The Annals of thoracic surgery
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A surgery of 349 cardiac surgeons showed that during a six-year period, a pump oxygenator accident serious enough to cause patient injury or death occurred one per 1,000 procedures. A total of 264 deaths occurred as a direct results of an accident. ⋯ Low-level alarm systems were reported to be used by 42% of the respondents and activated clotting times were used by 63%. Rigorous use of alarm systems and heparin monitoring could reduce the incidence of pump-related accidents.
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Innovation in the development of medical devices has been an important factor in the practive of health care in the United States. However, in a climate of increasing federal regulation, concern is expressed that such regulation can inhibit scientific creativity in the medical device industry. ⋯ Increasing regulation will divert research dollars from discovery efforts to regulatory maintenance. Surgeons can participate in the regulatory process by informing the public and the government on issues regarding safety and effectiveness of medical devices.