Description of Event or Problem · 0
OUR FACILITY HAS IDENTIFIED A RECURRING ISSUE WITH THE 3M ATTEST TYPE 5 STEAM CHEMICAL INTEGRATORS. OVER THE PAST SEVERAL MONTHS, MULTIPLE INTEGRATORS HAVE SHOWN VISIBLE DETERIORATION OF THE GREEN AND RED "ACCEPT" INDICATOR LAYER. THE DEFECTS INCLUDE CRACKING, PEELING, BUBBLING, FLAKING, AND CHIPPING OF THE COATING, WHICH IN SOME CASES EXPOSES THE WHITE BACKING UNDERNEATH. TO DATE, THE ISSUE HAS PRIMARILY BEEN OBSERVED IN PEEL-PACKED ITEMS, THOUGH WE ARE MONITORING WRAPPED SETS AND RIGID CONTAINERS AS A PRECAUTION. WHEN AFFECTED INTEGRATORS ARE OPENED, FLAKES FROM THE INDICATOR LAYER MAY TRANSFER ONTO SURGICAL INSTRUMENTS WITHIN THE PACK. WE HAVE REPORTED THE ISSUE TO SOLVENTUM/3M. THE MANUFACTURER CONFIRMED THEY HAVE RECEIVED SIMILAR REPORTS AND BELIEVE THE PROBLEM MAY BE RELATED TO SPECIFIC STERILIZATION CONDITIONS OR A SUPPLIER-RELATED MATERIAL DEFECT. THEY ADVISED THAT NEWER PRODUCTION LOTS DO NOT SHOW THE ISSUE. AT OUR FACILITY, ANY DEFECTIVE INTEGRATORS ARE IMMEDIATELY REMOVED FROM USE. ALL ITEMS FROM MATCHING LOT NUMBERS ARE QUARANTINED AND RETURNED TO THE MANUFACTURER. INSTRUMENTATION THAT MAY HAVE BEEN EXPOSED TO FLAKES IS REPROCESSED PER MANUFACTURER INSTRUCTIONS. ALTHOUGH 3M HAS STATED THAT STERILIZATION MONITORING ACCURACY IS NOT AFFECTED, OUR STERILE PROCESSING SERVICE CONSIDERS THESE INTEGRATORS NON-USABLE DUE TO THE RISK OF PARTICULATE TRANSFER ONTO INSTRUMENTS. THERE HAVE BEEN NO KNOWN PATIENT SAFETY IMPACTS.