1990年安全医疗器械法案:目前医院的要求和建议的行动。

H Alder
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引用次数: 0

摘要

自1990年《安全医疗器械法案》签署成为法律以来,围绕着它产生了大量的困惑。本文件回顾了用户报告和设备跟踪的当前状态——包括MEDWatch计划——以及最终法规的状态。此外,读者将了解这一切对医院的真正意义,以及现在必须向FDA报告的事件。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Safe Medical Devices Act of 1990: current hospital requirements and recommended actions.

Since the Safe Medical Devices Act of 1990 was signed into law, a great deal of confusion has surrounded it. This document reviews the current status of user reporting and device tracing--including the MEDWatch program--and the status of the final regulations. In addition, readers will learn what it all really means for hospitals and what incidents must now be reported to the FDA.

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