[Assessment of medical devices for home infusion]

Haute Autorité de Santé
Record ID 32016000259
Authors' objectives: For medical devices to be covered by the health insurance system, they need to be included on the list of products and services qualifying for reimbursement (LPPR). Products are included either under a common description covering a class of products (generic description) having the same indications or in the form of an individual entry with the product's commercial name (brand name). The National Committee for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) of the HAS is responsible for the medical assessment of these products. In particular, it periodically reassesses these generic descriptions. The review of the generic descriptions "Medical devices for home infusion" is the topic of this document; the services associated with the devices were also reassessed. On the occasion of this review, CNEDiMTS did not consider it appropriate to reassess external, portable and programmable insulin pumps on account of their recent entry (order of 17 July 2006) into the LPPR. Likewise, medical devices used for home parenteral nutrition were not included in this report because of their recent assessment by another working group (opinion of the HAS on home parental nutrition - current situation and methods of management, May 2008).
Authors' recommendations: Home-based infusion is an alternative to hospitalisation. This practice must nevertheless be strictly supervised in view of the risks of infection or of misuse. In particular, CNEDiMTS notes the importance of the application of standard precautions and rules of hygiene on account of the risk of infection associated with the routes of access used, regardless of whether these are peripheral or central. On the basis of the working group's opinion, CNEDiMTS recommends in particular: - to consider medical devices for home-based infusion as carriers for medicinal products and labile blood products and thus to make their coverage come under that for the products or medicinal products that have been prescribed, - the use of devices secured by healthcare professionals, - washing of hands by healthcare professionals before providing care, this practice being an elementary hygienic measure. The proposed nomenclature includes all devices considered by CNEDiMTS to be necessary for home-based infusion regardless of the different methods of management. In the absence of medico-technical arguments, CNEDiMTS has not pronounced on the following points: - listing for purchase or renting of medical devices for home-based infusion on the LPPR, - the supply of devices individually or as sets, - the sterile or non-sterile nature of the gloves used during care associated with the peripheral route, - the criteria for the assignment of different types of infusion pumps. The assignment of the pump should respond to the specific needs of the prescribed therapy; in order to respond to this need, the various types of pumps need to be made available
Project Status: Completed
Year Published: 2010
English language abstract: An English language summary is available
Publication Type: Not Assigned
Country: France
MeSH Terms
  • Humans
  • Equipment Safety
  • Infusion Pumps
  • Health Personnel
  • Hygiene
  • Gloves, Protective
Organisation Name: Haute Autorité de Santé
Contact Address: 2 avenue du Stade de France, 93218 Saint-Denis La Plaine Cedex, France. Tel: +33 01 55 93 71 88; Fax: +33 01 55 93 74 35;
Contact Name: has.seap.secretariat@has-sante.fr
Contact Email: has.seap.secretariat@has-sante.fr
This is a bibliographic record of a published health technology assessment from a member of INAHTA or other HTA producer. No evaluation of the quality of this assessment has been made for the HTA database.