Regulatory leaders should make better use of available data during postapproval monitoring of medical devices, two researchers from the Ann Arbor-based University of Michigan Center for Healthcare Outcomes and Policy wrote in a JAMA analysis.
Andrew M. Ibrahim, MD, and Justin D. Dimick, MD, examined the rise and fall in popularity of laparoscopic gastric bands for treating morbid obesity. They concluded clinical trial data for medical devices are often flawed, necessitating a new approach to postapproval monitoring.
Here are four insights into postapproval monitoring challenges.
1. Limited data collection during clinical trials — due to insufficient sample size or follow-up time — may lead to arguably premature device approvals. In the case of the gastric band, reoperation costs exceeded trial predictions, accounting for nearly 39 percent of the $2.1 billion spent on postapproval device surgeries.
2. The FDA often relies on voluntary reporting for postapproval monitoring, which likely will not capture a significant portion of adverse effects.
3. The authors noticed the gastric band could be monitored by administrative claims data, which contained procedure codes for placement, revision and removal of the gastric band. However, postapproval monitoring has not sufficiently taken this data into account.
"In 2011, when the FDA was reassessing the safety of the gastric band, available data from clinical trials suggested that device reoperations rates were as low as 4 percent," the authors wrote. "In that same year, nationally representative administrative claims demonstrated that reoperations totaled more than 50 percent of annual spending on the device."
4. However, the majority of medical devices do not have unique administrative device identifiers.
"Legislation that would require all FDA-approved devices to be trackable within data that are already collected could be a useful strategy to help ensure that, unlike the gastric band, the warning signs of other widely adopted devices are not missed," the authors concluded.
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