A new analysis finds longer regulatory review times for high-risk cardiovascular medical devices to be associated with fewer adverse event reports, and a lower likelihood of such reports citing serious injury or death.
The analysis, published in Nature Biomedical Engineering on Friday, raises questions about the trade-offs between speeding access to new devices and ensuring their safety.
Specifically, the authors looked at the number of adverse events reported to the US Food and Drug Administration (FDA) for high-risk cardiovascular devices approved from 2000-2010 in the first four years after approval.
According to the authors, high-risk cardiovascular devices showcase the balance between patient access and a thorough regulatory review, as such devices "are typically life-saving yet represent both the largest fraction of reported adverse events for high-risk devices and the largest share of the FDA's highest-risk recalls."
Based on their analysis, the authors say they found a statistically significant negative correlation between the length of review by FDA and whether a device would have adverse events reported, as well as how frequent and serious those reports were.
"We found that devices that experienced longer periods of regulatory review were less likely to be involved in both overall safety reports and the most severe post-market safety reports, even when controlling for other factors expected to be correlated with product risk," the authors write.
However, only 48 of the 106 devices identified were found to have adverse events reported to FDA's Manufacturer and User Facility Device Experience (MAUDE) database, which the authors attribute to underreporting. For the devices that had adverse events reported, the authors identified 8,721 unique adverse event reports. Of these, 1,026 involved product malfunctions, 1,681 involved patient injury, and 243 cited patient deaths.
Access vs. Safety
In the US, FDA is often criticized for being slow to approve new devices compared to the EU.
However, the standard for marketing devices differs significantly between the US and EU. In the US, device makers must demonstrate reasonable assurance of safety and effectiveness, whereas in the EU devices must demonstrate they are likely to be safe and will perform as intended.
While recent US efforts such as the 21st Century Cures Act , FDA's device priority review and expedited access programs, as well as the agency's plan to establish a National Evaluation System for Health Technology (NEST) have sought to speed access to new and innovative devices, policymakers in the EU have looked to increase the oversight of high-risk devices after high-profile safety issues such as the PIP breast implants scandal.
"Paradoxically, in light of regulatory evidence from the European Union, policymakers in the United States continue to advocate for the expedited regulatory review of more devices, which would increasingly shift part of the safety assessment of many new devices towards the postmarket period," the authors write.
However, in order for such a system to assure patient safety, the authors say there must be an increased emphasis on device safety surveillance and adverse event reporting.
Review times and adverse events for cardiovascular devices