A disproportionate number of medical devices recalled because of possible links to serious health problems or deaths — including external defibrillators and insulin infusion pumps — were approved under an abbreviated process that did not require advance testing on patients, according to a five-year study of such recalls.
More than 70% of the 113 recalled devices were cleared for market under a shorter Food and Drug Administration review because they were deemed similar to products already on the market, the study found.
Cardiovascular devices, chiefly external defibrillators, made up nearly a third of the recalled medical products from 2005 through 2009, the time covered by the review. A 2006 study linked defibrillator failure to more than 300 deaths over a 10-year period.
Only 21 of the recalls in the new study involved products approved after clinical trials. Eighty had been approved under the shorter process. Eight were exempt from FDA regulations, and four were counterfeit or categorized as "other."
The findings, published Monday in the Archives of Internal Medicine, showed that a recent update of the FDA's abbreviated review process, known as 510(k), was inadequate, said Diana Zuckerman, one of the study's coauthors.
Medical device companies have stretched the notion of "similar" far beyond regulators' intention when the law went on the books in 1976, said Zuckerman, president of the National Research Center for Women & Families. "The law has gotten looser and looser over time."
The FDA should increase the number of devices subject to the stricter review, known as pre-market approval, or devise an intermediate category with more rigor than the 510(k) process, said Steven Nissen, a Cleveland Clinic cardiologist and a study coauthor.
The findings buttress a 2009 Government Accountability Office report that dozens of high-risk devices did not meet the legal standard for abbreviated review, Nissen said.
The FDA is evaluating high-risk products approved through its abbreviated process to see whether they should be subject to more rigorous oversight, agency spokeswoman Karen Riley said in a statement.
The study is the latest chapter in a bitter debate between device makers and public health advocates. In August, the FDA released a draft of new rules that added stricter requirements to the shorter process.
Stephen Ubl, chief executive of the Advanced Medical Technology Assn., said the study was "fundamentally flawed" because "it focuses on the total number of recalls and ignores the fact that there are over 50,000 devices on the market."
Ubl pointed to other recent studies showing that the percentage of products recalled for serious health problems or deaths was tiny — less than half of 1 percentage point.
Nissen criticized that logic, saying the public would never regard that percentage of failures as acceptable in other endeavors with inherent risk, such as air travel. "I think we need to do better," he said.
Ubl said the device approval process lacked predictability and consistency and suffered from "declining FDA performance" in carrying out timely product reviews.
Stricter rules would stall innovation and force device makers to shift product development abroad, where approvals are faster, he said.
The FDA last month seemed to take heed of industry concerns. It tightened some requirements but delayed a decision on the toughest potential provisions, including beefing up agency authority to rescind product approvals and to force device makers to conduct post-market safety studies.
Zuckerman said she was hopeful the study would influence regulators to tighten standards.
"The process should be more stringent," she said. "It doesn't have to be slower."