Medical-device makers are slow to complete studies on the safety and effectiveness of medical devices such as pacemakers, heart valves and stents after the products enter the market. Some studies are never completed at all.
Researchers reviewed post-market clinical studies for more than two dozen high-risk medical devices introduced in 2010 and 2011. The majority weren't finished. That included 33 marketplace studies that the Food and Drug Administration required when it approved the devices.
The findings, published last week in JAMA, add to other study results that raise concerns about the quality of clinical research required by regulators for high-risk devices. The concerns come as Congress debates new legislation known as the 21st Century Cures Act, which has been criticized for relaxing safety standards for medical devices by allowing less rigorous evaluation before approval. Device manufacturers have praised the House-passed legislation for its potential to make the path to market for new products faster and less expensive.
Of the 33 marketplace studies required by the FDA, researchers identified six that had been completed as of October last year. Out of another 171 studies launched by manufacturers after devices entered the market, 20 had yielded results.
An FDA spokeswoman said some studies require more than the three to five years included in the JAMA analysis. The FDA uses additional sources to monitor safety, she added, including adverse-event reporting and disease registries.
But the lack of results leaves doctors and patients with only the safety information from studies done before the devices were approved. Those studies are often small and limited in duration, and they don't always employ randomized, controlled trials, said Dr. Joseph Ross of Yale University, one of the new study's four authors. Once devices are “out in the world, being used by thousands upon millions of people,” more safety information can be collected to inform doctors' and patients' choices, he said.
Timely results are critically important because devices are often replaced with newer versions after five to seven years. “The newest, greatest stent or defibrillator or hip is replaced by the next one in the world of medical-device technology,” and research becomes obsolete, Ross said.
The 21st Century Cures Act would increase dependence on post-market studies. The bill would “truncate” device approval, Dr. Aaron Kesselheim and Dr. Jerry Avorn of Harvard University wrote in the New England Journal of Medicine. Manufacturers would be able to win FDA approval with results from case studies and registries rather than clinical trials.
“That's going to increase risk to patients,” Kesselheim said in an interview. “You'll increase the risk of unsafe or ineffective devices being widely used in patients.”
