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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.
RESUMO
OBJECTIVE: Arteriovenous grafts (AVGs) are frequently needed in hemodialysis (HD) patients with unsuitable superficial veins. First cannulation of standard arteriovenous grafts (sAVGs) still require about 2 weeks after implantation. Early cannulation arteriovenous grafts (eAVGs) were suggested to overcome this shortcoming. The present randomized study proposed to compare the clinical outcomes of sAVGs and eAVGs in HD patients. METHODS: The present single-center randomized clinical study recruited 477 HD patients indicated for AVG creation. They included 236 in the sAVG group and 241 in the eAVG group. Eligible patients were simply randomized and allocated to the studied groups using 1:1 allocation ratio. Blinding was secured using the sealed envelope technique. Enrolled patients were followed up for 12 months. The primary outcome in the present study was primary, primary assisted, and secondary patency rates at 12 months. Other outcome parameters included time to first cannulation, graft complications, and mortality. RESULTS: Comparison between the studied groups regarding the primary outcomes revealed no statistically significant differences. Primary patency rate was 65.7% and 68.0% (P = .58) at 6 months and 53.8% and 56.4% (P = .57) at 12 months in the sAVG and eAVG groups, respectively. Primary assisted patency rate was 70.8% and 69.7% (P = .8) in patients with sAVG and eAVG, whereas the reported rates at 12 months were 59.3% and 61.0% (P = .71), respectively. Secondary patency rate was 78.4% and 73.9% (P = .25) at 6 months and 67.8% and 69.7% (P = .65) at 12 months in the sAVG and eAVG groups, respectively. As expected, patients in the eAVG group experienced significantly earlier cannulation when compared with patients in the sAVG group (median, 3.0 days; range, 1.0-9.0 days vs 19.0 days; range, 15.0-22.0 days; P < .001). CONCLUSIONS: Patients in the eAVG group have comparable outcomes to those in the sAVG group at 12 months with the added advantage of earlier time to first cannulation.