Background and importance Parenteral nutrition (PN) is an intravenous nutrition technique commonly used in intensive healthcare units. Considering the lack of marketed mixtures for the neonatal population, the preparation of PN is an essential, but complex and high risk hospital activity.
Aim and objectives To analyse the risks related to the process of preparing parenteral nutrition bags in the pharmacy department of a university maternity and neonatology hospital.
Material and methods This FMEA was performed in the sterile preparation unit from January to April 2020. A multidisciplinary team was recruited to firstly perform a process mapping followed by related failure mode mapping through brainstorming sessions. Then, the criticality score for each failure mode was determined by collectively voting on a scale from 1 to 10 for each index (severity, occurrence and no detection). The failure modes were prioritised according to the risk priority number (RPN), which is the product of the three indices. Finally, an action plan to control the highest RPN failure modes was developed.
Results We identified a total of 90 failure modes. The RPN ranged from 3 to 630. The rounded mean±SD was 108±60. The failure modes were considered ‘critical’ (n=31) for RPN ≥108, ‘to control’ (n=11) for 60<RPN<108 or ‘acceptable’ for RPN ≤60. The absence of pharmaceutical validation and the absence of agitation after the addition of each component had an RPN of 630. The steps with the highest cumulative criticality and the number of failure modes were production and quality control. The most critical substep was the aseptic filling in a closed system. A list of possible and achievable actions (n=46) was developed for the ‘critical’ and ‘to control’ failure modes with an appointed pilot for each action.
Conclusion and relevance Pharmaceutical validation was one of the most critical steps in our study. The optimal solution would be to invest in integrated commercial software. Production requires most of the improvements. The acquisition of an automated compounding device would minimise the risk. A second FMEA is needed to assess the impact of the changes undertaken. It will allow us to detect residual risks.
References and/or acknowledgements We thank all members of the work team for their involvement.
Gérard Landy. AMDEC guide pratique. 2ème édition. AFNOR.
Conflict of interest No conflict of interest
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