Risk analysis applied to the process of managing medical single use devices in a hospital pharmacy department.

Introduction: During the COVID-19 pandemic, single use medical devices' supply (SUMD) was marked by repetitive and unforeseen interruptions. The present study aimed to determine the risks related to the processes of management of medical devices in our CHU according to a method of failure mode, effect and criticality analysis (FMECA).

Methods: Qualified healthcare professionals were recruited to form a multidisciplinary consensus committee. By analyzing the process map, all failure modes, causes and consequences were identified through brainstorming meetings. They were then classified taking into account the criticality index (CI) calculated according to three parameters: frequency, severity, and detectability. The prioritization was carried out by considering the mean and the median values of the CI as limits. Corrective and preventive actions were then proposed.

Results: A total of 49 failure modes were identified, accumulating 4466 criticality points. The most critical step is that relating to the inter-depot order with a CI equal to 783 points. An action plan was developed, allows us to control 64% of the overall criticality of the risks linked to the process. Three main lines of action have been proposed: continuous training, especially for managerial and administrative tasks, logistical improvement (architectural reorganization and implementation of systems for securing the circuit of SUMDs) and support for the digitization of hospital pharmacy.

Conclusion: The FMECA is a consensual method, which makes it possible to propose actions in order to reduce the risks linked to the process of managing medical devices. Optimizing the estimation of needs, strengthening communication with stakeholders and securing the circuit are essential to guarantee the availability of SUMDs for the benefit of the patient.