Abstract
In this study, we analyzed Korean and foreign systems, focusing on high-risk medical devices that urgently need to be managed, and we present an life cycle calculation method for determining replacement time. A literature review was conducted to confirm the regulations of the medical device management system and life cycle by country, and a case analysis was performed to verify the replacement evaluation criteria of actual medical institutions. In addition, durability data from the Public Procurement Service, American Hospital Association, and Samsung Medical Center were used to calculate the life cycle of high-risk medical devices. The analysis showed that in the case of Korean and foreign medical device regulatory agencies, there were no specific life cycle regulations for high-risk medical devices. In addition, the important items in the medical device replacement evaluation were found to be the year of introduction, repair cost, component discontinuation, and several failures. On calculating the life cycle of high-risk medical devices revealed that the replacement time is 13 years for anesthesia machines, 14 years for defibrillators, 16 years for heart-lung machines, and 13 years for ventilators. To introduce a uniform medical device replacement standard and life cycle calculation method, the government will need to reorganize the medical device replacement laws and systems. In addition, in the case of medical institutions, it is necessary to secure patient safety by using expert groups to prepare specific life cycle standards that consider the characteristics of medical devices.