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医疗设备的不断发展实践。FDA检查后的管理。

Evolving practices of medical equipment. Management following FDA inspections.

作者信息

Hill D

机构信息

High Plains Baptist Hospital, Amarillo, TX 79106.

出版信息

J Clin Eng. 1992 Jan-Feb;17(1):49-57. doi: 10.1097/00004669-199201000-00021.

DOI:10.1097/00004669-199201000-00021
PMID:10117003
Abstract

This paper outlines one hospital's response to the changing needs for: quality of care; risk management; cost control; and regulatory agency requirements. All recall, update, and product safety alerts are now routed to the office of The Director of Materials Management. The director notifies the appropriate department manager, who must reply in writing. The Clinical Engineering Department maintains a historical data file for medical equipment, which includes service costs information. New purchasing forms and terms have been developed for use in purchasing equipment and service. Maintenance of accurate historical data for medical devices begins at purchase, and continues to installation and through ongoing service. This requires the cooperation of the manufacturer, the service vendor, and the clinical department using the device. Because technology management can improve the quality of care and reduce risk, it is worth doing and can also reduce costs.

摘要

本文概述了一家医院为应对在医疗质量、风险管理、成本控制以及监管机构要求等方面不断变化的需求所采取的措施。所有召回、更新及产品安全警报现在都传送到物资管理主任办公室。主任会通知相应的部门经理,部门经理必须以书面形式回复。临床工程部门为医疗设备维护一份历史数据文件,其中包括服务成本信息。已制定新的采购表格和条款用于设备及服务采购。医疗设备准确历史数据的维护从采购开始,持续到安装以及后续的服务过程。这需要制造商、服务供应商以及使用该设备的临床科室之间的合作。由于技术管理能够提高医疗质量并降低风险,所以值得去做,而且还能降低成本。

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