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

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.