms can form

Generally form on any surface that is exposed to non-sterile water or other liquids and is consistently found in many environments including industrial and medical systems

use enzymatic gels or foam

Biofiolms

Are produced by microorganisms and consist of a sticky rigid structure of organic contaminates

Slime layer anchored firmly to a surface and provides a protective environment for microorganisms to grow

Cleaning

Need to take special precautions with eye instruments due to

Delicate nature of the design

Sensitivity of eye tissue

Cleaning becomes a challenge

Manual cleaning may be only validated method

Manual cleaning is not as controlled (standardized) as mechanical cleaning

Dilemma

Some eye instrument manufacturer’s do not recommend ANY detergent

Source of confusion for end user

Need to challenge manufacturers

Enzymatic Cleaners

Organic substances which assist in the breakdown of soils

Facilitate the removal of blood and protein soils

Excellent for devices with lumens

Effectiveness dependent upon concentration, use temperature and contact time

Enzymatic Cleaners

Sold as liquid concentrates or powder

Generally more effective in warm water (110-140oF)

Enzyme activity can be inactivated above certain maximum temperatures (140oF)

Follow manufacturer’s directions

Use a thermometer – monitor water temperature

Principles of Cleaning

Must have manufacturer’s written instructions for cleaning of all devices processed

Follow all recommended steps using equipment recommended

Must wear PPE

Impervious gown, head cover, shoe covers, cuffed gloves, face shield

Manual Cleaning Process

May be the only cleaning process available

Items should be submerged, disassembled

Preferable to use 3-sink method; wash, rinse, rinse

Can also be used to remove deposits which were not removed during the pre-soak

Brush all serrations, crevices, tips, handles, and hinges.

Brushing should be done under the surface of the water to prevent aerosolization of contaminants.

Manual Cleaning – General Instructions

Handle instruments one at a time or in small numbers to avoid damage

Open hinged instruments

Disassemble multi-part instruments – keep parts together for easy reassembly after cleaning

Brush and flush all lumened devices

Clean all surfaces

Specialty Items

Cannulas, irrigation cannulas,irrigation/aspiration (I/A) handpieces, suction tips, cystotomes.

Use a brush of the appropriate size to clean the lumen; hold instrument and brush below the water surface

Manual Cleaning Detergents

Usually used for manual cleaning and as a pre-soak

Range from low foam to high foam products

Generally have neutral pH of 7 to 9

Sold as concentrates

Free rinsing

Always measure and dilute the detergent as specified by the detergent manufacturer

Water used to clean instruments should be discarded after each use

Manual Cleaning Implements

Soft bristle brushes, various sizes and lengths (no metal brushes)

Soft cloths

No abrasive items

No sponges

No materials which are permeable; i.e.. Wood

Implements used to clean instruments should be cleaned according to the manufacturer or at least daily, preferably after each use

Mechanical Cleaners

Do not put microsurgical instruments into a washer decontaminator unless it has a delicate cycle.

Can result in damage to instruments

Specialty Cleaner

Specialty cleaning and rinsing system for lumened devices such as Phaco and OZIL handpieces

Effectively cleans and rinses lumens

Must disinfect according to IFUs and document

Diamond Knives

The diamond knife is designed to make precision atraumatic cuts

The diamond knife has the sharpest cutting edge possible

Cost can range from $800 - $2,500 or more

Diamond Blade Knives

Cleaning: Immediately after using a diamond knife, the blade must be rinsed with demineralized water, preventing cell particles or viscoelastic materials from sticking to the blade.

Generally. ultrasonically clean holding the knife and suspending only the blade into the fluid.

The blade should not touch any other instruments or the sides of the cleaner.

Diamond Blade Knives

Never completely submerge a diamond knife in an ultrasonic cleaner.

At all time, (except cleaning) the blade should be in the retracted position to prevent damage.

Inspect with microscope.

Ultrasonic Cleaning

Uses sound waves transmitted through a solution

Sound waves produce tiny bubbles which implode - results in scouring action that cleans

Mechanical process = cavitation

Ultrasonic Cleaning

Effective to remove soils in hard-to-reach areas (box locks, mouth teeth, etc..)

Generally can only use detergents specifically formulated for ultrasonic cleaners - low foaming

Water temperatures usually 100 - 140 o F.

Can be used after manual cleaning

Ultrasonic Cleaning

Solution should be changed at least daily preferably after each use

Outbreaks of TASS have been associated with contaminated sonic baths

Unit should have a cover to contain aerosols

Items should not be stacked

Need to “de-gas” water

Ultrasonic Cleaning

Containers/baskets should have perforations; should be all metal mesh; no plastic

Should be located in Decontamination Area

cleaning process

more efficient than manual cleaning

Test the sonic for efficacy (daily???)

Testing Sonic

Rinsing

The most important part of the cleaning process

Essential to remove loosened debris

Should be performed with the volume and quality (sterile, distilled, or deionized water (if manual cleaning)

Water used to rinse instruments should be discarded after each use

Sterile distilled water recommended for final rinse to prevent mineral deposits and TASS

Lubrication

The use of instrument milk is beneficial to instruments to prevent corrosion and to keep moving parts from getting stiff.

However, not all instruments should be lubricated. The instrument manufacturer will indicate if this process is recommended.

Principles of Inspection/Assembly

All items should be prepared according to the device manufacturer’s written instructions (i.e. must the device be disassembled for sterilization?)

All hinged instruments should be in the open position to permit the sterilant to contact all surfaces of the jaws, blades, etc.

Items must be checked for cleanliness – the use of a lighted magnifying lamp is recommended to visualize defects such as cracked box locks, soils or missing tips.

Inspection

Best method is to use a microscope

Principles of Inspection/Assembly

All parts are present and functional

Use perforated or mesh bottom trays

All scissors should be tested for sharpness each time they are processed

Test that ratchets hold on clamps

Inspect hand held forceps that tips approximate

Test needle holders; ratchets hold and tips hold suture needle

Principles of Inspection/Assembly

Inspect that joints are not stiff

Use a lighted magnifying lamp or microscope to inspect

Inspect for rust, pitting, cracked box lock, etc.

Demagnetization of eye instruments may be needed

Separate delicate, sharp items

Use non-linting surgical towels, or paper sterilization bags to separate items inside set; not peel pack material

Refer to manufacturer’s IFUs regarding flushing of all lumened devices (AAMI states only for gravity cycles). Use sterile, distilled water

Ophthalmic Instruments

Look for defects:

Rusting common (especially if IUSS frequently used

Corrosion

Damage to tips/ teeth

Cords

Lumens (e.g. Phaco handpieces)

Stiffness

Sharpness

Spotting – Staining - Rust

Delicate Tips Require Protection

Can use small containers with silicone mat for individual instruments to provide protection.

