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Biomedical Polymers and Compounds™

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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.

PVC Remains Relevant in Medical Devices

Posted: November 22, 2017

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 advisory warning regarding the health risks of PVC several years ago; however, this has not stopped the use of this economical polymer in the competitive medical device market.

The Versatility of Medical Thermoplastic Urethanes

Posted: November 17, 2017

Thermoplastic urethanes (TPUs) fall within a class of materials known as thermoplastic elastomers (TPEs).  Yet, TPUs comprise a class of materials unto themselves due to versatility in the polymer chemistry.  As such, there are many types of medical TPUs, with distinctly different properties. 

Medical Plastics That Reduce Hospital Infections

Posted: November 9, 2017

One out of every 25 patients in U.S. acute care hospitals contract a health care associated infection, according to a survey by the Center for Disease Control (CDC).  One in every four of these are associated with medical devices. In-dwelling devices, such as central venous (CV) catheters, are particularly susceptible to bacteria colonization which can enter the blood stream.  Antimicrobial additives can be melt compounded into plastics to kill harmful bacteria on the surface of device components.

The Language of Medical Catheter Polymers

Posted: November 2, 2017

Durometer is arguably the most common polymer attribute discussed by medical catheter engineers.  For example, an ‘80A thermoplastic polyurethane (TPU)’ reference includes the durometer: 80, A scale. A measure of polymer hardness, durometer is directly applicable to certain catheter requirements. Soft polymer tips minimize vascular trauma. Harder catheter liners are necessary to resist abrasion from wires and instruments. Durometer also correlates to modulus, a measure of polymer flexibility that is important for catheter shafts.

Regulatory Considerations for Medical Polymers

Posted: October 25, 2017

Polymers used for medical devices must meet regulatory requirements specific to the application and geographic region.  Engineers and product designers should be aware of these regulations when specifying polymers for use in medical devices.

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