Immediate-Use Steam Sterilization in the OR...

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3M Infection Prevention SolutionsLearning Connection

Immediate-Use Steam Sterilization in the OR

October 8, 2013Martha Young, MS, BS, [email protected]

© 2012. All Rights Reserved.

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Disclosure

Martha Young, MS, BS, CSPDT

President Martha L.Young, LLC

Providing SAVVY Sterilization Solutions to Healthcare

Potential Conflicts of Interest

Educational Consultant to 3M

Learner Objectives

1. Define Immediate-Use Steam Sterilization

2. Review AORN and AAMI Recommended Practices

3 Disc ss Hot Topics Related to IUSS


3. Discuss Hot Topics Related to IUSS

The Joint CommissionNational Patient Safety Goals

NPSG.07.05.01

“Implement evidence-based practices for preventing surgical site infections.”

Element of performanceElement of performance

“Implements policies and practices aimed at reducing the risk of surgical site infections. These policies and practices meet regulatory requirements and are aligned with evidence-based guidelines (for example, the Center for Disease Control and Prevention [CDC] and/or professional organization guidelines).”

The Joint Commission. 2013 Hospital Accreditation Standards (HAS)

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Evidence-Based GuidelinesAssociation for the Advancement of Medical

Instrumentation (AAMI)

• Comprehensive guide to steam sterilization and sterility assurance in health care facilities ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 (Consolidated Text)

Association of Perioperative Registered Nurses (AORN)


Association of Perioperative Registered Nurses (AORN)

• Perioperative Standards and Recommended Practices (2013 Edition)

Centers for Disease Control and Prevention (CDC)

• Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008

Regulations & Recommended Practices

Establish State Of The ArtState-Of-The-Art

For

Sterile Processing

Sterilization Process Should Follow Recommended Practices

•Hospitals

•ASCs

•Ambulatory Health Centers (AHCs) (Clinics)

•Doctor Offices

•Dental Facilities

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The Joint Commission

Joint CommissionOnline July 2011

•Surveyors received in-depth training on sterilization processes through AAMI

•Since being trained citing for noncompliance for HLD/sterilization has gone from 10% to 40%gone from 10% to 40%

•Survey to ANSI/AAMI ST79

•Expect up-to-date ANSI/AAMI ST79 to be available to employees

http://www.jointcommission.org/assets/1/18/jconline_July_20_11.pdf*Louise Kuhny, TJC Standards and Survey Process, AORN webinar 9/22/2011.To order access at: http://www.aorn.com/Secondary.aspx?id=21189&terms=Webinars#axzz20596Ipvv

Objective 1Define Immediate-Use


Steam Sterilization

Is This An IUSS Cycle?

Q: Recently a healthcare facility told me they were no longer using IUSS to process instruments in the OR because they were using:

•Sterilization containers

D i i l t t ili ti l •Dynamic-air-removal steam sterilization cycle

•270-275ºF (132-135ºC), 4 minutes

A: Yes it is IUSS because it has no dry time


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Is This An IUSS Cycle?

Q: OR is using:

•Containers •Dynamic-air-removal steam sterilization cycle•270-275ºF (132-135ºC), 4 minutes•6 minute dry cycle

A: Yes this is an IUSS cycle

•Because the dry time is shorter than the 30 minutes recommended by the instrument manufacturer so there is a chance that the instruments, especially lumens, are not dry


AAMI Definition for IUSS

“Process designed for the cleaning, steam sterilization, and delivery of patient care items for immediate use. Previously known as flash sterilization.”