General Guidelines for Packaging

Instrument Sets

Use specialty containers to keep delicate instruments in place and prevent damage in transport and cleaning.

The single most effective means to prevent damage to eye instruments is to place them in specialty protective containers

The basket or container of the correct size to prevent instrument damage

Handling Eye Instruments

Place instruments in the tray so that they do not touch each other.

Locate each instrument in the tray to prevent movement and possible damage during handling.

Always keep delicate tips protected with a tip guard when the instrument is not in use.

Protective Container - Cataract Set

Finger Mats May Not Provide Adequate Protection

Paper Plastic Pouches

Widely used because of the visibility of the contents.

However, according to AAMI and AORN pouches should be used for 1-2, light weight instruments.

If packaging instruments separately, select the correct size pouch.

Allow approximately 1” distance from the device and the pouch edges.

Must ensure instruments packaged to protect from damage

General Guidelines for Packaging

Individual Instruments/Small Items

Use correct size packaging

Do not use rubber bands to secure instruments

Paper Plastic Pouches

Double pouching is not required (AORN, AAMI)

May be used for small items which would be difficult to keep together

If double pouching, do not fold over the edges of inside pouch

Inside pouch must lay flat

Tip Protectors

Obtain the manufacturer’s instructions for use.

Some can “catch” onto the instruments – can result in damage

You can use any tip protector that has been approved for use in a sterilization system; foam sleeves, plastic; paper/plastic.

Make sure device can be held open with protector on (e.g. scissors, clamps).

Must have manufacturer’s data that sterilant will penetrate through the tip protector.

Chemical Indicators (Types)

External (Type I) – used to distinguish an item that has been in a sterilizer from an item that has not

Internal chemical indicators (Type 3-4-5)

Should be used inside and outside each package. For wrapped sets, the internal chemical indicator should be located in the center of the pack, not the top.

Type 3 – responds to one parameter

Type 4 – responds to 2 or more parameters

Should use at least a Type 4 CI

Chemical Indicators

Type 5 – integrating indicators – correlate to the action of a biological test

Cannot substitute for a BI test

Type 6 – emulating indicators that respond to a specific cycle type, temperature and exposure time

Labeling Packages

Use a marking pen containing non-toxic, permanent ink and approved for the intended process (e.g., steam sterilization cycles).

Need documentation that marker is non-toxic.

Packages - label on the indicator tape used to close the package, never on the wrapping material itself.

Paper–plastic pouches - label only on the plastic side or on sterilization tape.

If a package is labeled directly on the packaging material, the

marker could damage the packaging material.

Exception is the plastic side of paper plastic pouches.

Table Top Sterilizers

Many ASCs use table top sterilizers

A table-top sterilizer is a ”compact steam sterilizer that has a chamber volume of not more than two cubic feet and that generates its own steam when distilled or deionized water is added by the user” (ANSI/AAMI ST79).

Table-top sterilizers -commonly found in smaller surgery centers where a high volume of sterilization processing does not take place.

Also found in doctors’ and dental offices.

Cycles

The device manufacturer’s sterilization instructions should always be followed

If the cycles provided by the sterilizer cannot be adjusted to conform to the device manufacturer’s instructions, the device should not be processed in that sterilizer.

Conventional Steam Sterilizers

Read the IFUs for exposure time, temperature and cycle time

Many have CJD cycles ONLY

Many have European temperatures only (e.g. 273oF)

Must reconcile IFU information

May have to separate sets to meet IFUs

E.g. some instruments require 10 minutes exposure

Water Quality

Water quality is just as important for table-top units as for sterilizers that use boiler-generated steam.

Distilled or deionized water is recommended to prevent the buildup of minerals in the reservoir and on processed devices.

Each day, before the sterilizer is used for the first time, the reservoir should be checked to ensure that there is enough water for the number of loads to be processed.

Maintenance

Perform all the recommended maintenance of the tabletop sterilizer

Document all maintenance (e.g. reservoir cleaned, gaskets cleaned, etc.

Documentation

All cycles run should be documented

All items processed must be documented

Specific name of device/tray

Quantity

All items must be identified with a lot control number (to facilitate recall)

Must include date sterilized, sterilizer #, load number

Expiration date or event related statement

Traceability to the patient if posterior eye tissue surgery (CJD)

Summary

Best practices for processing ophthalmic instruments requires knowledge of the standards and recommendations to prevent TASS

Manufacturers IFUs

Effective cleaning

Correct packaging methods and materials

Effective sterilization –

Processing equipment in good condition

Proper handling after sterilization

Monitoring of staff compliance with all stated policies and manufacturers’ instructions

Training and competencies for staff

Conclusion - The End

Successful patient outcomes require we develop effective policies, train staff and monitor for compliance

Careful handling of ophthalmic instruments will keep patients safe and reduce costs.

References

AAMI. Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. ST-79, 2017.

AORN. Standards and Recommended Practices. “Selection and Use of Packaging Systems”, AORN.

Centers for Disease Control (Hospital Infection Control Guidelines) 2008

American Society of Cataract & Refractive Surgeons. White Paper on TASS (2006).

The Basics of Sterile Processing textbook, 6th edition, Sterile Processing University, 2016.

Questions??????

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2

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4

5

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Page 12: Cleaning Protocols and Equipment - APIC MT€¦ · Identify AAMI recommended cleaning protocols to prevent TASS Review the AAMI preparation recommendations for instruments and sets

3/13/2019

12

Keeping Ophthalmic Instruments Safe

Nancy Chobin, RN, AAS, ACSP, CSPM, CFER

CEO Sterile Processing University

Lebanon, NJ

Copyright 2019

Objectives

Identify AAMI recommended cleaning protocols to prevent TASS

Review the AAMI preparation recommendations for instruments and sets

Review care and handling of ophthalmic instruments

Background

Time to perform a cataract procedure has decreased15-20 minutes.

The cost for a set of instruments can range from $6,000 to $8,000 or more

Urgency to turn the instruments around for the next case.

Instruments come in contact with the eye and thus body fluids.

They are considered contaminated and must receive the entire cleaning and sterilization process between patients.

Manufacturer’s Instructions

Instrument manufacturer should:

specify the pH of detergent (e.g. neutral pH)

may recommend a pre-soak in an enzymatic cleaner to help remove protein soils (e.g. body fluids)

specify if any special cleaning implements are needed (e.g. to clean out lumens).

