Retrospective and FMECA analysis of failures in closed-system devices.

INTRODUCTION: Cytotoxic drugs can be hazardous to healthcare workers involved in their preparation and/or administration. Exposure occurs during routine handling of drug vials and ampoules, preparation, administration and disposal of cytotoxic waste. The use of closed-system devices provides protection against exposure to cytotoxics, but these devices are the subject of numerous incidents. Given the nature of the drugs they contain, these incidents can be dangerous for the personnel handling them. OBJECTIVE: The aim of our study is to analyze material vigilance data relating to problems frequently encountered with the various consumables of the closed system and to assess the risk of exposure of personnel to cytotoxic drugs when using these using the Failure Mode and Criticality Analysis (FMECA) method. MATERIALS AND METHODS: Our study was conducted at the pharmacy of the National Institute of Oncology, the closed system drug transfer device (CSDT) used is a ChemoClave-ICU®, This device is mechanical and needleless For the materiovigilance study we carried out a retrospective study over the period from 2019 to 2022, analyzing materiovigilance data collected by National Institute of Oncology's materiovigilance and pharmacovigilance cell. Our team, trained in the FMECA method, conducted the study over a three-month period, between September and November 2022. The method was used to assess the risks incurred by staff when using the CSDT device to prepare cytotoxic drugs. CONCLUSION: Our study revealed that the most frequent incident was linked to a manufacturing defect in the device in question. According to the FMECA analysis, this incident represents a major risk, as its occurrence hampers the cytotoxic preparation process. CSDT have the advantage of being easy to use and acceptable to staff, but standards need to be developed and validated to assess the performance of these devices.

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

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.