© 2012. All Rights Reserved

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Definition 2.61

IUSS Should Meet The Following CriteriaCycle selection includes:

Type of cycle•Gravity-displacement or dynamic-air- removal

–Dynamic-air-removal should be used unless it l d d b d i gravity cycles recommended by device

manufacturer (8.6.2.1)


ANSI/AAMI ST79:20120 & A1:2012 & A2:2011 & A3:2013 & A4:2013 Introduction and Overview

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IUSS Should Meet the Following CriteriaCycle selection includes:

Temperature•270-275ºF (132-135ºC)

Time in a dynamic-air-removal sterilizer Time in a dynamic air removal sterilizer •Standard (e.g., 270-275ºF, 4 min) or •Extended (e.g., 270-275ºF, 10 min) (8.6.2.1)•Use the same cycle in OR as used in sterile processing (SP)•Follow the device manufacturer’s written IFU



IUSS Should Meet the Following CriteriaCycle selection includes:

Dry time:•0 to 1 minute or shorter than stated in IFU so contents wet ContainerizeT f i di t l i ti t h iTransfer immediately using aseptic techniqueOpen immediately, do not store for later use unless indicated by containment device manufacturer (8.8.5)



Implementation of Reusable Rigid Containers for IUSS AORN recommends the use of rigid sterilization containers validated for IUSS and cleared by FDA

Reduce risk of contamination during transport to point of use

E f t ti t t il fi ldEase of presentation to sterile field


AORN Recommended Practices for Sterilization, 2003 Recommendation VII.a.2, VII.e.

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When to Use IUSS

“Should be used only when there is insufficient time to process by the preferred wrapped or containerized method intended for terminal sterilization.”

Instrument dropped or otherwise contaminated by touching area outside of sterile field •Not another one available or an instrument to substitute


AORN Recommended Practice for Sterilization, 2013 Recommendation VII.a.

When to Use IUSS• Should only be used in selected clinical situations and in a

controlled manner*

• Selected clinical situations

• Define what is an emergency*• Risk to patient being under anesthesia greater than the risk associated


Risk to patient being under anesthesia greater than the risk associated with IUSS

• Implant in case of defined emergency with no other available option

• Exercise clinical judgment• Impossible to predict every situation where IUSS may be appropriate

*AORN Recommended Practices for Sterilization, 2013 Recommendation VII., VII.f.Personnel communications with Ramona Conner (AORN), Rose Seavey, Cynthia Spry

When to Use IUSS• Should only be used in selected clinical situations and in a

controlled manner

• Do not eliminate or modify any processing step• No short cuts or skipped steps because of time

• Follow instrument manufacturer’s IFU• Cleaning/decontamination (manual, possible mechanical washer,


ultrasonic, treated water)• Packaging (use FDA cleared IUSS packaging, clean and inspect

containers after every use)• Sterilization process (including cycle time, temperature, and dry time)• Monitoring of cycle (physical monitors, chemical and biological

indicators)

AORN Recommended Practices for Sterilization, 2013 Recommendation all sections of VII

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When Not to Use IUSS

“Should not be used as a substitute for sufficient instrument inventory.”

Should have enough inventory to supply the cases for the day without using IUSS


AORN Recommended Practice for Sterilization, 2013 Recommendation VII.a.

When Not to Use IUSS

Implants should not be sterilized for immediate use


ANSI/AAMI ST79:20120 & A1:2012 & A2:2011 & A3:2013 & A4:2013 Introduction and OverviewAORN Recommended Practices for Sterilization, 2013 Recommendation VII.f.CDC Guidelines for Disinfection and Sterilization in Healthcare Facilities, 2008 13A

Polling Question

Are you processing implants in IUSS?

YesNoDon’t know Don’t process implants

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An Evaluation of IUSS Practice

“A major concern regarding IUSS is that its convenience may lead to nonemergent, inappropriate use.”

Abuse of IUSS has potential to:

•Increase risk for development of SSI•Increased health care costs•Direct thermal injury to the patient


Scott L Zuckerman, et al. American Journal of Infection Control 40 (2012), accessed at: www.ajicjournal.org/issues


“Even if used appropriately, the stresses associated with an urgent need for the instrument may lead to skipped steps in the sterilization process and wide variability in practice.”

“Intraoperative contamination is the only acceptable Intraoperative contamination is the only acceptable reason to immediately sterilize instruments.”




Record rationale for IUSS

If IUSS is occurring inappropriately according to the current guidelines

Ch ti•Change practices

Use a safety checklist to ensure appropriate and correct indications for IUSS have been met


Scott L Zuckerman, et al. American Journal of Infection Control 40 (2012 ), accessed at: www.ajicjournal.org/issues

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Safety checklist to ensure appropriate and correct indications for IUSS have been met

Surgical instrument made unsterile and/or unusable (i.e., dropped to contaminate area)

Surgical case cannot be completed safely without contaminated surgical instrument

There are no remaining surgical instruments available that can accomplish identical goal of contaminated surgical instrument



An Evaluation of IUSS PracticeSafety checklist to ensure appropriate and correct indications for IUSS have been met

There is no available surgical instrument on the scrub technician’s tray

There is no surgical instrument available in the operative suite or There is no surgical instrument available in the operative suite or supply room


Scott L Zuckerman, et all American Journal of Infection Control 40 (2012), accessed at: www.ajicjournal.org/issues

Disadvantages of Using IUSS

•“Immediate use steam sterilization may be associated with increased risk of infections to patients.”

•“Time constraints may result in pressure on personnel to eliminate or modify one or more steps in the cleaning and y p gsterilization process.”

•Risk of contamination during transport of items to the point of use and during presentation to sterile field.


AORN Recommended Practices for Sterilization, 2013 Recommendation VII., VII.e.

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Polling Question

Do you use a safety checklist to ensure appropriate and correct indications for IUSS have been met?

YesNoDon’t know Don’t use IUSS

Objective 2Review AORN and AAMI


Recommended Practices

Cleaning

Clean, package and sterilize according to the manufacturer’s IFU

For cleaning need:

•Equipment (3 sinks, may need a mechanical and ultrasonic washer)•Cleaning agent•Tools (brushes)•Water quality (potable water for first rinse and deionized, distilled, or RO for final rinse)


ANSI/AAMI ST79:20120 & A1:2012 & A2:2011 & A3:2013 & A4:2013 Introduction and OverviewAORN Recommended Practices for Sterilization, 2013 Recommendation VII

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CleaningAppropriate cleaning processes

•Disassemble instruments•Brushing occurs under water

Wear appropriate PPEWear appropriate PPE

•Fluid-resistant face mask and eye protection•Liquid-resistant gown •Heavy-duty, waterproof long and cuffed gloves•Liquid-resistant shoe coverings


ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Section 7.4-7.5AORN Care of Instruments, 2013 Recommendation X

Cleaning Agents

Compatible with medical device and cleaning equipment

Use according to cleaning agent manufacturer’s written IFU:

•Use within shelf life •Dilute appropriately •Calculate volume of cleaning agent sink or solution container (A3:2012)•Monitor and document water/cleaning agent temperature


ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Section 7.5.2

Brushes and Other Cleaning Implements•Brushes and other cleaning implements should be single-use, disposable items and discarded after every use

•If brushes are reusable, they should be disinfected or sterilized at least daily (CDC says after each use)

•Manufacturer should provide correct brushes to useManufacturer should provide correct brushes to use

-Appropriate type-Size (diameter and length)-Bristle type-Material


ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Sections 7.5.3.2, 7.5.6 CDC, 2008 Guideline for Disinfection & Sterilization

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Packaging

•Recommended by instrument manufacturer’s IFU

•Do not change original container packaging unless receive written validated IFU from instrument manufacturer

•Provide protection for aseptic presentationp p p

•Unwrapped trays not recommended

ANSI/AAMI ST79:20120 & A1:2012 & A2:2011 & A3:2013 & A4:2013 Introduction and OverviewAORN Recommended Practices for Sterilization, 2013 Recommendation VII


Packaging

Rigid sterilization containers

•Use items immediately•Do not store for later use•Do not hold from one procedure to another

AORN Recommended Practices for Sterilization, 2013 Recommendation VII.a.2.© 2012. All Rights Reserved.

