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美国妇产科医师学会委员会意见第 769 号概要:再处理的一次性使用器械。

ACOG Committee Opinion No. 769 Summary: Reprocessed Single-Use Devices.

出版信息

Obstet Gynecol. 2019 Mar;133(3):600-601. doi: 10.1097/AOG.0000000000003125.

Abstract

The reprocessing and reuse of single-use instruments has become increasingly common. Although there are limited data on reprocessed single-use devices, existing studies have found a significant rate of physical defects, performance issues, or improper decontamination. There are currently no data in the medical literature of studies evaluating the cost-effectiveness of reprocessed single-use devices in gynecologic surgery. The use of a reprocessed single-use device provides no direct benefit to an individual patient or her physician. It is the operating surgeon's ethical responsibility to make a good faith effort to know whether reprocessed single-use devices are to be used, and to not use instruments if he or she has concerns about the quality or safety of the instrument(s). Studies on the safety, quality, and cost-effectiveness of reprocessed single-use devices in gynecologic surgery are needed. Physicians should be informed whether the instruments used in surgery are original or reprocessed, and adverse events should be reported to improve the safety information about reprocessed single-use devices. Obstetrician-gynecologists are encouraged to report adverse events and outcomes associated with medical devices to the U.S. Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database.

摘要

一次性器械的再处理和再利用变得越来越普遍。虽然再处理的一次性器械的数据有限,但现有研究发现其存在显著的物理缺陷、性能问题或消毒不当的情况。目前,在妇科手术中评估再处理的一次性器械的成本效益的研究在医学文献中尚无数据。使用再处理的一次性器械对个体患者或其医生没有直接益处。手术医生有责任真诚地尽力了解是否使用再处理的一次性器械,如果对器械的质量或安全性有疑问,不应使用这些器械。需要研究妇科手术中再处理的一次性器械的安全性、质量和成本效益。应告知医生手术中使用的器械是原始器械还是再处理器械,发生不良事件时应进行报告,以改善再处理的一次性器械的安全性信息。鼓励妇产科医生向美国食品和药物管理局的制造商和用户设施设备体验(MAUDE)数据库报告与医疗器械相关的不良事件和结果。

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