Cardiac device creativity and innovation under constraints: Exploring trends from the food and drug administration's device clearances and recalls.

Autor: Cremers T; Temple University Lewis Katz School of Medicine, Philadelphia, PA, United States., Kashem A; Temple University Lewis Katz School of Medicine, Philadelphia, PA, United States., Zhao H; Temple University Lewis Katz School of Medicine, Philadelphia, PA, United States., Toyoda Y; Temple University Lewis Katz School of Medicine, Philadelphia, PA, United States., Mokashi S; Temple University Lewis Katz School of Medicine, Philadelphia, PA, United States. Electronic address: mokashis@tuhs.temple.edu.
Jazyk: angličtina
Zdroj: Current problems in cardiology [Curr Probl Cardiol] 2024 Nov; Vol. 49 (11), pp. 102781. Date of Electronic Publication: 2024 Aug 08.
DOI: 10.1016/j.cpcardiol.2024.102781
Abstrakt: Background: Medical device expenditures have increased in the 21st century, with cardiac devices comprising an outsized portion of the market. Meanwhile, the disproportionate share of FDA recalls of cardiac devices is often overshadowed. Using the FDA 510(k) premarket notification pathway and FDA recalls issued from 2000 to 2020, this project seeks to engage our understanding of innovation and recalls in the cardiac device space.
Methods: 510(k) premarket notification submission dates, outcomes, and recalls from 1/1/2000 to 12/31/2019 were obtained from publicly available FDA data as a function of cardiac device innovation. We compared the annual number of 510(k) premarket clearances and FDA recalls from 1/1/2000 to 12/31/2009 to 1/1/2010 to 12/31/2019.
Results: We found 343 moderate risk cardiac medical devices cleared for sale between the years 2000 and 2020. Comparing the last 10 years of the study period to the first, the yearly number of cleared devices decreased 39.7 %, from 21.4 to just 12.9 (p = 0.0019), defying positive trends in U.S. GDP and healthcare expenditures. Meanwhile, the number of FDA recalls issued for these devices increased 94.5 % from 7.3 to 14.2 recalls per year (p = 0.031). 215 device recalls were issued; 78 % Class II and 16 % Class I which constitute serious, potentially fatal recalls.
Conclusions: While United States healthcare spending continues to trend upward, there was a distinct decrease in the number of new and updated cardiac devices entering the market between 2000 and 2020. Meanwhile, recalls of these devices have uncomfortably increased. Together, these trends suggest cardiac device innovation has become risk averse.
Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2024 Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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