Sterilization Process Monitoring

Monitoring Tools

• Physical monitors• Chemical indicators• Biological indicators


• Process challenge devices (PCDs)Test or challenge pack

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Biological Indicators

• Use for

• Release of implant and non-implant loads• Routine monitoring of the sterilization process• Qualification testing of the sterilization process

P d t t ti ( ill t di


• Product testing (will not discuss, see Section 10.9, 10.10)

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Section 10.5.3.2

Monitoring

Biological indicators (BIs) and BI process challenge devices (PCDs) not appropriate for cycle being tested

Information on appropriate BI PCDs to use is covered in ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 &

A4:2013

Section 10

And

BI and BI PCD manufacturer’s IFU


ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Section 2.95

Process Challenge Device (PCD) Definition

• Item designed to constitute a defined resistance to a sterilization process and used to assess performance of the process.”

• Representative of load and creates the greatest challengeE l t t th th t diffi lt it t t ili• Equal to or greater than the most difficult item to sterilize

• Placed in most difficult area in sterilizer for the sterilant to penetrate


ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Section 2.95

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BI PCD IUSS270ºF/132ºC Dynamic-air-removal Steam Sterilization Process

BI PCD Used Daily Packaging Used Routinely

Is this the correct BI PCD for the packaging routinely used?Incorrect The BI PCD does not represent the packaging routinely used which means you may miss a sterilization process failure


BI PCD IUSS270ºF/132ºC Dynamic-air-removal Steam Sterilization Process

BI PCD Used Daily Packaging Used Routinely

•• Correct BI PCD• Represents packaging routinely used


Correct or Incorrect BI PCD?


Incorrect- no basket in container

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Polling Question

Are you using the correct BI and BI PCD in the IUSS cycles being tested in your facility?

YesNoNoNeed to investigate!Not responsible for monitoring IUSS

Question Asked of TJC at IAHCSMM May 2012Question:

We use a 1 hour and 3 hour BI in our implant loads so we can release the implant in 1 hour. Is that correct?

AAnswer:

•No because each of those BIs are designed for and FDA cleared for different cycles

•This is an example of operator error and not using critical thinking

•Follow the BI and BI PCD manufacturer’s IFU


Joint Commission Observations

•BI test and control results not being recorded

•Need BI test and control to be from same lot


These slides were prepared based on what the author learned from a Joint Commission presentation at annual IAHCSMM meeting in May 2012

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Positive Biological Indicator (BI) Control

• Incubate a positive BI control each day a test vial is incubated in each incubator

• Positive control BI should be from same lot number as test BI

•Good Science


ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Sections 10.7.2.3, 10.7.3.3, 10.7.4.3


• Purpose is to verify the test system is working and ensure• Proper incubation temperature

• Placed into correct incubator• Incubator is functioning

• Presterilization viability of test spores• Capability of medium to promote growth of test spores


ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Sections 10.7.2.3, 10.7.3.3, , 10.7.4.3


• Read and record test and control results upon completion of incubation time

• If control test BI from lot fails:

• Test spores are non viable or dead


• Test spores are non viable or dead• Improper incubation

• Test results are invalid

• Determine why and rerun BI and load

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Sections 10.7.2.3, 10.7.3.3, , 10.7.4.3

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Polling Question

Are you running a control BI from the same lot number as the test BI in each incubator each day a test BI is incubated?

YesNo Don’t know

Bowie-Dick Test• Testing sterilizer performance daily

• Bowie-Dick Test monitors efficacy of air removal and steam penetration in

• 132-135°C/270-275°F dynamic-air-removal sterilizers (i.e., vacuum-assisted sterilizers)


• Detects:

• Air leaks

• Inadequate air removal

• Inadequate steam penetration

• Presence of non-condensable gases• Air or gases from boiler

ANSI/AAMI ST79 :2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Section 10.7.6

Bowie-Dick Test

Follow the sterilizer and Bowie-Dick test pack instructions for use

Run a warm up cycle

Pl k b tt h lf Place one pack on bottom shelf of sterilizer rack over drain

Run not more than 3.5 to 4 min, 132-135ºC/270-275ºF, no dry time


ANSI/AAMI ST79:2010 & A1:2010 & A2:2012 & A3:2012 & A4:2013 Section 10.7.6

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Bowie-Dick Test

• Uniform color change – Use• If not uniform, shut down and report to supervisor

• Remain in use• Retest• Call for repair

• Re-qualify if major repair


ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Sections 10.7.6.5

AORN RecommendationInternal Chemical Indicator (CI) For IUSS

•Use a Class 5 or Class 6 CI within each sterilization container

•“Class 6 indicators are cycle-specific and should be used l i th ifi l f hi h th l b l d ” only in the specific cycles for which they are labeled.”


