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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 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 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 CIs & BIs 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:79 2006

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 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 Youre 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! SPS medical Supply Corp. Sterilization Products & Services 6789 W. Henrietta Road Rush, NY 14543 USA Fax: (585) 359-0167 Ph: (800) 722-1529 Website: © SPSmedical Supply Corp. Certificate is available after viewing by calling SPSmedical or e-mailing Eliminating Sterile Outdates

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 22201-4795 703-525-4890 Fax: 703-276-0793 Association of periOperative Registered Nurses 2170 South Parker Road, Suite 300 Denver, CO 80231-5711 800-755-2676 Canadian Standards Association 5060 Spectrum Way Mississauga, Ontario L4W 5N6 CANADA 800-463-6727 Fax: (416) 747-2510 Certification Board for Sterile Processing & Distribution 2 Industrial Park, Suite 3 Alpha, NJ 08865 908-454-9555 International Assoc. of Healthcare Central Service Materiel Management 213 W. Institute Place, Suite 307 Chicago, IL 60610 312-440-0078 Fax: 312-440-9474


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