A MEDIVATORS FIELD SERVICE ENGINEER (FSE) REPORTED A FACILITY HAD NOT BEEN USING TEST STRIPS TO TEST THE MINIMUM REQUIRED CONCENTRATION (MRC) OF THE HIGH-LEVEL DISINFECTANT BEFORE EACH REPROCESSING CYCLE IN THEIR DSD-201 AUTOMATED ENDOSCOPE REPROCESSOR (AER). THERE IS POTENTIAL THAT THE DISINFECTANT CYCLE DID NOT REACH HIGH-LEVEL DISINFECTION, THUS THERE IS POTENTIAL FOR PATIENT CROSS-CONTAMINATION. IT IS REQUIRED PER THE AER USER MANUAL TO MONITOR MRC LEVELS. ADDITIONALLY, THE RAPICIDE GLUTARALDEHYDE INDICATOR TEST STRIP DIRECTIONS FOR USE INDICATE THAT THE DISINFECTANT SHOULD BE TESTED FOR MRC BEFORE EACH CYCLE. THE NUMBER OF ENDOSCOPES REPROCESSED WITHOUT CHECKING MRC IS UNKNOWN. MEDIVATORS FSE INFORMED THE FACILITY THAT IT IS REQUIRED TO TEST MRC BEFORE EACH DISINFECTANT CYCLE. THERE HAVE BEEN NO REPORTS OF PATIENT ADVERSE EVENTS. THIS COMPLAINT WILL CONTINUE TO BE MONITORED IN THE MEDIVATORS COMPLAINT HANDLING SYSTEM.
D
Patient 1
A MEDIVATORS FIELD SERVICE ENGINEER (FSE) REPORTED A FACILITY HAD NOT BEEN USING TEST STRIPS TO TEST THE MINIMUM REQUIRED CONCENTRATION (MRC) OF THE HIGH-LEVEL DISINFECTANT BEFORE EACH REPROCESSING CYCLE IN THEIR DSD-201 AUTOMATED ENDOSCOPE REPROCESSOR (AER). THERE IS POTENTIAL THAT THE DISINFECTANT CYCLE DID NOT REACH HIGH-LEVEL DISINFECTION, THUS THERE IS POTENTIAL FOR PATIENT CROSS-CONTAMINATION.