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[医院中与医疗器械相关不良事件的预防:明确德国患者安全联盟(APS)对麻醉设备使用者和操作者的建议]

[Prevention of medical device-related adverse events in hospitals: Specifying the recommendations of the German Coalition for Patient Safety (APS) for users and operators of anaesthesia equipment].

作者信息

Bohnet-Joschko Sabine, Zippel Claus, Siebert Hartmut

机构信息

Walcker-Stiftungsprofessur für Management und Innovation im Gesundheitswesen, Fakultät für Wirtschaftswissenschaft, Universität Witten/Herdecke, Witten, Deutschland.

Walcker-Stiftungsprofessur für Management und Innovation im Gesundheitswesen, Fakultät für Wirtschaftswissenschaft, Universität Witten/Herdecke, Witten, Deutschland.

出版信息

Z Evid Fortbild Qual Gesundhwes. 2015;109(9-10):725-35. doi: 10.1016/j.zefq.2015.06.001. Epub 2015 Jul 16.

DOI:10.1016/j.zefq.2015.06.001
PMID:26699261
Abstract

BACKGROUND

The use and organisation of medical technology has an important role to play for patient and user safety in anaesthesia.

OBJECTIVES

Specification of the recommendations of the German Coalition for Patient Safety (APS) for users and operators of anaesthesia equipment, explore opportunities and challenges for the safe use and organisation of anaesthesia devices.

METHODS

We conducted a literature search in Medline/PubMed for studies dealing with the APS recommendations for the prevention of medical device-related risks in the context of anaesthesia. In addition, we performed an internet search for reports and recommendations focusing on the use and organisation of medical devices in anaesthesia. Identified studies were grouped and assigned to the recommendations. The division into users and operators was maintained.

RESULTS

Instruction and training in anaesthesia machines is sometimes of minor importance. Failure to perform functional testing seems to be a common cause of critical incidents in anaesthesia. There is a potential for reporting to the federal authority. Starting points for the safe operation of anaesthetic devices can be identified, in particular, at the interface of staff, organisation, and (anaesthesia) technology.

CONCLUSIONS

The APS recommendations provide valuable information on promoting the safe use of medical devices and organisation in anaesthesia. The focus will be on risks relating to the application as well as on principles and materials for the safe operation of anaesthesia equipment.

摘要

背景

医疗技术的使用和组织在麻醉领域对患者及使用者安全起着重要作用。

目的

明确德国患者安全联盟(APS)针对麻醉设备使用者和操作者的建议,探讨麻醉设备安全使用及组织方面的机遇与挑战。

方法

我们在Medline/PubMed中进行文献检索,查找有关APS在麻醉领域预防与医疗设备相关风险的建议的研究。此外,我们在互联网上搜索专注于麻醉中医疗设备使用和组织的报告及建议。对识别出的研究进行分组并归入相应建议。使用者和操作者的划分保持不变。

结果

麻醉机的操作指导和培训有时不太受重视。未进行功能测试似乎是麻醉中严重事件的常见原因。存在向联邦当局报告的可能性。尤其在人员、组织和(麻醉)技术的接口处,可以确定麻醉设备安全操作的切入点。

结论

APS的建议为促进麻醉中医疗设备的安全使用和组织提供了有价值的信息。重点将放在与应用相关的风险以及麻醉设备安全操作的原则和材料上。

相似文献

1
[Prevention of medical device-related adverse events in hospitals: Specifying the recommendations of the German Coalition for Patient Safety (APS) for users and operators of anaesthesia equipment].[医院中与医疗器械相关不良事件的预防:明确德国患者安全联盟(APS)对麻醉设备使用者和操作者的建议]
Z Evid Fortbild Qual Gesundhwes. 2015;109(9-10):725-35. doi: 10.1016/j.zefq.2015.06.001. Epub 2015 Jul 16.
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User reporting of medical device related incidents.用户对医疗器械相关事件的报告。
Med Device Technol. 2003 May;14(4):26-9.
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[Harm related to medical device use - legal and organisational risks].
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[Helsinki Declaration on Patient Safety in Anaesthesiology--Part 8: SOP for checking equipment and drugs].《麻醉学患者安全赫尔辛基宣言——第8部分:设备与药品检查标准操作规程》
Anasthesiol Intensivmed Notfallmed Schmerzther. 2013 Sep;48(9):538-42. doi: 10.1055/s-0033-1355233. Epub 2013 Sep 18.
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[Experiences and recommendations of the German Federal Institute for Drugs and Medical Devices (BfArM) concerning clinical investigation of medical devices and the evaluation of serious adverse events (SAE)].德国药品和医疗器械联邦研究所(BfArM)关于医疗器械临床研究及严重不良事件(SAE)评估的经验与建议
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Safe Medical Devices Act: management guidance for hospital compliance with the new FDA requirements.《安全医疗器械法案》:医院遵守美国食品药品监督管理局新要求的管理指南
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[Safety of medical devices].[医疗器械的安全性]
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Biomed Tech (Berl). 2016 Apr 1;61(2):239-48. doi: 10.1515/bmt-2015-0214.

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