Medical Materials Blog

Polymers in Implantable Applications

There are four leading classes of biomaterials used in implantable applications, including metals, ceramics, composites and polymers. The use of one material type over the other varies greatly based on a range of criteria, including functional use, performance requirements and cost.

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 …

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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. …

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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 …

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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 …

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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 …

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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 …

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