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[西德超声诊断设备的质量保证。现行法规的经验]

[Quality assurance in ultrasound diagnostic equipment in West Germany. Experiences with current regulations].

作者信息

Trier H G

出版信息

Ultraschall Med. 1985 Oct;6(5):255-64. doi: 10.1055/s-2007-1006066.

Abstract

Since 1980, the Health Service (KBV) of the FRG has introduced regulations for quality assurance of diagnostic ultrasound equipment. This step was taken to limit overshooting expansion of echography and Health Service costs. The author describes experiences and problems arising from application of the KBV regulations. Preventing diagnostic ultrasound from developing institutional structures and being included in existing health and safety acts, resulted in a lack of legitimate and qualified structures for quality assurance of the methods. This deficiency of structures also compromises the quality assurance by KV regulations and thus produces an administrative torso. Therefore, in West Germany, the first step to improve quality assurance ought to be to look for appropriate institutions for qualified equipment testing.

摘要

自1980年以来,联邦德国的卫生服务机构(KBV)出台了诊断超声设备质量保证的相关规定。采取这一步骤是为了限制超声检查的过度扩张以及卫生服务成本。作者描述了KBV规定实施过程中出现的经验和问题。由于未能使诊断超声形成机构性架构并纳入现有的健康与安全法案,导致缺乏对该方法进行质量保证的合法且合格的架构。这种架构上的缺陷也损害了KBV规定的质量保证,从而产生了一个行政上的残缺部分。因此,在西德,改善质量保证的首要步骤应该是寻找合适的机构进行合格的设备检测。

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