Shepherd N
DEVTEQ, Walnut Creek, CA 94598.
J Clin Eng. 1993 Sep-Oct;18(5):441-52.
The purpose of FDA's device tracking regulations is to ensure that tracked devices can be traced from the device manufacturing facility to the person who receives the benefit of the device, that is, the patient. Although the manufacturer has the responsibility for establishing and monitoring the tracking program for their devices, the user facility has a key responsibility in assuring its success. The FDA initially identified 21 devices that require tracking and recently added two more to the list. This paper discusses the tracking system and the responsibilities of the manufacturer and the user facility. Information on each of the initial 21 devices to be tracked is presented, including device nomenclature, description, potential health risks, panel classification and regulation number, risk class, ECRI number, and references.
美国食品药品监督管理局（FDA）设备追踪法规的目的是确保被追踪的设备能够从设备制造工厂追溯到受益于该设备的人，即患者。尽管制造商有责任为其设备建立和监控追踪程序，但使用机构在确保该程序成功方面也负有关键责任。FDA最初确定了21种需要追踪的设备，最近又在清单中增加了两种。本文讨论了追踪系统以及制造商和使用机构的责任。文中列出了最初要追踪的21种设备各自的信息，包括设备名称、描述、潜在健康风险、专家组分类和法规编号、风险等级、医疗设备风险信息及事件索引（ECRI）编号和参考文献。
