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Biomedical Polymers and Compounds™

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FDA Biological Testing of Medical Device Materials

Posted: March 9, 2018

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. 

Thermoplastic Polyesters in Medical Devices

Posted: March 1, 2018

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.

Fluoropolymers in Medical Catheters

Posted: February 16, 2018

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.

Nano Reinforcement of Medical Polymers

Posted: February 2, 2018

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 far more effective. 

Material Changes for FDA Regulated Medical Devices

Posted: January 19, 2018

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.

Silicones in Medical Devices

Posted: January 10, 2018

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 to semi-rigid implants. 

Catheter Pushability and Navigation

Posted: January 1, 2018

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.

Insulation Properties of Medical Plastics

Posted: December 14, 2017

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.

FDA and ISO Standards for Medical Devices

Posted: December 7, 2017

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 and Cosmetic Act and defined in section 21 part 820 of the Code of Federal Regulations (21 CFR part 820).

FDA Regulatory Requirements for New Medical Devices

Posted: November 29, 2017

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.

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