Medical Devices: Evidence and Research (Jun 2011)
Mechanical performances of elastomers used in diffusers
Abstract
Gérard Guiffant1, Jean-Jacques Durussel1, Patrice Flaud1, Jean-Pierre Vigier1, Christian Dupont2, Philippe Bourget3, Jacques Merckx11University Paris Diderot, Paris, France; 2University Teaching Hospital Cochin, Paris, France; 3University Teaching Hospital Necker-Enfants Malades, Paris, FranceAbstract: The use of elastomeric diffusers (EDs) has grown together with the expansion of home care. In these devices, the fill volume of the drug reservoir and the flow rate are preset and cannot be modified. The elastomer, which makes up the reservoir walls, is what makes the infusate flow due to the pressure it exerts. The purpose of this work was to quantify, under standardized experimental conditions and following recommended conditions of use, the mechanical performances of the 2 commonly used elastomers (silicone and polyisoprene) and their impact on infusion flow rate consistency. Results show that they exhibit different mechanical performances which leads to concerns regarding the use of these devices for some intravenous (IV) therapies.Keywords: elastomeric diffusers, perfusion, drug administration rate, infusion flow, infusion devices