Specify water quality for cleaning and rinsing

However, need to reconcile this information with AAMI and ASORN, AORN, ASCRS and the CDC.

Manufacturer’s Instructions

Also known as Instructions for Use (IFUs)

Keep on file - readily available to processing personnel.

Ensure IFUs followed each and every time the instrument is processed.

Employee training should complement the AAMI guidelines as well as manufacturers’ instructions

Eye instrumentation is extremely delicate and as such requires very special handling and processing to prevent damage. All personnel handling eye instrumentation should ensure careful handling.

Example of Steam Sterilization IFU

Prevacuum High Temperature Autoclave: 274˚F (134˚C) for 3 minutes; wrapped.

NOTE: As per ANSI/AAMI ST79:2010 and A1:2010 270˚F (132˚C) for 4 minutes and 275˚F (135˚C) for 3 minutes are acceptable minimum cycle times for dynamic-air-removal steam sterilization cycles.

Standard Gravity Autoclave: 250˚F (121˚C) for 30 minutes; wrapped.

High Speed (Flash) Autoclave: 270˚F (132˚C) for 10 minutes; unwrapped.

Training and Competencies

Employee competencies should be verified in the processing protocols for processing ophthalmic instruments

Competencies should be verified initially and annually

Utilize resources such as ophthalmic instrument company's educational materials

Reconcile with national standards

Cleaning

Removal of contamination from an item to the extent necessary for further processing or for the intended use.

Involves the use of detergent and water, of adherent visible soil (i.e. blood, pus, protein) from the surfaces, crevices, serrations, jaws and lumens of instruments, devices and equipment, by a manual or mechanical process.

Due to their design, eye instrument challenging to clean

Very small lumens, very delicate tips, can easily break/damage

Pre-Cleaning in Room

Treat with demineralized water to prevent drying of bioburden.

Saline, disinfectants, and chlorinated solutions can cause pitting

and corrosion and should never be used for soaking instruments

Instruments should not remain in water for lengthy periods of time.

–– Biofilms may form, particularly within lumens.

Decontamination

According to OSHA, “the use of physical or chemical means to remove, inactivate, or destroy blood-borne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, use, or disposal.” [29 CFR 1910.1030]

NOTE—Generally used in health care facilities to refer to all pathogenic organisms, not just those transmitted by blood

First and most critical step in breaking the chain of disease transmission

Why Is Cleaning Important?

Process of disinfection or sterilization dependent upon direct contact of the sterilant or disinfectant with the surface of the item

Protein left on items can be “baked on” in the sterilizer

Why are some facilities only “wiping off” the instruments? “Cleaning with water? Alcohol?

TASS – Focus

Toxic Anterior Segment Syndrome (TASS) – main focus by AAMI and AORN

TASS - an acute inflammatory response of the anterior chamber of the eye.

May lead to severe visual impairment if it is not recognized and treated in a timely manner.

Many causes including detergents, water quality, steam quality, instruments, etc.

Major concern is when endotoxins form

Causes of TASS (ASCRS)*

Detergent residues (in general)

Endotoxins

Preservatives

Residues from sterilization processing

Residues of detergents inside a reusable cannula or instrument

Cement sealant on bags of irrigating solution which has leached out

All can induce TASS and cause severe damage to ocular tissue

* American Society of Cataract and Refractive Surgeons

TASS

Particular care must be taken in the processing of intraocular surgical instruments to help ensure that foreign substances or materials associated with the instruments will not be introduced into the anterior chamber of the eye during surgery.

TASS

Outbreaks of TASS have often been linked to the failure to follow the processing procedures recommended by the instrument manufacturer

Specific instrument cleaning and sterilization recommendations intended to diminish the risk of TASS associated with intraocular surgical instruments have been published by the American Society for Cataract and Refractive Surgery (ASCRS, 2006).

Also in AAMI ST-79 as an Annex

ASCRS Recommendations

An adequate inventory of the necessary intraocular surgical instruments should be maintained in order to allow for the timely processing of instruments between cases.

Major issue in surgery centers

Insufficient inventory of instruments leads to short cuts in cleaning

ASCRS Recommendations

Adequate time must be allowed for processing instruments according to the manufacturer’s instructions; otherwise, the cleaning and sterilization of the instruments will be ineffective.

ASCRS Recommendations

A designated cleaning area and equipment specific to the cleaning of intraocular surgical instruments should be identified.

Whenever possible, intraocular surgical instruments should be processed separately from general surgical instruments and equipment in order to reduce the potential for cross-contamination by material or residue from the general surgical instruments

ASCRS Recommendations

Instruments should be pre-cleaned immediately following use.

Gross debris should be removed, and instrument lumens should be flushed with sterile distilled water or another suitable agent as recommended in the room at the end of the procedure

ASCRS Recommendations

Only cleaning agents that have been recommended by the manufacturer should be used.

Particular attention should be paid to the specified concentration of cleaning agent and to the recommended water quality.

ASCRS Recommendations

Final rinsing of the instrument should be performed with sterile, distilled, or deionized water, unless otherwise specified by the manufacturer.

The water used to clean or rinse instruments should be discarded after each use.

ASCRS Recommendations

If an ultrasonic cleaner is used to process the instruments, it should be emptied, cleaned, rinsed, and dried at least daily or, preferably, after each use.

Brushes and other cleaning tools should be cleaned and sterilized as recommended by the manufacturer at least daily or, preferably, after each use.

ASCRS Recommendations

Cleaning and sterilization equipment should be properly maintained.

Foreign materials such as endotoxin or heavy metals may be deposited onto the instruments during processing and induce TASS

Water Quality

Water used to for the final rinse of the device should have a low endotoxin content to avoid pyrogens on processed

devices.

Can lead to pyrogenic reactions (i.e., fever) in patients.

Adequate cleaning and rinsing should result in low bioburden

Essential to the effectiveness of terminal sterilization and to the protection of patients from pyrogens.

