This past spring, Joshua Oukrop, a 21-year old Minnesota college student
with familial hypertrophic cardiomyopathy, died of cardiac arrest when his
implantable cardioverter-defibrillator (ICD) short-circuited and failed to
resuscitate him.1 Guidant Corporation (Indianapolis,
Ind), the maker of his ICD, was aware of the potential for this type of malfunction,
having observed 26 similar failures out of 37 000 devices.1,2 The
company, however, decided not to notify physicians of the flaw for more than
3 years after first detecting it.1,2 As
implantations of complex electrophysiological devices become increasingly
commonplace, the number of patients affected by defective devices can be expected
to increase. Understanding the history of medical device regulation, the benefits
and limitations of technology, the obligations of manufacturers, the expectations
of physicians and patients, and the responsibilities of national physician
and industry organizations can provide a framework for improving the medical
device reporting and notification systems.
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