■2022年3月,医疗器械促进协会(AAMI)发布了美国国家标准协会(ANSI)/AAMIST91:2021,其最新的全面更新,灵活,和半刚性内窥镜后处理。这些更新的标准建议在可能的情况下对高风险内窥镜进行灭菌,并为预清洗提供新的建议,泄漏测试,手动清洗,目视检查,自动后处理,干燥,storage,和内窥镜的运输。
■将ANSI/AAMIST91:2021与ANSI/AAMIST91:2015进行了比较,发现了导致时间和/或成本增加的主要后处理差异。通过明确的建议纳入或从文献中获取时间估计值。所有费用都是使用公开资源估算的。
■更新的标准代表了在后处理时间和支出方面,每个程序可能增加24.3分钟和52.35至67.57美元,分别,不包括资本投资。每个程序的资本成本高度依赖于设施的程序量。
■新的AAMI标准建议进行一些重大更改,如灭菌,用于在使用之间重新处理和管理内窥镜的设施。随着越来越多的设施增加其后处理方法以反映更新的标准,他们这样做是有代价的,并造成了几次延误。随着后处理的发展,设施应考虑其真实成本和替代解决方案,如一次性内窥镜。
OBJECTIVE: In March 2022, the Association for the Advancement of Medical Instrumentation (AAMI) released the American National Standards Institute (ANSI)/AAMI ST91:2021, their latest update on comprehensive, flexible, and semirigid endoscope reprocessing. These updated standards recommend the sterilization of high-risk endoscopes when possible and provide new recommendations for the precleaning, leak testing, manual cleaning, visual inspection, automated reprocessing, drying, storage, and transport of endoscopes.
METHODS: ANSI/AAMI ST91:2021 was compared with ANSI/AAMI ST91:2015 for major reprocessing differences that result in either time and/or cost increases. Time estimates were captured by explicit recommendation inclusion or taken from the literature. All the costs were estimated using publicly available resources.
RESULTS: The updated standards represent a potential 24.3-minute and 52.35 to 67.57 United States dollars increase per procedure in terms of reprocessing time and spending, respectively, not including capital investments. Capital costs per procedure were highly dependent on the procedure volume of the facility.
CONCLUSIONS: The new AAMI standards recommend several major changes, such as sterilization, for facilities to reprocess and manage endoscopes between uses. As more facilities increase their reprocessing methods to reflect the updated standards, they do so at a cost and introduce several delays. As the reprocessing landscape evolves, facilities should consider their true costs and alternative solutions, such as single-use endoscopes.