Cleaning, Packaging and Sterilization of Instruments
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Transcript of Cleaning, Packaging and Sterilization of Instruments
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Cleaning, Packaging and Sterilization of
Instruments Provided by:
McKesson CorporationMcKesson Medical-Surgical
Richmond, VA
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Continuing Education Program
Following established protocols for
instrument processing is an important
aspect of modern health care as it helps
to minimize the patient’s risk for
infection of the surgical site.
This program reviews the most current
recommended practices for instrument
processing and is approved through
two national sterile processing
organizations.
IAHCSMM and CBSPD offer certification programs for sterile
processing personnel
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INSTRUMENT PROCESSING
There are six (6) recommended
steps for Instrument Processing:
1. Cleaning
2. Inspection
3. Packaging
4. Sterilization
5. Storage & Delivery
6. Quality Assurance
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STEP 1 - CLEANING
Cleaning of instruments should be performed in a designated area, immediately after the surgical procedure.
Quick cleaning removes blood or debris much easier, and canminimize corrosion, pitting orinstrument staining.
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STEP 1 - CLEANING
Whenever possible, it is best to mechanically clean instruments with an ultrasonic or washer
using a neutral pH detergent.
Mechanical cleaning has been proven to be up to 16 times more effective over manual cleaning.
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STEP 1 - CLEANING
Ultrasonic cleaners use high frequency sound waves tocreate microscopic bubbles that collapse.
This “cavitation” process is very effective in getting into the serrations, box locks and crevices of instruments.
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STEP 1 - CLEANING
After cleaning, thoroughly rinse instruments with tap water to ensure loosened debris and detergents are removed.
If the tap water is of poor quality, consider using treated water as a final rinse to avoid instrument staining.
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STEP 2 - INSPECTION
Each instrument must be
critically inspected after
each cleaning for residual
debris or damage.
Replace instruments as
needed and never sterilize
a “dirty” instrument.
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In addition, check eachinstrument for proper function and lubricate those that have “metal to metal” action.
Instruments with stiff joints could be a sign of inadequate cleaning.
STEP 2 - INSPECTION
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STEP 3 - PACKAGING
Instrument packaging should be done in a clean, low contamination area using only FDA approved materials, such as:• Sterilization pouches• Sterilization wrappers• Sterilization containers
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STEP 3 - PACKAGING
Sterilization pouches are for packaging single instruments and small, light weight items.
Paper/plastic pouches allowthe user to see the packaged instruments and are available in heat-seal & self-seal design for use with all sterilization processes.
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STEP 3 - PACKAGING
When packaging instruments,
be sure to select an appropriate
size pouch and to place hinged
instruments in an open position
to allow sterilant contact.
For quality control, be sure to
include a chemical indicator
inside and a lot label outside.
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STEP 3 - PACKAGING
To assist sterilization and aid drying, always place pouches facing each other and on edge using a pouch divider.
Inexpensive pouch dividers are available for small and large sterilizers.
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STEP 3 - PACKAGING
Sterilization wrap is used forpackaging instrument cassettes and/or trays.
To allow sterilant to reach the instruments and to not trap air inside the package, cassettes and trays should be perforated.
Wrap should be snug to prevent low spots that could collect condensate, but not too tight to cause strike through.
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STEP 3 - PACKAGING
Instrument trays should be
double wrapped to maintain
sterility per the wrap mfg’s
instructions for use.
Instrument trays should be
wrapped in a way that allows
for sterile presentation of the
processed items.
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STEP 3 - PACKAGING
Wrapped packs should be sealed
with 1”, 3/4” or ½” sterilization
indicator tape.
For quality control, be sure to
include a chemical indicator
inside and a lot label outside.
Class 5
Class 4
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STEP 3 - PACKAGING
Wrapped packs (being heavier)
should be placed on the lower
shelf of the sterilizer.
Loading heavier items on the
bottom shelf and lighter items
on the top, enables condensate
to drain out without wetting
other items in the load.To maintain sterility, packages need to be
visibly dry before transporting to a sterile storage area
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STEP 3 - PACKAGING
Sterilization containers can be used to process instruments or sets. Containers offer excellent protection during storage and transport to the sterile field.
