Approval-adjusted recall rates of high-risk medical devices from 2002-2016 across food and drug administration device categories

Comeron W. Ghobadi, Timothy M. Janetos, Shelun Tsai, Leah J Welty, Jessica R. Walter, Shuai Xu

Research output: Contribution to journalArticle

Abstract

Between 2002 and 2016, 806 million medical devices were recalled. When approving a device, the FDA employs advisory boards organized by medical specialty (e.g. cardiovascular) to make approval recommendations. Previous work has demonstrated high numbers of recalled orthopedic and cardiovascular devices; however, no prior studies have controlled for the number of approvals by advisory board. The purpose of this study is to identify device fields at higher risk for safety problems. This study compares specialty-specific, approval-adjusted recall rates of high-risk medical devices from 2002 to 2016 by utilizing publicly available FDA data on recalls and approvals. Devices approved under general hospital (113), anesthesiology (98), and cardiovascular (98) advisory boards constituted 71% of all class I recalls. For devices approved via the more rigorous pre-market approval pathway, those under the purview of the general hospital (0.25 recalls/approval, 95% CI 0.15 - 0.41) advisory board had a significantly higher rate than average (p<0.05). For 510(k) cleared devices, microbiology (6.0 recalls/clearance, 95% CI 3.4 - 10.6), anesthesiology (0.04 recalls/clearance, 95% CI 0.03 - 0.04), general hospital (0.02 recalls/clearance, 95% CI 0.02 - 0.02), and cardiovascular (0.010 recalls/ clearance, 0.009 to 0.015) advisory boards had significantly higher recall rates than average (p<0.05). Future regulatory resources should be directed towards device areas and approval pathways that pose a higher risk for safety problems.

Original languageEnglish (US)
Pages (from-to)77-92
Number of pages16
JournalIssues in law & medicine
Volume34
Issue number1
StatePublished - Mar 1 2019

Fingerprint

United States Food and Drug Administration
Equipment and Supplies
General Hospitals
Anesthesiology
Device Approval
Safety
Microbiology
Orthopedics
Medicine

ASJC Scopus subject areas

  • Issues, ethics and legal aspects
  • Health Policy

Cite this

Ghobadi, Comeron W. ; Janetos, Timothy M. ; Tsai, Shelun ; Welty, Leah J ; Walter, Jessica R. ; Xu, Shuai. / Approval-adjusted recall rates of high-risk medical devices from 2002-2016 across food and drug administration device categories. In: Issues in law & medicine. 2019 ; Vol. 34, No. 1. pp. 77-92.
@article{098a0c6dfa5a4d5e9e13c0294aa81344,
title = "Approval-adjusted recall rates of high-risk medical devices from 2002-2016 across food and drug administration device categories",
abstract = "Between 2002 and 2016, 806 million medical devices were recalled. When approving a device, the FDA employs advisory boards organized by medical specialty (e.g. cardiovascular) to make approval recommendations. Previous work has demonstrated high numbers of recalled orthopedic and cardiovascular devices; however, no prior studies have controlled for the number of approvals by advisory board. The purpose of this study is to identify device fields at higher risk for safety problems. This study compares specialty-specific, approval-adjusted recall rates of high-risk medical devices from 2002 to 2016 by utilizing publicly available FDA data on recalls and approvals. Devices approved under general hospital (113), anesthesiology (98), and cardiovascular (98) advisory boards constituted 71{\%} of all class I recalls. For devices approved via the more rigorous pre-market approval pathway, those under the purview of the general hospital (0.25 recalls/approval, 95{\%} CI 0.15 - 0.41) advisory board had a significantly higher rate than average (p<0.05). For 510(k) cleared devices, microbiology (6.0 recalls/clearance, 95{\%} CI 3.4 - 10.6), anesthesiology (0.04 recalls/clearance, 95{\%} CI 0.03 - 0.04), general hospital (0.02 recalls/clearance, 95{\%} CI 0.02 - 0.02), and cardiovascular (0.010 recalls/ clearance, 0.009 to 0.015) advisory boards had significantly higher recall rates than average (p<0.05). Future regulatory resources should be directed towards device areas and approval pathways that pose a higher risk for safety problems.",
author = "Ghobadi, {Comeron W.} and Janetos, {Timothy M.} and Shelun Tsai and Welty, {Leah J} and Walter, {Jessica R.} and Shuai Xu",
year = "2019",
month = "3",
day = "1",
language = "English (US)",
volume = "34",
pages = "77--92",
journal = "Issues in Law and Medicine",
issn = "8756-8160",
publisher = "National Legal Center for the Medically Dependent and Disabled Inc",
number = "1",

}

Approval-adjusted recall rates of high-risk medical devices from 2002-2016 across food and drug administration device categories. / Ghobadi, Comeron W.; Janetos, Timothy M.; Tsai, Shelun; Welty, Leah J; Walter, Jessica R.; Xu, Shuai.

