Device Review Process Faulted

Recalled Medical Products Were Cleared in Abbreviated Manner, Study Says

Most of the medical devices recalled in recent years because of serious or life-threatening hazards were initially cleared for market through an abbreviated approval system that doesn’t require testing on patients, according to a study in the Archives of Internal Medicine.

The study by a Washington health-research group and the Cleveland Clinic’s Steven Nissen comes after the Food and Drug Administration proposed changes to tighten the faster approval system, known as 510(k), but put off some of its toughest proposals for further study under pressure from device makers.

Of 113 medical devices that were subject to recalls between 2005 and 2009, 80 were allowed on the market through the 510(k) program, the study found. About a third of the recalled devices were cardiovascular products, including several brands of external defibrillators.

“These findings suggest that reform of the regulatory process is needed to ensure the safety of medical devices,” said the authors. The lead author, Diana Zuckerman, heads the National Research Center for Women & Families, a group that has advocated stiffer approval standards for medical devices.

The 510(k) process is popular with the industry because it can save time and money in regulatory reviews, and industry lobbyists have been campaigning on Capitol Hill against radical revisions to the program.

The process requires that the proposed device be similar to a product already marketed, and is intended for low and moderate-risk devices.

The industry’s lobbying group, the Advanced Medical Technology Association, or AdvaMed, said the study is flawed because it looks at the number of recalls without comparing that to the number of devices that didn’t have problems. AdvaMed-supported studies say that more than 99% of the devices cleared through 510(k) don’t face recalls.

Overall, the 510(k) program has a “remarkable safety record with extremely low recall rates,” AdvaMed said.

“Adoption of the paper’s recommendations would actually harm American patients by further delaying access to safe and effective treatments,” said AdvaMed’s president Stephen Ubl. The group represents top device makers such as Johnson & Johnson and Medtronic Inc.

In an interview, Dr. Nissen dismissed the criticism, saying the withdrawn products are used on millions of Americans. “We are looking at the recalls that the FDA deemed serious, potentially life-threatening … We found—to my surprise—that more than 70% of them got through the FDA on the fast-track 510(k),” he said.

The study, using FDA data, said that nearly 20% of the one million external defibrillators in use have been recalled, and “hundreds of deaths” are attributed to their malfunctions. The FDA has proposed tougher rules that would require the external defibrillators to undergo the same kind of review that implanted defibrillators get.

Makers of external defibrillators defended their safety record and said the devices can save lives of people who suffer sudden heart attacks in public places. A spokesman for Medtronic, which makes some of the devices cited in Dr. Nissen’s article, said a study looking at 1,600 of the devices found no device failures or clinical harm.

Jonathan Rennert, president of Zoll Medical Corp., said the problem with his company’s external defibrillator, involving the batteries, didn’t manifest itself until several years after it went into use. “I don’t believe a more stringent approval path would have made a difference,” he said.

A 510(k) costs the FDA an average of about $20,000 per application compared to more than $800,000 for a full device review by the agency, according to the report. A full review includes evaluation of safety-and-efficacy clinical trials.

Companies pay user fees that cover about a quarter of those review costs, but the real expense comes from conducting trials that may cost millions of dollars.

The FDA began reconsidering the 510(k) process in 2009 after articles in The Wall Street Journal about a knee implant that got 510(k) approval in 2008 over repeated objections from FDA scientists and managers. A government report in 2009 said that the abbreviated clearance process was being overused.

The changes proposed by the FDA last month to the 510(k) would leave the general contours of the program intact and won praise from the industry.

FDA spokeswoman Karen Riley said Monday that while “even one recall is too many,” the 80 recalls cited in the new study “represent a small number of the devices cleared via this program and don’t reflect the thousands of people who have benefited from these devices.”