Physical Area

Separate area – dedicated to cleaning of ophthalmic instruments

Away from any other type of surgical instruments

Temp 60-65oF

Humidity 30-60%

Air exchanges 10/hour negative

Monitor temperature and humidity daily and document

FIRST STEP

Must have manufacturer’s instructions for cleaning of all devices; method, implements and chemicals recommended

Steps in the Cleaning Process

Pre-Cleaning in room

Contain contaminated items at the point of use

Transport to Decontamination (confined and contained)

Sort

Soak

Wash

Rinse/Dry

Pre-Cleaning - Transport

Instruments should be pre-cleaned immediately following use

Remove gross debris and flush lumens with sterile distilled water (or other agent as recommended by the instrument manufacturer)

Keep instruments moist to avoid drying of soils

Many now recommend cleaning immediately or within 30 minutes of use

Transport in closed container (confine/contain)

Container should be labeled as biohazard (OSHA)

Soaking

Can pre-soak with a detergent

Use of enzyme detergents preferred – but only if recommended by the instrument manufacturer

Assists in the loosening of soils to facilitate cleaning

Do NOT soak in fluids for prolonged periods of time - biofilms can form

Generally form on any surface that is exposed to non-sterile water or other liquids and is consistently found in many environments including industrial and medical systems

use enzymatic gels or foam

Biofiolms

Are produced by microorganisms and consist of a sticky rigid structure of organic contaminates

Slime layer anchored firmly to a surface and provides a protective environment for microorganisms to grow

Cleaning

Need to take special precautions with eye instruments due to

Delicate nature of the design

Sensitivity of eye tissue

Cleaning becomes a challenge

Manual cleaning may be only validated method

Manual cleaning is not as controlled (standardized) as mechanical cleaning

Dilemma

Some eye instrument manufacturer’s do not recommend ANY detergent

Source of confusion for end user

Need to challenge manufacturers

Enzymatic Cleaners

Organic substances which assist in the breakdown of soils

Facilitate the removal of blood and protein soils

Excellent for devices with lumens

Effectiveness dependent upon concentration, use temperature and contact time

Enzymatic Cleaners

Sold as liquid concentrates or powder

Generally more effective in warm water (110-140oF)

Enzyme activity can be inactivated above certain maximum temperatures (140oF)

Follow manufacturer’s directions

Use a thermometer – monitor water temperature

Principles of Cleaning

Must have manufacturer’s written instructions for cleaning of all devices processed

Follow all recommended steps using equipment recommended

Must wear PPE

Impervious gown, head cover, shoe covers, cuffed gloves, face shield

Manual Cleaning Process

May be the only cleaning process available

Items should be submerged, disassembled

Preferable to use 3-sink method; wash, rinse, rinse

Can also be used to remove deposits which were not removed during the pre-soak

Brush all serrations, crevices, tips, handles, and hinges.

Brushing should be done under the surface of the water to prevent aerosolization of contaminants.

Manual Cleaning – General Instructions

Handle instruments one at a time or in small numbers to avoid damage

Open hinged instruments

Disassemble multi-part instruments – keep parts together for easy reassembly after cleaning

Brush and flush all lumened devices

Clean all surfaces

Specialty Items

Cannulas, irrigation cannulas,irrigation/aspiration (I/A) handpieces, suction tips, cystotomes.

Use a brush of the appropriate size to clean the lumen; hold instrument and brush below the water surface

Manual Cleaning Detergents

Usually used for manual cleaning and as a pre-soak

Range from low foam to high foam products

Generally have neutral pH of 7 to 9

Sold as concentrates

Free rinsing

Always measure and dilute the detergent as specified by the detergent manufacturer

Water used to clean instruments should be discarded after each use

Manual Cleaning Implements

Soft bristle brushes, various sizes and lengths (no metal brushes)

Soft cloths

No abrasive items

No sponges

No materials which are permeable; i.e.. Wood

Implements used to clean instruments should be cleaned according to the manufacturer or at least daily, preferably after each use

Mechanical Cleaners

Do not put microsurgical instruments into a washer decontaminator unless it has a delicate cycle.

Can result in damage to instruments

Specialty Cleaner

Specialty cleaning and rinsing system for lumened devices such as Phaco and OZIL handpieces

Effectively cleans and rinses lumens

Must disinfect according to IFUs and document

Diamond Knives

The diamond knife is designed to make precision atraumatic cuts

The diamond knife has the sharpest cutting edge possible

Cost can range from $800 - $2,500 or more

Diamond Blade Knives

Cleaning: Immediately after using a diamond knife, the blade must be rinsed with demineralized water, preventing cell particles or viscoelastic materials from sticking to the blade.

Generally. ultrasonically clean holding the knife and suspending only the blade into the fluid.

The blade should not touch any other instruments or the sides of the cleaner.

Diamond Blade Knives

Never completely submerge a diamond knife in an ultrasonic cleaner.

At all time, (except cleaning) the blade should be in the retracted position to prevent damage.

Inspect with microscope.

Ultrasonic Cleaning

Uses sound waves transmitted through a solution

Sound waves produce tiny bubbles which implode - results in scouring action that cleans

Mechanical process = cavitation

Ultrasonic Cleaning

Effective to remove soils in hard-to-reach areas (box locks, mouth teeth, etc..)

Generally can only use detergents specifically formulated for ultrasonic cleaners - low foaming

Water temperatures usually 100 - 140 o F.

Can be used after manual cleaning

Ultrasonic Cleaning

Solution should be changed at least daily preferably after each use

Outbreaks of TASS have been associated with contaminated sonic baths

Unit should have a cover to contain aerosols

Items should not be stacked

Need to “de-gas” water

Ultrasonic Cleaning

Containers/baskets should have perforations; should be all metal mesh; no plastic

Should be located in Decontamination Area

cleaning process

more efficient than manual cleaning

Test the sonic for efficacy (daily???)

Testing Sonic

Rinsing

The most important part of the cleaning process

Essential to remove loosened debris

Should be performed with the volume and quality (sterile, distilled, or deionized water (if manual cleaning)

Water used to rinse instruments should be discarded after each use

Sterile distilled water recommended for final rinse to prevent mineral deposits and TASS

Lubrication

The use of instrument milk is beneficial to instruments to prevent corrosion and to keep moving parts from getting stiff.

However, not all instruments should be lubricated. The instrument manufacturer will indicate if this process is recommended.

Principles of Inspection/Assembly

All items should be prepared according to the device manufacturer’s written instructions (i.e. must the device be disassembled for sterilization?)

All hinged instruments should be in the open position to permit the sterilant to contact all surfaces of the jaws, blades, etc.

Items must be checked for cleanliness – the use of a lighted magnifying lamp is recommended to visualize defects such as cracked box locks, soils or missing tips.

Inspection

Best method is to use a microscope

Principles of Inspection/Assembly

All parts are present and functional

Use perforated or mesh bottom trays

All scissors should be tested for sharpness each time they are processed

Test that ratchets hold on clamps

Inspect hand held forceps that tips approximate

Test needle holders; ratchets hold and tips hold suture needle

Principles of Inspection/Assembly

Inspect that joints are not stiff

Use a lighted magnifying lamp or microscope to inspect

Inspect for rust, pitting, cracked box lock, etc.

