MANAGING STERILIZATION PROCESS MONITOR FAILURES

Transcription

1 MANAGING STERILIZATION PROCESS MONITOR FAILURES Joseph F. LeBouef, RST, CST, CRCST, CHL Regional Sterile Processing Educator, Kaiser Foundation Health Plan of the Northwest President, IAHCSMM Cascade Chapter

2 Why Monitor the Sterilization Process? Critical items contact normally sterile tissues of the body-items must be sterile You can t see sterility You can t reasonably verify or test sterility Sterility is a probability function, affected by: Human factors Equipment and utility issues 2

3 Types of Sterilization Monitors Physical Mechanical charts, printouts or graphs Chemical Indicate exposure to sterilizing agent Biological Measure lethality of cycle 3

4 Information provided: Physical Monitors Whether or not the sterilizer performed as instructed Parametric only Only measures at one location in chamber No indication of whether sterilant reached device or if lethality was achieved 4

5 Chemical Monitors (Indicators) Information provided: Whether adequate sterilant concentration and/or other critical variables required for sterilization occurred at specific location inside sterilizer chamber or processed package No measure of cycle lethality Both external and internal for each package 6 Classifications not hierarchical 5

6 Classification of Chemical Indicators Class I: Process Indicators React to 1 critical variable Used to differentiate items that were exposed from those that were not Class II: Indicators for Use in Specific Tests Special tests (Bowie-Dick/DART - used to assess dynamic air removal sterilizer s ability to remove air) 6

7 Classification of Chemical Indicators Class III: Single Variable Indicators React to 1 critical variable Indicates performance in relation to at least 1 stated value Not commonly used Class IV: Multi-variable Indicators React to at least 2 critical variables May be used as internal pack monitors 7

8 Classification of Chemical Indicators Class V: Integrating Indicators React to ALL critical variables Used as internal pack monitors Performance must mimic biological performance Class VI: Emulating Indicators React to ALL critical variables Used as internal pack monitors Performance does not mimic biological performance Cycle specific 8

9 Placement of Chemical Indicators AAMI: Placed in area least accessible to sterilant penetration For containers, refer to manufacturer s written instructions AORN: For wrapped items: 1 in geographical center of package, on each level if multiple levels For containerized items: placed in 2 opposing corners, on each level 9

10 Biological Monitors (Indicators) Only monitor that directly measures cycle lethality Steam, H2O2 and ozone processes use known quantities of highly resistant Geobacillus stearothermophilus spores Specifically designed for particular modality employed Sterilizers monitored on routine basis and with ALL implantable devices Steam: at least weekly, preferably daily H2O2: at least daily Ozone: every cycle 10

11 Application of Biological Indicators Placed directly over drain, on lowest shelf of sterilization cart/rack Indicator must be specifically approved for use in the modality employed: 250⁰ F gravity displacement air removal (example: 3M 1292 BROWN top BI) 270⁰ F gravity displacement air removal (example: 3M 1291 BLUE top BI) 270⁰ F dynamic (pre-vac) air removal (example: 3M 1292 BROWN top BI, possibly in a process challenge device) All modalities employed must be tested 11

12 Application of BIs (Continued) Unprocessed BI used as control test to ensure viability of spores Daily, and With each new lot number of BI Implantable devices should not be released until BI results are known If emergency necessitates early release, an exception form should be used to communicate risk to provider 12

13 Exception Form for Premature Release of Implantable Device/Tray NOTE In a documented emergency situation, implantable devices will be released from quarantine without the biological monitor result. This form should accompany the implant to the Operating Room. Operating Room personnel should complete this form and return it to Central Service within 24 hours. PLEASE COMPLETE ALL INFORMATION: DATE: SHIFT: TIME: AM PM PERSON COMPLETING THIS REPORT IN CENTRAL SERVICE: The following implantable devices/trays were prematurely released to the Operating Room: NAME OF OR PERSON REQUESTING PREMATURE RELEASE OF DEVICES: OPERATING ROOM REPORT: PATIENT NAME: SURGEON NAME: TIME OF PROCEDURE: AM PM DATE: REASON PREMATURE RELEASE WAS NEEDED: WHAT COULD HAVE PREVENTED PREMATURE RELEASE OF THIS DEVICE/TRAY? NAME OF OR PERSON COMPLETING THIS REPORT: DATE REPORT COMPLETED: FORM RETURNED TO CENTRAL SERVICE ON: 13

14 When Monitors Indicate Failure Quarantine items/remove sterilizer from service If reason is apparent (incorrect cycle selected, sterilizer loaded improperly, etc.) Correct issue, repackage and reprocess items If reason is not apparent Recall all items processed since last negative biological test Any items used must be communicated to Infection Prevention & Control and to provider responsible for care of patient 14

15 Minor repair If Failure Results in Repair of a Sterilizer Routine monitors performed, then sterilizer released into service Major repair Repairs that effect the basic performance of the sterilizer (chamber welding, major refitting of piping, software overhaul, etc.) Sterilizer must be requalified 15

16 Steam Sterilizer Qualification Performed when a new sterilizer is installed, a sterilizer s location is changed or it undergoes major repair 3 back-to-back biological indicators performed in an empty chamber 3 Bowie-Dick/DART tests performed backto-back in an empty chamber Sterilizers quarantined until test results are obtained 16

17 Questions? Thank you! 17

18 References ANSI/AAMI ST79:2010 & Amendment 1/Amendment 2 AORN Perioperative Standards and Recommended Practices,