Description of Event or Problem · 1
THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR A LEFT TYMPANOMASTOIDECTOMY AND BILATERAL ADENOIDECTOMY. DURING THE PROCEDURE, THE SURGEON USED AN INSTRUMENT FROM THE PEDS PANETTI ENDOSCOPIC OTOLOGY SET (INSTRUMENT #30-1860) TO SUCTION FLUID ON A DRAPE IN THE STERILE FIELD. THE SURGEON FOUND THAT THE SUCTION WAS CLOGGED. THE RN FLUSHED THE LUMEN USING SALINE INTO A BOWL AND THERE APPEARED TO BE BIOBURDEN THOUGHT TO BE CLOTTED BLOOD EXPELLED FROM THE LUMEN. THE INSTRUMENT DID NOT COME INTO DIRECT CONTACT WITH THE PATIENT; HOWEVER, THE FLUID SUCTIONED FROM THE DRAPE WAS IN CONTACT WITH THE SURGICAL INCISION RAISING CONCERN FOR CONTAMINATION. THE BOWL AND INSTRUMENT WERE REMOVED FROM THE STERILE FIELD. THE PATIENT WAS NOT RE-PREPPED AND RE-DRAPED. 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. MANUFACTURER IS SPIGGLE & THEIS. DISTRIBUTOR IS (B)(4).