AORN Sterilization 2013 Recommendation VII.c.3.

Routine Load Release of Implant Loads • Physical monitors

• Read and initial

• External process indicator (Class 1) on outside of every package unless internal CI is available


• Read before package is issued or opened in OR

• Internal CI(s) (Class 3, 4, 5, 6) inside each package

• Read before package is placed on sterile field

AORN Sterilization 2013 Recommendation VII.c.1., XX.d.1., XX.f.2., XX.h.1.AORN Sterile Technique 2013 Recommendation VI.a.2, VI.f.2, VI.f.4ANSI/AAMI ST79:2010 & A1:2010 & A 2:2011 & A3:2012 & A4:2013 Section 10.5.1, 10.5

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Routine Load Release of Implant Loads

•A PCD containing a BI and a Class 5 integrating indicator

-Quarantine until BI results available

•Evaluation of all data by an experienced •Evaluation of all data by an experienced, knowledgeable person

•Do not distribute load if any data suggests a sterilization process failure


AORN Sterilization in Perioperative Practice Setting, 2013, Recommendation XVI ANSI/AAMI ST79:2010 & A1:2010 & A 2:2011 & A3:2012 & A4:2013 Section 10.6.3

Routine Load Release of Implant Loads

•“Each load should be monitored if it contains implantable objects. If feasible, implantable items should not be used until the results of spore tests are known to be negative.” (CDC)

•“Releasing implants before the BI results are known is unacceptable and should be the exception, not the rule.” (AAMI)


CDC, 2008 Guideline for Disinfection & Sterilization ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Section 10.5.3.2, 10.6.3

Routine Load Release of Implant Loads •Class 5 integrating indicator used to release implant in emergency situations.

•“Emergency situations should be defined.”

Class 6 emulating indicators cannot be used to •Class 6 emulating indicators cannot be used to release implants early or as a replacement for a BI


ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Section 10.5.3.2, 10.6.3

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Early Release of Implant Loads

•Exception form for premature release of implantable device/tray in defined emergency situations

-Name of implant-Name of patientName of surgeon-Name of surgeon

-Reason for premature release-What could have prevented the premature release-Critical that this documentation be fully traceable to the patient


ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Section 10.6.3, Annex L

The Joint CommissionNew Emphasis for 2011

• Exception form (AAMI ST79, 10.6 and Annex L)

• Early release of implant is unacceptable; an exception form must be completed

• WHO can authorize early release of implants?


• Signature not required• Should be a department of surgery policy• Suggest it be a surgeon

These slides were prepared based on what the author learned from a Joint Commission presentation at IAHCSMM in May 2011

Routine Load Release of Non-Implant Loads • Physical monitors

• Read and initial

• External process indicator (Class 1) on outside of every package unless internal CI is available


• Read before package is issued or opened in OR

• Internal CI(s) (Class 3, 4, 5, 6) inside each package

• Read before package is placed on sterile field

AORN Sterilization 2013 Recommendation VII.c.1., XX.d.1., XX.f.2., XX.h.1.AORN Sterile Technique 2013 Recommendation VI.a.2, VI.f.2, VI.f.4ANSI/AAMI ST79:2010 & A1:2010 & A 2:2011 & A3:2012 & A4:2013 Section 10.5.1, 10.5

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Routine Load Release of Non-implants

•Optional monitoring of load with a PCD containing a -BI-BI and a Class 5 CI -Class 5 integrating indicator-Class 6 emulating indicatorClass 6 emulating indicator

•Evaluation of all data by an experienced, knowledgeable person•Do not distribute load if any data suggests a sterilization process failure

ANSI/AAMI ST79:2010 & A1:2010 & A 2:2011 & A3:2012 & A4:2013 Section 10.5.4


Polling Question

Are you releasing implants before the BI results are available?

