Scientific Online Resource System

Annual for Hospital Pharmacy

A clinical audit of sterile medical devices: A french experience of quality and safety improvement in hospital services

Valeria Vinciguerra, Annie Fagot-Gandet, Cyril Boronad


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.

Full Text


Medical devices - European Commission. files/meddev/2_1_6_ol_en.pdf (accessed 15 Apr 2015).

Sécuriser le cycle des Dispositifs Médicaux Stériles dans les Etablissements de Santé. (accessed 20 Aug 2013).

Sécurisation du cycle des dispositifs médicauxen etablissements de sante, Outil Inter Diag Dispositifs Médicaux Stériles. journees_lille/conferences_lille/15oralelille.pdf (accessed 30 Dec 2014).

Sécurisation du cycle des Dispositifs, Médicaux en Etablissements de Santé, Outil Inter Diag Dispositifs Médicaux Stériles. 2012/12/AT15_TALLA_ANAP_Inter-Diag_Dispositifs-M%C3%A9dicaux-St%C3%A9riles_jiqhs2012.pdf (accessed 30 Dec 2014).

Management of Medical Devices. Areas requiring further strengthening, global forum on medical devices, Bangkok, 2010. 03_medical_devices_management_david_porter.pdf (accessed 28 May 2015).

A guide to clinical audit - Appendix7. wp-content/uploads/2013/ 07/a_guide_to_clinical_audit.pdf (accessed 20 May 2014).

Ministero della Salute Italiano, Dipartimento della qualita“ direzione generale della programmazione sanitaria, dei livelli essenziali di assistenza e dei principi etici di sistema, l’audit clinico. pubblicazioni_1552_ allegato.pdf (accessed 6 Jan 2015).

Maripuu H, Mamoon AA, Kearney MP. An audit of antimicrobial treatment of Нискоer respiratory and urinary tract infections in a hospital setting. Eur J Hosp Pharm 2014;21:139–44.

Dodds LJ. Pharmacist contributions to ensuring safe and accurate transfer of written medicines-related discharge information: lessons from a collaborative audit and service evaluation involving 45 hospitals in England. Eur J Hosp Pharm 2014;21:150–5.

Brøndgaard Nielsen L, Croft Buck T. Clinical pharmacy: developing the role of the pharmacists. Eur J Hosp Pharm 2012;19:547–8.

Audit des systemes d’information hospitaliers aupres d’etablissements representatifs, rapport final, May 2014. detablissements-representatifs/ (accessed 31 May 2015).

Centre Hospitalier de Cannes. cannes-3.html (accessed Jan 2015).

Centre Hospitalier de Cannes. (accessed Apr 2015).


Article Tools
Email this article (Login required)