Growing Safety Problems of Heart-Device Implants

A study has found that safety alerts or recall notices on pacemakers or implantable cardioverter-defibrillators (ICDs) have been increasing since 1995, with more than 500,000 of U.S. devices affected by safety alerts or recalls between 1990 and 2000. Moreover, the number of alerts and recalls is expected to continue to grow, according to researchers at Brigham and Women's Hospital (Boston, MA, USA). The study was published in the August 15, 2001, issue of The Journal of the American Medical Association (JAMA).

Although pacemakers comprise more than 75% of such devices, the rate of alerts and recalls is much higher for ICDs, which accounted for 75% of the US$870 million cost of the advisories between 1990 and 2000. The researchers say the increase in advisories may be caused by increased scrutiny on the part of the U.S. Food and Drug Administration (FDA) and also by the fact that the newer devices offer new features and are more complex than previous devices. More than 50% of recalls and alerts are hardware advisories, usually caused by manufacturing defects. The rest are firmware advisories, caused by programming problems. Fortunately, few deaths have been determined to have been caused by malfunction of the devices.

The researchers express the hope that the remarkable technologic advances made in pacemakers and ICDs will be accompanied by a similarly strong effort by manufacturers and the FDA to improve the safety of the devices and thereby reduce the recall rate. In a separate article in JAMA, Kim A. Eagle, M.D., advises three system changes that could help solve the safety problem. These are to require longer periods of preapproval testing and surveillance, to involve non-industry representatives in regulatory oversight, and to devise a tracking system involving parties other than industry alone. Dr. Eagle is with the division of cardiovascular disease, University of Michigan Medical Center (Ann Arbor, USA).