1. Cleaning, Packaging & Sterilization of Surgical Instruments

2. Presented by SPSmedical
Largest sterilizer testing Lab in North America with over 50 sterilizers
Develop and market sterility assurance products that offer advanced technologies
Provide full day sterilization Seminars and Facility audits for compliance with standards and recommended practices
Corporate member: CSA and AAMI, serving on numerous sterilization committees

3. 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 is intended to provide
an “overview” of current
recommended practices and is
accredited by both national sterile
processing organizations.
Approved for 1.5 contact hours through IAHCSMM and 1.0 contact hour through CBSPD

4. Meets in Washington, DC throughout each year and
Association for the Advancement of Medical Instrumentation
Meets in Washington, DC throughout each year and
establishes best practices for sterilization which
become the American national standards.
Membership includes:
Health care facilities
Health care organizations
Government agencies
Medical device manufacturers
Testing labs and Consultants

5. Association of periOperative Registered Nurses
Recommended Practices are developed by the AORN
Recommended Practices Committee and approved by
the AORN Board of Directors.
The Joint Commission inspects
facilities for compliance with
best practices.

6. INSTRUMENT PROCESSING
There are six (6) recommended steps for Instrument Processing:
Decontamination
Inspection
Packaging
Sterilization
Storage & Delivery
6. Quality Assurance

7. DECONTAMINATION Soiled instruments should be
cleaned and disinfected in a designated area, immediately after the surgical procedure. Quick cleaning removes blood or debris much easier and can minimize staining, corrosion or pitting of instruments.
If there is a delay in cleaning, keep the blood from drying by placing a wet towel over the instruments or soak with an enzymatic solution.

8. DECONTAMINATION Mechanical cleaning is a safer
practice for staff and a more effective process over manual cleaning.
Therefore, whenever possible,
mechanically clean instruments,
using warm water and a neutral
pH detergent.

9. DECONTAMINATION 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.

10. INSPECTION All instruments should be critically inspected after
each cleaning for residual
debris or damage.
Replace instruments as
needed and never sterilize
a “dirty” instrument.

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

12. PACKAGING Instrument packaging should be done in a clean and low
contamination area, using
FDA approved products:
Sterilization pouches
Sterilization wrappers
Sterilization containers

13. PACKAGING
Sterilization pouches are recommended for packaging single instruments and small, light weight items.
Paper/plastic pouches allow
you to see the contents and are
available in heat seal and self seal
design and a wide selection of
sizes.

14. PACKAGING When pouching instruments, select an appropriate and be
sure to remove any excess air before sealing.
For quality assurance, include
a multi-variable indicator or an integrator, inside to verify the sterilization parameters were met.
Indicator
Integrator

15. PACKAGING
To assist sterilization and aid drying, place pouches facing each other and on edge using a pouch divider.
Double pouching instruments is okay if desired, but be sure to select the correct size pouches.

16. PACKAGING Sterilization wrap is recommended
to be used for packaging instrument
trays or cassettes.
For an effective barrier and to
maintain sterility until point of
use, be sure to double wrap per
the wrap mfg’s Instructions For
Use (IFU) and FDA clearance.

17. PACKAGING Wrap in a way that allows sterile presentation of the
processed tray or cassette.
Select the appropriate size
wrap and be careful not to
wrap too tight or too loose as
this can compromise sterility
by creating air pockets or
allowing strike through.

18. PACKAGING Wrapped instruments should be sealed with a color change
indicator tape. Latex/Lead free indicator tape is now available.
For quality assurance, include
a multi-variable indicator or
an integrator inside, to verify
sterilization parameters were
met.
Indicator Integrator

19. PACKAGING Wrapped trays (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 should be visibly dry before removing from the sterilizer

20. PACKAGING
Sterilization containers are also available to package instrument trays. Made of rigid metal or plastic, filters allow the sterilant to enter the case and sterilize the items.
Posts or instrument stringers
should be used to separate and
keep hinged instruments in their
open position.
For quality assurance, be sure to include
a chemical indicator or integrator
inside every case prior to processing

21. PACKAGING Packaging systems (pouches,
wrapped sets or rigid containers)
can be mixed in the same load
providing they are approved for
use with the sterilization process.
Rigid containers offer excellent
protection during storage and can
be stacked without compromising
sterility.

22. 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 most common types of steam sterilizers

23. 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.

24. STERILIZATION
Always process instruments according to the sterilizer or instrument manufacturer’s validated cycle parameters.
Some common sterilizer cycle exposure times are:
250°F/121°C for 30 minutes
270°F/132°C for 10 minutes
273°F/135°C for 4 minutes
Dry times are additional and can be from 20 to 40 minutes, depending on load type.

