Impact of expanding indications on the safety of pacemakers and defibrillators.

The number of patients living with a pacemaker or implantable cardioverter defibrillator (ICD) increased markedly during the 1990's. Expanding device indications and increasing device sophistication has important implications for patient and device safety. While the FDA is responsible for assessing the safety and efficacy of medical devices, manufacturers, physicians, patients, medical professional societies, and legislators will all play a role in ensuring that medical device patients continue to receive safe, quality medical care.