Information Disclosure, Medical Device Regulation, and Device Safety: The Case of Cook Celect IVC Filters.

Autor:	Kadakia KT; Harvard Medical School, Boston, Massachusetts (K.T.K.)., Bikdeli B; Center for Outcomes Research and Evaluation, Yale New Haven Hospital, New Haven, Connecticut; Cardiovascular Medicine Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts; and Thrombosis Research Group, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts (B.B.)., Gupta A; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California (A.G.)., Dhruva SS; Philip R. Lee Institute for Health Policy Studies, University of California, San Francisco, and Section of Cardiology, Department of Medicine, San Francisco Veterans Affairs Medical Center, San Francisco, California (S.S.D.)., Ross JS; Center for Outcomes Research and Evaluation, Yale New Haven Hospital; Section of General Internal Medicine and the National Clinician Scholars Program, Department of Internal Medicine, Yale School of Medicine; and Department of Health Policy and Management, Yale School of Public Health, New Haven, Connecticut (J.S.R.)., Krumholz HM; Center for Outcomes Research and Evaluation, Yale New Haven Hospital; Department of Health Policy and Management, Yale School of Public Health; and Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut (H.M.K.).
Jazyk:	angličtina
Zdroj:	Annals of internal medicine [Ann Intern Med] 2024 Dec; Vol. 177 (12), pp. 1711-1718. Date of Electronic Publication: 2024 Nov 19.
DOI:	10.7326/ANNALS-24-00089
Abstrakt:	Although medical devices are widely used in clinical practice, clinicians and the public have limited access to information on how devices are tested, regulated, and used, posing challenges to patient safety. This article uses Cook Medical's Celect inferior vena cava (IVC) filter, a medical device used for prevention of pulmonary embolism, as a case study of the transparency gap in medical device regulation. Recently unsealed court documents from litigation related to Celect reveal that the device's clinical study protocol did not follow U.S. Food and Drug Administration (FDA) guidance for IVC filter testing and that study outcome definitions for IVC perforation had lower sensitivity for detecting adverse events than those recommended by professional societies. Furthermore, a comparison of court documents and the public record indicates that adverse events and patient deaths were misreported to FDA reviewers and were inaccurately reported in the published literature and on the device label, providing patients and clinicians with inaccurate information about the device's safety. The Celect IVC filter case demonstrates the need for regulatory reforms to ensure that critical safety data are accessible to the FDA, clinicians, and patients to inform decision making. Competing Interests: Disclosures: Disclosure forms are available with the article online.
Databáze:	MEDLINE
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