Yes, with Early Release form Yes, without paperworkNo, neverDon’t know Don’t process implants

Immediate-Use Steam Sterilization Cycles (IUSS)Routine Efficacy Testing

•Weekly, preferably daily

•BI PCD in empty cycle

Sterilizer Qualification Testing

•After major event

•BI PCD in 3 consecutive empty p y y p ycycles

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Sections 10.7.4, 10.8.4


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Immediate-Use Steam Sterilization Cycles (IUSS)Routine Efficacy Testing

Representative BI PCD* using one or more BIs and one or more CIs in the empty tray configuration•Perforated mesh bottom open

Qualification Testing

Representative BI PCD* using one or more BIs and one or more CIs•Perforated, mesh bottom, open

surgical tray•Rigid sterilization container system•Protective organizing case•Single type of tray configurationEach type of tray configuration used should be tested used should be tested

•Select one representative tray configuration

* No commercial BI PCDs are available for IUSS sterilization

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Sections 10.7.4, 10.8.4© 2012. All Rights Reserved.

Immediate-Use Steam Sterilization Cycles (IUSS)

Routine Efficacy Testing

Representative BI PCD

Placed on bottom shelf over the drain

Qualification Testing

Representative BI PCD

Placed on bottom shelf over the drainthe drain

Otherwise empty chamber

Weekly, preferably daily

After Bowie-Dick test if dynamic air-removal

the drainOtherwise empty chamber

Three consecutive cycles

Before Bowie-Dick test if dynamic air-removal

ANSI/AAMI ST79:2010 & A1:2010 & A:2011 & A3:2012 & A4:2013 Sections 10.7.4 and 10.8.4© 2012. All Rights Reserved.

When To Do a Recall

If cause of failure immediately identified and confined to one

If cause of failure not identified• Quarantine load, recall all items

Sterilization process failure (BI, CI, or Physical Monitor)

Quarantine load, remove sterilizer from service, investigate cause of failure

identified and confined to one load or item (e.g., using incorrect sterilization cycle)

•No recall, correct problem and reprocess load

Quarantine load, recall all items processed since last negative BI

• Determine cause of failure

• Major repair-qualification testing

• Minor repair-return to use

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Section 10.7.5, Figure 12


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Running a BI PCD in Every Load and Quarantining•Standardization of BI monitoring policy

•Less chance of human error (human factors issue)•Ensure meeting recommended practices requirements g p qrelated to monitoring of cycles and packaging used

•Ensure monitoring all loads with implants

•Quicker detection of IUSS container failures resulting from poor functioning mechanical filters or leaks due to damaged gaskets


Running a BI PCD in Every Load and Quarantining

•Quicker detection and correction of process failures

•Eliminates recalls

•Reduce patient risk because less patients involved

•Save money

•Peace of mind


IUSS AORN Documentation• Item(s) processed• Patient on whom the items were used• Type of cycle (e.g., gravity-displacement, dynamic-air-

removal)• Cycle parameters used (e.g., temperature, duration of

cycle)


y )• Monitoring results• Day and time cycle was run• Operator information (person who initiated cycle and

retrieved item from cycle)• Reason for IUSS•

AORN Sterilization 2013 Recommendation VII.g.1.

