Cleaning, Packaging and Sterilization of Instruments

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Cleaning, Packaging and Sterilization of
Instruments

• Provided by
• McKesson Corporation
• McKesson 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 patients 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
• Cleaning
• Inspection
• Packaging
• Sterilization
• 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 can
• minimize corrosion, pitting or
• instrument 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 to
• create 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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STEP 2 - INSPECTION

• In addition, check each
• instrument for proper
• function and lubricate
• those that have metal
• to metal action.
• Instruments with stiff
• joints could be a sign
• of inadequate cleaning.

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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 allow
• the 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 for
• packaging 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 mfgs
• 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
• manufacturers validated
• Instructions For Use.
• Some common sterilizer cycle
• recommendations are
• 250F/121C for 30 minutes
• 270F/132C for 10 minutes
• 273F/135C 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
• 132-135C for 22 minutes
• Pre-vacuum sterilizer
• 132-135C 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 require
• an air removal check before
• using. This daily test is done
• with 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 273F 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 55-60C
• incubator and biological indicator vials.
• Sterilizer failure is noted if the BI grows
• during incubation. Growth is observed by
• a 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 sterilizer
• failure.
• 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
• Cleaning
• Inspection
• Packaging
• Sterilization
• 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 on
• 10 AAMI sterilization standards
• committees provides seminar
• Speakers to health care
• organizations.
• For technical questions and
• CE Certificates, please call
• 1-800-722-1529 or E-mail
• education_at_spsmedical.com

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References
ANSI/AAMI ST352003
ANSI/AAMI ST33 1996
Guidelines for the selection and use of reusable
rigid container systems for EO Steam
sterilization in HC facilities, 2ed
Safe handling and biological decontamination of
reusable medical devices in health care
facilities and in nonclinical settings
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References
ANSI/AAMI ST37 1996
ANSI/AAMI ST46 2002
Flash sterilization Steam sterilization of
patient care items for immediate care use
Steam sterilization and sterility assurance in
health care facilities
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References
ANSI/AAMI ST 66 1999
ANSI/AAMI ST 60 1996
Sterilization of health care products-Chemical
indicators- Part 2 Class 2 indicators for air
removal test sheets and packs
Sterilization of health care products-Chemical
indicators- Part 1 General requirements
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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 Pouches
• 73-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 Pouches
• 73-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 Wrap
• 73-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 Tape
• 73-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 yds

Label 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 Indicators
• 73-SIS250 4 Steam Strip
• 73-SIL250 8 Steam Strip
• 73-GIL250 8 EO Strip
• 73-DMS250 8 Dual Strip

• Chemical Integrators
• 73-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 Indicators
• 73-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 60C Dry Block Incubator, 16 mm
• 73-NDB060 60C Dry Block Incubator, 11 mm
• 73-PP012 Mail-In System (12 bx)
• 73-PP052 Mail-In System (52 bx)