3M™ Attest™ Sterile U Web Meeting March 19, 2009

1. 3M™ Attest™ Sterile U Web MeetingMarch 19, 2009 How Long Did They Go? Healthcare Facilities Share Flash Reduction Best Practices

2. Welcome! • Facilitator: Tammy Torbert, 3M Sterilization Assurance • Speaker: Dorothy Larson, 3M Technical Service • Panelist: Francis Zieman, 3M Technical Service • Housekeeping: • Questions; • -Mute feature (*7=unmute; *6=mute) • -“Chat” feature • Technical difficulties • CE Credits • Post session follow-up • For more information: www.3M.com/AttestSterileUOnline

3. Discussion Topics • Define flash sterilization • Discuss the Association of periOperative Registered Nurses (AORN) and the Association for the Advancement of Medical Instrumentation’s (AAMI’s) recommended practice on flash sterilization • Discuss issues associated with flash sterilization • Describe an effective quality assurance program for flash sterilization • Discuss Flash Reduction Best Practices

4. Quality Control Recommended Practices • ANSI/AAMI Comprehensive guide to steam sterilization and sterility assurance in health care facilities, ST79:2006/A1:2008 • AORN • Recommended Practices for Sterilization in Perioperative Practice Setting, 2009 • Recommended Practices for Selection and Use of Packaging Systems for Sterilization, 2009 • Recommended Practices for Surgical Instruments and Powered Equipment, 2009

5. AAMI and AORN • AAMI • Guidelines for the use, care and/or processing of medical device or system to ensure a device is used safely and effectively and its performance will be maintained • AORN • Standards and recommended practices serve as the basis for policies and procedures • Promote safety and optimal outcomes for patients

6. Flash Sterilization • Process designed for the steam sterilization of patient care items for immediate use. AAMI ST79

7. Flash Sterilization - History Reprocessing of dropped instruments mid-procedure Unwrapped, 270 deg. F. Gravity cycle only -No dry time High Temperature Sterilization AAMI ST79

8. Flash Sterilization - Today High temperature (270-275°F/ 132-135°C) No dry time/ No storage Sterilization Process: - Gravity - Dynamic-air-removal Packaging expanded beyond mesh-bottom surgical tray Photo courtesy of Rose Seavey, The Children's Hospital - Denver AAMI ST79

9. Flash Sterilization - Packaging • Perforated, mesh bottom, open surgical tray • Rigid sterilization container system • Protective organizing case • Single-wrapped surgical tray AAMI ST79

10. Flash Sterilization - Packaging • AORN recommends the use of rigid sterilization containers • Reduce risk of contamination during transport to point of use • Ease of presentation to sterile field AORN

11. Types of Steam Sterilization Processes • Gravity Displacement • Dynamic-Air-Removal by • Prevaccuum • Steam-flush pressure-pulse (SFPP) AAMI ST79

12. Flash Sterilization • Minimum Flash Cycle Times for Gravity Steam Sterilization Cycles AAMI ST79

13. Flash Sterilization • Minimum Flash Cycle Times for Dynamic-Air-Removal Steam Sterilization Cycles AAMI ST79

14. QUESTION: Review information in following table – is this a flash cycle?

15. QUESTION:Review information in following table – is this a flash cycle? ANSWER: YES! Remember, flash sterilization is the steam sterilization of patient care items for immediate use!

16. ANSI/AAMI ST79 Section 10 Quality Control • Four levels of testing 1 2 3 4

17. Routine Load Release Nonimplants • Physical monitors • External process indicator (Class 1) on every package • Internal CI (Class 3, 4 or 5) inside every package • Optional monitoring of load with a PCD containing a • BI • BI and a Class 5 CI • Class 5 integrating indicator • Evaluation of all data by an experienced, knowledgeable person • Do not distribute load if any data suggests a sterilization process failure AAMI ST79

18. Routine Load Release Implants • Physical monitors • External process indicator (Class 1) on every package • Internal CI (Class 3, 4 or 5) inside every package • A PCD containing a BI and a Class 5 integrating indicator • Evaluation of all data by an experienced, knowledgeable person • Do not distribute load if any data suggests a sterilization process failure AAMI ST79

19. Sterilization Process Monitoring Tools • Physical Monitors • Chemical Indicators • Biological Indicators

20. Physical Monitors • Verify that parameters of sterilization cycle are met • Recording charts • Gauges • Tape • Printouts • Digital displays AORN & AAMI

21. ANSI/AAMI/ISO 11140-1, 2005 Sterilization of health care products-Chemical indicators - Part 1: General requirements • Class 1 Process Indicators • Class 2 Indicators for use in Specific Tests • Class 3 Single Variable Indicators • Class 4 Multi-variable Indicators • Class 5 Integrating Indicators • Class 6 Emulating Indicators

22. Chemical Indicators • Class 1: Process Indicators • Use with individual units to indicate that the unit has been directly exposed to the sterilization process • Exposure Control (e.g., indicator tapes) • Distinguish between processed and unprocessed units • Designed to react to one or more of the critical process variables AAMI ST79

23. Chemical Indicators • Class 2: Indicators for Specific Tests • Equipment Control • Testing sterilizer performance • Bowie-Dick Test monitors efficacy of air removal and steam penetration in 270-275°F dynamic-air removal sterilizers (i.e., vacuum assisted sterilizers) AAMI ST79

24. Chemical Indicators Internal CIs – Class 3, 4, 5 • Tests conditions inside individual packs • Internal chemical indicator inside each package • Use inside each pack, wrapped tray, flash tray or container in area least accessible to sterilant – identifies sterilant penetrated AORN & AAMI

