1. Cleaning, Packaging & Sterilization of Instruments
Presented by:
SPSmedical Supply Corp.
6789 W. Henrietta Road ∙ Rush, NY USA

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
Woman owned business, certified by the state of NY

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 two 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:
Cleaning
Inspection
Packaging
Sterilization
Storage & Delivery
6. Quality Assurance

7. STEP 1 - CLEANING Cleaning of instruments (manual
or mechanical) should be
performed in a designated area,
immediately after the surgical
procedure.
Quick cleaning removes blood
or debris much easier and can
minimize instrument staining,
corrosion or pitting.

8. STEP 1 - CLEANING Mechanical cleaning is a safer
practice for staff and has been
proven to be up to 16 times more
effective over manual cleaning.
Therefore, whenever possible,
mechanically clean instruments,
using warm water and a neutral
pH detergent.

9. 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.

10. STEP 2 - INSPECTION Each instrument should be
critically inspected after
each cleaning for residual
debris or damage.
Replace instruments as
needed and never sterilize
a “dirty” instrument.

11. STEP 2 - 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. STEP 3 - PACKAGING Instrument packaging should
be done in a clean and low
contamination area, using
FDA approved products:
Sterilization pouches
Sterilization wrappers
Sterilization containers

13. STEP 3 - PACKAGING Sterilization pouches are 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. STEP 3 - PACKAGING When pouching instruments, be
sure to select an appropriate
size pouch and to remove any
excess air before sealing.
For quality assurance, include a
chemical indicator/integrator,
inside to verify the sterilization
parameters were met.
Chemical indicators verify some parameters have been met
Chemical integrators verify all parameters have been met

15. STEP 3 - PACKAGING
To assist sterilization and aid drying, place pouches facing each other and on edge using a pouch divider.
SPSmedical has inexpensive pouch dividers available for small and large sterilizers.

16. STEP 3 - PACKAGING Sterilization wrap may be used
for packaging instrument sets.
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 and FDA clearance.

17. STEP 3 - 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. STEP 3 - PACKAGING Wrapped instruments should be
sealed with a color change
indicator tape.
For quality assurance, include a
chemical indicator or integrator
inside, to verify sterilization
parameters were met.
Indicator Integrator

19. STEP 3 - 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 transporting to a sterile storage area

20. STEP 3 - PACKAGING Sterilization containers can be
used to process instrument sets.
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. STEP 3 - 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. 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 most common types of steam sterilizers

23. 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.

24. STEP 4 - STERILIZATION Always process according
to the sterilizer or instrument
manufacturer’s validated
cycle parameters.
Some common sterilizer cycle parameters are:
250°F/121°C for 30 minutes
270°F/132°C for 10 minutes
273°F/135°C for 4 minutes

25. STEP 4 - STERILIZATION
Not all instruments can be processed at common or “normal” cycle times. For example, SYNTHES General graphic cases:
Gravity sterilizer:
270°F/132°C for 22 minutes
Pre-vacuum sterilizer:
270°F/132°C for 8 minutes

26. 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.

27. STEP 5 – 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.

28. STEP 5 – 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.

29. STEP 6 – Quality Assurance
Sterility assurance of processed instruments should be
routinely verified using three (3) types of indicators:
1) Physical
2) Chemical
3) Biological

30. STEP 6 – 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.

31. STEP 6 – Quality Assurance
2) Chemical Indicators change color or
show movement during processing, to
verify sterilization parameters were met.
These devices are available in tape, card
and strip formats for use with all processes.

32. STEP 6 – Quality Assurance
Chemical indicators should be on the
outside and inside of all packages to
visibly show they have been
processed.
Some chemical indicators are FDA
cleared as “integrators” which can
measure all parameters of sterilization
inside the package.

33. 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, before
the first load of the day.
Most table top sterilizers are
gravity displacement and do
not require this special test.

34. 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 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

35. STEP 6 – 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 a medical
implant.

36. STEP 6 – Quality Assurance
Biological Indicators are processed along
with a load for all sterilizers, except flash.
After processing, SPSmedical BI vials are
activated by crushing and then incubated at
60°C for 24 hrs.
Sterilizer failure is noted if the spores in
the vial grow during incubation. Growth is
observed by a color change in the media
from purple to yellow.

37. STEP 6 – 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 24 hr BI, along with a Class 5 integrator for immediate
release of load and is FDA cleared for use with standard or
extended sterilization cycles.

38. STEP 6 – 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.
SPSmedical recommends adding a
Class 5 integrator, as it will tell you
immediately what the BI will tell
you after incubation.

39. STEP 6 – Quality Assurance
Biological Indicators can also be
sent to an outside Lab for 3rd
party verification.
The SPSmedical mail-in systems
use BI strips and pre-paid mailer
envelopes. After processing, the
BI strip is mailed to the SPS lab
for 24 hr incubation and a Test
Report is returned.
If a failure is recorded, SPSmedical calls the user with recommendations and instructions to retest

40. STEP 6 – Quality Assurance
Mail-in spore testing of sterilizers is
very popular with medical device
mfg’s and private offices.
SPSmedical provides this 3rd party
service to thousands of customers
each day. For user convenience,
test reports are also posted
* Password protected

41. 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
Sterilizers that fail the biological test, should not be used until a passed test is recorded

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

43. TEST - What did you just learn?
1. Name the 6 recommended steps?
2. What is considered the best way to clean?
3. Why should you inspect instruments?
4. Name 3 types of sterile packaging?
5. Which sterilization process is preferred?
6. How long do packages remain sterile?
7. Is autoclave tape a reliable sterility indicator?
8. Chemical indicators have how many classes?
9. Steam sterilizers should be BI tested how often?
10. EO gas sterilizers should be BI tested how often?

44. CE Certificate Available
This continuing education program
was developed and produced by
SPSmedical Supply Corp.
Participants who view this program
may request a Certificate with CE
contact hours at no charge directly
from SPSmedical.
1.0 hr Certification Board for Sterile Processing & Distribution
1.5 hrs International Association of Central Service Material Managers

45. THANK YOU! SPSmedical Supply Corp. Sterilization Products & Services
6789 W. Henrietta Road
Rush, NY USA
Fax: (585)
Ph: (585)
website:
For technical questions or to
receive your Certificate,
call: or
© 2008, SPSmedical Supply Corp.

46. References & Resources
Association for the Advancement of Medical Instrumentation (AAMI)
1110 North Glebe Road, Suite 220, Arlington, VA
Fax: Website:
Association of periOperative Registered Nurses (AORN)
2170 South Parker Road, Suite 300 Denver, CO
Fax: Website:
American Society for Healthcare Central Service Professionals (ASHCSP)
One N. Franklin Avenue, Suite Chicago, IL  60606
Fax:  Website:
International Association of Healthcare Central Service Material
Management (IAHCSMM)
213 W. Institute Place, Suite Chicago, IL 60610
Fax: Website:

47. 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
Audio Seminars are presented each month for 1.0 CE credit to sterile processing personnel certified through CBSPD and IAHCSMM

48. AAMI Standards on CD
Get all 50+ AAMI standards and guidance documents for sterilization on
a CD-ROM! CD-ROM is searchable, printable, portable, and economical.
Every AAMI document covering sterilization in health care facilities,
sterilization equipment, and industrial sterilization process control is
included. In addition, are important FDA and CDC guidance documents,
Code of Federal Regulations sections pertaining to sterilization, and
sterilization articles from the AAMI peer-reviewed journal Biomedical
Instrumentation & Technology.
ORDER CODE: STBKCD
List Price: $655 Member Price: $475