As with wrapped trays, loading containers on the bottom shelf and lighter items on the top, enables condensate to drain away from lighter packages.
Some rigid containers can be stacked during sterilization; however, all can be stacked
during storage to save space
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STEP 4 - STERILIZATION
Steam sterilization is CDC
recommended as the process
of choice whenever possible.
Steam under pressure is
considered safe, fast and the
most cost effective sterilization
method for health care
facilities. Gravity displacement and pre-vacuum
are the two common types of steam sterilizers
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STEP 4 - STERILIZATION
Steam sterilizers are Class II
medical devices subject to FDA
approval per a 510(k) clearance
letter.
They are available in a wide
variety of shapes and sizes for
sterilization of heat-stable
instruments.
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STEP 4 - STERILIZATION
Always process according to the sterilizer or instrument manufacturer’s validated Instructions For Use.
Some common sterilizer cycle recommendations are:
• 250°F/121°C for 30 minutes• 270°F/132°C for 10 minutes• 273°F/135°C for 4 minutes
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STEP 4 - STERILIZATION
Not all instruments can be processed
at common or “normal” cycle times.
For example, SYNTHES General
graphic cases:
• Gravity sterilizer:
132-135°C for 22 minutes
• Pre-vacuum sterilizer:
132-135°C for 8 minutes
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STEP 5 – Storage & Delivery
Sterile items should be stored in a
manner that reduces the potential
for contamination.
The shelf-life of sterile packages
is event related and depends on
the quality of the packaging
material, storage conditions and
amount of handling.
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STEP 5 – Storage & Delivery
Sterile packages should always be handled with care. Avoid dragging, crushing, bending, compressing or puncturing, as this will compromise the sterility of the contents.
Be sure to inspect sterile packages before distributing. Do not use any package that is damaged, wet or opened.
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STEP 5 – Storage & Delivery
Sterility maintenance bags
(dust covers) may be used
to protect items that could
be subjected to
environmental challenges
or multiple handling
before use.Should be 2-3 mils thick and applied
ASAP after sterilization and after the item has cooled.
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STEP 6 – Quality Assurance
Chemical indicators should be placed
on the outside/inside of each package
to visibly show they have been
processed.
Biological indicators should be run
at least weekly to verify sterilization
and recorded as part of your formal
Infection Control – QA program.
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STEP 6 – Quality Assurance
Chemical Indicators are available
in tape, card and strip formats for
use with all processes.
These devices change color as
indicated, for the process they
are monitoring.
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STEP 6 – Quality Assurance
Most large steam sterilizers are pre-vacuum and requirean air removal check before using. This daily test is donewith a Bowie-Dick test pack.
Most table top sterilizers are gravity displacement and do not require this special test.
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STEP 6 – Quality Assurance
Test Procedure: Place a Bowie-Dick test pack on the lowest shelf, over the drain in an empty chamber at 273°F for 3.5 or 4 minutes.
After processing, the indicator sheet inside the test pack must show a uniform color change to pass.
A shortened cycle omitting dry time should be run first to properly heat
up the sterilizer.
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STEP 6 – Quality Assurance
Biological Indicators are processed along with a load for sterilizer verification. For steam sterilizers, users purchase a 55-60°C incubator and biological indicator vials. Sterilizer failure is noted if the BI grows during incubation. Growth is observed bya color change in the media from purple to yellow.
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STEP 6 – Quality Assurance
Biological Indicators can also be sent to an outside Lab for 3rd party documentation.
Mail-in systems use BI strips and pre-paid mailer envelopes. Users simply run the BI strip and then mail. A Lab Report is returned and placed on a “password protected” website: www.checkyourtest.com
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STEP 6 – Quality Assurance
While sterilizers can and do mechanically fail, human error is the leading cause of sterilizerfailure.
