How to calculate the life cycle of high-risk medical devices for patient safety

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.

The High Price of Equity in Pulse Oximetry: A cost evaluation and need for interim solutions

“…Such disparities contribute to increased morbidity and mortality among patients of color, a pressing issue that cannot be relegated to the lengthy timelines associated with natural equipment replacement cycles. 9 Our analysis reveals that full equipment overhaul is neither cost-effective nor timely, thereby mandating prioritized attention at federal and industry levels for alternative solutions.…”

In‐house virtual surgical planning and guided mandibular reconstruction is less precise, but more economical and time‐efficient than commercial procedures

“…The regulatory environment for medical devices, such as those used in VSP and guided mandibular reconstruction, plays a critical role in ensuring patient safety and procedural efficacy. 31,32 The European Union (EU) and the United States have adopted specific guidelines and regulations for medical devices to ensure strict standards of safety and effectiveness. 33,34 These regulations are essential to the approval and use of VSP tools, as they help to standardize and harmonize the quality and performance of these products, 32 but also make it difficult to use in-house planning solutions.…”

“…However, it should be noted that freehand mandibular reconstruction is rarely performed in clinics today, and a planning procedure such as that presented by Rommel et al is difficult to implement due to changes in Medical Device Act. The regulatory environment for medical devices, such as those used in VSP and guided mandibular reconstruction, plays a critical role in ensuring patient safety and procedural efficacy 31,32 . The European Union (EU) and the United States have adopted specific guidelines and regulations for medical devices to ensure strict standards of safety and effectiveness 33,34 .…”