Most cardiovascular devices recalled between 2013 and 2022 lacked premarket clinical testing and postmarket surveillance, new research finds.
Summary: A cross-sectional study published in Annals of Internal Medicine found that most cardiovascular devices subject to Class I recalls between 2013 and 2022 were approved without premarket clinical testing or postmarket surveillance. The study analyzed 137 recall events involving 157 unique devices and found that only 19% had undergone clinical trials before approval, with most trials being nonrandomized and unblinded. The lack of rigorous testing raises concerns about the safety and effectiveness of these devices, which impact thousands of patients annually.
Three key takeaways:
- The study found 71% of recalled devices were moderate-risk 510(k) devices, and 28% were high-risk premarket approval devices.
- Only 19% of the recalled devices underwent premarket clinical testing, often lacking sufficient evidence for their original authorization.
- Researchers emphasize the public health implications due to the significant safety concerns affecting thousands of patients.
A cross-sectional study of cardiovascular devices subject to Class I recalls from 2013 through 2022, found that most recalled devices did not undergo clinical testing before authorization and were not required to undergo postmarket surveillance studies.
Even when premarket clinical testing was conducted, there was often a lack of evidence to support their original authorization. Researchers say these findings have important public health implications because recalls affect thousands of patients each year.
The study is published in Annals of Internal Medicine.
Recalled Cardiovascular Devices
Researchers from Harvard Medical School, Yale School of Medicine, and the University of California, San Francisco performed a cross-sectional analysis of all Class I recalls involving cardiovascular devices from 1 January 2013 through December 2022 using data from the US Food and Drug Administration’s annual log to characterize the device recalls and the clinical evidence supporting their initial authorization.
The researchers found that there were 137 Class I recall events affecting 157 unique cardiovascular devices during the study timeframe. About 71% of the recalls were for moderate-risk 510(k) devices and about 28% were for high-risk premarket approval devices.
Only about 19% of the recalled devices underwent premarket clinical testing, and evidence was usually generated from a single nonrandomized, unblinded clinical trial using surrogate measures with no active control.
According to the study authors, these findings illustrate the limited clinical evidence supporting the use of cardiovascular devices later found to have serious safety concerns.
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