March 2, 2021

Study Calls Approval Process for Medical Devices Flawed

The government’s system for regulating many medical devices should be abandoned and replaced because it fails to examine their safety and effectiveness before sale, according to one of the nation’s top scientific groups.

In a report, released Friday, a panel of the Institute of Medicine found that the existing rules were never intended to provide safeguards for screening out dangerous or ineffective products. The panel urged the Food and Drug Administration to devise a new regulatory system for the so-called moderate risk devices — a category that now includes artificial hips, external heart defibrillators and hospital pumps — because the current system 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 Institute of Medicine and a lawyer who has worked closely with device producers.

The report, which was commissioned by the F.D.A., follows a number of recalls of medical devices, like one involving so-called metal-on-metal artificial hips that have failed in thousands of patients, crippling some of them. Those implants received little, if any, testing in patients prior to being implanted in tens of thousands of people.

The report’s findings are certain to touch off an intense lobbying battle over the shape of any future regulations, as device companies moved quickly to attack the study’s findings. Even before the report’s release, allies of the industry had waged an aggressive campaign to discredit it, and had taken legal steps intended to bar the F.D.A. from adopting its recommendations.

Soon after the study’s release, the country’s biggest trade group, the Advanced Medical Technology Association, which represents such industry giants as Medtronic, Boston Scientific and Johnson Johnson, unequivocally rejected the report, saying it did not deserve “serious consideration” from Congress or the Obama administration.

Abandoning the current approval system “would be a disservice to patients and the public health,” the group’s chief executive, Stephen J. Ubl, said in a prepared statement.

Dr. David Challoner, who served as the panel’s chairman, said that members of the group were stunned when they realized that the current system could not be salvaged. The F.D.A. had asked to panel to examine what modifications to current regulations might be useful.

“We surprised ourselves,” Dr. Challoner said.

Dr. Jeffrey E. Shuren, the director of the F.D.A.’s Center for Devices and Radiological Health, said in a statement that many of the report’s findings “parallel changes already under way at the F.D.A. to improve how we regulate devices.” He said he did not believe the existing regulatory system should be scrapped, adding that any significant changes would have to be approved by Congress. The Institute of Medicine review covered the approval system for a wide range of moderate-risk products, known as the 510(k) clearance process. It did not examine devices that carry the highest risk to patients if they fail, like implanted heart defibrillators. Those products go through a separate regulatory pathway that requires extensive testing before sale.

The big problem, the study found, is that the Congressional law that created the 510(k) pathway, the Medical Device Amendments of 1976, required producers of such products only to show that they were “substantially equivalent,” or similar, to one already on the market.

The standard does not require a producer to show that a new device is safe or effective, or even to provide evidence that an earlier device on which a new application is based works well.

The committee’s report emphasized that its members believed most medical devices in use were safe and beneficial. But it added that the existing regulatory system made it impossible to identify problematic or useless ones.

“The committee concludes that the 510(k) process lacks the legal basis to be a reliable premarket screen of the safety and effectiveness” of moderate-risk devices, the report concluded, adding, “Furthermore, that it cannot be transformed into one.” The panel concluded that the F.D.A. should act quickly to determine whether artificial joints, such as hips, which are currently approved through the 510(k) process, should have to undergo the type of rigorous scrutiny that high-risk devices now go through prior to sale.

A small industry trade group, the Medical Device Manufacturers Association, also issued a release saying it was “concerned about efforts to overhaul a regulatory pathway that would create additional uncertainties and slow patient access to medical therapies.”

Among other recommendations, the report also urged the F.D.A. to quickly tighten the way it tracked the performance of implanted devices and other products once on the market, and said the agency needed to move more quickly to stop the sales of harmful ones.

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. More recently, they have criticized the Institute of Medicine’s review as biased.

Last month, the Washington Legal Foundation, a pro-business group, filed a petition with the F.D.A. arguing that the agency was statutorily barred from adopting any of the report’s recommendations because of what it claimed was the panel’s bias.

The legal foundation argued that the Institute of Medicine, which is part of the National Academy of Sciences, had failed to balance the panel by including officials from the device industry, the investment community or patients who had benefited from devices. An F.D.A. official said the agency was happy with the panel’s composition, which included doctors, academics and three lawyers, included two who worked closely with the industry.

The report on Friday addressed several complaints by the industry on possible new regulation, including the claim that toughened rules would slow the introduction of innovative products that could benefit patients.

The panel said there was no way of assessing, based on a review of available evidence, whether current regulations were having either a positive or a negative effect on innovation. The group, however, recommended that the F.D.A. assemble a group to review the issue.

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