Call for better monitoring of new devices after sudden death of college student

May 29 2005

Thousands of people with diseased hearts who have undergone surgical implantation of a cardiac defibrillator, a mechanical device inserted under the skin that shocks a heart when it beats improperly, will be concerned after the death recently of a 21-year-old college student with a genetic heart abnormality who died of cardiac arrest while on a bicycle trip.

Although it is not disputed, not even by the manufacturer Guidant Corp., that his defibrillator short-circuited, his family and doctors question why Guidant did not inform them about the electrical flaw it had known about for three years.

The incident has sparked a debate on whether a medical device manufacturer has the right to withhold safety information about its product from the public, and to decide when such information is relevant to the people who use its products.

A company spokesperson for Guidant says they had not felt it was necessary to alert doctors about the defibrillators because the known failure rate was low. Guidant claims to know of 25 other cases in which its defective defibrillator (the Ventak Prizm 2, model 1861) malfunctioned but without a fatal consequences.

Doctors for the student are arguing that they would have replaced his defibrillator had they known about the flaw because he faced a high risk of sudden death without it and as a direct result of his son's death, the student's father has had his own Guidant defibrillator surgically replaced.

Medical device manufacturers who withhold safety information about products are violating a social contract with the public and possibly place patients at risk. By concealing relevant information they make it impossible for patients and doctors to make rational decisions about health care.

Ethically and legally, doctors are expected to engage patients in a process of "informed consent" whenever treatment decisions are being made.

More than 500,000 medical device models, from surgical staples to defibrillators, are made by 23,000 manufacturers and marketed in the United States.

Initially the Food and Drug Administration is responsible for monitoring the safety of regulated medical devices through a passive surveillance system which relies on health care professionals to suspect that an adverse event might be related to a medical device and to report it to the manufacturer and/or the FDA.

The under-reporting of adverse events is a major problem.

Pre-marketing research of medical devices is generally performed on only a limited number of selected patients with less severe diseases, newly approved devices should possibly be scrutinized proactively for safety and efficacy once they are marketed and used by greater numbers of real-life patients with varying degrees of illness and other medical problems. According to the National Center for Health Statistics, a medical device is used for almost every patient, and more than 4 percent of the population has at least one implanted device. This has great significance for public health.

The FDA needs in future to monitor the safety and efficacy of medical devices through a more reliable, system that eliminates liability concerns when health care workers and patients suspect and report device problems in good faith.