Description of Event or Problem · 0
NOT SURE IF THIS IS WHERE I REPORT THIS. WE HAVE BEEN ASKED TO PROCESS AN ITEM FROM CIRCUMFLEX (PRODUCT # (B)(6)). THE IFU (INSTRUCTIONS FOR USE) FOR STERILIZATION IS PRE VACUUM AT 250 (131C) FOR 30 MINUTES WITH A 30-MINUTE DRY. THIS ISN'T A REAL CYCLE. THE IFU LOOKS LIKE IT WAS FROM CHAT GPT. WHEN I CALL THE COMPANY, THEY SAY TO "JUST RUN IT ON THE SAME CYCLE AS A NEEDLE HOLDER." THEY SENT ME A PAPER WITH THEIR LETTER HEAD THAT SAID IT CAN BE RAN ON A 4-MINUTE CYCLE AND A 30-MINUTE DRY, AFTER I TOLD THEM THAT WAS A STANDARD CYCLE FOR A NEEDLE HOLDER AT OUR HOSPITAL. THIS COMPANY DOESN'T SEEM LIKE THEY GOT THERE IFU ACCREDITATION FROM THE FDA (FOOD AND DRUG ADMINISTRATION) AND I DON'T FEEL COMFORTABLE USING THIS INSTRUMENT AT MY HOSPITAL. WITH THE LACK OF CARE GOING INTO THESE ITEMS, I WONDER THE LACK OF CARE GOING INTO THEIR IMPLANTS.