WEDNESDAY, April 26, 2006 (HealthDay News) -- Guidelines to bring order to the now disorderly realm of implanted heart devices have been proposed by a leading U.S. medical organization.
One indication of the degree of disorder was the inability of leaders of the organization, the Heart Rhythm Society, to say at a press conference Wednesday how many Americans now have implanted pacemakers or defibrillators.
It is "not unreasonable" to assume that more than one million Americans have such devices, said Dr. Mark D. Carlson, professor of medicine at Case Western Reserve University in Cleveland and leader of the task force that developed the guidelines. But more definite information is not available, he said.
Another indicator prompted one of the recommendations -- that all devices removed from patients be returned to the manufacturer for analysis. "Most devices now are not being returned," said Dr. Anne B. Curtis, president of the society and chief of the division of cardiology at the University of South Florida, Tampa.
The reliability -- or lack of it -- of these devices has become an issue primarily because of problems at the Guidant Corporation, which last year first reported that about 28,000 pacemakers had defects that could make them malfunction. The company later acknowledged that it had not issued alerts about life-threatening defects in some of its implanted defibrillators.
Curtis sidestepped a question about whether any one company was more responsible for problems with the devices. It is "an industry-wide issue," she said.
A pacemaker is designed to keep the heart beating regularly; a defibrillator delivers a shock to restart a malfunctioning heart.
The proposed guidelines call for:
- Greater transparency in the post-market surveillance, analysis, and reporting of information.
- The establishment of new systems to identify malfunctioning devices more quickly.
- Standard notification and communication to physicians and patients from the manufacturer when a device malfunction is identified. Manufacturers, the U.S. Food and Drug Administration, and physicians are encouraged to work together to prevent "adverse events" due to device malfunctions.
The society's guidelines would also have manufacturers establish independent committees to monitor performance of their devices after they are implanted. The guidelines also ask that the FDA establish a committee to address device malfunction, something the agency has already done.
While manufacturers participated in preparation of the guidelines, they have not said specifically that they will establish such committees, Carlson said. But, he added, "industry is receptive to this idea."
Another recommendation is that the FDA should establish "a unique and specialized" database to focus on the devices. Carlson said he could not estimate the cost of the database.
Such FDA action would depend on additional funding for the agency, Curtis said. "We'll be going to the appropriate committees in Congress that have jurisdiction over the FDA," she said.
The guidelines also call for industry and the FDA to settle on agreed-upon wording when discussing the devices, Curtis said. "Manufacturers and the FDA should use identical terminology when describing problems," she said. Most specifically, she said, the word "recall" should not be used when a device malfunction is reported, because that might prompt unnecessary removal of some devices. "It should be changed to 'class 1 notification or class 1 report,' " Curtis said.
Just-released studies underscored the concern surrounding the reliability of pacemakers and defibrillators. One study examined data supplied by device manufacturers to the FDA from 1990 to 2002, a period when 2.25 million pacemakers and 415,780 defibrillators were implanted in Americans. During that time, 8,834 pacemakers and 8,489 defibrillators were removed because they malfunctioned, according to the findings in April 26 issue of the Journal of the American Medical Association.
A companion study in the same issue of the journal that reviewed data from three registries from North America, Denmark and the United Kingdom found similar malfunction rates.
And the issue of device-replacement safety was highlighted this week by a Canadian study that found an 8 percent incidence of complications, such as infections, in replacement operations.
The proposed guidelines will be open for public comment until May 30 and will also be discussed at an open house at the society's annual meeting, May 17-20, in Boston. As for the manufacturers, Curtis said, "We have every confidence that they will look carefully at these guidelines."
To view or comment on the recommendations, visit the Heart Rhythm Society.