Demagnetization of eye instruments may be needed

Separate delicate, sharp items

Use non-linting surgical towels, or paper sterilization bags to separate items inside set; not peel pack material

Refer to manufacturer’s IFUs regarding flushing of all lumened devices (AAMI states only for gravity cycles). Use sterile, distilled water

Ophthalmic Instruments

Look for defects:

Rusting common (especially if IUSS frequently used

Corrosion

Damage to tips/ teeth

Cords

Lumens (e.g. Phaco handpieces)

Stiffness

Sharpness

Spotting – Staining - Rust

Delicate Tips Require Protection

Can use small containers with silicone mat for individual instruments to provide protection.

General Guidelines for Packaging

Instrument Sets

Use specialty containers to keep delicate instruments in place and prevent damage in transport and cleaning.

The single most effective means to prevent damage to eye instruments is to place them in specialty protective containers

The basket or container of the correct size to prevent instrument damage

Handling Eye Instruments

Place instruments in the tray so that they do not touch each other.

Locate each instrument in the tray to prevent movement and possible damage during handling.

Always keep delicate tips protected with a tip guard when the instrument is not in use.

Protective Container - Cataract Set

Finger Mats May Not Provide Adequate Protection

Paper Plastic Pouches

Widely used because of the visibility of the contents.

However, according to AAMI and AORN pouches should be used for 1-2, light weight instruments.

If packaging instruments separately, select the correct size pouch.

Allow approximately 1” distance from the device and the pouch edges.

Must ensure instruments packaged to protect from damage

General Guidelines for Packaging

Individual Instruments/Small Items

Use correct size packaging

Do not use rubber bands to secure instruments

Paper Plastic Pouches

Double pouching is not required (AORN, AAMI)

May be used for small items which would be difficult to keep together

If double pouching, do not fold over the edges of inside pouch

Inside pouch must lay flat

Tip Protectors

Obtain the manufacturer’s instructions for use.

Some can “catch” onto the instruments – can result in damage

You can use any tip protector that has been approved for use in a sterilization system; foam sleeves, plastic; paper/plastic.

Make sure device can be held open with protector on (e.g. scissors, clamps).

Must have manufacturer’s data that sterilant will penetrate through the tip protector.

Chemical Indicators (Types)

External (Type I) – used to distinguish an item that has been in a sterilizer from an item that has not

Internal chemical indicators (Type 3-4-5)

Should be used inside and outside each package. For wrapped sets, the internal chemical indicator should be located in the center of the pack, not the top.

Type 3 – responds to one parameter

Type 4 – responds to 2 or more parameters

Should use at least a Type 4 CI

Chemical Indicators

Type 5 – integrating indicators – correlate to the action of a biological test

Cannot substitute for a BI test

Type 6 – emulating indicators that respond to a specific cycle type, temperature and exposure time

Labeling Packages

Use a marking pen containing non-toxic, permanent ink and approved for the intended process (e.g., steam sterilization cycles).

Need documentation that marker is non-toxic.

Packages - label on the indicator tape used to close the package, never on the wrapping material itself.

Paper–plastic pouches - label only on the plastic side or on sterilization tape.

If a package is labeled directly on the packaging material, the

marker could damage the packaging material.

Exception is the plastic side of paper plastic pouches.

Table Top Sterilizers

Many ASCs use table top sterilizers

A table-top sterilizer is a ”compact steam sterilizer that has a chamber volume of not more than two cubic feet and that generates its own steam when distilled or deionized water is added by the user” (ANSI/AAMI ST79).

Table-top sterilizers -commonly found in smaller surgery centers where a high volume of sterilization processing does not take place.

Also found in doctors’ and dental offices.

Cycles

The device manufacturer’s sterilization instructions should always be followed

If the cycles provided by the sterilizer cannot be adjusted to conform to the device manufacturer’s instructions, the device should not be processed in that sterilizer.

Conventional Steam Sterilizers

Read the IFUs for exposure time, temperature and cycle time

Many have CJD cycles ONLY

Many have European temperatures only (e.g. 273oF)

Must reconcile IFU information

May have to separate sets to meet IFUs

E.g. some instruments require 10 minutes exposure

Water Quality

Water quality is just as important for table-top units as for sterilizers that use boiler-generated steam.

Distilled or deionized water is recommended to prevent the buildup of minerals in the reservoir and on processed devices.

Each day, before the sterilizer is used for the first time, the reservoir should be checked to ensure that there is enough water for the number of loads to be processed.

Maintenance

Perform all the recommended maintenance of the tabletop sterilizer

Document all maintenance (e.g. reservoir cleaned, gaskets cleaned, etc.

Documentation

All cycles run should be documented

All items processed must be documented

Specific name of device/tray

Quantity

All items must be identified with a lot control number (to facilitate recall)

Must include date sterilized, sterilizer #, load number

Expiration date or event related statement

Traceability to the patient if posterior eye tissue surgery (CJD)

Summary

Best practices for processing ophthalmic instruments requires knowledge of the standards and recommendations to prevent TASS

Manufacturers IFUs

Effective cleaning

Correct packaging methods and materials

Effective sterilization –

Processing equipment in good condition

Proper handling after sterilization

Monitoring of staff compliance with all stated policies and manufacturers’ instructions

Training and competencies for staff

Conclusion - The End

Successful patient outcomes require we develop effective policies, train staff and monitor for compliance

Careful handling of ophthalmic instruments will keep patients safe and reduce costs.

References

AAMI. Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. ST-79, 2017.

AORN. Standards and Recommended Practices. “Selection and Use of Packaging Systems”, AORN.

Centers for Disease Control (Hospital Infection Control Guidelines) 2008

American Society of Cataract & Refractive Surgeons. White Paper on TASS (2006).

The Basics of Sterile Processing textbook, 6th edition, Sterile Processing University, 2016.

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Page 13: Cleaning Protocols and Equipment - APIC MT€¦ · Identify AAMI recommended cleaning protocols to prevent TASS Review the AAMI preparation recommendations for instruments and sets

3/13/2019

13

Keeping Ophthalmic Instruments Safe

Nancy Chobin, RN, AAS, ACSP, CSPM, CFER

CEO Sterile Processing University

Lebanon, NJ

Copyright 2019

Objectives

Identify AAMI recommended cleaning protocols to prevent TASS

Review the AAMI preparation recommendations for instruments and sets

Review care and handling of ophthalmic instruments

Background

Time to perform a cataract procedure has decreased15-20 minutes.

