Background and importance In the case of non-centralised sterilisation units, there is a lack of understanding of the effectiveness of different steam sterilisation processes. In such cases, the risk of failure is major. This may lead to the non-sterility of treated medical devices which can affect patient health.

Aim and objectives The aim of the study was to determine the risks related to the steam sterilisation processes in non-centralised sterilisation units of our teaching hospital according to a failure mode and effects analysis (FMEA) method.

Material and methods Healthcare professionals were recruited to form a multidisciplinary study team. They proceeded to build the process cartography and the cause–effect diagram. Then, they were divided into small groups, and each one worked on one step or field. By adopting brainstorming meetings, the groups defined all related failure modes that could occur, indicating causes and consequences. These failure modes were classified based on the criticality index (CI) calculated according to the following parameters: severity of the potential effect, detection probability and likelihood of occurrence. Prioritisation was carried out by adopting the median and mode values of CI as limits and pertinent corrective and preventive actions were then proposed.

Results A total of 135 failures modes were detected, accumulating 17 790 points of criticality. CI values ranged from 36 to 288. The step of autoclaving exhibited the highest median CI with value of 170, followed by the sterilisation package step, with a median CI value of 147. The highest CI was related to the failure mode ‘autoclave not qualified’ with a CI value of 288. Sixty-eight (67%) failure modes were considered as critical, 39 (22%) as failure modes to control and 28 (11%) as acceptable. After prioritisation, three main action were defined: writing of the documentary system, training of personnel and qualification of the autoclaves.

Conclusion and relevance The applied FMEA method was useful to prioritise actions in order to efficiently minimise risks related to the steam sterilisation process. Training personnel on steam sterilisation units strengthens their knowledge on hazards and good practices, and is essential to guarantee the safety of both personnel and patients.

References and/or acknowledgements We thank all members of the multidisciplinary team for their involvement in the project.

No conflict of interest.