25. 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.

26. Storage & Delivery Sterile packages should always be
handled with care. Avoid dragging,
crushing, bending, compressing or
puncturing, as this can compromise
sterility.
Be sure to inspect sterile packages
before distributing. Do not use any
package that is damaged, wet or
opened.

27. Storage & Delivery Sterility maintenance bags
(dust covers) may be used
to provide additional protection
to wrapped instruments that
could be subjected to adverse
environmental conditions or
multiple handling before use.
Dust covers should be 2-3 mils thick and applied ASAP after sterilization, once the package has cooled.

28. Quality Assurance
Sterility assurance of processed instruments should be routinely
verified using three (3) types of indicators:
1) Physical
2) Chemical
3) Biological

29. Quality Assurance 1) Physical indicators are the time,
temperature and pressure gauges
built into sterilizers.
These readings should be recorded
for every cycle and verified prior to
unloading the sterilizer.
Hospital sterilizers are required to
have a chart or printout, whereas this is optional for sterilizers
located in private offices or clinics.

30. Quality Assurance 2) Chemical indicators change color or
show movement during processing, to
verify sterilization parameters were met.
Chemical indicators should be used with
every package on the outside and inside.

31. Quality Assurance
If your facility has a large steam sterilizer, it is typically a
pre-vacuum type sterilizer that requires an air removal check before using.
This daily check is done with a
Bowie-Dick test pack, usually
before the first load of the day.
Most table top sterilizers are
gravity displacement and do
not require this special test;
however, recently table top
prevacuum sterilizers (Class B) have been introduced.

32. 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 exposure time.
After processing, the color change
indicator inside the test pack should
show a uniform color to pass.
Retain the indicator as part of
your Infection Control records.
PASS FAIL

33. Quality Assurance 3) Biological indicators provide users
the highest level of sterility assurance
and contain bacterial spores available
in plastic vial or paper strip format.
Steam sterilizers should be biological
tested at least weekly, preferably daily
and every load that contains an implant.

34. Quality Assurance A BI inside a Test Pack should be
used to monitor large sterilizers when
processing packaged instruments.
Steam - place on the bottom shelf,
directly above the drain with a load.
The SPSmedical Steam BI test pack
includes a BI, along with a Class 5 integrator for immediate
release of load, and is FDA cleared for use with standard or
extended sterilization cycles.

35. Quality Assurance Flash sterilizers are different in that
the BI is not placed inside a test pack
or with a load, but rather in an empty
tray over the drain.
If a rigid container is used, then a
BI should be run inside the container without a load. AORN standards now recommends using a sealed container when flashing, that is FDA cleared for use with flash sterilization.

36. Quality Assurance Biological Indicators can also
be sent to an outside Lab for 3rd
party verification.
This system is most popular with private offices and uses paper BI strips and pre-paid mailer. After processing, the BIs are mailed to the Lab for incubation and a Test Report is returned.
If a failure is recorded, SPSmedical calls the user with recommendations and instructions to retest

37. Quality Assurance While sterilizers can and do
mechanically fail, human
error is the leading cause of
sterilizer failure, e.g.
Cold start
Wrong cycle
Overloading
Improper packaging
According to the CDC, sterilizers that fail the routine BI test should not be used until a passed test is recorded.

38. SPSmedical thanks you for taking the time to review…
The six (6) recommended steps for Instrument Processing:
Decontamination
Inspection
Packaging
Sterilization
Storage & Delivery
Quality Assurance

39. Monthly Audio Seminars
Continuing Education
Additional Self-Study CD-ROMS available:
Hazard Communication
Decontamination, You & Biofilms
Personal Protective Equipment
Cleaning Surgical Instruments
Selection & Use of Packaging Systems
Steam Sterilization: Process of Choice
Flash Sterilization in the OR
Safe & Effective Use of ETO
Sterilization Quality Assurance
Eliminating Sterile Outdates
CJD: A Sentinel Event
Monthly Audio Seminars

40. Purchasing AAMI Standards
If your organization is not a member of AAMI, you may want to purchase the Standards directly from SPSmedical at our member discount. We can save you 40-50% depending on the document.
For example:
ORDER CODE: AAMI ST:79
List Price: $240
Member Price: $120

41. Cleaning, Packaging and Sterilization of Surgical Instruments
THANK YOU!
SPSmedical Supply Corp.
Sterilization Products & Services
6789 W. Henrietta Road
Rush, NY USA
Fax: (585)
Ph: (800)
Website:
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Cleaning, Packaging and Sterilization of Surgical Instruments
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