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Study Faults Approval Process for Medical Devices


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 Friday by one of the nation’s top scientific groups.

An artificial hip. A study said they should be monitored before and after they are sold.

One component of an all-metal artificial hip.

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.

Even before the report’s release, allies of industry had waged an aggressive campaign to discredit it, and had taken legal steps intended to bar the F.D.A. from accepting its recommendations.

On Friday, a trade group that represents device industry giants like Medtronic, Boston Scientific and Johnson & Johnson dismissed the report, saying it did not deserve serious consideration from Congress or the Obama administration.

“This would be a disservice to patients and the public health,” Stephen J. Ubl, the head of that group, the Advanced Medical Technology Association, said in a statement.

For their part, patient groups and some doctors applauded the panel’s finding, saying that it was urgent to create a system that examined a device’s benefits and harms before large numbers of patients were exposed to it. Dr. Gregory D. Curfman, the executive editor ofThe New England Journal of Medicine, a leading publication, called the study “path-breaking in its conclusions.”

F.D.A. officials appeared to be caught off-guard. In 2009, the agency had asked the Institute of Medicine to undertake the study to examine specific procedures that the agency might employ to strengthen one of the regulatory pathways that it uses to approve medical devices. Instead, it got a report that determined the system’s legal underpinning was hopelessly flawed.

The study reviewed a system known as the 510(k) clearance process under which moderate-risk products are approved by the F.D.A. The study 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 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.

The committee’s report emphasized that its members believed most medical devices in use were safe and beneficial. But the panel concluded that existing rules had created a daisy-chain system of regulation, in which new devices simply piggy-back on earlier ones, without any examination of their safety or their value to patients.

“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.” Dr. Jeffrey E. Shuren,  the director of the F.D.A. Center for Devices and Radiological Health, said in a statement that he did not believe the existing regulatory system should be scrapped, adding that any significant changes would have to be approved by Congress.  He added that the agency was already making changes to improve the 510(k) review process.

“FDA believes that the 510(k) process should not be eliminated but we are open to additional proposals and approaches for continued improvement of our device review programs,” Dr. Shuren said in a statement.

The panel also concluded in its report that the F.D.A. should act quickly to determine whether artificial joints, like 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 before sale. In other recommendations, the report urged the F.D.A. to quickly tighten the way it tracked the performance of devices once they are on the market, and said the agency needed to move more rapidly 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.

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, claiming the panel was biased because it did not include industry officials, investors or patients who had benefited from devices. The report on Friday addressed several other 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 panel, however, recommended that the F.D.A. assemble a group to review the issue.

Dr. David R. Challoner, who served as the panel’s chairman, said that its members were stunned when they realized that the current system could not be salvaged. “We surprised ourselves,” he said.

  • Barry Meier – Study of Medical Device Rules Is Attacked, Unseen (earlsview.com)
  • Study Faults Approval Process for Medical Devices (nytimes.com)
  • Study of Medical Device Rules Is Attacked, Unseen (nytimes.com)
  • Report on medical-device rules attacked sight unseen (seattletimes.nwsource.com)
  • Panel Calls for Rewrite of Medical Device Rules (news.sciencemag.org)
  • 510(k) reforms: FDA downplays the impact of the IOM study on the eve of its release (earlsview.com)
  • U.S. advisers call for overhaul of FDA device approval process (msnbc.msn.com)
  • Panel says medical device review system ‘flawed’ (cbc.ca)
  • Medical-device review system doesn’t do its job, FDA told (seattletimes.nwsource.com)
  • FDA Should Abandon Approval Process: Experts (abcnews.go.com)
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