The medical device industry is touting a study it says debunks the Food & Drug Administration’s claims that there’s a safety benefit from the slower, more rigorous regulatory process in the U.S.
The conclusions are based on a new study, paid for by the Advanced Medical Technology Assn., that compares four years of recall data from U.S. and EU regulatory bodies.
The study, “EU Medical Device Approval Safety Assessment,” conducted by the Boston Consulting Group, matched four years of medical device recall data for the United Kingdom, Germany, Switzerland and Ireland and compared it with similar U.S. data. The report’s authors conclude that there is no material difference between the regulatory regimes in the U.S. and Europe, from a safety perspective.
“Differences between the two systems do not ultimately affect performance,” according to authors Scott Davis, Erik Gilbertson and Simon Goodall. “In addition, given the expectation that the EU approves more devices than the U.S., it is likely that the EU recall rate may actually be slightly lower than the U.S. rate.”
AdvaMed, the industry council for the American medical device industry, touted the results as yet more evidence that the U.S. is losing its leadership position in medical technology, primarily because of the allegedly burdensome FDA regulatory process.
“It’s well-documented that it takes longer to bring medical technology to market in the U.S. than it does in Europe. Today’s report suggests that the delay denies patients access to the most up-to-date treatments and cures without a corresponding increase in safety,” Advamed president and CEO Stephen J. Ubl said in prepared remarks.
But there still may be some wriggle room in AdvaMed’s claims that EU regulators are just as good at spotting dangerous devices as their American counterparts.
The BCG study’s authors admit that an apples-to-apples comparison of device recall data wasn’t possible, due to the de-centralized nature of the EU’s regulatory system and differences in terminology. And accurate data from France — one of the EU’s largest medical device markets — was not counted due to incomplete data.
The report also relied heavily on two recent studies in comparing the recall rates in the U.S. and Europe, rather than the FDA’s Medical and Radiation Emitting Device Recall database, because the Boston Group authors could match only 28 percent of their records to the FDA’s internal database.
One of those studies, conducted by Ralph Hall of the University of Minnesota, estimated a rate of recall of 0.45 percent for 510(k)-approved devices over 10 years. The other study, conducted by the Battelle Memorial Institute, estimated a rate of recall of 0.16 percent, based on the total number of 510(k) approvals since 1998.
Hall, the author of the Minnesota study, recently told Minnesota Public Radio that the FDA needs to be more cautious in its overhaul of the 510(k) program and is carrying out reforms without proper data.