The cost for a set of instruments can range from $6,000 to $8,000 or more

Urgency to turn the instruments around for the next case.

Instruments come in contact with the eye and thus body fluids.

They are considered contaminated and must receive the entire cleaning and sterilization process between patients.

Manufacturer’s Instructions

Instrument manufacturer should:

specify the pH of detergent (e.g. neutral pH)

may recommend a pre-soak in an enzymatic cleaner to help remove protein soils (e.g. body fluids)

specify if any special cleaning implements are needed (e.g. to clean out lumens).

Specify water quality for cleaning and rinsing

However, need to reconcile this information with AAMI and ASORN, AORN, ASCRS and the CDC.

Manufacturer’s Instructions

Also known as Instructions for Use (IFUs)

Keep on file - readily available to processing personnel.

Ensure IFUs followed each and every time the instrument is processed.

Employee training should complement the AAMI guidelines as well as manufacturers’ instructions

Eye instrumentation is extremely delicate and as such requires very special handling and processing to prevent damage. All personnel handling eye instrumentation should ensure careful handling.

Example of Steam Sterilization IFU

Prevacuum High Temperature Autoclave: 274˚F (134˚C) for 3 minutes; wrapped.

NOTE: As per ANSI/AAMI ST79:2010 and A1:2010 270˚F (132˚C) for 4 minutes and 275˚F (135˚C) for 3 minutes are acceptable minimum cycle times for dynamic-air-removal steam sterilization cycles.

Standard Gravity Autoclave: 250˚F (121˚C) for 30 minutes; wrapped.

High Speed (Flash) Autoclave: 270˚F (132˚C) for 10 minutes; unwrapped.

Training and Competencies

Employee competencies should be verified in the processing protocols for processing ophthalmic instruments

Competencies should be verified initially and annually

Utilize resources such as ophthalmic instrument company's educational materials

Reconcile with national standards

Cleaning

Removal of contamination from an item to the extent necessary for further processing or for the intended use.

Involves the use of detergent and water, of adherent visible soil (i.e. blood, pus, protein) from the surfaces, crevices, serrations, jaws and lumens of instruments, devices and equipment, by a manual or mechanical process.

Due to their design, eye instrument challenging to clean

Very small lumens, very delicate tips, can easily break/damage

Pre-Cleaning in Room

Treat with demineralized water to prevent drying of bioburden.

Saline, disinfectants, and chlorinated solutions can cause pitting

and corrosion and should never be used for soaking instruments

Instruments should not remain in water for lengthy periods of time.

–– Biofilms may form, particularly within lumens.

Decontamination

According to OSHA, “the use of physical or chemical means to remove, inactivate, or destroy blood-borne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, use, or disposal.” [29 CFR 1910.1030]

NOTE—Generally used in health care facilities to refer to all pathogenic organisms, not just those transmitted by blood

First and most critical step in breaking the chain of disease transmission

Why Is Cleaning Important?

Process of disinfection or sterilization dependent upon direct contact of the sterilant or disinfectant with the surface of the item

Protein left on items can be “baked on” in the sterilizer

Why are some facilities only “wiping off” the instruments? “Cleaning with water? Alcohol?

TASS – Focus

Toxic Anterior Segment Syndrome (TASS) – main focus by AAMI and AORN

TASS - an acute inflammatory response of the anterior chamber of the eye.

May lead to severe visual impairment if it is not recognized and treated in a timely manner.

Many causes including detergents, water quality, steam quality, instruments, etc.

Major concern is when endotoxins form

Causes of TASS (ASCRS)*

Detergent residues (in general)

Endotoxins

Preservatives

Residues from sterilization processing

Residues of detergents inside a reusable cannula or instrument

Cement sealant on bags of irrigating solution which has leached out

All can induce TASS and cause severe damage to ocular tissue

* American Society of Cataract and Refractive Surgeons

TASS

Particular care must be taken in the processing of intraocular surgical instruments to help ensure that foreign substances or materials associated with the instruments will not be introduced into the anterior chamber of the eye during surgery.

TASS

Outbreaks of TASS have often been linked to the failure to follow the processing procedures recommended by the instrument manufacturer

Specific instrument cleaning and sterilization recommendations intended to diminish the risk of TASS associated with intraocular surgical instruments have been published by the American Society for Cataract and Refractive Surgery (ASCRS, 2006).

Also in AAMI ST-79 as an Annex

ASCRS Recommendations

An adequate inventory of the necessary intraocular surgical instruments should be maintained in order to allow for the timely processing of instruments between cases.

Major issue in surgery centers

Insufficient inventory of instruments leads to short cuts in cleaning

ASCRS Recommendations

Adequate time must be allowed for processing instruments according to the manufacturer’s instructions; otherwise, the cleaning and sterilization of the instruments will be ineffective.

ASCRS Recommendations

A designated cleaning area and equipment specific to the cleaning of intraocular surgical instruments should be identified.

Whenever possible, intraocular surgical instruments should be processed separately from general surgical instruments and equipment in order to reduce the potential for cross-contamination by material or residue from the general surgical instruments

ASCRS Recommendations

Instruments should be pre-cleaned immediately following use.

Gross debris should be removed, and instrument lumens should be flushed with sterile distilled water or another suitable agent as recommended in the room at the end of the procedure

ASCRS Recommendations

Only cleaning agents that have been recommended by the manufacturer should be used.

Particular attention should be paid to the specified concentration of cleaning agent and to the recommended water quality.

ASCRS Recommendations

Final rinsing of the instrument should be performed with sterile, distilled, or deionized water, unless otherwise specified by the manufacturer.

The water used to clean or rinse instruments should be discarded after each use.

ASCRS Recommendations

If an ultrasonic cleaner is used to process the instruments, it should be emptied, cleaned, rinsed, and dried at least daily or, preferably, after each use.

Brushes and other cleaning tools should be cleaned and sterilized as recommended by the manufacturer at least daily or, preferably, after each use.

ASCRS Recommendations

Cleaning and sterilization equipment should be properly maintained.

Foreign materials such as endotoxin or heavy metals may be deposited onto the instruments during processing and induce TASS

Water Quality

Water used to for the final rinse of the device should have a low endotoxin content to avoid pyrogens on processed

devices.

Can lead to pyrogenic reactions (i.e., fever) in patients.

Adequate cleaning and rinsing should result in low bioburden

Essential to the effectiveness of terminal sterilization and to the protection of patients from pyrogens.

