Security FMECA as method to assess the exposure risk of healthcare worker to residual cytotoxic drug contaminations on workplace surfaces

6 October 2017

L. Lê1,2, D. Martinez1, P. Prognon1,2, E. Caudron1,2 1 Service Pharmacie, Hôpital européen Georges Pompidou, AP-HP, Paris, France
2 Lip(Sys)2, Chimie analytique pharmaceutique, Université Paris Sud, Paris Saclay, Chatenay-Malabry, France


Exposure of healthcare workers who daily handle cytotoxic, mutagenic or teratogenic drugs constitutes an important issue in compounding unit regarding the quantity of handled drugs. Because workplace surfaces represent the main risk of exposure, an analysis of the safety of the process based on FMECA (failure modes effects and criticality analysis) was conducted.


This method conducted by a multidisciplinary team from 2011 to 2017 have evaluated a priori risk of exposure of the chemotherapy compounding process, from the raw material reception to final product delivery. After identification of failure modes, risks were quantified by the risk priority number (RPN) calculated from the environmental residual contamination, protective equipment and the duration of exposure of each operator; and then hierarchized to annually revised corrective actions.


25 potential failure modes were identified and since 2016, 16 corrective actions principally focused on the awareness of operators and improvement of practices were applied. In 2011, the cumulated risk was 912 with inacceptable risk observed for pharmacy technicians and cleaning technicians; and tolerable under control risks for other operators. In 2017, the cumulated risk was decreased at 272 (-70%) with acceptable risks for all operators despite a 20% increase in our activity.


This standardized method allows the evaluation of the most critical situations in our unit to prevent and anticipate the risk of occupational exposure to cytotoxic drugs. RPN as a quality indicator contributes to identify, prioritize and reduce risk associated to the cytotoxic compounding drug process before incidents occur.

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