Description of Event or Problem · 0
TELEFLEX O'REILLY ESOPHAGEAL RETRACTOR USED ON GASTRIC BYPASS PROCEDURES. WHEN GOING THROUGH THE DECONTAMINATION PROCESS IN STERILE PROCESSING, IT WAS NOTED THAT AFTER CLEANING AND DISINFECTION BLOOD CONTINUED COMING OUT OF THE DISTAL TIP WHEN AN EMPLOYEE FLUSHED IT WITH ALCOHOL ON THE CLEAN SIDE OF SPD. THE RETRACTOR WAS RETURNED TO THE DIRTY SIDE OF SPD TO UNDERGO CLEANING AND DISINFECTION (FLUSH AND SOAK WITH ENZYMATIC CLEANER, FORCED AIR, REPEAT FLUSHING, 10-MINUTE ULTRASONIC CYCLE FOLLOWED BY 30 MIN WASH CYCLE) AFTER TWO CYCLES OF THIS DECONTAMINATION PROCESS, WHEN FLUSHED WITH ALCOHOL, BLOOD WAS STILL COMING FROM THE DISTAL THE RETRACTOR. THE RETRACTOR WAS AGAIN SENT BACK THROUGH THE DECONTAMINATION PROCESS FOR A THIRD TIME IN WHICH DID YIELD NO MORE BLOOD WHEN FLUSHED WITH ALCOHOL. AT THIS POINT OUR SPD MANAGER DECIDED TO LOOK AT IT WITH OUR BAROSCOPE JUST TO BE SAFE. IMMEDIATELY HE SAW BIO BURDEN AT THE DISTAL TIP. HE WENT AND PUSHED THE CAMERA ALL THE WAY THROUGH AND SAW MORE BIO BURDEN. HE WENT AND REPEATED ALL THE STEPS AGAIN IN DECON. AFTER COMING OUT OF THE WASH, HE USED THE BAROSCOPE AGAIN AND SAW THAT BIO BURDEN WAS STILL PRESENT AT THE DISTAL TIP, BUT THE BIO BURDEN FURTHER BACK WAS GONE. I HAD DECIDED AT THIS POINT TO LOOK AT ALL THE OPEN ESOPHAGEAL RETRACTOR USING THE BAROSCOPE. UPON LOOKING WE SAW BIO BURDEN, PITTING AND RUST IN ALL OF THE ONES WE LOOKED AT. HE (SPD MANAGER) CONTACTED THE COMPANY TO SEE IF THERE WERE MORE UPDATED IFU'S, BUT HE WAS PROVIDED GENERIC IFU'S FOR SOAKING AND STERILIZATION. THE SPD MANAGER TOLD THE COMPANY REPRESENTATIVE THAT IT DOESN'T TALK ABOUT FLUSHING OR BRUSHING THE CANNULA IN THIS IFU. HE SAID HE WOULD ESCALATE THIS UP TO HIS PROJECT MANAGER, BUT IT WOULD BE SOMETIME BEFORE HE WOULD HEAR BACK BECAUSE OF THE HOLIDAY. AS OF TODAY (B)(6) 2022, WE STILL HAVE NOT HEARD BACK. OF NOTE THE SPD MANAGER DID TRY TO BRUSH THE INTERNAL COMPONENTS, BUT STRUCTURES INSIDE THE RETRACTOR DON'T ALLOW THE BRUSH TO ADVANCE AND THE RETRACTOR CANNOT BE DISASSEMBLED CLEANING AND DISINFECTION. DUE TO THE POSSIBILITY OF EXPOSURE TO PATIENT'S D/T THE EQUIPMENT NOT BEING ABLE TO BE EFFECTIVELY CLEANED/DISINFECTED/STERILIZED AND ALSO WITH VISIBLE BIOBURDEN, WE SEQUESTERED THE INSTRUMENTS, CONTACTED THE NYSDOH AND OUR EPIDEMIOLOGIST. FDA SAFETY REPORT ID# (B)(4).