Background and importance During the COVID-19 pandemic, the management of medical devices was foreseen by repetitive and unforeseen breaks. To optimise management a risk analysis is necessary.

Aim and objectives The present study aimed to determine risks related to the medical devices management processes in our teaching hospital according to a failure mode and effects analysis (FMEA) method.

Material and methods Skilled health care professionals were recruited to form a multidisciplinary study team (pharmacists, nurses, administrative agent, and pharmacy technician). They proceeded to draft the process cartography. They defined all related failure modes that could occur indicating causes and consequences through brainstorming meetings. These failure modes were classified considering the criticality index (CI) calculated according to the indices: severity of the potential effect, detection probability, and likelihood of occurrence. Prioritisation was carried out considering the mean and the median values of CI as limits. Corrective and preventive actions were then proposed.

Results A total of 44 failures modes were defined accumulating 4176 points of criticality. CI values ranged from 12 to 336. The step of delivery processing exhibited the highest median CI with a value of 120 (min = 63 – max = 144) followed by the ordering step with a median CI value of 80 (min = 27 – max = 144). The highest CI was related to the failure mode ‘erroneous estimate of need when defining the purchasing framework’ with CI value of 336. Sixteen (36%) failure modes were considered as critical, 6 (14%) as failure modes to control and 22 (50%) as acceptable. After prioritisation, three main axes to act were proposed: architectural reorganisation (by securing premises, organisation of flows, and strengthening of storage capacity), improvement of the medical device management software, and setting up a monitoring system for the conduction of the various purchasing frameworks.

Conclusion and relevance The FMEA method was a consensual tool that permits proposal actions reducing risks related to the medical devices management process. Optimising the prediction of needs, strengthening communication with user services, and securing access are essential to guarantee the availability of medical devices for the ultimate benefit of the patient.

Conflict of interest No conflict of interest