25. AORN • Placement of internal chemical indicators AORN

26. Chemical Indicator Placement • Rigid container • Place two CIs inside rigid containers • Place one in each of two opposite corners AORN

27. Chemical Indicator Placement • Multi-layer container • Place two CIs in each level of multi-level rigid container • Place one in each of two opposite corners on each level AORN

28. Chemical Indicator Placement • Multi-level container • Supplied by the manufacturer,holes in tray, has to be wrapped • Place a CI in center on each level AORN

29. Chemical Indicator Placement Wrapped instrument trays • Place CI in geometric center, not on the top AORN

30. Routine Load Release Nonimplants – Flash Sterilization • Class 5 Integrating Indicator PCD for releasing flash loads • PCD must be representative of load • Open surgical tray • Rigid sterilization container • Protective organization case • Single-wrapped surgical tray • Class 5 Integrating Indicator also serves as internal CI AAMI ST79

31. Biological Indicators • Definition • Test system containing viable microorganisms providing a defined resistance to a specified sterilization process AAMI ST79

32. 1291, Blue Cap BI 270°F/132°C, gravity 3M™ Attest™ Rapid Readout Biological Indicators - Flash Cycles • 1292, Brown Cap BI • 270°F/132°C, dynamic-air-removal

33. Biological Indicators AAMI ST79 • AAMI and AORN - Weekly, preferably daily and implants AAMI ST79 & AORN

34. Routine Load Release Implant Loads “Emergency situations should be defined” AAMI ST79

35. Implant Loads – Flash Cycles • “In an emergency, when flash sterilization of an implant is unavoidable, a rapid-action BI and a Class 5 chemical integrating indicator (or enzyme-only indicator) should be run with the load. The implant should be quarantined on the back table and should not be released until the rapid-action BI provides a negative result.” AORN

36. Biological Indicators • “Rationale: The use of BIs provides evidence of efficacy by challenging the sterilizer with a large number of highly resistant bacterial spores. Biological monitoring provides the only direct measure of the lethality of a sterilization cycle. Sterilizer manufacturers validate their sterilization cycles using BIs; therefore, routine sterilizer efficacy monitoring in health care facilities should also be conducted using BIs.” (section 10.5.3.2) AAMI ST79

37. Record Keeping • “Documentation establishes accountability.” • AORN Sterilization Recommended Practice AORN

38. Implant Loads - Flash Cycles • “Flash sterilization should not be used for implantable devices except in cases of emergency when no other option is available.” Photo courtesy of Rose Seavey, The Children's Hospital - Denver AORN

39. Flash Sterilization - AORN Documentation • Log or data base to trace sterilized items used on patients should include: • Information on each load • Item(s) processed • Patient receiving the item(s) • Cycle parameters used (e.g., temperature, duration of cycle) • Day and time cycle is run • Operator information • Reason for flash sterilization AORN

40. Routine Efficacy Testing Establishing a regular pattern of testing the efficacy of the sterilization process Qualification Testing Testing of sterilizer after events occur that affect the ability of the sterilizer to perform Sterilizer installation Relocation Malfunction Major repairs of sterilizer or utilities Sterilization process failures Routine Sterilizer Efficacy MonitoringSterilizer Qualification Testing AAMI ST79

41. Flash sterilization cycles

42. Process Challenge Device (PCD) Definition • “Item designed to constitute a defined resistance to a sterilization process and used to assess performance of the process.” • Representative of load and creates the greatest challenge • Equal to or greater than the most difficult item to sterilize • Placed in most difficult area in sterilizer for the sterilant to penetrate AAMI ST79

43. Process Challenge Device (PCD) • User assembled • Challenge test pack or tray ( e.g., flash tray) • *Note there are no commercially available – FDA Cleared PCDs available for flash sterilization AAMI ST79

44. Quality Assurance ProgramSterilization Process Monitoring • Monitoring Tools • Physical monitors • Chemical indicators • Biological indicators • Process challenge devices (PCDs) Test or challenge pack Results – Integrate results of all monitoring controls; determine if an effective sterilization process AAMI ST79

45. QUESTION: • If a biological indicator (BI) is positive, do you only recall that load?

46. QUESTION: If a BI is positive, do you only recall that load? • ANSWER: • If determined to be an operator error • e.g.,.. using incorrect sterilization cycle • No recall, don’t use load • If not operator error or don’t know reason • Recall all items processed since last negative BI • Reprocess all retrieved items

47. Biological Indicator Monitoring Frequency • Why monitor every load? • Universal standard of patient care • Reduces variability and chance for errors • To be certain all implants, including those in loaners sets, are appropriately monitored • To ensure all cycle types used are tested with a BI • To ensure all types of packaging used in flash sterilization are tested with a BI • To reduce the risk, cost, and impact of a recall • To reduce the risk/cost of healthcare-associated infections (HIAs)

48. The Joint Commission • Organizational policies/procedures should be based on most stringent: • Laws and regulations • Accepted practice guidelines • Current scientific knowledge • And, are consistent throughout facility

49. Issues Associated with Flash Sterilization • Time Pressures • skipped steps in cleaning/decontamination • Flashing large and/or multiple trays • increases cycle and cooling time • Loaner Instrumentation AAMI ST79

50. Loaner Instrumentation Issues • Patient Safety • Timelines (flashing is not recommended) • Communication (OR, SPD, Vendor) • Quality • MDM Reprocessing Guidelines • Adequate time • Implants • Potential for lost items