Device-vigilance and environment of the medical practice

Abstract

Introduction: The Device-vigilance (DV) manages incidents or risk of incidents related to the use of medical devices (MD). In Tunisia, absence of a regulatory framework organizing DV is the major obstacle to caregivers’ involvement in this system.
Objective: 1/Compare knowledge, attitudes and practices of our UHC’s physicians regarding the establishment of DV system (medical versus surgical) and 2/Detect effect of healthcare’s environment on risk’s perception linked to the use of MD.
Methods: It is a descriptive cross-sectional and comparative study type knowledge, attitudes and practices; among all physicians of our UHC who are users of MD during their practice.
A self-administered pre-established pre-tested questionnaire has been established. Data seizure and analyzing was performed using SPSS software20.0. Test adopted was the X2 (Pearson)(p<0.05) with correction using Yates or exact test Fischer.
Results: A statistically significant difference in favor of physicians exercising in medical services is reported for the knowledge of standardized reporting form’s existence(p=0.04).
Physicians practicing in surgical services report incidences and risk of incidences regarding MD use significantly more than their colleague of medical services. For attitudes, surgical physicians perceive the responsible of the reporting as any caregiver (p=0.007).As for the practices, they are for the presence of MD’s organized management in the service of exercise(P<10-4).
Conclusion: At any healthcare environment, lack of knowledge, inadequacy of the attitudes and readjustment of practices among our physicians must be filled. The promulgation of regulatory texts is necessary in order to promote DV’s sector of and to ensure the safety of both patients and caregivers.