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Medical devices (MDs) cover a wide variety of products. They accompany changes in medical practice in step with technology innovations. Innovations in the field of MDs can improve the conditions of use of health technology and/or modify the organisation of care beyond the strict diagnostic or therapeutic benefit for the patients. However, these non purely clinical criteria seem to be only rarely documented or taken into account in the assessment of MDs during reimbursement decisions at national level or for formulary listing by hospitals even though multidimensional models for the assessment of health technologies have been developed that take into account the views of all stakeholders in the healthcare system In this article, after summarising the background concerning the assessment of health technologies in France, a definition of non-clinical criteria for the assessment of MDs is proposed and a decision tree for the assessment of MDs is described. Future lines of approach are proposed as a conclusion.

Resume Les dispositifs medicaux (DM) couvrent une large variete de produits. Ils accompagnent, au gre des innovations technologiques, l’evolution des pratiques medicales. Les innovations dans le champ du DM peuvent ameliorer les conditions d’utilisation de la technologie de sante et/ou modifier l’organisation des soins au-dela du strict benefice therapeutique ou diagnostique pour le patient. Cependant, ces criteres non purement cliniques semblent n’etre que rarement documentes ou pris en compte dans l’evaluation des DM lors des decisions de remboursement au niveau national ou de referencement au niveau des etablissements de sante alors meme que des modeles d’evaluation multidimensionnelle des technologies de sante, prenant en compte le point de vue de l’ensemble des acteurs du systeme de sante, ont ete elabores. Dans cet article, apres avoir rappele le contexte de l’evaluation des technologies de sante en France, une definition des criteres d’evaluation non clinique des DM est proposee et un arbre de decision pour l’evaluation des DM est decrit. Des pistes de reflexion sont proposees en conclusion.

International audience; BACKGROUND: Natural rubber latex is a recognized allergen, but a recent meta-analysis failed to find any association between latex exposure and allergy in health care workers (HCWs). OBJECTIVES: A meta-analysis was carried out under the auspices of the French National Regulatory Authority to assess the allergic risk induced by latex gloves in HCWs. METHODS: The risk of work-related exposure to latex for the development of latex allergy was assessed. Prevalence and incidence rates of latex sensitization or allergy were compared in HCWs and in the general population. Exposure-response relationships were assessed in HCWs. RESULTS: Latex allergy was found in 4.32% (range, 4.01% to 4.63%) of HCWs and in 1.37% (range, 0.43% to 2.31%) of the general population. Latex-positive skin prick test responses ranged from 2.1% to 3.7% in the general population and from 6.9% to 7.8% for the HCWs. HCWs exposed to latex showed an increased risk of hand dermatitis (odds ratio [OR], 2.46; 95% CI, 2.11-2.86), asthma or wheezing (OR, 1.55; 95% CI, 1.15-2.08), rhinoconjunctivitis (OR, 2.73; 95% CI, 1.97-3.81), and at least one generic symptom (OR, 1.27; 95% CI, 1.09-1.47). Sensitization to latex was significantly associated with asthma and rhinoconjunctivitis. By contrast, exposure to latex was not associated with a significantly increased risk of positive skin prick test responses to latex (OR, 1.47; 95% CI, 0.94-2.30). CONCLUSION: HCWs have an increased risk of sensitization and allergic symptoms to latex. CLINICAL IMPLICATIONS: Prevention of latex allergy in HCWs is needed.