Surgical Instruments Guide 2017-2018 - 17

Instrument Reprocessing Steps
STEP 1 - TRANSPORTATION

STEP 5 - STERILE STORAGE

Contaminated instruments should be handled carefully
to prevent exposure using appropriate personal
protection equipment (PPE). Place in a sealed, leak
proof container (displaying a biohazard symbol) to
prevent percutaneous injuries during transport to the
instrument reprocessing area.

STEP 2 - CLEANING and INSPECTION

TIP:

Cleaning is the
most important
step in instrument
reprocessing!

Cleaning should be performed as soon as
possible, in a designated area, using
appropriate personal protection equipment
(PPE). Quick cleaning removes blood and
other body fluids much easier and also
minimizes instrument staining, corrosion and/or pitting.
Be sure to clean instruments according to the
manufacturers' instructions for use (IFU), paying
attention to detergent type and dilution, water quality
and temperature, brush type and size, etc. After cleaning,
each instrument should be thoroughly rinsed and inspected prior
to packaging. If the instrument is in need of repair, be sure to set it
aside and/or contact a Supervisor to review. Be sure to lubricate
hinged instruments and handpieces, per the instrument
manufacturers' written IFU.

STEP 3 - PACKAGING

After inspection, package instruments
using FDA approved products to
maintain sterility until point of use.
Peel pouches are recommended for
single, lightweight items, whereas, instrument trays or cassettes
should be double wrapped and secured with sterilization indicator
tape. For quality assurance, each packaging system should have
an internal chemical indicator to show the sterilant reached inside
the package where the instruments are located. A Class 5 chemical indicator (integrator) is recommended for immediate-use steam
sterilization (IUSS) cycles and when processing implants.

STEP 4 - STERILIZATION

After packaging, load the sterilizer with lighter items on top and
heavier items on the bottom. Peel pouches should be placed on
edge, facing the same direction. Wrapped trays may be placed
flat or on their side, depending on their design. Steam sterilization
should be used whenever possible and autoclaves are available
in either Gravity Displacement or Dynamic Air Removal cycles.
Be sure to check with the instrument manufacturers' IFU to confirm
the cycle type and parameters (e.g. exposure time and temperature). In addition to exposure time, a dry time of 20-30 minutes
is typically needed at the end of the cycle to ensure all packages
are visibly dry after processing. The necessary dry time should be
included in the instrument manufacturers' written IFU.

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After sterilization, inspect all
packages for proper color change of
the external chemical indicator. Do not
handle any package that is visibly wet as this
will compromise sterility of the items inside. Sterile
packages should be stored in a clean, dry location. The shelf-life
of sterile items is event-related and depends on the quality of the
packaging material, storage conditions, the conditions during
transport, and amount of handling.

STEP 6 - QUALITY ASSURANCE

Sterility assurance should be verified using three types of indicators
(physical, chemical and biological).
Physical indicators are the time, temperature and pressure gauges
built into sterilizers. These readings should be recorded after each
cycle and verified prior to unloading the sterilizer. A sterilizer
printout is ideal and should be kept as part of formal infection
prevention records.
Chemical indicators should be used on the outside and inside of
every package. For steam sterilization, a Class 5 integrating
chemical indicator may be used daily or with every load for
increased sterility assurance. Special Note: Prevacuum dynamic air
removal steam sterilizers (also known as Class B sterilizers) should
be tested daily using a Bowie-Dick type test. This test checks for
proper air removal which allows this type of steam sterilizer to
run faster cycles.

Biological indicators (also known as spore tests) should be used to
test sterilizer efficacy at least weekly, preferably daily, and every
load with an implant. BIs are available in either a mail-in service
or an in-office system for user convenience. A BI is processed along
with the load and then sent to an outside lab for incubation (mail-in
service) or activated and incubated by the user (in-office system).
Each day the sterilizer is tested, an unprocessed BI (from the same
lot) should be incubated as a Control. Sterilizer failure is noted if
the test BI grows during incubation. While sterilizers can and do
mechanically fail, the leading cause of sterilizer failure is operator
error (e.g. running from a cold start, wrong cycle, over loading or
improper packaging).

For more comprehensive information, refer to AAMI standards
and CDC guidelines.

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Table of Contents for the Digital Edition of Surgical Instruments Guide 2017-2018