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Background Cross-contamination of hospital preparations is one of the most frequent problems in hospitals. It is responsible for quality defects of the drug and the consequences can be very serious. The failure mode and effects criticality analysis (FEMECA) is a simple and effective tool for minimising the high risk related to the cross-contamination of preparations. Purpose The aim is to realise a risk analysis using FEMECA, focused on the preparation process of anti-cancer drugs in a paediatric hospital and to propose corrective and preventive actions in minimising the risks. Material and methods The first step was to carry out a cause-effect diagram (Ishikawa diagram), that facilitates the identification of possible causes of cross-contamination during preparation. After that, we identified all failure modes and possible risks for each step of the preparation process and we listed each failure mode, and assigned a score for likelihood occurrence (1 to 4), severity (1 to 4) and detection (1 to 4). Finally, the risk priority number was calculated by multiplying the three scores and identifying the critical points associated with preparation. The rating of each criterion is based on predetermined rating tables. Results We classified the identified risks according to their criticality, and defined priority areas of work. Thus, the criticality values suggest focusing on five major risks in priority: contamination of the hood; contaminated materials (syringes, serum pouch); bad identification of materials; errors in the use of raw materials; and poor cleaning. Improvement measures have been defined and implemented to reduce major risks to an acceptable level, such as: training preparers in good manufacturing practices; cleaning; biodecontamination of materials before preparation; and development of a cleaning procedure. Conclusion In general, FEMECA gave satisfactory results, with no critical risk and 30% of the major risks decreased after the implementation of corrective and preventive actions. The continuous training of staff, the traceability of each stage of the process and the good organisation of the circuit makes it possible to reduce the risk of cross-contamination and to guarantee good quality preparations that can be administered safely to the patient. References and/or acknowledgements 10.1136/ejhpharm-2018-eahpconf.470 No conflict of interest. |
