3 HOUR RAPID ATTEST BIOLOGICAL INDICATOR 3M CORORATE HEADQUARTERS 3M CTR

I WORK IN SURGICAL SERVICES, STERILE PROCESSING DEPT. WE UTILIZE THE 3M HEALTHCARE STERILIZATION BIOLOGICALS. PRODUCT# 41382F 3 HOUR RAPID BIOLOGICAL TEST PACK, CONSISTS OF THE 1292 BROWN CAP 3 HOUR EARLY READOUT. CURRENTLY, MFR STATES THAT WE CAN READ THE BIOLOGICAL INDICATOR EARLY ENZYME AT 3 HOURS AS A FINAL SPORE READ, THEN DISCARD. CONCERN IS THAT THE ORIGINAL FDA CLEARANCE FOR THIS PRODUCT FROM 1995 WAS CLEARED AS A DUAL COMPONENT SYSTEM. RAPID READ AT 3 HOURS, CONTINUAL INCUBATION FOR A FINAL VISUAL READ AT 48 HOURS. QUESTION: ARE WE MISUSING THE PRODUCT AS IT WAS ORIGINALLY CLEARED BY DISCARDING THE BIOLOGICAL AFTER 3 HOURS, AND NOT FINISHING THE 2ND COMPONENT AS CONTINUAL INCUBATION FOR 48 HOURS? THE PRODUCT WAS CLEARED FOR A 4 MINUTE STERILIZATION EXPOSURE TIME. THROUGH THE YEARS, THERE HAS BEEN SURGICAL INSTRUMENTATION THAT HAS BEEN VALIDATED FOR STERILIZATION BEYOND THE 4 MINUTES, HENCE "EXTENDED CYCLE" TIMES. THE MFR CONDUCTED AN "IN-HOUSE" STUDY AND DETERMINED THAT THEIR PRODUCT ALSO WORKS IN "EXTENDED CYCLES" UP TO 20 MINUTES, HOWEVER, THERE ARE NO PLANS TO SUBMIT THIS STUDY TO THE FDA FOR CLEARANCE. SHOULD THERE BE CONCERN OF MONITORING THESE "EXTENDED CYCLE" TIMES WITH THIS PRODUCT WITHOUT THE FDA CLEARANCE? MOST OF THESE EXTENDED CYCLES ARE ORTHOPAEDIC IMPLANTS AND INSTRUMENT TRAYS. IS THIS AN INTERRUPTION OF "BEST" PRACTICE TO ASSURE THE STERILITY TO MAINTAIN THE SAFETY OF OUR SURGICAL PTS? GIVEN THE RECENT FDA ADVISORY ON THE (B) (4) SYS 1 MACHINE, SHOULD HEALTH CARE FACILITIES BE CONCERNED WITH USING PRODUCTS BEYOND THEIR ORIGINAL CLEARANCE AND ALSO FOLLOW MFRS STATEMENTS ON A PRODUCT WITHOUT FDA CLEARANCE FOR ITS CLAIM?