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Single-Use Bag Valve Masks: Evaluation of Device Design and Residual Bioburden Analytical Methods
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作者 Sarah Zemitis Melinda Harman +1 位作者 Zachary Hargett Donna Weinbrenner 《Journal of Biomedical Science and Engineering》 2018年第9期235-246,共12页
Background: A recent survey of in-hospital reprocessing in Tanzanian hospitals identified bag-valve masks (BVM) as a commonly reused single-use device. In low- and middle-income countries (LMIC), in-hospital reprocess... Background: A recent survey of in-hospital reprocessing in Tanzanian hospitals identified bag-valve masks (BVM) as a commonly reused single-use device. In low- and middle-income countries (LMIC), in-hospital reprocessing supports neonatal resuscitation strategies by helping to maintain adequate supplies of BVM. However, there is a need for device-specific protocols defining reprocessing procedures and inspection criteria to overcome variations in reprocessing practices between hospitals. The purposes of this study were: 1) to complete a comprehensive design review and identify challenges to reprocessing BVMs;and 2) to investigate three different residual bioburden analysis methods for assessing the efficacy of decontaminating a disposable BVM. Methods: New, unused bag-valve-masks were contaminated with Staphylococcus epidermidis and Artificial Mucus Soil to simulate the worst case soiling conditions. Devices underwent one of five disinfection protocols, including one currently used in a LMIC hospital. Three analytical (two quantitative and one qualitative) methods were selected to evaluate residual bioburden on the device following decontamination. Results: Of all protocols tested, only the positive control and the Soap and Bleach protocols met disinfection targets. Most cleaning outcomes were consistent from trial to trial for each protocol. However, cleaning outcomes varied greatly for the Alcohol Wipe protocol. For the residual bioburden analyses, the two quantitative methods produced similar results, but the qualitative measurement exhibited increased variability. Conclusion: While this study revealed positive disinfection outcomes for the Tanzanian hospital decontamination protocol, more studies are required to support these findings. Design features of the BVM mask presented challenges to cleaning and drying during different decontamination protocols, as seen in the variability in the Alcohol Wipe protocol performance. These findings support the case for a device-specific protocol for the BVM. Given proper hospital personnel training and available resources, in-hospital reprocessing could support neonatal resuscitation strategies and other demands for manual resuscitation by helping to maintain adequate supplies of BVM. 展开更多
关键词 Reprocessing Low-Resource BAG VALVE Mask single-use device Low-and Middle-Income Countries Newborn Resuscitation
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一次性使用医疗器械复用的风险评价和质量控制技术 被引量:5
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作者 魏慧慧 段晓杰 +4 位作者 刘万卉 黄清泉 杨昭鹏 王玉梅 徐丽明 《中国医疗器械杂志》 2018年第5期368-371,共4页
一次性使用高值耗材类医疗器械在许多国家,如美国、德国及英国等是允许重复使用的,但是,必须满足严格的监管要求。除了监管政策法规,如市场准入方式、GMP的特殊规定外,在技术层面对复用存在的潜在风险控制和质量保障体系有严格的要求。... 一次性使用高值耗材类医疗器械在许多国家,如美国、德国及英国等是允许重复使用的,但是,必须满足严格的监管要求。除了监管政策法规,如市场准入方式、GMP的特殊规定外,在技术层面对复用存在的潜在风险控制和质量保障体系有严格的要求。因此,有效的风险评估和风险控制技术是保证复用器械安全有效、质量可控的关键。该文通过分析监管体系较完善的美国、德国及英国对复用医疗器械监管方面的技术要求,结合相关文献的最新报道,讨论了如何进行科学风险评估的措施;重点介绍了一些风险控制的技术,为进一步研究一次性使用高值医疗器械复用的风险控制措施和制定监管决策提供参考。 展开更多
关键词 一次性使用医疗器械 复用 风险评估 风险控制技术
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一次性使用医疗器械复用的监管现状 被引量:3
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作者 魏慧慧 王玉梅 +3 位作者 段晓杰 刘万卉 杨昭鹏 徐丽明 《中国医疗器械杂志》 2018年第3期210-214,共5页
一次性使用医疗器械的复用在国际上普遍存在,然而,各国的监管方式不同,甚至很多国家还没有将复用纳入监管。该文介绍和分析了国内外一次性使用医疗器械复用的监管状况;重点介绍了美国、德国和英国一次性使用医疗器械复用监管文件及监管... 一次性使用医疗器械的复用在国际上普遍存在,然而,各国的监管方式不同,甚至很多国家还没有将复用纳入监管。该文介绍和分析了国内外一次性使用医疗器械复用的监管状况;重点介绍了美国、德国和英国一次性使用医疗器械复用监管文件及监管模式;讨论了如何进行科学的风险评估和有效的风险控制;为建立适合中国的监管模式,研发相关标准、指南或规范以及制定相应的风险控制策略提供参考。 展开更多
关键词 一次性使用医疗器械 复用 风险评价 风险控制 监管现状
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