JAMA: High-risk devices come with minimal safety studies

Amid growing pushback over the FDA's regulation of medical devices, a new study shows that many high-risk therapeutic devices that get the agency's approval have limited studies proving their safety and efficacy.

Researchers looked at the 28 high-risk devices approved in 2010 and 2011 through the FDA's Premarket Approval pathway, using ClinicalTrials.gov, a publicly accessible database, to track clinical studies for the products before and after they hit the market. Regulators used roughly one study per device to determine whether to grant marketing approval, the researchers found, and there were 33 FDA-required postmarket studies for the 28 products.

Five devices did not have any postmarket studies, and another 13 products had three or fewer postmarket analyses, according to study results published in a recent issue of the Journal of the American Medical Association (JAMA). And only 6 of the required 33 studies had been completed as of October 2014.

Joseph Ross

The numbers mark a stark difference in how devices are regulated in the U.S. and abroad, Dr. Joseph Ross, senior author on the study and a professor at Yale School of Medicine, told Reuters. While device regulation in the U.S. "is well known to be more rigorous than in other parts of the world," there still is no comprehensive way to review evidence for high-risk devices, Ross said, as quoted by the news outlet.

The U.K. allows devices onto the market more quickly but follows the products once they hit the market. But the U.S. does not have the same kind of system in place to track devices and record problems, he added, a potential setback to ensuring the products' safety.

The findings also come as lawmakers, regulators and experts look for better ways to monitor medical devices. Some have suggested using a unique device identifier code for each device to make them easier to track once they're approved, or including each implantable device in searchable records. But "there's not a one size fits all policy" when it comes to regulating the devices, Dr. Josh Rising, director of healthcare programs at the Pew Charitable Trusts, who was not involved with the study, told Reuters. "The FDA needs to look at each device that comes through and assess what's going to be needed," he said.

- here's the JAMA study abstract
- read the Reuters story