title: The non-hermetically sealed pacemaker myth, or, Navy-Ribicoff 22,000-FDA-Weinberger o.
abstract: Although the Secretary of Health, Education and Welfare recently stated that hermetic sealing of all implanted cardiac pacemakers, as recommended by the Navy in 1969, is inadvisable, several small manufacturers are already marketing hermetically sealed devices (CPI, Pacesetter), all of the over 600 nuclear pacers implanted to date have been hermetically sealed, and belatedly the major manufacturers are developing hermetically sealed units. Total hermetic sealing of all implantable electronic devices has been technically feasible for years, and it is essential that device legislation include mandatory encapsulation standards.
mesh_terms: D001698:Biomedical Engineering / Q000592:standards*; D004582:Electronics, Medical / Q000295:instrumentation; D010138:Pacemaker, Artificial / Q000009:adverse effects / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration