Study on the formulation of maintenance and inspection guidelines for life support devices

Abstract

(Purpose) The objective of the present study was to compile guidelines for the maintenance and inspection of medical devices.

(Materials and Methods) The subjects comprised devices under the Medical Care Act. Regarding the method of formulation, the guidelines related to existing training and maintenance, instruction manuals for typical products and others were analyzed. Based on these, the matters to be stated in the guidelines were extracted and the guidelines were completed after review by the academic societies.

(Results) For training, items were extracted mainly by analyzing medical accident cases. Regarding maintenance and inspections, the items stated in the existing maintenance and inspection guidelines were analyzed from the viewpoints of inspection details, procedures, and implementation frequency.

(Conclusion) It is necessary to promote the proper and safe use of medical devices by standardizing the training and maintenance of medical devices. We aim to formulate guidelines that can be implemented in clinical practice.