Physical Area

Separate area – dedicated to cleaning of ophthalmic instruments

Away from any other type of surgical instruments

Temp 60-65oF

Humidity 30-60%

Air exchanges 10/hour negative

Monitor temperature and humidity daily and document

FIRST STEP

Must have manufacturer’s instructions for cleaning of all devices; method, implements and chemicals recommended

Steps in the Cleaning Process

Pre-Cleaning in room

Contain contaminated items at the point of use

Transport to Decontamination (confined and contained)

Sort

Soak

Wash

Rinse/Dry

Pre-Cleaning - Transport

Instruments should be pre-cleaned immediately following use

Remove gross debris and flush lumens with sterile distilled water (or other agent as recommended by the instrument manufacturer)

Keep instruments moist to avoid drying of soils

Many now recommend cleaning immediately or within 30 minutes of use

Transport in closed container (confine/contain)

Container should be labeled as biohazard (OSHA)

Soaking

Can pre-soak with a detergent

Use of enzyme detergents preferred – but only if recommended by the instrument manufacturer

Assists in the loosening of soils to facilitate cleaning

Do NOT soak in fluids for prolonged periods of time - biofilms can form

Generally form on any surface that is exposed to non-sterile water or other liquids and is consistently found in many environments including industrial and medical systems

use enzymatic gels or foam

Biofiolms

Are produced by microorganisms and consist of a sticky rigid structure of organic contaminates

Slime layer anchored firmly to a surface and provides a protective environment for microorganisms to grow

Cleaning

Need to take special precautions with eye instruments due to

Delicate nature of the design

Sensitivity of eye tissue

Cleaning becomes a challenge

Manual cleaning may be only validated method

Manual cleaning is not as controlled (standardized) as mechanical cleaning

Dilemma

Some eye instrument manufacturer’s do not recommend ANY detergent

Source of confusion for end user

Need to challenge manufacturers

Enzymatic Cleaners

Organic substances which assist in the breakdown of soils

Facilitate the removal of blood and protein soils

Excellent for devices with lumens

Effectiveness dependent upon concentration, use temperature and contact time

Enzymatic Cleaners

Sold as liquid concentrates or powder

Generally more effective in warm water (110-140oF)

Enzyme activity can be inactivated above certain maximum temperatures (140oF)

Follow manufacturer’s directions

Use a thermometer – monitor water temperature

Principles of Cleaning

Must have manufacturer’s written instructions for cleaning of all devices processed

Follow all recommended steps using equipment recommended

Must wear PPE

Impervious gown, head cover, shoe covers, cuffed gloves, face shield

Manual Cleaning Process

May be the only cleaning process available

Items should be submerged, disassembled

Preferable to use 3-sink method; wash, rinse, rinse

Can also be used to remove deposits which were not removed during the pre-soak

Brush all serrations, crevices, tips, handles, and hinges.

Brushing should be done under the surface of the water to prevent aerosolization of contaminants.

Manual Cleaning – General Instructions

Handle instruments one at a time or in small numbers to avoid damage

Open hinged instruments

Disassemble multi-part instruments – keep parts together for easy reassembly after cleaning

Brush and flush all lumened devices

Clean all surfaces

Specialty Items

Cannulas, irrigation cannulas,irrigation/aspiration (I/A) handpieces, suction tips, cystotomes.

Use a brush of the appropriate size to clean the lumen; hold instrument and brush below the water surface

Manual Cleaning Detergents

Usually used for manual cleaning and as a pre-soak

Range from low foam to high foam products

Generally have neutral pH of 7 to 9

Sold as concentrates

Free rinsing

Always measure and dilute the detergent as specified by the detergent manufacturer

Water used to clean instruments should be discarded after each use

Manual Cleaning Implements

Soft bristle brushes, various sizes and lengths (no metal brushes)

Soft cloths

No abrasive items

No sponges

No materials which are permeable; i.e.. Wood

Implements used to clean instruments should be cleaned according to the manufacturer or at least daily, preferably after each use

Mechanical Cleaners

Do not put microsurgical instruments into a washer decontaminator unless it has a delicate cycle.

Can result in damage to instruments

Specialty Cleaner

Specialty cleaning and rinsing system for lumened devices such as Phaco and OZIL handpieces

Effectively cleans and rinses lumens

Must disinfect according to IFUs and document

Diamond Knives

The diamond knife is designed to make precision atraumatic cuts

The diamond knife has the sharpest cutting edge possible

Cost can range from $800 - $2,500 or more

Diamond Blade Knives

Cleaning: Immediately after using a diamond knife, the blade must be rinsed with demineralized water, preventing cell particles or viscoelastic materials from sticking to the blade.

Generally. ultrasonically clean holding the knife and suspending only the blade into the fluid.

The blade should not touch any other instruments or the sides of the cleaner.

Diamond Blade Knives

Never completely submerge a diamond knife in an ultrasonic cleaner.

At all time, (except cleaning) the blade should be in the retracted position to prevent damage.

Inspect with microscope.

Ultrasonic Cleaning

Uses sound waves transmitted through a solution

Sound waves produce tiny bubbles which implode - results in scouring action that cleans

Mechanical process = cavitation

Ultrasonic Cleaning

Effective to remove soils in hard-to-reach areas (box locks, mouth teeth, etc..)

Generally can only use detergents specifically formulated for ultrasonic cleaners - low foaming

Water temperatures usually 100 - 140 o F.

Can be used after manual cleaning

Ultrasonic Cleaning

Solution should be changed at least daily preferably after each use

Outbreaks of TASS have been associated with contaminated sonic baths

Unit should have a cover to contain aerosols

Items should not be stacked

Need to “de-gas” water

Ultrasonic Cleaning

Containers/baskets should have perforations; should be all metal mesh; no plastic

Should be located in Decontamination Area

cleaning process

more efficient than manual cleaning

Test the sonic for efficacy (daily???)

Testing Sonic

Rinsing

The most important part of the cleaning process

Essential to remove loosened debris

Should be performed with the volume and quality (sterile, distilled, or deionized water (if manual cleaning)

Water used to rinse instruments should be discarded after each use

Sterile distilled water recommended for final rinse to prevent mineral deposits and TASS

Lubrication

The use of instrument milk is beneficial to instruments to prevent corrosion and to keep moving parts from getting stiff.

However, not all instruments should be lubricated. The instrument manufacturer will indicate if this process is recommended.

Principles of Inspection/Assembly

All items should be prepared according to the device manufacturer’s written instructions (i.e. must the device be disassembled for sterilization?)

