Medical Device Reprocessing Quality Assurance. 3M All Rights Reserved.

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1 Medical Device Reprocessing Quality Assurance

2 Additional Content Qualification Testing Flash Sterilization Extended Cycles Recalls Wet Packs Finish 2

3 Qualification Testing and Required Monitoring Installation Qualification Operational Qualification Ensures equipment is properly installed Performance Verifies that Qualification sterilizer is working of Loads Products properly Performed by manufacturer of Documents Products retained by facility Process: Verifies Requirements: that devices loads used used can can be be sterilized of Process: Loads 3 When Biological new materials, Indicator PCDs processes, or conditions are introduced 3 Most Test Includes Bowie-Dick sets challenging packaging, (with Tests multiple devices (pre-vac configurations, indicators) product sterilizers and cycle families only) PCDs variables, selected Requirements: Surround Test sets and devices PCDs with placed multiple throughout BIs and normal CIs load After Monitor major sterilization repairs, relocation, construction in sterilization area After unexplained sterilization failures, changes in steam supply Annually (at minimum) 3

4 Qualification Testing Summary Qualification Testing Requirements Frequency Z314.3 Clause Installation Performed by manufacturer. Keep documents. At installation 12.3 Operational Performed by facility. 3 BI PCDs and 3 Bowie-Dick test packs. After major changes; At least annually 12.4 Performance (products) Performance (loads) Multiple BIs and CIs around representative devices. Multiple BIs and CIs throughout representative load. After changes in materials, processes, devices, load configurations, previously verified cycle conditions

5 Additional Content Qualification Testing Flash Sterilization Extended Cycles Recalls Wet Packs Finish 5

6 Flash Sterilization (IUSS) (Clause 13) IUSS: Immediate Use Steam Sterilization New term introduced in 2012 Definition: emergency sterilization of devices By-passes several typical reprocessing steps Only used when routine sterilization cannot be done All practical measures shall be taken to avoid the need for flash The Canadian Standards Association. Effective sterilization in health care facilities by the steam process. CSA Z Shall not flash sterilize: 6 Implants Complete sets or trays

7 Flash Sterilization (IUSS) Requirements Each facility must have policies for flash sterilization Traceability of all devices that are flash sterilized Necessary in the event of a recall Documentation of event Patient and doctor name Time and date Device identification Training and education for people doing flash sterilization Includes OR staff! 7

8 Flash Sterilization (IUSS) Requirements Flash sterilizer work area: Not in an operating room Not near sources of contamination In a restricted access area, near to where devices will be used Sterile storage in a different room Device decontamination: Not to be done in a scrub sink Appropriate enzymatic or disinfectant must be used Follow manufacturer s instructions for use for cleaning products Appropriate PPE must be used 8

9 Flash Sterilization (IUSS) Requirements Validated containers/trays/wrapping for flash sterilization must be used Specific cycle conditions (time and temperature) may be provided by the manufacturer Process requirements: Minimum temperature of 132 C 4 minutes for non-porous loads (vacuum cycle) 10 minutes for non-porous loads (gravity cycle) 3 minutes for porous loads 9

10 Flash Sterilization (IUSS) Requirements Monitoring: Same as for typical steam sterilization Biological monitoring daily for sterilizer(s) in use Bowie-Dick test for vacuum sterilizers Chemical indicators placed in trays/containers/packs Storage: Devices shall not be stored 10

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12 Recalls Recall required when there is doubt about device sterility Failed sterilization indicators Failed performance qualification Necessary to recall back to last successful test Recall Procedure: Release recall order 2. Collect devices (according to facility policy) 3. Reprocess devices 4. Release recall report

13 Recalls Recall Order Identify devices and departments in recall Identify load control labels in recall Specify action required (e.g. return to MDRD) Recall Report 13 Detail the circumstances for recall List devices, departments, and people involved State percentage of devices recalled Include incident report for uncollected devices Specify corrective actions

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15 Questions? 15 All statements, technical information and recommendations herein are based on data we believe to be reliable, but the accuracy or completeness thereof is not guaranteed. There is no representation, warranty, guarantee or other obligation of 3M or its employees arising out of this presentation. Please refer to specific product packaging, user instructions and related documents for complete details. 3M shall not be liable for any loss and/or damage, whether direct, indirect, incidental, special or consequential arising out of this presentation, or the sale, use or misuse of 3M products or the user s inability to use such product. 3M, Comply, SteriGage, and Attest are trademarks of 3M. Used under license in Canada.