In: Issues in law & medicine, Vol. 34, No. 1, 01.03.2019, p. 77-92.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Approval-adjusted recall rates of high-risk medical devices from 2002-2016 across food and drug administration device categories

AU - Ghobadi, Comeron W.

AU - Janetos, Timothy M.

AU - Tsai, Shelun

AU - Welty, Leah J

AU - Walter, Jessica R.

AU - Xu, Shuai

PY - 2019/3/1

Y1 - 2019/3/1

N2 - Between 2002 and 2016, 806 million medical devices were recalled. When approving a device, the FDA employs advisory boards organized by medical specialty (e.g. cardiovascular) to make approval recommendations. Previous work has demonstrated high numbers of recalled orthopedic and cardiovascular devices; however, no prior studies have controlled for the number of approvals by advisory board. The purpose of this study is to identify device fields at higher risk for safety problems. This study compares specialty-specific, approval-adjusted recall rates of high-risk medical devices from 2002 to 2016 by utilizing publicly available FDA data on recalls and approvals. Devices approved under general hospital (113), anesthesiology (98), and cardiovascular (98) advisory boards constituted 71% of all class I recalls. For devices approved via the more rigorous pre-market approval pathway, those under the purview of the general hospital (0.25 recalls/approval, 95% CI 0.15 - 0.41) advisory board had a significantly higher rate than average (p<0.05). For 510(k) cleared devices, microbiology (6.0 recalls/clearance, 95% CI 3.4 - 10.6), anesthesiology (0.04 recalls/clearance, 95% CI 0.03 - 0.04), general hospital (0.02 recalls/clearance, 95% CI 0.02 - 0.02), and cardiovascular (0.010 recalls/ clearance, 0.009 to 0.015) advisory boards had significantly higher recall rates than average (p<0.05). Future regulatory resources should be directed towards device areas and approval pathways that pose a higher risk for safety problems.

AB - Between 2002 and 2016, 806 million medical devices were recalled. When approving a device, the FDA employs advisory boards organized by medical specialty (e.g. cardiovascular) to make approval recommendations. Previous work has demonstrated high numbers of recalled orthopedic and cardiovascular devices; however, no prior studies have controlled for the number of approvals by advisory board. The purpose of this study is to identify device fields at higher risk for safety problems. This study compares specialty-specific, approval-adjusted recall rates of high-risk medical devices from 2002 to 2016 by utilizing publicly available FDA data on recalls and approvals. Devices approved under general hospital (113), anesthesiology (98), and cardiovascular (98) advisory boards constituted 71% of all class I recalls. For devices approved via the more rigorous pre-market approval pathway, those under the purview of the general hospital (0.25 recalls/approval, 95% CI 0.15 - 0.41) advisory board had a significantly higher rate than average (p<0.05). For 510(k) cleared devices, microbiology (6.0 recalls/clearance, 95% CI 3.4 - 10.6), anesthesiology (0.04 recalls/clearance, 95% CI 0.03 - 0.04), general hospital (0.02 recalls/clearance, 95% CI 0.02 - 0.02), and cardiovascular (0.010 recalls/ clearance, 0.009 to 0.015) advisory boards had significantly higher recall rates than average (p<0.05). Future regulatory resources should be directed towards device areas and approval pathways that pose a higher risk for safety problems.

UR - http://www.scopus.com/inward/record.url?scp=85069261698&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85069261698&partnerID=8YFLogxK

M3 - Article

C2 - 31179672

AN - SCOPUS:85069261698

VL - 34

SP - 77

EP - 92

JO - Issues in Law and Medicine

JF - Issues in Law and Medicine

SN - 8756-8160

IS - 1

ER -