All hinged instruments should be in the open position to permit the sterilant to contact all surfaces of the jaws, blades, etc.

Items must be checked for cleanliness – the use of a lighted magnifying lamp is recommended to visualize defects such as cracked box locks, soils or missing tips.

Inspection

Best method is to use a microscope

Principles of Inspection/Assembly

All parts are present and functional

Use perforated or mesh bottom trays

All scissors should be tested for sharpness each time they are processed

Test that ratchets hold on clamps

Inspect hand held forceps that tips approximate

Test needle holders; ratchets hold and tips hold suture needle

Principles of Inspection/Assembly

Inspect that joints are not stiff

Use a lighted magnifying lamp or microscope to inspect

Inspect for rust, pitting, cracked box lock, etc.

Demagnetization of eye instruments may be needed

Separate delicate, sharp items

Use non-linting surgical towels, or paper sterilization bags to separate items inside set; not peel pack material

Refer to manufacturer’s IFUs regarding flushing of all lumened devices (AAMI states only for gravity cycles). Use sterile, distilled water

Ophthalmic Instruments

Look for defects:

Rusting common (especially if IUSS frequently used

Corrosion

Damage to tips/ teeth

Cords

Lumens (e.g. Phaco handpieces)

Stiffness

Sharpness

Spotting – Staining - Rust

Delicate Tips Require Protection

Can use small containers with silicone mat for individual instruments to provide protection.

General Guidelines for Packaging

Instrument Sets

Use specialty containers to keep delicate instruments in place and prevent damage in transport and cleaning.

The single most effective means to prevent damage to eye instruments is to place them in specialty protective containers

The basket or container of the correct size to prevent instrument damage

Handling Eye Instruments

Place instruments in the tray so that they do not touch each other.

Locate each instrument in the tray to prevent movement and possible damage during handling.

Always keep delicate tips protected with a tip guard when the instrument is not in use.

Protective Container - Cataract Set

Finger Mats May Not Provide Adequate Protection

Paper Plastic Pouches

Widely used because of the visibility of the contents.

However, according to AAMI and AORN pouches should be used for 1-2, light weight instruments.

If packaging instruments separately, select the correct size pouch.

Allow approximately 1” distance from the device and the pouch edges.

Must ensure instruments packaged to protect from damage

General Guidelines for Packaging

Individual Instruments/Small Items

Use correct size packaging

Do not use rubber bands to secure instruments

Paper Plastic Pouches

Double pouching is not required (AORN, AAMI)

May be used for small items which would be difficult to keep together

If double pouching, do not fold over the edges of inside pouch

Inside pouch must lay flat

Tip Protectors

Obtain the manufacturer’s instructions for use.

Some can “catch” onto the instruments – can result in damage

You can use any tip protector that has been approved for use in a sterilization system; foam sleeves, plastic; paper/plastic.

Make sure device can be held open with protector on (e.g. scissors, clamps).

Must have manufacturer’s data that sterilant will penetrate through the tip protector.

Chemical Indicators (Types)

External (Type I) – used to distinguish an item that has been in a sterilizer from an item that has not

Internal chemical indicators (Type 3-4-5)

Should be used inside and outside each package. For wrapped sets, the internal chemical indicator should be located in the center of the pack, not the top.

Type 3 – responds to one parameter

Type 4 – responds to 2 or more parameters

Should use at least a Type 4 CI

Chemical Indicators

Type 5 – integrating indicators – correlate to the action of a biological test

Cannot substitute for a BI test

Type 6 – emulating indicators that respond to a specific cycle type, temperature and exposure time

Labeling Packages

Use a marking pen containing non-toxic, permanent ink and approved for the intended process (e.g., steam sterilization cycles).

Need documentation that marker is non-toxic.

Packages - label on the indicator tape used to close the package, never on the wrapping material itself.

Paper–plastic pouches - label only on the plastic side or on sterilization tape.

If a package is labeled directly on the packaging material, the

marker could damage the packaging material.

Exception is the plastic side of paper plastic pouches.

Table Top Sterilizers

Many ASCs use table top sterilizers

A table-top sterilizer is a ”compact steam sterilizer that has a chamber volume of not more than two cubic feet and that generates its own steam when distilled or deionized water is added by the user” (ANSI/AAMI ST79).

Table-top sterilizers -commonly found in smaller surgery centers where a high volume of sterilization processing does not take place.

Also found in doctors’ and dental offices.

Cycles

The device manufacturer’s sterilization instructions should always be followed

If the cycles provided by the sterilizer cannot be adjusted to conform to the device manufacturer’s instructions, the device should not be processed in that sterilizer.

Conventional Steam Sterilizers

Read the IFUs for exposure time, temperature and cycle time

Many have CJD cycles ONLY

Many have European temperatures only (e.g. 273oF)

Must reconcile IFU information

May have to separate sets to meet IFUs

E.g. some instruments require 10 minutes exposure

Water Quality

Water quality is just as important for table-top units as for sterilizers that use boiler-generated steam.

Distilled or deionized water is recommended to prevent the buildup of minerals in the reservoir and on processed devices.

Each day, before the sterilizer is used for the first time, the reservoir should be checked to ensure that there is enough water for the number of loads to be processed.

Maintenance

Perform all the recommended maintenance of the tabletop sterilizer

Document all maintenance (e.g. reservoir cleaned, gaskets cleaned, etc.

Documentation

All cycles run should be documented

All items processed must be documented

Specific name of device/tray

Quantity

All items must be identified with a lot control number (to facilitate recall)

Must include date sterilized, sterilizer #, load number

Expiration date or event related statement

Traceability to the patient if posterior eye tissue surgery (CJD)

Summary

Best practices for processing ophthalmic instruments requires knowledge of the standards and recommendations to prevent TASS

Manufacturers IFUs

Effective cleaning

Correct packaging methods and materials

Effective sterilization –

Processing equipment in good condition

Proper handling after sterilization

Monitoring of staff compliance with all stated policies and manufacturers’ instructions

Training and competencies for staff

Conclusion - The End

Successful patient outcomes require we develop effective policies, train staff and monitor for compliance

Careful handling of ophthalmic instruments will keep patients safe and reduce costs.

References

AAMI. Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. ST-79, 2017.

AORN. Standards and Recommended Practices. “Selection and Use of Packaging Systems”, AORN.

Centers for Disease Control (Hospital Infection Control Guidelines) 2008

American Society of Cataract & Refractive Surgeons. White Paper on TASS (2006).

The Basics of Sterile Processing textbook, 6th edition, Sterile Processing University, 2016.

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