用失效模式、影响及危害度分析法研究PET应用程序中的人为因素

Failure mode, effects and criticality analysis research on human factors in clinical PET application

目的通过对临床正电子发射断层显像（PET）应用程序中的人因分析，找出较高风险的步骤并提出针对性措施，降低职业人员的潜在照射风险。方法采用现场调查、填写调查表、建立失效模式影响及危害度分析表、专家评估的方法获得基本资料，并对其进行统计分析。比较分别配备自动分装设备和手动分装设备医院工作流程的相对风险。结果通过临床PET应用程序分析，获得了其中的10个相对高风险步骤，其中有8个步骤存在于化学合成的工作中，并提出风险控制措施。比较配备自动分装设备和手动分装设备医院的工作流程，相对风险值分别为2．28±0．99和3．20±2．01，差异有统计学意义（t=2．56，P〈0．05）。化学合成工作中，有76％的步骤采用手动分装模式的相对风险值大于自动分装模式。结论失效模式、影响及危害度分析（FMECA）方法应用于临床PET应用程序中的风险评估是有效的，对其风险控制提供了重要依据。

Objective To identify the steps with potentially higher risk through the analysis of human factors in clinical PET application so as to provide the efficient measures to reduce the risk of potential exposures. Methods The basic data were obtained through field investigation, questionnaire, failure mode, risk identification, FMECA and expert＇s evaluation, with statistical analysis made. Comparison was made of the relative risk values of automatic encapsulation equipment and manual encapsulation ones. Results The 10 steps with potentially higher risks were identified through analyzing human factors of clinical PET application, of which 8 occurred in the phase of chemical synthesis. The measures to control risk were addressed for the steps with higher risk. The results show that the relative risk value of the clinical process with automatic encapsulation equipment was 2.28 ＋ 0. 99 and the one with manual encapsulation equipment was 3.20 ±2. 01 （t =2.56,P 〈0.05） , with the latter being 76% of the former. Conclusions Failure mode and FMECA are effective in risk evaluation of clinical PET application, which can provide important basis for risk control.