Silicones in Medical Devices
Silicones are widely used in medical devices because they are biocompatible, biodurable (do not degrade over time), do not produce extractables (a concern with leaching plasticizers from flexible PVC), and are unlikely to cause allergic reactions (a concern with latex). Medical applications for silicones are far ranging from wound care gels to flexible drainage tubes […]
Catheter Pushability and Navigation
Two common criteria for catheter shafts are pushability and navigation. Pushability refers the force applied by a physician to advance the catheter to the designated therapeutic site. Navigation refers to the ability of the catheter shaft to move freely through the non-linear vascular pathway. To advance a vascular catheter, sufficient push force must be exerted […]
Insulation Properties of Medical Plastics
Plastics are generally considered insulators, but can transmit some electrical energy at higher frequencies. The effectiveness of a material as an insulator is usually measured by dielectric constant and dissipation factor properties. Dielectric constant measures how well an insulator stores electrical energy so as to isolate electrical elements from each other and the ground. This […]
ProPell™ Low Friction Compounds
Definition: ProPell™ low friction compounds use non-migratory additives to enhance the surface of polymer components and reduce friction. This technology is particularly beneficial in soft polymers, such as polyurethanes, which are inherently tacky and have high frictional properties. ProPell™ polymer compounds are USP Class VI compatible and well suited for extrusion and injection molding of medical […]
FDA and ISO Standards for Medical Devices
The Food and Drug Administration (FDA) requires that medical device manufacturers establish and follow quality systems to help ensure products consistently meet applicable requirements and specifications. The quality system regulations (QSR) for FDA regulated products are known as current good manufacturing practices (CGMP). These requirements were first implemented in 1978 under the Federal Food, Drug […]
Bioresorbable Polymer Compounds for Implantable Devices
Definition: Bioresorbable polymers are inherently biocompatible, yet hydrolytically unstable. This allows for applications in temporary implants that are intended to be absorbed and metabolized by the body. A range of physical and degradation properties allows these polymers to be used for applications that include orthopedic fixation, vascular stents, tissue engineering and controlled drug delivery. Common bioresorbable […]
Foster Appointed Distributor of Resirene SMMA Copolymers for Healthcare Market
PUTNAM, CT USA – (December, 5 2017) – Foster Corporation, a leader in polymer solutions for healthcare markets, has been appointed exclusive distributor of Resirene CET® styrene methyl methacrylate (SMMA) copolymers for the United States and Canadian medical markets effective November 1, 2017. Foster will also offer custom compounds based on SMMA copolymers, including custom colors and impact modified […]
Nano Particle Reinforced Polymer Technology for Medical Devices
Definition: Nano clay particles can be added to medical plastics in low loadings to improve rigidity while preserving elongation and surface finish. This is advantageous in thin wall applications, such as catheters which require improved rigidity for pushability. These non-organic, platelet-shaped particles can also improve barrier, thermo-mechanical, flame resistance and processing properties of medical polymers. Purpose: Provide […]
FDA Regulatory Requirements for New Medical Devices
The Food and Drug Administration (FDA) requires that medical devices distributed in the United States must first meet the several requirements. These include facility registration, device listing, device approval, clinical studies, quality systems, labeling requirements and medical device reporting. 1. Facility Registration – Device manufacturers and distributors in the US must register their facility with […]
PVC Remains Relevant in Medical Devices
Polyvinyl chloride (PVC) represents as much as one-third of the volume of polymers used in the manufacture of medical devices. Common device applications for PVC include intravenous (IV) tubing and blood bags. Environmental and health advocates have expressed concerns for years regarding the use of the polymer in medical applications, and the FDA issued an […]