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使用故障模式影响及危害性分析(FMECA)方法对中心细胞毒性药物制备单元人员暴露的风险评估。

Risk assessment of personnel exposure in a central cytotoxic preparation unit using the FMECA method.

机构信息

Faculty of Medicine and Pharmacy, Mohammed V University, Rabat, Morocco.

Ibn Sina University Hospital, Rabat, Morocco.

出版信息

J Oncol Pharm Pract. 2023 Dec;29(8):1884-1892. doi: 10.1177/10781552231153625. Epub 2023 Jan 31.

Abstract

INTRODUCTION

Personnel involved in the preparation of cytotoxics are exposed to them and the resulting risks. To protect themselves, many means of protection are currently implemented. Nevertheless, the exposure of these manipulators remains a possibility to be considered.

MATERIALS AND METHODS

The study was conducted during the period (October-November 2022) in the pharmacy of the National Institute of Oncology (INO), a hospital structure specializing in cancer care. The Failure Mode, Effects and Criticality Analysis method was used to assess the risks of exposure of personnel in a central cytotoxic preparation unit and then calculate the criticality index (CI  =  severity  ×  frequency  ×  detectability). The risks were classified into toxic, traumatic, chemical, and environmental risks. We have cited 12 failure modes of which nine are minor and three are major. The three major modes cited are essentially related to the particulate environment, direct contact and daily passive inhalation of handling.

CONCLUSION

Our study shows that in our institution, the analysis of the risk of exposure of personnel to cytotoxics remains important, hence the interest of automaton in charge of preparations and which will gradually take charge of all the preparations. The existing procedures and the pharmacotechnical equipment used also contribute to protection and risk reduction.

摘要

简介

参与细胞毒素制剂制备的人员会接触到这些制剂,从而面临相应的风险。为了保护自己,目前采取了许多防护措施。然而,这些操作人员仍有可能暴露于其中。

材料与方法

本研究于 2022 年 10 月至 11 月在国家肿瘤研究所(INO)药房进行,该药房是一家专门从事癌症治疗的医院结构。我们使用失效模式、影响和关键性分析方法来评估细胞毒素中央制剂制备单元中人员暴露的风险,然后计算关键性指数(CI = 严重性×频率×可检测性)。风险分为毒性、创伤性、化学和环境风险。我们列举了 12 种失效模式,其中 9 种为轻微失效,3 种为主要失效。列举的三种主要失效模式主要与颗粒环境、直接接触和日常被动吸入处理有关。

结论

我们的研究表明,在我们的机构中,对细胞毒素操作人员暴露风险的分析仍然很重要,因此自动化负责制剂制备具有重要意义,它将逐渐负责所有的制剂制备。现有的程序和使用的制药设备也有助于保护和降低风险。

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