title: [Device-vigilance at University Hospital in Central Eastern Tunisia: a survey conducted among physicians].
abstract: BACKGROUND
  The University Hospital Farhat Hached Sousse (Tunisia), has implemented a device-vigilance (DV) system, according to ANCSEP (National Agency of the Sanitary and Environmental Control of Products) guidelines, in order to manage the risk more effectively in hospital and to improve the quality and safety of patient care. In Tunisia the lack of regulation regarding device vigilance is the major obstacle to caregiver vigilance. The objective of this study is to establish the knowledge, attitudes, and clinical practice of University Hospital physicians regarding the implementation of the DV system.
  
  
  METHODS
  We conducted a descriptive cross-sectional study of KAP (knowledge, attitudes and practices) among all the physicians working at the University Hospital Farhat Hached Sousse (Tunisia) who were users of medical devices (MDs) in the practice of their profession. A self-administered, pre-established and pre-testing questionnaire was developed. Data were collected and analyzed using SPSS20.0 software.
  
  
  RESULTS
  The response rate was 51.9 % (183/95). A lack of knowledge about DV has been reported. More than half of the respondents didn't know the local correspondent of health establishment and the existence of a standardized vigilance reporting form. Regarding the attitudes, 89,5% express their interest in setting up a DV system and 37,5% acknowledged that the vigilance reporting form should be filled by the caregiver notifying the incident. Regarding the procedures, the majority of physicians confirmed the absence of an organized maintenance management of the MDs in the practice of their services. 90.5% express their wishes to receive information but few of them express their wishes to receive proper training (57.9%).
  
  
  CONCLUSIONS
  A lack of information and training in a sensitive field which need to be heavily regulated has been a topic of discussion. The promulgation of regulatory texts is necessary in order to promote MD sector and guarantee the safety of patient and their users.
authors.affiliation: Service d'Hygiène Hospitaliére, CHU Farhat Hached, Sousse, Tunisie.
authors.forename: Mohamed
authors.initials: M
authors.lastname: Mahjoub
authors.affiliation: Service de Médecine Légale, CHU Farhat Hached, Sousse, Tunisie.
authors.forename: Maher
authors.initials: M
authors.lastname: Jedidi
authors.affiliation: Service de Médecine Légale, CHU Farhat Hached, Sousse, Tunisie.
authors.forename: Tasnim
authors.initials: T
authors.lastname: Masmoudi
authors.affiliation: Service d'Hygiène Hospitaliére, CHU Farhat Hached, Sousse, Tunisie.
authors.forename: Nabiha
authors.initials: N
authors.lastname: Bouafia
authors.affiliation: Service d'Hygiène Hospitaliére, CHU Farhat Hached, Sousse, Tunisie.
authors.forename: Mansour
authors.initials: M
authors.lastname: Njah
mesh_terms: D000328:Adult; D001291:Attitude of Health Personnel; D003430:Cross-Sectional Studies; D004864:Equipment and Supplies / Q000592:standards*; D005260:Female; D017408:Guidelines as Topic; D007722:Health Knowledge, Attitudes, Practice; D006785:Hospitals, University; D006801:Humans; D008297:Male; D008875:Middle Aged; D010820:Physicians / Q000523:psychology* / Q000592:standards; D011358:Product Surveillance, Postmarketing; D012308:Risk Management / Q000379:methods; D011795:Surveys and Questionnaires; D014416:Tunisia
keywords: Physicians; attitudes; device-vigilance; knowledge; medical devices; procedures