Balancing innovation and medical device regulation: the case of modern metal-on-metal hip replacements

Jason J Howard1,2 1Division of Orthopedic Surgery, Department of Surgery, Sidra Medical and Research Center, 2Department of Orthopedic Surgery, Weill Cornell Medical College, Doha, Qatar Abstract: Due to problems with wear particle generation and subsequent loosening using conventional metal-on-poly...

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Autor principal:	Howard JJ
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2016
Materias:	medical devices regulation safety and effectiveness metal-on-metal hip replacement Medical technology R855-855.5
Acceso en línea:	https://doaj.org/article/1f9c3f6732da49a48b3dfff02b464033
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spelling	oai:doaj.org-article:1f9c3f6732da49a48b3dfff02b4640332021-12-02T06:34:19ZBalancing innovation and medical device regulation: the case of modern metal-on-metal hip replacements1179-1470https://doaj.org/article/1f9c3f6732da49a48b3dfff02b4640332016-08-01T00:00:00Zhttps://www.dovepress.com/balancing-innovation-and-medical-device-regulation-the-case-of-modern--peer-reviewed-article-MDERhttps://doaj.org/toc/1179-1470Jason J Howard1,2 1Division of Orthopedic Surgery, Department of Surgery, Sidra Medical and Research Center, 2Department of Orthopedic Surgery, Weill Cornell Medical College, Doha, Qatar Abstract: Due to problems with wear particle generation and subsequent loosening using conventional metal-on-polyethylene total hip replacements, there has been a shift toward alternative bearing systems, including metal-on-metal (MoM), for younger, more active patients with degenerative joint disease. Based on positive results from early short-term clinical studies, MoM hip replacements were readily adopted by orthopedic surgeons with thousands being implanted worldwide over the past decade. Unacceptably high revision rates reported by two national joint registries called into question the rigorousness of the regulatory approval process for these implants, particularly with respect to premarket data requirements to prove safety, effectiveness, and the appropriateness of the regulatory pathway chosen. The purpose of this review was to investigate the balance between facilitating the introduction of new medical technologies and the need to ensure safety and effectiveness through comprehensive regulatory assessment. The case of MoM hip replacement devices was used to frame the investigation and subsequent discussions. The regulatory approval processes and post-market surveillance requirements associated with three common MoM hip replacements (two resurfacings: the Birmingham and articular surface replacement and the articular surface replacement XL total hip replacement) were investigated. With respect to modern MoM hip replacement devices, the balance between facilitating the introduction of these new medical technologies and the need to ensure safety and effectiveness through comprehensive regulatory assessment was not achieved. The lessons learned from these experiences have application beyond joint replacements to the introduction of new medical technologies in general, particularly for those who have a significant potential for harm. In this regard, a series of recommendations have been developed to contribute to the evolution of the medical device regulatory process. Keywords: medical devices, regulation, safety and effectiveness, metal-on-metal hip replacementHoward JJDove Medical Pressarticlemedical devicesregulationsafety and effectivenessmetal-on-metal hip replacementMedical technologyR855-855.5ENMedical Devices: Evidence and Research, Vol 2016, Iss Issue 1, Pp 267-275 (2016)
institution	DOAJ
collection	DOAJ
language	EN
topic	medical devices regulation safety and effectiveness metal-on-metal hip replacement Medical technology R855-855.5
spellingShingle	medical devices regulation safety and effectiveness metal-on-metal hip replacement Medical technology R855-855.5 Howard JJ Balancing innovation and medical device regulation: the case of modern metal-on-metal hip replacements
description	Jason J Howard1,2 1Division of Orthopedic Surgery, Department of Surgery, Sidra Medical and Research Center, 2Department of Orthopedic Surgery, Weill Cornell Medical College, Doha, Qatar Abstract: Due to problems with wear particle generation and subsequent loosening using conventional metal-on-polyethylene total hip replacements, there has been a shift toward alternative bearing systems, including metal-on-metal (MoM), for younger, more active patients with degenerative joint disease. Based on positive results from early short-term clinical studies, MoM hip replacements were readily adopted by orthopedic surgeons with thousands being implanted worldwide over the past decade. Unacceptably high revision rates reported by two national joint registries called into question the rigorousness of the regulatory approval process for these implants, particularly with respect to premarket data requirements to prove safety, effectiveness, and the appropriateness of the regulatory pathway chosen. The purpose of this review was to investigate the balance between facilitating the introduction of new medical technologies and the need to ensure safety and effectiveness through comprehensive regulatory assessment. The case of MoM hip replacement devices was used to frame the investigation and subsequent discussions. The regulatory approval processes and post-market surveillance requirements associated with three common MoM hip replacements (two resurfacings: the Birmingham and articular surface replacement and the articular surface replacement XL total hip replacement) were investigated. With respect to modern MoM hip replacement devices, the balance between facilitating the introduction of these new medical technologies and the need to ensure safety and effectiveness through comprehensive regulatory assessment was not achieved. The lessons learned from these experiences have application beyond joint replacements to the introduction of new medical technologies in general, particularly for those who have a significant potential for harm. In this regard, a series of recommendations have been developed to contribute to the evolution of the medical device regulatory process. Keywords: medical devices, regulation, safety and effectiveness, metal-on-metal hip replacement
format	article
author	Howard JJ
author_facet	Howard JJ
author_sort	Howard JJ
title	Balancing innovation and medical device regulation: the case of modern metal-on-metal hip replacements
title_short	Balancing innovation and medical device regulation: the case of modern metal-on-metal hip replacements
title_full	Balancing innovation and medical device regulation: the case of modern metal-on-metal hip replacements
title_fullStr	Balancing innovation and medical device regulation: the case of modern metal-on-metal hip replacements
title_full_unstemmed	Balancing innovation and medical device regulation: the case of modern metal-on-metal hip replacements
title_sort	balancing innovation and medical device regulation: the case of modern metal-on-metal hip replacements
publisher	Dove Medical Press
publishDate	2016
url	https://doaj.org/article/1f9c3f6732da49a48b3dfff02b464033
work_keys_str_mv	AT howardjj balancinginnovationandmedicaldeviceregulationthecaseofmodernmetalonmetalhipreplacements
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Balancing innovation and medical device regulation: the case of modern metal-on-metal hip replacements

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