Connecting Across Competencies: Leveraging Best Practices for Processing.

Q4 Medicine

Biomedical Instrumentation and Technology Pub Date : 2021-03-01 DOI:10.2345/0899-8205-55.s3.6

Terra A Kremer, Kaumudi Kulkarni, Christopher Ratanski, Lorraine Floyd, Christopher Anderson

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引用次数: 0

Abstract

The AAMI working group ST/WG 93 is finalizing a standard (AAMI ST98) for the cleaning validation of reusable medical devices based on guidance from the technical information report AAMI TIR30:2011/(R)2016. A number of analytical best practices are being considered for this new standard. Test method suitability for processing cleaning validations historically has been established using one positive control and performing an extraction efficiency. The new cleaning validation standard is proposed to require a change from only one replicate test sample to three when performing method suitability. This change will affect manufacturers; therefore, the value of and consideration for performing these additional replicates requires explanation. This article discusses how variation of validation parameters can affect the accuracy and precision during method suitability testing. Multiple replicates are needed to understand the variability of method extraction and impact on cleaning validations of reusable medical devices.

查看原文本刊更多论文

跨能力连接:利用处理的最佳实践。

AAMI工作组ST/WG 93正在根据技术信息报告AAMI TIR30:2011/(R)2016的指导，最终确定可重复使用医疗器械的清洁验证标准(AAMI ST98)。这个新标准正在考虑许多分析性最佳实践。历史上已经建立了适用于处理清洗验证的测试方法，使用一个阳性对照并执行萃取效率。新的清洁验证标准建议在执行方法适用性时，要求从只有一个重复测试样品更改为三个。这一变化将影响制造商;因此，需要解释执行这些额外复制的价值和考虑因素。本文讨论了验证参数的变化如何影响方法适用性测试的准确性和精密度。需要进行多次重复，以了解方法提取的可变性以及对可重复使用医疗器械清洁验证的影响。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Biomedical Instrumentation and Technology Computer Science-Computer Networks and Communications

CiteScore

1.10

自引率

0.00%

发文量

期刊介绍： AAMI publishes Biomedical Instrumentation & Technology (BI&T) a bi-monthly peer-reviewed journal dedicated to the developers, managers, and users of medical instrumentation and technology.