細胞傷害性薬物調製におけるリスク評価：FMECAアプローチ

The preparation of injectable chemotherapy drugs is a critical process, given their toxicity and the large number of stakeholders involved. As such, systematic and proactive risk assessment is required.

To analyze the risks associated with the cytotoxic drug preparation process using the failure mode, effects, and criticality analysis (FMECA) method within a centralized cytotoxic drug preparation unit (CCDPU).

An analytical study was conducted in a CCDPU over a 6-month period. The risk analysis was performed using the FMECA method. An action plan was developed to address critical scenarios. A second FMECA cycle was conducted to evaluate the effectiveness of the implemented actions.

A total of 189 failure modes were identified, of which 2% were deemed unacceptable and 30% were tolerable when controlled. An action plan was developed based on training, double visual inspection, and the implementation of analytical control. During the follow-up FMECA, a reduction of 23% in the overall criticality index was observed, with a significant improvement in criticality levels. Of the 60 actions, 73% were completed, and an updated action plan was proposed.

These results demonstrate the CCDPU team's genuine commitment to risk management and the usefulness of the FMECA method in a continuous improvement approach to the cytotoxic preparation circuit.