title: [New medical device hospital assessment: what kind of clinical data?].
abstract: BACKGROUND
  Since 2003, the AP-HP medical devices committee (CODIMS) assess the therapeutic relevance of innovated medical device (MD) for the French AP-HP hospitals' group. To accomplish this task, the CODIMS asks manufacturers to bring out clinical arguments to justify the use of their MD in hospital. This work analyses retrospectively after 8years, all assessed MD until March 2011 and the scientific quality of the clinical data submitted by manufacturers to the CODIMS to purchase their MD.
  
  
  METHODS
  All MD were classed according to their certification's level (I, IIa, IIb, III, DMIA). The quality of available clinical studies (CS) provided by manufacturers for each case was assessed and classed according to five clinical relevance levels based on the evidence-based medecine standards (1-2: high methodology; 3-5: low methodology).
  
  
  RESULTS
  One hundred and three MD files (80 % of class IIb and III MD) were analysed by the CODIMS (630CS). Our results highlight the lack of relevance of files that are provided to assess innovated MD: 29 files without any CS; concerning class IIb (32DMS, 221CS) and III (50, 342CS) MD, only 6 % of CS presented a correct clinical relevance level. And the situation did not get better during this assessment period.
  
  
  CONCLUSIONS
  The CODIMS deplore the poor clinical relevance of files provided to assess MD (wrong comparator, inappropriate ends-points, insufficient follow-up to assess long-term security, small population studied). Future legislative developments for MD assessment are expected to improve this situation.
authors.affiliation: helene.beaussier@gmail.com
authors.forename: H
authors.initials: H
authors.lastname: Beaussier
authors.forename: H
authors.initials: H
authors.lastname: Junot
authors.forename: S
authors.initials: S
authors.lastname: Lancrenon
authors.forename: P
authors.initials: P
authors.lastname: Faure
mesh_terms: D002568:Certification; D002986:Clinical Trials as Topic; D018795:Device Approval / Q000331:legislation & jurisprudence / Q000592:standards*; D004864:Equipment and Supplies / Q000145:classification / Q000592:standards; D019317:Evidence-Based Medicine; D005602:France; D006761:Hospitals; D006801:Humans; D012189:Retrospective Studies