• Cold start• Wrong cycle• Overloading• Improper packaging
After processing, the BI strip is mailed to an outside Laboratory for incubation. After 24 hrs, a formal Lab Report is returned
to verify steam sterilization
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McKesson thanks you for taking the time to review…
The six (6) recommended steps
for Instrument processing:
1. Cleaning
2. Inspection
3. Packaging
4. Sterilization
5. Storage & Delivery
6. Quality Assurance
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CE Certificate Available
This continuing education program
was developed and produced by
SPSmedical Supply Corp. for the
McKesson Corporation.
Customers who view this program
may request a complimentary CE
Certificate from SPSmedical.
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SPSmedical Supply Corp.
The largest sterilizer testing Lab in North America with over 48 sterilizers, SPSmedical serves on10 AAMI sterilization standardscommittees & provides seminarSpeakers to health care organizations.
For technical questions andCE Certificates, please call: 1-800-722-1529 or E-mail: [email protected]
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ANSI/AAMI ST35:2003
Safe handling and biological decontamination
of reusable medical devices in health care
facilities and in nonclinical settings
References
ANSI/AAMI ST33: 1996
Guidelines for the selection and use of
reusable rigid container systems for
EO & Steam sterilization in HC
facilities, 2ed
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ANSI/AAMI ST37: 1996
Flash sterilization – Steam sterilization
of patient care items for immediate
care use
References
ANSI/AAMI ST46: 2002
Steam sterilization and sterility assurancein health care facilities
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ANSI/AAMI ST 66: 1999
Sterilization of health care products-Chemical indicators- Part 2: Class
2 indicators for air removal test sheets and
packs
ANSI/AAMI ST 60: 1996
Sterilization of health care products-Chemical
indicators- Part 1: General requirements
References
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McKesson Brand Sterility Assurance Products
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McKesson Brand Sterility Assurance Products
To assist users in meeting their sterility assurance needs, contact
your local McKesson Representative and ask for the following
McKesson brand quality products:
PACKAGING MONITORING
• Self-Seal & Heat-Seal Pouches • Chemical Indicators
• Disposable Sterilization Wrap • Biological Indicators
• Sterilization Indicator Tape • B-D and BI Test Packs
• Record Keeping System • Incubators/Record Books
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McKesson Brand Sterile Packaging Products
Self-Seal Pouches73-SSP381 3.5” x 9”
73-SSP382 5.25” x 10”
73-SSP383 7.5” x 13”
73-SSP387 8” x 16”
73-SSP391 12” x 18”
Heat-Seal Pouches73-HSP250 4” x 8”
73-HSP254 5.25” x 10”
73-HSP255 5.25” x 15”
73-HSP256 6” x 10”
73-HSP257 7.5” x 13”
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McKesson Brand Sterile Packaging Products
Sterilization Wrap73-HDW1515 15” x 15”
73-HDW1818 18” x 18”
73-HDW2020 20” x 20”
73-HDW2424 24” x 24”
73-HDW3030 30” x 30”
Sterilization Tape73-ST048 3/4” x 60
yds
73-ST036 1” x 60 yds
73-BT048 3/4” x 60 yds
73-BT036 1” x 60 yds
73-GT036 1” x 60 ydsLabel Applicator 73-MDG001 Load Record Label 73-URL012 Load Record Card 73-DLC250 Records Envelope 73-LEB100
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McKesson Brand Sterilization Monitoring Products
Chemical Indicators73-SIS250 4” Steam Strip
73-SIL250 8” Steam Strip
73-GIL250 8” EO Strip
73-DMS250 8” Dual Strip
Chemical Integrators73-SSI100 Steam (100 pk)
73-SSI1000 Steam (1,000 pk)
73-STP025 Steam Test Pack
Daily Air Removal Test 73-SBD030 Bowie-Dick Test Pack
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McKesson Brand Sterilization Monitoring Products
Biological Indicators73-SCS025 Steam vial (25 bx)73-SCS100 Steam vial (100 bx)73-SBT025 Steam Test Pack w/25 controls
73-SBT255 Steam Test Pack w/5 controls
73-PCS025 Peracetic Acid Culture Set (for STERIS System 1)73-NDB055 60°C Dry Block Incubator, 16 mm73-NDB060 60°C Dry Block Incubator, 11 mm
73-PP012 Mail-In System (12 bx)73-PP052 Mail-In System (52 bx)