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A clinical audit of sterile medical devices: a French experience of quality and safety improvement in hospital services
  1. Valeria Vinciguerra1,
  2. Annie Fagot-Gandet2,
  3. Cyril Boronad2
  1. 1Specialization School in Hospital Pharmacy, University of the Studies of Turin, Turin, Italy
  2. 2Hospital Centre of Cannes (Centre Hospistalier de Cannes-CH Cannes), Cannes, France
  1. Correspondence to Dr Annie Fagot-Gandet, Hospital Centre of Cannes (Centre Hospistalier de Cannes-CH Cannes), 15 Avenue des Broussailles—CS 50008, Cannes 06414, France; a.FAGOT-GANDET{at}


Objectives To audit the quality and safe management of sterile medical devices (SMDs), to examine the pharmacist's role in a multidisciplinary team, and to provide an example of hospital staff assessment of SMDs.

Methods SMD management was assessed using the National Agency for Support to the Performance of Health and Medical-Social Establishment tool in the Hospital Centre of Cannes, France, in August 2013. Safety policy in the healthcare establishment, and the SMD cycle in the hospital pharmacy, SMD cycle and care practices in the visceral–vascular–urological surgery care unit were evaluated by four health professionals and three hospital pharmacists. A total of 1850 references to SMDs for the hospital pharmacy and 1110 references to SMDs for the care unit were analysed. The percentage of risk control was defined as: 0–33% ‘low’, 34–66% ‘medium’, 67–100% ‘high’.

Results Risk control was ‘high’ (67%) for the safety policy in the health establishment, ‘high’ (68%) and ‘medium’ (64%) for the SMD cycle in the hospital pharmacy and the care unit, respectively, and ‘high’ (88%) for the care practices. Good scores were obtained in both services.

Conclusions Safety and quality standards were investigated, and satisfied. Training of health professionals and information about, and the presence of, detailed procedures for safety policy and care practices showed good results. The main weak points were a deficit in IT support and a lack of procedures in the SMD cycle. The hospital pharmacist was shown to be a key figure in the multidisciplinary team.

  • Sterile Medical Device Cycle
  • Multidisciplinary work
  • Risk factors
  • Safety

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