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IUSS Documentation

•Document monitoring results along with name of patient

•“Ideally, every reprocessed medical device, especially an implant, should be fully traceable to the patient on whom it is

d i h it i i l t d ”*†used or in whom it is implanted.”*†


*AORN Recommended Practices for Sterilization, 2013 Recommendation VII.g. †ANSI/AAMI ST79:20120 & A1:2012 & A2:2011 & A3:2013 & A4:2013 Section 10.3.1

Objective 3Discuss Hot Topics Related


to IUSS

JC Surveys: Observations About IUSS Won’t cite an organization for sterilizing instruments for immediate use

•Will check to see if data is being collected when IUSS is used

•Check to see if action is being taken to reduce IUSS based on data

•If not will cite under performance improvement standards


John Rosing, OR Manager, Oct. 2012

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JC Surveys: Observations About IUSS Data Collection•Collect number of IUSS episodes attributed to lack of instruments

•OR leadership evaluates data

C ll t ti l d t thl•Collect routinely and aggregate monthly

•OR leadership submits data to Infection Control committee for evaluation

•Data presented to hospital’s finance department to justify purchase of more instruments


John Rosing, OR Manager, Oct. 2012

Polling Question

Are you collecting data monthly on when IUSS is done and why in order to reduce its use?

YesNoDon’t know

Benchmark for IUSS

Benchmark against yourself

No national benchmark available for IUSS•Goal is to decrease the use of IUSS

•Improve patient outcomesImprove patient outcomes

Determine monthly IUSS rates to determine trends

•Divide number of IUSS cycles per month by the number of cases per month

•Also divide number of IUSS per month by the number of trays used


February 2011 Clinical Issues-Calculating flash sterilization rates, AORN, available for members at www.AORN.org, http://www.aornjournal.org/content/ClinicalIssues

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Benchmark for IUSS

Take a more detailed look at each service to identify

•Types of instrument being IUSS•Specific surgeons whose procedures require higher numbers of IUSS•Time of day instruments are IUSS •Reasons for IUSS •Document to allow tracing



IUSS Sterilization AORN Documentation• Item(s) processed• Patient on whom the items were used• Type of cycle (e.g., gravity-displacement, dynamic-air-

removal)• Cycle parameters used (e.g., temperature, duration of

cycle)


y )• Monitoring results• Day and time cycle was run• Operator information (person who initiated cycle and

retrieved item from cycle• Reason for IUSS

AORN Sterilization 2013 Recommendation VII.g.1.

Benchmark for IUSS

•Develop an action plan to decrease IUSS based on data

•Develop policies and procedures for quality monitoring of IUSS

•Monitor compliance with each stepp p•Analyze postoperative SSI that may be related to IUSS



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Risk Assessment: How to Eliminate IUSS

•“As part of the effort to reduce surgical site infections, conduct periodic risk assessment for surgical site infections in a time frame determined by the hospital.”*

•Conduct a risk assessment to determine the reasons the healthcare facility is using IUSS•Determine how to eliminate all reasons except contamination intraoperatively


*The Joint Commission. 2013 Hospital Accreditation Standards (HAS) NPSG.07.05.01, EP4

Risk Assessment: How to Eliminate IUSS

•Management teams from the OR, SP, ICP and risk management work together

•Develop policies and procedure to ensure IUSS is not done for convenience

•Abuse of IUSS “has potential to increase risk for development of SSI”


Scott L Zuckerman, et al. American Journal of Infection Control 40 (2012)

Polling Question

Have you done a risk assessment to determine how to eliminate all reasons for IUSS except contamination intraoperatively?

YesNoDon’t know

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IUSS Summary

•Use critical thinking skills

•Be knowledgeable about evidence-based recommended practices and standards (AAMI, AORN, CDC)

•Appropriate training and education

•Certification

•Certification Board (CBSPD) (www.sterileprocessing.org)IAHCSMM (www.iahcsmm.org)


www.aami.org/publications/standards/ST79_Immediate_Use_Statement.pdf

IUSS Summary

•Do not process implants by immediate use except in documented emergency situations and no other option is available

•Only process devices and loads that have been validated with the specific cycle employedwith the specific cycle employed

•“Instrument inventories should be sufficient to meet anticipated surgical volume and permit the time to complete all critical elements of reprocessing.”


www.aami.org/publications/standards/ST79_Immediate_Use_Statement.pdf

Reduce Patient Risk

• Keep Up-to-date on recommended practices

• Follow manufacturer’s most up-to-date written IFU

• Don’t take shortcuts

Eli i t IUSS t i it ti• Eliminate IUSS except in emergency situations


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Thank You


WWW.3M.com/IPEducation

Questions?


