Availability of Unique Device Identifiers for Class I Medical Device Recalls From 2018 to 2022-Reference-Cited by-同舟云学术

Availability of Unique Device Identifiers for Class I Medical Device Recalls From 2018 to 2022

Published:2023-07-01 Issue:7 Volume:183 Page:735
ISSN:2168-6106
Container-title:JAMA Internal Medicine
language:en
Short-container-title:JAMA Intern Med

Author:

Mooghali Maryam¹²,Ross Joseph S.¹²³,Kadakia Kushal T.⁴,Dhruva Sanket S.⁵⁶

Affiliation:

1. Section of General Internal Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut

2. Yale Collaboration for Regulatory Rigor, Integrity, and Transparency, Yale School of Medicine, New Haven, Connecticut

3. Center for Outcomes Research and Evaluation, Department of Health Policy and Management, Yale School of Public Health, Yale-New Haven Health System, New Haven, Connecticut

4. Harvard Medical School, Boston, Massachusetts

5. Section of Cardiology, Department of Medicine, University of California San Francisco School of Medicine, San Francisco

6. San Francisco Veterans Affairs Health Care System, San Francisco, California

Abstract

This cross-sectional study describes the inclusion of unique device identifier in recall notices for moderate- and high-risk medical devices in the US.

Publisher

American Medical Association (AMA)

Subject

Internal Medicine

Link

https://jamanetwork.com/journals/jamainternalmedicine/articlepdf/2804635/jamainternal_mooghali_2023_ld_230006_1687982078.52184.pdf

Reference6 articles.

1. Fulfilling the promise of unique device identifiers.;Dhruva;Ann Intern Med,2018

2. US Food and Drug Administration. Recalls background and definitions. Accessed February 2, 2023. https://www.fda.gov/safety/industry-guidance-recalls/recalls-background-and-definitions?

3. US Food and Drug Administration, Department of Health and Human Services. 21 CFR Parts 16, 801, 803, et al. Unique device identification system; final rule. Fed Regist. 2013;78(185):58786-58828. Accessed February 2, 2023. https://www.govinfo.gov/content/pkg/FR-2013-09-24/pdf/2013-23059.pdf

4. US Food and Drug Administration. Medical device recalls. Accessed February 2, 2023. https://www.fda.gov/medical-devices/medical-device-safety/medical-device-recalls

5. National Library of Medicine. AccessGUDID: identify your medical device. Accessed February 2, 2023. https://accessgudid.nlm.nih.gov

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1. Unique Device Identifiers for Medical Devices at 10 Years;JAMA Internal Medicine;2023-10-01

2. Unique Device Identifiers—Missing in Action;JAMA Internal Medicine;2023-10-01

3. Characterization of US Food and Drug Administration Class I Recalls from 2018 to 2022 for Moderate- and High-Risk Medical Devices: A Cross-Sectional Study;Medical Devices: Evidence and Research;2023-05