Description of Event or Problem · 1
POTENTIAL LOW RISK EXPOSURE OF <160 PTS TO AN INCOMPLETE DISINFECTION OF AN SPECIFIC UPPER GI ENDOSCOPE BETWEEN (B)(6) 2003 AND (B)(6) 2010, IN AN OUTPATIENT ENDOSCOPY DEPT. THERE WAS A CHANGE IN DESIGN BETWEEN TWO SERIES OF SCOPES REGARDING TWO CHANNELS. THE OLYMPUS GIF-2T100 SERIES SCOPE HAD AN INTERNAL CONNECTION BETWEEN THE TWO CHANNELS JUST BELOW THE INSTRUMENTAL CHANNEL PORTS WHICH ALLOWED FOR FLOW OF ENZYMATIC CLEANING SOLUTION, HIGH LEVEL DISINFECTANT, AND RINSE WATER BETWEEN THE CHANNELS. THIS REQUIRED THAT THE INSTRUMENT CHANNEL PORTS BE CAPPED DURING THESE PARTS OF THE CLEANING PROCESS. CLINICALLY THIS IS AN IMPORTANT DISTINCTION TOO, BECAUSE THIS IS HOW THE DOUBLE SUCTION WORKED WHEN UTILIZING BOTH CHANNELS FOR SUCTIONING. THE OLYMPUS GIF-2T160 SERIES SCOPE WAS DESIGNED WITHOUT THIS INTERNAL CONNECTION. ALL CONNECTIONS WERE DESIGNED TO BE EXTERNAL. THE BIOPSY VALVES - WHICH IS A SINGLE PIECE FOR THIS TYPE OF SCOPE, AS IT WAS FOR THE 100- HAS A SUCTION SWITCHOVER LEVER WHICH ALLOWS YOU TO USE BOTH CHANNELS FOR SUCTIONING. THIS IS NOT USED FOR PRE-CLEANING OR HLD. A NEW PIECE OF CLEANING EQUIPMENT IS REQUIRED, THE CHANNEL CONNECTION TUBE. THERE IS NO DOCUMENTATION OF TRAINING BY OLYMPUS REGARDING THIS DESIGN CHANGE WHEN THIS SCOPE WAS INTRODUCED IN 2002 OR IN 2007. ANOTHER CONCERN IS THAT THE SCOPES LOOK THE SAME EXCEPT FOR A VERY DISCRETE SERIES NUMBER DIFFERENCE. WHEN THIS SCOPE WAS USED, THIS IS WHAT WAS HAPPENING: AT THE POINT OF USE, WATER AND/OR ENZYMATIC SOLUTION WAS SUCTIONED THROUGH THE SCOPE CHANNELS UNTIL RETURNS WERE CLEAR. AT THE POINT OF REACHING OUR CLEANING ROOM, THE SCOPE WAS PLACED IN A SINK OF ENZYMATIC SOLUTION, THE EXTERNAL PARTS OF THE SCOPE WERE CLEANED MANUALLY WITH A SPONGE. ALL VALVES AND ACCESSIBLE INTERNAL CHANNELS WERE BRUSHED WITH ENZYMATIC SOLUTION UNTIL THE BRUSH WAS CLEAN AND FEE OF DEBRIS. BOTH OF THE INSTRUMENT CHANNELS WERE BRUSHED UNTIL CLEAR RETURNS. THIS IS WHERE THE PROBLEM HAPPENED. ALL CHANNELS SHOULD HAVE BEEN FLUSHED WITH ENZYMATIC SOLUTION. ONE OF THE INSTRUMENT CHANNELS WAS NOT, BECAUSE OUR STAFF WERE CAPPING THE INSTRUMENT CHANNEL PORTS -AS THEY DID WITH THE 100 SERIES SCOPE- INSTEAD OF USING THE "CHANNEL CONNECTION TUBE". THIS SAME ISSUE CARRIED OVER TO THE HLD PROCESS. THE RIGHT OR B INSTRUMENT CHANNEL DID NOT RECEIVE THE CORRECT FLUSHING WITH ENZYMATIC SOLUTION AND FLUSHING/CONTACT WITH HIGH LEVEL DISINFECTANT. WE HANG HE SCOPES VERTICALLY TO DRY AFTER CLEANING INTERESTING THAT OVER THE YEARS, WE DID NOT SE UNUSUAL DRIPPING OR DRAINAGE FROM THESE SCOPES. A WHITE TOWEL SITS ON THE FLOOR BENEATH THE SCOPES AND ANY COLORED DRAINAGE FROM THE AFFECTED CHANNEL WOULD HAVE BEEN READILY APPARENT. DATES OF USE: (B)(6) 2003 - (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: SCOPING FOR UPPER GI BLEED.