Research: Evaluation of Orthopedic Hip Device Recalls by the FDA from 2007 to 2017.

Databases, Factual Device Approval Medical Device Recalls United States United States Food and Drug Administration

Journal

Biomedical instrumentation & technology
ISSN: 0899-8205
Titre abrégé: Biomed Instrum Technol
Pays: United States
ID NLM: 8905560

Informations de publication

Date de publication:
01 Nov 2020
Historique:
entrez: 18 12 2020
pubmed: 19 12 2020
medline: 6 1 2021
Statut: ppublish

Résumé

Medical device recalls have increased in the previous two decades. Orthopedic devices are estimated to constitute 12% of all medical devices recalled. Medical devices enter the market via the Food and Drug Administration's (FDA's) premarket approval (PMA) or 510(k) pathways. This article evaluates orthopedic hip device recalls between Jan. 1, 2007, and Dec. 31, 2017. We hypothesized that the 510(k) approval process would have substantially higher recall rates for defective devices. The FDA's device recall database was queried for all orthopedic hip devices from Jan. 1, 2007, to Dec. 31, 2017. Each recall included product description, recall number, device class, date of recall posting, date of recall termination, manufacturer, FDA-determined cause for recall, number of recalled units, distribution, product classification, and method of approval [510(k), PMA, or unspecified]. In total, 774 orthopedic hip devices were recalled between Jan. 1, 2007, and Dec. 31, 2017. The 510(k) approval process constituted 85% of hip device recalls. The most common FDA-determined cause of hip device recalls was device design, which constituted 37% of 510(k)-approved device recalls but only 6% of PMA-approved device recalls. The most recalled hip devices were hip prostheses. Orthopedic hip device recalls have shown a decrease of about 10 recalls per year during the 11-year period of analysis. Devices approved through the 510(k) process, compared with the PMA process, were more likely to be recalled for design defects. Although device design is the most common reason for device recall, many recalls are due to suboptimally standardized processes (e.g., packaging, process controls, device labeling). Overall, orthopedic hip device recalls decreased during the period of analysis (2007-17).

Sections du résumé

BACKGROUND BACKGROUND
Medical device recalls have increased in the previous two decades. Orthopedic devices are estimated to constitute 12% of all medical devices recalled. Medical devices enter the market via the Food and Drug Administration's (FDA's) premarket approval (PMA) or 510(k) pathways. This article evaluates orthopedic hip device recalls between Jan. 1, 2007, and Dec. 31, 2017. We hypothesized that the 510(k) approval process would have substantially higher recall rates for defective devices.
METHODS METHODS
The FDA's device recall database was queried for all orthopedic hip devices from Jan. 1, 2007, to Dec. 31, 2017. Each recall included product description, recall number, device class, date of recall posting, date of recall termination, manufacturer, FDA-determined cause for recall, number of recalled units, distribution, product classification, and method of approval [510(k), PMA, or unspecified].
RESULTS RESULTS
In total, 774 orthopedic hip devices were recalled between Jan. 1, 2007, and Dec. 31, 2017. The 510(k) approval process constituted 85% of hip device recalls. The most common FDA-determined cause of hip device recalls was device design, which constituted 37% of 510(k)-approved device recalls but only 6% of PMA-approved device recalls. The most recalled hip devices were hip prostheses. Orthopedic hip device recalls have shown a decrease of about 10 recalls per year during the 11-year period of analysis.
CONCLUSION CONCLUSIONS
Devices approved through the 510(k) process, compared with the PMA process, were more likely to be recalled for design defects. Although device design is the most common reason for device recall, many recalls are due to suboptimally standardized processes (e.g., packaging, process controls, device labeling). Overall, orthopedic hip device recalls decreased during the period of analysis (2007-17).

Identifiants

DOI: 10.2345/0899-8205-54.6.418 PMID: 33339030
pubmed: 33339030
pii: 449920
doi: 10.2345/0899-8205-54.6.418
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

418-426

Informations de copyright

© Copyright AAMI 2020. Single user license only. Copying, networking, and distribution prohibited.

Auteurs

Wesley Peters (W)

Carl Pellerin (C)

Cory Janney (C)

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Classifications MeSH

questionsmedicales.fr › Sciences de l'information › Mémorisation et recherche des informations › Bases de données comme sujet › Bases de données factuelles › Research: Evaluation of Orthopedic Hip Device...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Sécurité des produits de consommation › Agrément de dispositif › Research: Evaluation of Orthopedic Hip Device...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Sécurité des produits de consommation › Rappels et retraits de produits › Rappels de dispositifs médicaux › Research: Evaluation of Orthopedic Hip Device...
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