1. ELIMINATING STERILE OUTDATES
(EVENT-RELATED STERILITY ASSURANCE)

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 on-site Facility audits for compliance with best practices
Corporate member: CSA and AAMI, serving on numerous sterilization working groups

3. Meets in Washington, DC throughout each year and
Association for the Advancement of Medical Instrumentation
Meets in Washington, DC throughout each year and
establishes guidelines for sterility assurance which
become our American National Standards.
Membership includes:
Healthcare facilities
Healthcare organizations
Government agencies
Medical device manufacturers
Testing Labs and Consultants

4. best practices. Recommended Practices are developed by the AORN
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.

5. Objectives At the end of this program, participants will be able to…
understand the difference between time and event-related sterility assurance,
explain why sterility is event-related and not time related
identify the steps to an event-related sterility assurance policy within their facility.

6. Time vs Event-Related
Time – When a healthcare facility puts an arbitrary “Expires” date on every item they sterilize. These shelf- life dates are typically 6 – 12 months from date of processing. Event-Related – When a healthcare facility puts the date of processing on items they sterilize and marks it “sterile unless damaged or opened”.

7. Shelf Life “The shelf life of packaged sterile item is event related”.
AORN Standards, Recommended
Practices and Guidelines
“The shelf-life of a packaged sterile item is event-
related and depends on the quality of the packaging
material, the storage conditions during transport, and
the amount of handling.” AAMI Standards

8. In 1683, Louis Pasteur sterilized flasks of fermentable liquids
Today some of these flasks
are on display in the
Smithsonian – STILL
STERILE AFTER MORE
THAN 300 YEARS!

9. Recommended Practices
“Sterility is an event related function, not time related, and that if sterilized items are protected properly by wrap and storage procedures, (and the sterilizers’ function is monitored) items can be given an indefinite shelf life” - Carole H. Patterson, Associate Director for Interpretation, Dept. of Standards JCAHO
“Shelf life of a packaged sterile item is event related” – AORN Recommended Practices

10. Benefits of Event-Related Sterility Assurance
TIME SAVER –
No longer will staff need to:
Pull expired packs from
sterile storage.
Reprocess the packs clean, package, sterilize…and return them!

11. Benefits of Event-Related Sterility Assurance
MONEY SAVER –
Reduces consumable usage:
Pouches
Wrap & Tape
Filters
CI’s & BI’s
Labels
Record Cards
Envelopes

12. AAMI Standards State:
“The shelf life of a packaged sterile item is event-related and depends on the quality of the packaging material, the storage conditions the conditions during transport, and the amount of handling.”
-AAMI ST:

13. Regardless of when, where or how processed…
Sterile packs are subject to
contamination in many
ways at any time!
Plastic dust covers may be used to protect and extend the shelf life of properly sterilized items.
Or, use peel pouches as a method of protecting items.

14. To Eliminate Sterile Outdates
Select approved packaging,
Monitor the sterilization process,
Control the events surrounding the handling and storage of sterile items until they are used.
** The only instance in which event-related sterility is not advisable is when using medication or materials within the package that can deteriorate with time, such as balloon catheters.

15. Packaging Selection Obtain a copy of each Mfg.’s Lab Report and choose
the most
appropriate one.

16. AORN Standards State That Packaging System Should…
1. Permit sterilization to take place
2. Maintain sterility until opened
3. Provide aseptic delivery

17. Sterilization Monitoring
1) Physical
2) Chemical
3) Biological

18. Sterile Storage Open shelving may be used, but should be:
2” from outside walls
8 to 10” from floor
18” from ceiling fixture
not crunched, bent, compressed, punctured or near any location that could become wet. Doors closed, proper ceiling tiles, etc…

19. Sterile Storage Sterile items should not be stored under sinks, near
windows or doors, on the floor, near exposed pipes or
vents and/or in high traffic areas.
Heavy trays should be stored on middle shelves for ease
of handling by staff. Rigid containers are designed to
allow stacking; however, heavy “wrapped” trays should
not be stacked as this can compromise sterility.

20. How To Start 1. Establish a written policy 2. Do a cost/benefit study
3. Present the new policy to the IC committee
4. Write & distribute a memo to staff and begin training
5. Implement policy

21. Establish a Written Policy and be Sure to Include:
SUBJECT
OBJECTIVE
POLICY STATEMENT
PROCEDURES

22. Do a Cost/Benefit Study
Consider each of the following:
Labor
Materials
Sterilizer costs
This study helps to educate those involved in the
procedure about the immediate payback if they
incorporate change.

23. Present to Infection Control Committee
Offer monitoring suggestions:
First In, First Out (FIFO)
inventory rotation,
Periodic lab culturing to
verify sterility,
Ongoing review of infection
rates within the facility.

24. Event Related Sterility
After Approval
Write & distribute MEMO to staff and all related depts.
Describe new event-related sterility assurance policy and provide rational...
Offer to meet with depts. that have questions or concerns regarding new policy!
Event Related Sterility
Assurance
Policy

25. Implement New Policy But only after in-servicing all
personnel who handle sterile
packs!
Emphasize that everyone is
responsible to inspect sterile
packs prior to use!

26. Remember to Reject Packages that are:
DAMAGED
OPENED
or WET, regardless
of what the label says!

27. Cooperation and Teamwork
are required between all departments to make it
work!

28. So When You’re Asked… How long do sterile packs remain sterile?
Answer truthfully: Until they become contaminated!

29. Conclusion Event-related sterility assurance can and will
work for your facility, providing there is a total
Quality commitment to practice established
standards for proper packaging, sterilization,
storage, handling and inspection of all sterile
packs!

30. THANK YOU! SPSmedical Supply Corp. Sterilization Products & Services
6789 W. Henrietta Road
Rush, NY USA
Fax: (585)
Ph: (800)
Website:
© SPSmedical Supply Corp.
Eliminating Sterile Outdates
Certificate is available after viewing by calling SPSmedical or ing

31. Purchasing AAMI Standards
If your organization is not a member of AAMI, you may purchase the Standards directly from SPSmedical at our member discount. The member discount saves you 40-50% depending on the document.
For example:
ORDER CODE: AAMI ST:79
List Price: $220
Member Price: $110

32. References & Resources
Association for the Advancement of Medical Instrumentation
1110 North Glebe Road, Suite 220, Arlington, VA
Fax:
Association of periOperative Registered Nurses
2170 South Parker Road, Suite 300 Denver, CO
Canadian Standards Association
5060 Spectrum Way Mississauga, Ontario L4W 5N6 CANADA
Fax: (416)
Certification Board for Sterile Processing & Distribution
2 Industrial Park, Suite 3 Alpha, NJ 08865
International Assoc. of Healthcare Central Service Materiel Management
213 W. Institute Place, Suite Chicago, IL 60610
Fax: