title: [Introduction of Health technology assessment at hospital].
abstract: BACKGROUND
  The Medical Devices Committee (CODIMS) of the Assistance publique-Hôpitaux de Paris (AP-HP) is responsible for deciding whether innovative and costly sterile medical devices (SMD) should be adopted for the AP-HP network and for issuing recommendations on their proper use. The aim of this study was to qualify retrospectively the level of evidence of clinical studies used for the device evaluations by the CODIMS in 2012 and 2013 and to analyze the relationship between levels of evidence and decisions.
  
  
  METHODS
  Executive summaries written in 2012 and 2013 about studied SMD was analyzed and the level of evidence of clinical studies used was qualified in high/low levels of evidence according to the scale of Sackett et al. Then, levels of evidence were correlated to decisions published by the CODIMS.
  
  
  RESULTS
  Sixty-one files of SMD (72.1% of implantable MD) have been evaluated (225 clinical studies). Among them, only 28% of clinical studies had a high level of evidence (and 28.6% of MD at-risk) and 18% did not have any clinical studies. The CODIMS delivered an unfavourable opinion for 16 SMD: only 28 clinicals studies were available for evaluation. Among these, only 6 studies had a high level of evidence.
  The amount and level of evidence of clinical studies is naturally correlated to admittance of SMD. These findings suggest that the clinical evidence used to demonstrate safety and efficacy for high-risk medical devices is based on clinical studies with poor quality data, making more difficult the evaluation of SMD in hospital. The development of a multi-criteria tool to help decision-making would improve the process of SMD evaluation by the CODIMS.
authors.affiliation: Centre hospitalier Montperrin, 13617 Aix-en-Provence, France. Electronic address: aurelie.boudard@gmail.com.
authors.forename: A
authors.initials: A
authors.lastname: Boudard
authors.affiliation: Agence générale des équipements et des produits de santé, 75005 Paris, France. Electronic address: anne-laure.cordonnier@eps.aphp.fr.
authors.forename: A-L
authors.initials: AL
authors.lastname: Cordonnier
authors.affiliation: Hôpital européen Georges-Pompidou, 75015 Paris, France. Electronic address: nicolas.martelli@aphp.fr.
authors.forename: N
authors.initials: N
authors.lastname: Martelli
authors.affiliation: Agence générale des équipements et des produits de santé, 75005 Paris, France. Electronic address: philippe.lechat@aphp.fr.
authors.forename: P
authors.initials: P
authors.lastname: Lechat
authors.affiliation: Agence générale des équipements et des produits de santé, 75005 Paris, France. Electronic address: martine.sinegre@aphp.fr.
authors.forename: M
authors.initials: M
authors.lastname: Sinègre
authors.affiliation: Hôpital européen Georges-Pompidou, 75015 Paris, France. Electronic address: judith.pineau@aphp.fr.
authors.forename: J
authors.initials: J
authors.lastname: Pineau
mesh_terms: D004864:Equipment and Supplies; D019317:Evidence-Based Medicine; D006739:Hospital Administration; D006801:Humans; D010297:Paris; D012189:Retrospective Studies; D013673:Technology Assessment, Biomedical
keywords: Clinical studies; Dispositif médical; Evaluation; Hospital; Hôpital; Level of evidences; Medical devices; Niveau de preuve; Études cliniques; Évaluation