SARNS STERNAL SAW II SYSTEM

Description of Event or Problem

IDENTIFIED INCREASE IN THE INCIDENCE OF STERNAL WOUND INFECTIONS THROUGH NORMAL INVESTIGATION PROCESS. ONE COMPONENT EVALUATED WAS THE EQUIPMENT USED. THE PIECE OF EQUIPMENT AT QUESTION IS THE STERNAL SAW. IT WAS SENT TO THE MFR AT HOSP'S REQUEST TO INVESTIGATE INTERNALLY TWO AREAS OF CONCERN: 1. DOES THE MFR'S RECOMMENDATION FOR CLEANING ADEQUATELY REMOVE BIOLOGICAL MATTER, I.E., TISSUE, BLOOD, BONE, ETC. 2. DETERMINE IF THE INTEGRITY OF THE BLADE HOUSING WAS INTACT. BASED ON OBSERVATIONS THERE ARE A FEW POINTS THAT MFR WOULD LIKE TO REINFORCE REGARDING THE RECOMMENDED CLEANING PROCEDURE. FIRST, MFR WOULD LIKE TO STRESS THAT IT IS IMPORTANT TO CLEAN THE SAW AS SOON AS POSSIBLE AFTER EACH CASE. ALLOWING BLOOD TO DRY ON THE SURFACES MAKES IT MORE DIFFICULT TO ADEQUATELY CLEAN THE SAW. SEVERAL OF IT'S CUSTOMERS HAVE MADE MFR AWARE THAT THEY PREFER TO PLACE THE SAW INTO A CLEANING SOLUTION WHILE STILL IN THE OR, IMMEDIATELY AFTER USE. WHEN USING A MANUAL CLEANING METHOD, USE A SOFT BRISTLE BRUSH TO REMOVE BLOOD AND DEBRIS FROM THE SAW. IT IS IMPORTANT TO CONCENTRATE ON INTERFACE AREAS BETWEEN SURFACES NOTABLY THE SLOT IN THE CHUCK, THE FRONT OF THE CHUCK WHERE THE BLADE ENTERS, AND THE FOOT PIECE OF THE BLADE PROTECTOR. WHEN CLEANING THE CHUCK MAKE SURE TO ROTATE THE CHUCK ACTION TO ASSIST ADEQUATE CLEANING. BE SURE TO FULLY EXTEND THE CHUCK AND SCRUB THE CHUCK SHAFT, ESPECIALLY AT THE INTERFACE SURFACES AND ON THE BOTTOM OF THE SHAFT. TO FURTHER IMPROVE YOUR CLEANING PROCESS, MFR MAKES THE FOLLOWING RECOMMENDATIONS: BASED UPON THE HIGHER CONCENTRATION OF STAINING ON THE BOTTOM OF THE CHUCK SHAFT, IT APPEARS THAT HOSP MAY BE HAVING DIFFICULTY ADEQUATELY CLEANING THIS AREA OF THE DEVICE. TO MAKE IT EASIER TO GAIN ACCESS TO THIS AREA, THE BLADE PROTECTOR CAN BE REMOVED TO BETTER SCRUB THE BOTTOM OF THE CHUCK, THE PROTECTOR AND THE POCKET. THE PROTECTOR CAN BE REMOVED BY LOOSENING THE SETSCREW ON THE SIDE OF THE SAW WITH A 5/64 ALLEN WRENCH. IN ORDER TO MINIMIZE THE POTENTIAL FOR BLOOD AND OTHER BIOMATERIALS FROM SURGERY TO FLOW BACK TOWARDS THE SAW, CO RECOMMENDS THAT THE SAW BE SET ON ITS SIDE OR TOP IMMEDIATELY AFTER USE. HOSP REPORTED THAT THE STERILIZATION CYCLE USED IS A PREVACUUM CYCLE WITH A 4 MINUTE EXPOSURE AT 272 DEGREES F. WITH A 30 MINUTE DRY TIME. THIS CYCLE IS NOT RECOMMENDED FOR ROUTINE STERILIZATION OF THE STERNAL SAW. BASED ON AAMI ST37 THESE TYPES OF SHORT CYCLES ARE BEST USED ON DEVICES WITH REDUCED BIOBURDEN AND NO GROSS SOIL. MFR RECOMMENDS USE OF THIS CYCLE WITH A SAW THAT HAS BEEN MINIMALLY CONTAMINATED, FOR EXAMPLE ONE IN WHICH THE STERILE BARRIER WAS COMPROMISED AFTER CLEANING AND STERILIZATION. MFR RECOMMENDS THAT HOSP INCREASE THE STERILIZATION EXPOSURE TO 20 MINUTES AT 270 DEGREES F. FOR ROUTINE STERILIZATION. ALSO IT IS RECOMMENDED THAT THE STERNAL SAW BE RETURNED EVERY 6 MONTHS FOR ROUTINE PREVENTATIVE MAINTENANCE AND EXAMINATION. PART OF THAT PROCEDURE INVOLVES A THOROUGH CLEANING OF THE SAW. MFR RECORDS INDICATE THAT THESE SAWS WERE PURCHASED IN EARLY 1997 AND THEY HAVE NEVER BEEN RETURNED FOR SERVICE.