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非密封起搏器的谬论,或者说,海军-里比科夫22000例-美国食品药品监督管理局-温伯格诉讼案

The non-hermetically sealed pacemaker myth, or, Navy-Ribicoff 22,000-FDA-Weinberger o.

作者信息

Tyers G F, Brownlee R R

出版信息

J Thorac Cardiovasc Surg. 1976 Feb;71(2):253-4.

PMID:1246150
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.

摘要

尽管卫生、教育和福利部部长最近表示,按照海军1969年的建议对所有植入式心脏起搏器进行气密密封并不可取,但几家小型制造商已经在销售气密密封装置(CPI、Pacesetter),迄今为止植入的600多个核起搏器都是气密密封的,主要制造商也在姗姗来迟地开发气密密封装置。多年来,对所有可植入电子设备进行完全气密密封在技术上是可行的,而且设备立法必须包括强制性的封装标准。

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