Materiovigilance in health centers: The role of notifiers to ensure safer use of medical devices

Abstract

Background: The implementation of efficient health and vigilance strategy is one of the essential aspects of the health policy of public and private health establishments, in order to reduce the risk of incidents due to medical devices.

Aim: The objective of this study is to demonstrate the importance of user notification and to recognize the role of nursing staff in the materiovigilance process.

Methods: This is a retrospective study of materiovigilance cases notified for three years (2016, 2017, and 2018) at the National Institute of Oncology. The evaluation of the incidents was carried out with the aim of taking the necessary measures to prevent and minimize risk.

Results: Seven thousand three hundred and eight cases of materiovigilance during the 3 years were collected. A spontaneous collection of reports was predominant (70%). The distribution of the number of incidents by the profile of notifiers shows that reports come from surgeons and much more from nurses. The surgical block (35.7%) and medical oncology services (14.3%) were the services that reported more; the majority of the observed adverse events were attributed to infusion sets (n=7105). Four serious cases of materiovigilance. reported during these 3 years at the level of the vigilance unit considered the most relevant were detailed with examples of immediate actions taken and risk minimization actions.

Conclusion: This study highlights the characteristics of incidents reported. The role of the nursing staff and the strong presence of nurses in the vigilance system has been well demonstrated, thus reducing the risk of side effects due to medical devices.

Keywords: Declarations; Dispositifs médicaux; Déclarations; Health care personnel; Infirmières; Materiovigilance; Matériovigilance; Medical devices; Nurses; Personnel de santé.