F.D.A. Plans to Intensify Oversight of Heart Devices
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By BARRY MEIER
Published: April 7, 2006
The Food and Drug Administration plans to strengthen how it monitors critical heart devices like defibrillators by appointing outside medical experts to help it review the safety of units already on the market, a top agency official says.
The move would be the first time the F.D.A. would have outside experts regularly advising it about the safety of medical devices being sold, said Dr. Daniel G. Schultz, director of the agency's Center for Devices and Radiological Health. Traditionally, the F.D.A. has used its advisory panels to help it decide whether to permit the sale of a new device.
The agency's decision comes as a medical group that represents doctors who implant devices prepares to release a report recommending changes in how data about heart units is collected and disclosed. Among other proposals, the group, the Heart Rhythm Society, may urge manufacturers to establish an outside panel to review product safety and help companies decide when to issue alerts, people involved in the group said.
Both the agency's action and the medical group's report, which will be released in a few weeks, follow a controversy last year over decisions by the Guidant Corporation not to publicize life-threatening defects in some of its defibrillators. The episode also highlighted gaps in the F.D.A.'s oversight of such products, as well as a lack of uniform standards in the industry governing how and when device flaws are disclosed.
For his part, Dr. Schultz said in a telephone interview that the F.D.A. plans to expand an existing advisory panel that reviews and approves new heart devices for sale, adding members who will help the agency oversee the safety of marketed products. Those experts will be asked to help the F.D.A. interpret data from device manufacturers and will also be available to advise the F.D.A. on how best to respond to immediate problems like recalls, he said.
Dr. Schultz acknowledged that the agency's action was a response in part to the criticism it had received for how it oversees the safety of medical devices on the market, including defibrillators. To do that job, the agency relies on reports from manufacturers. But such data was not always quickly circulated within the agency, a situation Dr. Schultz said he was working to address.
In the past, the F.D.A. has asked an advisory panel to review an approved device when questions have arisen, but that has happened only rarely, Dr. Schultz said.
"We recognize that we need to do a better job and that we need to do a better job in leveraging outside expertise," he said. "This seemed like a logical first step in doing that."
A defibrillator is a device that uses electricity to interrupt a chaotic and potentially fatal heart rhythm. The use of such units, which can cost up to $35,000 each, is growing; this year, more than 150,000 heart patients in this country are likely to get one. The units are generally highly reliable and save many lives but, as with any product, problems can develop.
Guidant's failure to alert doctors and patients for years about electrical defects in some of its defibrillator came to light in May when The New York Times published an article about the problem. It was also only then that the F.D.A. began investigating Guidant, though agency records showed that regulators had received earlier reports of short circuits in the company's units.
Seven patients are known to have died in episodes during which a Guidant defibrillator short-circuited, though the number of fatalities is probably higher because doctors only recently became aware of the problem.
Dr. Schultz said the agency planned to start appointing new experts to the panel within the next few months and expected the process to be completed by October. He said that one problem the agency faced was finding experts who did not have financial ties to heart device manufacturers.
The agency's action is apparently in line with a recommendation contained in a report that the Heart Rhythm Society plans to release May 2. Last fall, in the wake of recalls by Guidant and other device producers, the group appointed a task force to recommend ways to improve the gathering and dissemination of information about device performance.
The F.D.A, Guidant and other manufacturers of heart devices, like Medtronic and St. Jude Medical, have been involved in developing the forthcoming proposals.
The chairman of the task force, Dr. Mark D. Carlson of Case Western Reserve University, declined to comment on the group's recommendations, saying they were still being completed. In separate interviews, several other cardiologists on the task force also declined to comment, but they added that the group was strongly considering recommending that companies create independent safety boards.
The proposal is striking because it mirrors a recommendation made last month by a separate panel of doctors and other experts appointed by Guidant to review its handling of safety issues and to suggest changes in company policy. According to that report, such an outside advisory board would regularly monitor the safety of a company's products and help it determine when it should alert doctors and patients and what it should say.
Several doctors, including some working on the Heart Rhythm Society's report, said they were concerned that manufacturers, even when trying to do the right thing, faced an inherent conflict in making safety-related decisions that could affect sales.
Officials of Medtronic and St. Jude said they were awaiting the publication of the group's report before commenting on it. A spokesman for Boston Scientific, which agreed earlier this year to acquire Guidant, said recently that the company was considering which of the Guidant panel's recommendations to adopt.
In recent months, all those companies have started regularly disclosing more detailed data about product performance as part of their regular reports to doctors.
The report by the Heart Rhythm Society is also expected to urge doctors and others to be more aggressive in reporting device-related problems and to recommend that a unit be checked at the time of a patient's death to determine if its failure might have been a factor.
In addition, the group is expected to recommend that better guidelines be developed for doctors to use when determining whether to remove a unit that is the subject of a recall or an alert. One concern is that the risk of infection from replacement surgery can, in some cases, outweigh the risk posed by a device, especially for patients whose lives are not dependent on a heart unit.
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