1. Selection and Use of Packaging Systems

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 National standards. Membership includes: Health care facilities Health care organizations Government agencies Medical device manufacturers Testing Labs and Consultants

4. Program Objectives At the end of this program, participants will be able to… identify the different packaging systems. explain guidelines for evaluation, selection, and use of packaging systems for items to be sterilized. understand how each system ensures and maintains the sterility of the package contents.

5. Packaging Systems Should… be appropriate to item(s) being sterilized permit closure of items resist tears, punctures be free of holes, toxic ingredients and low linting permit aseptic delivery

6. Packaging Systems Should… maintain sterility until point of use be appropriate to method of sterilization have favorable cost/benefit ratio be used in accordance to mfg’s instructions

7. Packaging Systems for steam sterilization should… provide adequate air removal permit steam penetration and direct contact with surfaces permit adequate drying permit use of material compatible with the process maintain the integrity of the system

8. Packaging Systems for ethylene oxide sterilization should… be permeable to EO, moisture and air permit aeration maintain material compatibility maintain the integrity of the system

9. Packaging Systems for Gas plasma sterilization should… be permeable to the process maintain material compatibility be made of a material recommended by the mfg. and used according to the mfg. recommendations maintain the integrity of the system

10. Packaging Systems Wrapped items should… be assembled, handled, and wrapped in a manner that provides for aseptic presentation. be wrapped with the appropriate size material to prevent gapping, billowing and air pockets from forming.

11. Packaging Systems Wrapped items should… be sequentially wrapped using two barrier-type wrappers (or one fused or bonded, double layer) disposable, non-woven wrapper according to the mfg’s FDA’s clearance.

12. Packaging Systems Indicator tape (not safety pins, paper clips, staples or other sharp objects) should be used to secure wrapped items. Rubber bands may be used only if authorized by the wrap manufacturer. Lead/Latex Free Steam Indicator Tape now available from SPSmedical

13. Sterilization Packaging (Peel Pouches) Should… have as much air removed as possible, provide a proven integrity seal, and be hermetically sealed. Double peel packaging is not necessary for routine sterilization; however, double packaging may facilitate containment of multiple items to facilitate aseptic presentation. Caution: Some pouches contain peel off chemical indicator strips. Check with the manufacturer for the specific Class of CI as not all comply with AAMI recommendations for a Class 3, 4 or 5 internal chemical indicator.

14. Sterilization Packaging (Peel Pouches) Should be used for small, lightweight, low profile items and placed on edge in the sterilizer. If you choose to double pouch items, place plastic to plastic – paper to paper and select proper size(s). Inexpensive pouch dividers for both small and large sterilizers are available from SPSmedical

15. Packaging Systems Rigid containers should… be used in accordance with mfg.’s recommendations, have approved sterilization parameters, be designed/constructed of materials compatible with sterilization processes, and have filters and/or valve systems that are secure and in proper working order.

16. Packaging Systems Rigid containers should… have filter plates that can be inspected for proper working condition before and after sterilization, have their integrity evaluated periodically, and should be tamper proof.

17. Packaging Systems Newly purchased systems should be cleaned and decontaminated per mfg’s recommendations before initial use and between uses prior to sterilization. Follow mfg’s instructions for choice of detergent and be sure to RINSE thoroughly after cleaning.

18. Packaging Systems Wrapped packs… should be labeled prior to sterilization. labeling should include, but not be limited to: –a description of package contents –initials of packager, and a lot control number. –labeling should be done on the indicator tape and not on the wrapper itself. AORN Recommends labeling all packages PRIOR to sterilization

19. Packaging Systems Peel pouches may be labeled on the plastic portion or on self-sealing tab. Markers should be indelible, non-bleeding and nontoxic. Industrial Sharpie® pen (Item No. 13601) is specially formulated for Steam sterilization

20. Packaging Systems The shelf life of a packaged sterile item is “event-related.” The length of time a product is considered sterile is dependent on the… type and configuration of packaging materials used, number of times an item is handled before it is used, and the number of personnel who handled the package.

21. Packaging Systems storage on open or closed shelves, environmental conditions of the storage area (eg, cleanliness, temperature, humidity), and use of dust covers and method of sealing. The length of time a sterile product can maintain sterility is dependent on the…

22. Packaging Systems Policies and procedures for the selection and use of packaging systems should be written, reviewed periodically, and readily available within the practice setting. These recommended practices should be used as guidelines for the development of policies and procedures for packaging.

23. Packaging Systems Policies and procedures establish authority, responsibility, and accountability for the selection and use of packaging systems within the practice setting. Policies and procedures also establish guidelines for performance improvement activities to be used in monitoring packaging system efficacy.

24. ! 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: www.spsmedical.com © SPSmedical Supply Corp. Certificate is available after viewing by calling SPSmedical or e-mailing education@spsmedical.com education@spsmedical.com Selection and Use of Packaging Systems

25. 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

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