Recall rate rises for heart devices

By Christy Oglesby
CNN

ATLANTA, Georgia (CNN) -- The rate of recalls and safety alerts for pacemakers and defibrillators, devices that regulate heart rhythm, increased during 1990 to 2000 with the sharpest rise occurring since 1999, according to a new study.

Researchers determined that the U.S. Food and Drug Administration, the federal agency that regulates medical devices, issued 52 advisories or alerts for pacemakers and implantable cardioverter-defibrillators during that period. But the principal investigator emphasized that few devices malfunction and the growing advisory rate might be linked to increased usage of such mechanical devices.

By the end of 2000, more than 900,000 people used such devices, an 49-percent increase since 1990.

RESOURCES Read details of the study in the Journal of the American Medical Association

"I can tell you that 52 advisories in 11 years is a high number," said Dr. William Maisel, the study's lead author. "That's one every two to three months. That's a high frequency."

An editorial that accompanies the study, which appears in the August 15 edition of the Journal of the American Medical Association, recommends longer preapproval testing periods, earlier involvement of non-industry representatives charged with finding and reporting patterns in device failure, and a device tracking system.

Deciphering the data

Dr. David Feigal, director of the FDA's center for devices, said the study is a starting point for a discussion on what evaluations should take place before and after the devices are on the market. Additionally, he said pacemakers are designed to be reprogrammed and even replaced within four to eight years.

Feigal said the number of advisories and recalls illustrates the industry's and the FDA's vigilance in detecting potential problems before they develop into serious issues.

Dr. Marshall Stanton, medical director at Medtronic, the manufacturer of half of all pacemakers and ICDs in the world, said understanding the numbers in the study will prevent patient alarm.

Of the 52 advisories, 11 involved Medtronic products, he said. One such advisory involved only 12 ICDs, but the company issued an alert for all 10,000.

"It is important to know that the number of devices they are talking about is not the same number of people that had to have something done…. The vast majority of those people do not have to have devices explanted."

Study specifics

The researchers conducted the study to determine pacemaker and ICD advisory rates, identify trends in the rates and examine their clinical and financial effects. They estimated the financial toll during the 11 years to be about $870 million, including hospital stays, the cost of replacement parts and physician services. The immeasurable cost, the study said, is the shaken confidence that patients and their families have in the devices.

But patients should know that although 500,000 devices have been the subject of advisories or recalls, not many devices malfunction, said author Maisel, who is an assistant physician at Brigham and Women's Hospital in Boston, Massachusetts, and a medial instructor at Harvard University.

"Only a small percentage malfunction," Maisel said. "Patients shouldn't perceive that they will stop working. They are actually very reliable devices."

The study found:

Pacemakers were recalled in 9 of the 11 years studied and ICDs were recalled in 8 of 11 years; 1990 was the only recall-free year.

Since 1990, 65 percent of the devices have been recalled since January 1999, including 71 percent of the recalled pacemakers and 42 percent of the recalled ICDs.

Some 75 percent of advisories were Class I or Class II recalls, meaning there was a reasonable probability of adverse health effects or death, or use may cause temporary and reversible adverse health consequences, or the probability of serious health problems is remote.

The advisory rate for ICDs is higher than that of pacemakers.

Maisel suspects that the ICD advisory rate might be higher because ICDs are more complicated devices. The fact that they are perceived as being life-sustaining might lower the threshold for issuing alerts.