Healthcare Associated Infection Prevention

Definition: One in every 25 patients has at least one hospital associated infection.  One in every four of these is related to a medical device, such as indwelling cathters.  Antimicrobial additives, such as ionic silver, can be added to medical plastics to prevent or reduce the infection from these devices. Purpose: Provide an understanding of the causes […]

Foster Corporation Introduces Newest ProPell™ “T” Translucent Compounds

PUTNAM, CT, USA – (September 13, 2018) – Foster Corporation, a leader in polymer solutions for medical devices, introduces its newest technology with ProPell™ “T” which offers lower lubricity and translucency in medical device components when added to lower durometer TPU and Pebax* polyamide elastomer compounds. Similar to the existing ProPell™ product line, ProPell™ “T” offers […]

Foster Appointed Distributor of Repsol Polyolefins

PUTNAM, CT USA – (March 23, 2018) – Foster Corporation, a leader in polymer solutions for healthcare markets, has been appointed distributor of Repsol’s healthcare polyolefins portfolio: polypropylene, polyethylene and ethylene-vinyl acetate (EVA) copolymers for the North American healthcare markets effective January 1, 2018.  Repsol Healthcare® medical grade polyolefins are used in a wide range of healthcare […]

FDA Biological Testing of Medical Device Materials

Prior to marketing a device, the FDA requires biological evaluation to determine potential toxicity resulting from contact of component materials with the body.  The intention of such testing is to ensure device materials do not produce adverse local or systemic effects; are not carcinogenic; or, do not produce adverse reproductive and developmental effects. The specific […]

Thermoplastic Polyesters in Medical Devices

Polyethylene terephthalate (PET) is most commonly used in medical devices such as sutures and implantable textiles.  Polybutylene terephthalate (PBT), an alternative thermoplastic polyester, is also used in medical devices such as injection molded connectors for pulse oximeters, tips for electrosurgical instruments and clips for breathing masks. Polyesters are produced by reacting terephthalic acid with alcohol. […]

Fluoropolymers in Medical Catheters

Fluoropolymers are commonly used for the construction of medical catheters.  Polytetrafluoroethylene (PTFE) is the material of choice for low friction, inner liners of guide catheters used in cardiology and neurology.  Fluorinated ethylene propylene (FEP) is used for vascular access sheaths and shrink tubing. Although used in state-of-the-art medical devices, these materials are not new.  The […]

Nano Reinforcement of Medical Polymers

Enhancing strength and rigidity of polymers used for non-medical applications is often achieved by adding glass, carbon, and other fibrous materials to the polymer during melt compounding.  These fillers are too large for the extremely small geometries and thin wall sections of minimally invasive medical devices.  In such applications, nano clay reinforcement of polymers is […]

Material Changes for FDA Regulated Medical Devices

Changes in formulations of materials used for manufacturing patient-contacting medical devices or device components often require submission of a new 510(k) by the device manufacturer.  This is because formulation changes can affect the biocompatibility, material properties and performance of a device. The FDA defines material formulation changes to include the following: – Changes to the chemical composition […]

Animal Derived Materials in Medical Devices

Definition: Animal Derived Materials (ADMs) include any substance derived from the body of any animal, including fat, flesh, blood, milk and eggs.  ADMs are used in polymers to stabilize formulations, enhance properties and aid in processing.  Recent medical device regulatory trends have increased demand for polymers free of ADMs. Purpose: Provide an understanding of Animal Derived Materials […]