The government’s system for approving medical devices has come under fire in a recent study by the Institute of Medicine. The study recommends the current process be scrapped because it is not protecting consumers. This was detailed in a recent article in the New York Times. Here are excerpts:
The government’s system for regulating many medical devices like artificial hips should be abandoned and replaced because it fails to examine their safety and effectiveness before sale, according to a report released by one of the nation’s top scientific groups.
The report’s unequivocal recommendation to scrap the current system was unexpected, and it unleashed reactions ranging from outright rejection by industry officials, an embrace by patient groups and seeming disbelief from federal regulators, who had commissioned the review.
The report by the Institute of Medicine follows several recalls of medical devices in recent years, like one involving so-called metal-on-metal hip replacements used in thousands of patients, crippling some of them. In its report, the panel found that existing rules used to approve many devices were never intended to play the critical role of screening out dangerous or ineffective products.
The panel urged the Food and Drug Administration to devise a new approval system for so-called moderate-risk devices — a category that now includes artificial hips, external heart defibrillators and hospital pumps — concluding that the current one was not fixable.
“If you want to make sure that a product is safe and effective, you have to start by asking the question whether it is safe and effective,” said William Vodra, a member of the 12-person panel assembled by the Institute of Medicine and a lawyer who has worked closely with device producers.
The Institute of Medicine, a part of the National Academy of Sciences, is a widely respected organization that is asked to review many complex public health issues. It is not immediately clear what impact, if any, the report will have or how its findings can be adopted; the recommendations are only advisory to the F.D.A. But at a minimum it quickly defined the boundaries of what is likely to be a high-powered Washington lobbying battle in coming months over the outlines of future device regulation.
The big problem, the study found, is that the federal law that created the 510(k) pathway, the Medical Device Amendments of 1976, required the makers of those products only to show that they were “substantially equivalent,” or similar, to one already on the market.
In many ways, the report is a rebuke to the medical device industry and its allies, who have been waging a campaign over the last year to dispute the need for any new regulations.