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Performance testing protocol for closed-system transfer devices used during pharmacy compounding and administration of hazardous drugs

机译:药房配制和危险药物管理中使用的封闭系统传输设备的性能测试协议

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摘要

ObjectivesThe United States National Institute for Occupational Safety and Health (NIOSH) is developing a protocol to assess the containment performance of closed system transfer devices (CSTDs) when used for drug preparation (task 1) and administration (task 2) and published a draft protocol in September 2016. Nine possible surrogates were proposed by NIOSH for use in the testing. The objectives of this study were to: (A) select the most appropriate surrogate; (B) validate the NIOSH protocol using this surrogate; and (C) determine the containment performance of four commercial CSTDs as compared with an open system of needle and syringe using the validated NIOSH protocol.
机译:目标美国国家职业安全与健康研究所(NIOSH)正在制定一项协议,以评估封闭系统转移装置(CSTD)用于药物制备(任务1)和管理(任务2)时的密闭性能,并发布了协议草案在2016年9月。NIOSH提出了9种可能的替代方案用于测试。这项研究的目的是:(A)选择最合适的替代品; (B)使用此代理验证NIOSH协议; (C)使用经过验证的NIOSH协议,确定与开放式针头和注射器系统相比,四种商用CSTD的密闭性能。

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