Chiozza Maria Laura, Ponzetti Clemente
Quality management Service, University-Hospital of Padua, Italy.
Clin Chim Acta. 2009 Jun;404(1):75-8. doi: 10.1016/j.cca.2009.03.015. Epub 2009 Mar 17.
Patient safety is a management issue, in view of the fact that clinical risk management has become an important part of hospital management. Failure Mode and Effect Analysis (FMEA) is a proactive technique for error detection and reduction, firstly introduced within the aerospace industry in the 1960s. Early applications in the health care industry dating back to the 1990s included critical systems in the development and manufacture of drugs and in the prevention of medication errors in hospitals. In 2008, the Technical Committee of the International Organization for Standardization (ISO), licensed a technical specification for medical laboratories suggesting FMEA as a method for prospective risk analysis of high-risk processes. Here we describe the main steps of the FMEA process and review data available on the application of this technique to laboratory medicine. A significant reduction of the risk priority number (RPN) was obtained when applying FMEA to blood cross-matching, to clinical chemistry analytes, as well as to point-of-care testing (POCT).
鉴于临床风险管理已成为医院管理的重要组成部分，患者安全是一个管理问题。失效模式与效应分析（FMEA）是一种用于错误检测和减少的前瞻性技术，于20世纪60年代首次在航空航天工业中引入。20世纪90年代在医疗行业的早期应用包括药物研发和生产中的关键系统以及医院用药错误的预防。2008年，国际标准化组织（ISO）技术委员会批准了一项针对医学实验室的技术规范，建议将FMEA作为高风险流程前瞻性风险分析的方法。在此，我们描述FMEA过程的主要步骤，并回顾有关该技术在检验医学中应用的现有数据。将FMEA应用于血型交叉配血、临床化学分析物以及即时检验（POCT）时，风险优先数（RPN）显著降低。
