title: Adverse events with medical devices in anesthesia and intensive care unit patients recorded in the French safety database in 2005-2006.
abstract: BACKGROUND
  French regulations require that adverse events involving medical devices be reported to the national healthcare safety agency. The authors evaluated reports made in 2005-2006 for patients in anesthesiology and critical care.
  
  
  METHODS
  For each type of device, the authors recorded the severity and cause of the event and the manufacturer's response where relevant. The authors compared the results with those obtained previously from the reports (n = 1,004) sent in 1998 to the same database.
  
  
  RESULTS
  The authors identified 4,188 events, of which 91% were minor, 7% severe, and 2% fatal. The cause was available for 1,935 events (46%). Faulty manufacturing was the main cause of minor events. Inappropriate use was the cause in a significantly larger proportion of severe events than minor events (P < 0.001) and was usually considered preventable via improved knowledge or device verification before use. Compared to with that in 1998, the annual number of reported events doubled and the rate of severe events decreased slightly (12-10%, P = 0.03). The rate of events related to manufacturing problems remained stable (59-60%, P = nonsignificant), and the rate of events caused by human errors was 32-42% (P = 0.01). There were no changes in the mortality rate (2% in both studies).
  
  
  CONCLUSIONS
  The number of adverse events related to medical devices indicates a need for greater attention to these complex pieces of equipment that can suffer from faulty design and manufacturing and from inappropriate use. Improvements in clinician knowledge of medical devices, and to a lesser extent improvement in manufacturing practices, should improve safety.
authors.affiliation: Pôle d'Anesthésie Réanimation of the Centre Hospitalier Universitaire, Université d'Angers, Angers Cedex 9, France. lbeydon.angers@invivo.edu
authors.forename: Laurent
authors.initials: L
authors.lastname: Beydon
authors.forename: Pierre Yves
authors.initials: PY
authors.lastname: Ledenmat
authors.forename: Christophe
authors.initials: C
authors.lastname: Soltner
authors.forename: Frédéric
authors.initials: F
authors.lastname: Lebreton
authors.forename: Vincent
authors.initials: V
authors.lastname: Hardin
authors.forename: Dan
authors.initials: D
authors.lastname: Benhamou
authors.forename: François
authors.initials: F
authors.lastname: Clergue
authors.forename: Gérard
authors.initials: G
authors.lastname: Laguenie
mesh_terms: D000758:Anesthesia / Q000009:adverse effects*; D000765:Anesthesia, Conduction / Q000009:adverse effects; D000776:Anesthesiology / Q000295:instrumentation*; D003422:Critical Care; D016208:Databases, Factual; D004868:Equipment Failure; D004864:Equipment and Supplies / Q000009:adverse effects*; D005602:France / Q000453:epidemiology; D017052:Hospital Mortality / Q000639:trends; D006801:Humans; D007362:Intensive Care Units; D019300:Medical Errors / Q000706:statistics & numerical data* / Q000639:trends; D011358:Product Surveillance, Postmarketing; D012449:Safety