References


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Evidence-Based Guidelines

Association for the Advancement of Medical Instrumentation (AAMI)

Comprehensive guide to steam sterilization and sterility assurance in health care facilities assurance in health care facilities, ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 (Consolidated Text)

ANSI/AAMI ST79 Recommended Practice

If You Have This AAMI Document

What To Purchase What To Download Free

ANSI/AAMI ST79: 2006

Purchase ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012( lid d )(Consolidated Text)

ANSI/AAMI ST79:2006 and A1:2008 & A2:2009

Purchase ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012(Consolidated Text)

Download A4:2013 PDF and replace pages

ANSI/AAMI ST79 Recommended PracticeIf You Have This AAMI Document


ANSI/AAMI ST79:2010 & A1:2010 (Consolidated Text)

Download A2:2011 PDF and replace pagesThen download A3:2012 and replaceA3:2012 and replace pagesThen download A4:2013 and replace pages

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 (Consolidated Text)

Download A3:2012 PDF and replace pagesThen download A4:2013 and replace pages

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ANSI/AAMI ST79 Recommended Practice

If You Have This AAMI Document


ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012

Most up‐to‐date to purchase

& A3:2012 (Consolidated Text)

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 (Consolidated Text)

Download A4:2013 PDF and replace pages

How to Purchase AAMI Guidelines for Your Reference Library

1. Order at:

http://marketplace.aami.org

In search field near top right corner of screen type in g yspecific standard (ST58, etc)

2. Phone order at 1-877-249-8226 or 1-240-646-7031

Also available to order through AORN and IAHCSMM at AAMI membership prices

How to Purchase AAMI Guidelines for Your Reference Library

A free PDF of present and future amendment(s) may be downloaded by visiting http://www aami org/publications/standards/st79 hthttp://www.aami.org/publications/standards/st79.html, which also includes information on how to update your copy of ST79 when free amendments are available.Print and save to your hard drive.

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AORN Perioperative Standards and Recommended Practices (2013)

-Recommended Practices for SterilizationSterilization-Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment-Recommended Practices for Sterile Technique

AORN Standards for Your Reference Library

AORN Standards can be purchased through AORN using the following options:

• Internet: www.aorn.org•Call: 1-800-755-2676 x 1 or 303-755-6304 x 1 (Monday-Friday, 8AM to 4:30PM mountain standard time)

•Fax: 303-750-3212•By mail: AORN, Inc., Customer Service/Book Orders, 2170 South Parker Road, Suite 300, Denver, CO 80231-5711, USA


Centers for Disease Control and Prevention (CDC) Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008

Available at no cost: http://www.cdc.gov/hicpac/Disinfection_Sterilization/13_0Sterilization.html

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References for Rigid Containers

•Rigid Container Systems (Part I), IAHCSMM Communique: July/August 2010

Available at: http://iahcsmm.org/Recertification/LessonPlans/CIS_lessonPlans/CIS Lessons/CIS 220 htmlssonPlans/CIS_Lessons/CIS_220.html

•Rigid Container Systems (Part II), IAHCSMM Communique: September/October 2010

Available at:http://iahcsmm.org/Recertification/LessonPlans/CIS_lessonPlans/CIS_Lessons/CIS_221.html

References for Biological Indicators and Process Challenge Devices

Martha Young. Load Control Monitoring Using Process Challenge Devices. 3M™ Sterile U, Feb 2011.

Available at: http://solutions.3m.com/wps/portal/3M/en_US/Sterilization/3MSterileU/

References for Biological Indicators and Process Challenge Devices

Martha Young. Sterilizer Qualification Testing Using Process Challenge Devices. 3M™ Sterile U, July 2010.

Available at: http://solutions.3m.com/wps/portal/3M/en_US/Sterilization/3MSterileU/

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