Failure mode effects and criticality analysis of medical endoscopes

Abstract

Objective To determine the important functional units of medical endoscopes and provide a theoretical basis for improving the maintenance and repair of hospital medical equipment. Methods The units of medical endoscopes were analyzed by the failure mode effects and criticality analysis (FMECA) method to determine the important functional unit. The maintenance methods of the important functional units were proposed and compared with those obtained by a medical equipment repair company. Results According to the risk priority number (RPN) score> 36, the important functional units of the medical endoscope were determined as electrical interface, water bottle interface, suction interface, housing, chain, pliers pipeline, water gas pipeline, jacket, charge coupled device (CCD) glass, guided beam glass and nozzles. These units require clinical operators to focus on and perform regular maintenances. Compared with the results obtained by the company, human factors were considered as a greater impact on the reliability of medical endoscopes. Conclusions For clinical operators, the operation training of medical endoscopes should be strengthened to avoid human-induced failures. Key words: Failure mode effects and criticality analysis; Medical endoscopes; Reliability