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How to calculate the life cycle of high-risk medical devices for patient safety
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 manageme...
Autores principales: | , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Frontiers Media S.A.
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9515981/ https://www.ncbi.nlm.nih.gov/pubmed/36187681 http://dx.doi.org/10.3389/fpubh.2022.989320 |
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author | Seo, Gihong Park, Sewon Lee, Munjae |
author_facet | Seo, Gihong Park, Sewon Lee, Munjae |
author_sort | Seo, Gihong |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-9515981 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
spelling | pubmed-95159812022-09-29 How to calculate the life cycle of high-risk medical devices for patient safety Seo, Gihong Park, Sewon Lee, Munjae Front Public Health Public Health 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. Frontiers Media S.A. 2022-09-14 /pmc/articles/PMC9515981/ /pubmed/36187681 http://dx.doi.org/10.3389/fpubh.2022.989320 Text en Copyright © 2022 Seo, Park and Lee. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
spellingShingle | Public Health Seo, Gihong Park, Sewon Lee, Munjae How to calculate the life cycle of high-risk medical devices for patient safety |
title | How to calculate the life cycle of high-risk medical devices for patient safety |
title_full | How to calculate the life cycle of high-risk medical devices for patient safety |
title_fullStr | How to calculate the life cycle of high-risk medical devices for patient safety |
title_full_unstemmed | How to calculate the life cycle of high-risk medical devices for patient safety |
title_short | How to calculate the life cycle of high-risk medical devices for patient safety |
title_sort | how to calculate the life cycle of high-risk medical devices for patient safety |
topic | Public Health |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9515981/ https://www.ncbi.nlm.nih.gov/pubmed/36187681 http://dx.doi.org/10.3389/fpubh.2022.989320 |
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