Description of Event or Problem · 0
I AM A FELLOWSHIP TRAINED TRANSPLANT SURGEON AND I AM CURRENTLY WORKING AS A RECOVERY SURGEON FOR OUR REGIONAL OPO (ORGAN PROCUREMENT ORGANIZATION) FOR THE LAST SIX YEARS. OVER A YEAR AGO, WE STARTED, AS AN OPO, TO UTILIZE THE ORGANOX METRA LIVER PERFUSION DEVICE TO IMPROVE QUALITY AND ENHANCE UTILIZATION OF DCD LIVER GRAFTS. THIS PUMP REQUIRES THE OPERATOR TO REMAIN IN A SUSTAINED FORWARD FLEXION WHILE ESTABLISHING A HEMOSTATIC CONNECTION BETWEEN THE LIVER GRAFT AND THE PUMP LINES. THIS POSTURE HAS CAUSED SIGNIFICANT DISCOMFORT TO MY LOWER BACK AS WELL AS MY NECK AREA IN THE FORM OF SEVERE MUSCLE SPASMS AND DIFFICULTY STANDING UP. ANOTHER AREA OF CONCERN IS THE HEIGHT THAT THE LIVER BASIN IS LOCATED ON THIS DEVICE. THE BASIN IS AT KNEE LEVEL, WHICH MANDATES THE ABOVEMENTIONED AWKWARD POSTURE REQUIRED TO OPERATE IT AS WELL AS CREATING REAL CONCERNS REGARDING STERILITY. AS A SURGEON OF OVER 20 YEARS' EXPERIENCE, ANYTHING BELOW THE LEVEL OF YOUR HIPS IS ACTUALLY CONSIDERED NON-STERILE IN PRACTICE. WHILE OPERATING THIS PUMP NOT ONLY DO WE HAVE TO BEND DOWN AND SUSTAIN A VERY UNNATURAL POSTURE BUT ALSO THE FIELD WE ARE OPERATING ON IS AT THE LEVEL OF OUR KNEES. THIS, IN MY OPINION CREATES A REAL CONCERN FOR MAINTAINING STERILITY. A THIRD CONCERN I HAVE IS THE INSUFFICIENCY OF THE SIZE OF THE STERILE DRAPE THAT'S INCLUDED IN THE DISPOSABLES PACK THAT WE ARE USING TO ISOLATE THE LIVER BASIN FROM THE NON-STERILE SURFACES OF THE PUMP: IT LEAVES LARGE AREAS OF THE PUMP BODY EXPOSED, THUS INCREASING THE RISK OF CONTAMINATION. THERE IS, SUPPOSEDLY A LIFT SYSTEM THAT THE COMPANY HAS COMMERCIALLY AVAILABLE TO RAISE THE PUMP UP TO A MORE ERGONOMIC WORKING HEIGHT BUT DESPITE MY NUMEROUS REQUESTS, WE AS AN OPO HAVE NOT BEEN ABLE UTILIZE ONE YET. UNTIL THESE CONCERNS ARE ADDRESSED, I BELIEVE A SAFETY PAUSE SHOULD BE CONSIDERED FOR THE USE OF THE ORGANOX METRA DEVICE.