RIGID BRONCHOSCOPY ENDOSCOPES AND INSTRUMENTS

Description of Event or Problem

OUR STERILE PROCESSING DEPARTMENT RECENTLY RECEIVED A NEW KARL STORZ INSTRUMENT SET FOR STERILIZATION. UPON REVIEW OF THE INSTRUCTIONS FOR USE (IFU) GENERAL REPROCESSING INSTRUCTIONS FOR KARL STORZ PRODUCTS IT WAS DETERMINED THAT THERE ARE NO DECONTAMINATION INSTRUCTIONS WITHIN THE IFU. UPON INQUIRY FOR CLARIFICATION AND GUIDANCE WITH THE KARL STORZ LOCAL REPRESENTATIVE, TECHNICAL AFFAIRS, AND REGULATORY AFFAIRS, WE RECEIVED A LETTER BACK WITH THE FOLLOWING VERBIAGE, "IN THE U.S., WE DO NOT REQUIRE ANY ADDITIONAL DECONTAMINATION OUTSIDE OF THESE VALIDATED INSTRUCTIONS." WE ARE TRYING TO ENABLE OUR STAFF TO BE ABLE TO PROCESS THESE DEVICES SAFELY WITHOUT RISK. WELL ESTABLISHED STERILE PROCESSING STANDARDS OF PRACTICE HAVE ALWAYS INDICATED A DECONTAMINATION PROCESS FOLLOWING CLEANING TO RENDER A DEVICE "SAFE TO HANDLE" BEFORE INSPECTION / PREPARATION / ASSEMBLY FOR STERILIZATION. ISN'T IT PART OF THE PREMARKED APPROVAL PROCESS TO ENSURE ITEMS HAVE CLEAR INSTRUCTIONS FOR PROCESSING, TO INCLUDE DECONTAMINATION? WE RECEIVED SOME TRAINING RECENTLY AND IT REPORTED SOME OF OUR FACILITIES HAVE RECEIVED ACCREDITATION SURVEY FINDINGS FOR NOT GETTING CLARIFICATION FROM A DEVICE MANUFACTURER WHEN THEIR IFU WAS VAGUE. WHEN WE TRIED TO GET GUIDANCE FOR DECONTAMINATION OF THESE INSTRUMENTS, THEY PROVIDED US A LETTER SAYING ALL THEY NEED TO PROVIDE ("IN THE US") IS CLEANING AND STERILIZATION INSTRUCTIONS. PT CODE: 4582. DEVICE CODE: 1120. REFERENCED REPORTS-MW5185737, MW5185739.