Description of Event or Problem · 1
THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR REVISION OF THE RIGHT OSSICULAR CHAIN RECONSTRUCTION, EVALUATION OF RE-CURRENT "CHOLEASTOMA", AND LEFT SIDED REMOVAL OF RETAINED MIDDLE EAR TUBE. THE SAME PEDS PANETTI INSTRUMENT SET WAS USED DURING THIS PROCEDURE, BY THE SAME SURGEON. THE SURGEON WAS UNABLE TO ESTABLISH SUCTION THROUGH THE INSTRUMENT. THE INSTRUMENT WAS REMOVED FROM THE STERILE FIELD AND FLUSHED BY THE SCRUB TECH ON THE BACK TABLE. AFTER FLUSHING, DEBRIS APPEARING TO BE BIOLOGICAL MATTER WAS EXPELLED FROM THE INSTRUMENT. THE STERILE FIELD WAS BROKEN DOWN, AND THE PATIENT WAS RE-PREPPED AND RE-DRAPED. THE INSTRUMENT SET WAS REPLACED. THE VENDOR RECOMMENDED CLEANING THE INSTRUMENTS USING A 3 MACH IRRIGATION SYSTEM AND A HIGH PRESSURE WATER SOURCE. WE DO NOT OWN A 3 MACH IRRIGATION SYSTEM, BUT WAS ASSURED BY THE VENDOR THAT THE IN-HOUSE PURE PROCESSING FLEXI-PUMP WOULD PROVIDE ADEQUATE VOLUME AND PRESSURE TO FLUSH THE INSTRUMENTS EFFICIENTLY AND TO DECONTAMINATE THE INSTRUMENTS. WE HAVE SUBSEQUENTLY BEEN TOLD THE PURE PROCESSING FLEXI-PUMP DOES NOT PROVIDE ADEQUATE VOLUME AND PRESSURE TO FLUSH AND DECONTAMINATE THE INSTRUMENTS EFFECTIVELY. THE PEDIATRIC OPERATING ROOM NURSING STAFF ALSO RECEIVED IN-SERVICE TRAINING OF INSTRUMENT USE. THIS TRAINING DID NOT INCLUDE SPECIFIC PRE-CLEANING INSTRUCTIONS THAT, PER THE IFU, INCLUDE USING A WIRE TO CHECK INNER LUMEN PATENCY, RINSING INSTRUMENTS WITH A SUITABLE CLEANER OR DISINFECTANT, AND STORING INSTRUMENTS IN A SUITABLE CLEANER OR DISINFECTANT IF NOT PROCESSED WITHIN ONE HOUR AFTER USAGE. THE INSTRUMENTS WERE TAKEN OUT OF SERVICE TO UNDERGO FURTHER EVALUATION OF THE CLEANING/DECONTAMINATION PROCESS AND DETERMINE PATIENT EXPOSURE SINCE THE INSTRUMENTS SETS WERE PUT IN USE. MANUFACTURER RESPONSE FOR SURGICAL INSTRUMENT SET, PANETTI ENDOSCOPIC INSTRUMENT SET (PER SITE REPORTER).