Premarket research not conducted for many CV devices subject to class I recall
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Key takeaways:
- Less than 20% of recalled CV devices underwent premarket clinical testing, most of which were premarket approval devices.
- Despite FDA requirements, postmarket surveillance was infrequent.
Many recently recalled cardiovascular devices did not undergo premarket testing prior to FDA approval, and postmarket studies of the devices were slow and infrequent, researchers reported.
The results of a cross-sectional analysis to evaluate the rigor of premarket and postmarket studies of CV devices recalled from 2013 to 2022 were published in the Annals of internal Medicine.
“Safety concerns sometimes arise once devices are in clinical use, particularly as devices are used in more patients and with longer follow-up than during premarket testing. When safety issues arise, devices may be voluntarily recalled by manufacturers or the FDA,” Claudia See, MD, MBA, of the department of medicine at the University of California, San Francisco, and colleagues wrote. “Although only 1% of FDA-authorized devices are subject to class I recalls, these recalls affect millions of patients and take years to resolve.
“Cardiovascular devices are the most common device type subject to class I recalls, accounting for approximately one-third,” the researchers wrote. “It is unknown what evidence of safety and effectiveness was available for recalled cardiovascular devices upon market entry or if the FDA required specific safety monitoring of these devices in clinical practice. With device recalls attracting increasing scrutiny from clinicians and policymakers, such information could help inform efforts to advance patient safety.”
The researchers conducted the present analysis to identify clinical and regulatory characteristics of CV devices with designated class I recalls from 2013 through 2022.
An FDA-designated class I recall is considered the most serious type of recall, as it means the agency has determined that use of the device or system may cause injury or death.
Trends in CV device recalls
Researchers used the FDA Medical Device Recalls database to identify 137 FDA class I recalls affecting 157 unique CV devices between 2013 and 2022, 26.8% of which had multiple class I recalls. Each recalled device represented 953 to 28,446 individual units distributed.
In addition, the number of reported safety events before the class I recall was initiated ranged from six to 54 complaints.
Of the recalled devices, 71.3% were moderate-risk 510(k) devices, 28.7% were high-risk premarket approval devices and 31.4% of all recalls were attributed to device design, the most common reason for recall, according to the analysis.
Overall, 19.1% of recalled CV devices underwent premarket clinical testing, including 6.2% of 510(k) devices, 85% of premarket approval devices and 24% of premarket approval supplement devices.
Eighty percent of device trials used surrogate measures as primary endpoints and 70.6% used composite primary endpoints.
Moreover, 22 (48.9%) of the recalled premarket approval devices were required by the FDA to undergo postapproval study, 14 of which had reporting delays. No 510(k) CV devices were required to undergo postmarket surveillance.
“Cardiovascular devices with class I recalls were infrequently subjected to premarket or postmarket testing, with recalls affecting thousands of patients annually,” the researchers wrote. “These findings illustrate the limited clinical evidence supporting the use of cardiovascular devices later found to have serious safety concerns.”
Treat devices ‘more like drugs’
In a related editorial, Ezekiel J. Emanuel, MD, PhD, of the department of medical ethics and health policy at the Healthcare Transformation Institute at the Perelman School of Medicine and department of health care management at Wharton School, University of Pennsylvania, discussed these “sobering” results.
“If there are limitations of See and colleagues’ analysis it is that it does not go far enough,” Emanuel wrote. “If the FDA applied the same logic it uses to regulate devices to drugs, it could be argued that one statin is substantially equivalent to another statin or one PD-1 inhibitor is substantially equivalent to another. But the FDA does not accept this chain of reasoning for drugs. Being a ‘me-too’ drug does not permit the skipping of phase 1, 2 and 3 of clinical testing, while being a ‘me-too’ device usually does.
“See and colleagues’ assessment of device regulation is sobering and reminds us that device regulation should emulate drug regulation,” he wrote. “For all its limitations, drug regulation is more standardized, has greater reliance on the accumulation of substantial, controlled clinical research, with equivalent evidentiary requirements for ‘me-too’ drugs. Devices need to be treated more like drugs and postmarket surveillance of both drugs and devices should become routine.”
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