Lekhy C
Methodist Health Systems, Memphis, TN.
J Healthc Qual. 1993 Jan-Feb;15(1):36-8. doi: 10.1111/j.1945-1474.1993.tb00077.x.
The Safe Medical Devices Act (SMDA) of 1990 (Public Law 101-629) is a federal law that became effective November 28, 1991. The SMDA mandates all facilities that use medical devices (referred to as device user facilities) to report serious injuries, serious illnesses, and deaths to the U.S. Food and Drug Administration (FDA) and the manufacturer. The purpose of the act is to protect the public by ensuring that medical devices are not unsafe for their intended use.
1990年的《安全医疗器械法案》（SMDA）（公法101 - 629）是一项联邦法律，于1991年11月28日生效。该法案要求所有使用医疗器械的机构（称为器械使用机构）向美国食品药品监督管理局（FDA）和制造商报告严重伤害、严重疾病和死亡情况。该法案的目的是通过确保医疗器械在预期使用中不存在不安全因素来保护公众。
