The Versatility of Medical Thermoplastic Urethanes
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. TPUs are copolymers of hard and soft segmented molecular chains that exhibit […]
Medical Plastics That Reduce Hospital Infections
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 […]
Sterilization Technologies for Medical Devices
Definition: The three primary methods for sterilizating medical devices include radiation, ethylene oxide and steam. Device type, quantity to be sterilized and packaging are a few considerations for selecting the appropriate method. Polymers used in the device components must also be considered, since some can degrade or diminish in functionality from the sterilization process. Purpose: Provide an […]
The Language of Medical Catheter Polymers
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 […]
Overview of Medical Polymers
Definition: Thermoplastics play a critical role in modern medical devices. Amorphous and crystalline thermoplastics offer distinct performance properties. Within these categories are a variety of specific polymers suitable for a wide range of device components. Purpose: An overview of amorphous and crystalline thermoplastics, along with specific examples and attributes for each category. View Presentation
Regulatory Considerations for Medical Polymers
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. 21 CFR Color Additives Color additives include dyes and pigments derived from vegetables, animals, minerals or other sources that impart color […]
Color Additives for Medical Device Plastics
Definition: Pre-color compounds and color concentrates for medical applications are most commonly manufactured using two categories of color additives: FDA Food Contact Pigments, and FDA Medical Device Pigments. The selection of one pigment classification over the other may affect the FDA approval process for medical devices. Purpose: Selection of pigments suitable for medical device plastics View Presentation
Material Price v. Component Cost
Thermoplastics are sold by unit weight (e.g., $/lb, €/kg). However, the material cost for a plastic component must consider component volume and density of the plastic. For thermoplastics, density is reported as ‘specific gravity.’ Specific gravity is the ratio of the density of the thermoplastic to the density of water (i.e., SGP = DP/DW). The density […]
Polymer Compounding Basics
Definition: Upgrading or adding value of polymers or polymer systems through melt blending & mixing of additives into a polymer matrix or melt mixing two or more polymers together to make an alloy Purpose: Tailor properties to satisfy a specific applications requirements View Presentation
Polysulfones in Healthcare Applications
Elastomeric polymers offer flexibility to navigate complex anatomical pathways via catheters. Modulus, a measure of strength relative to elongation, is the material property that provides a relative comparison of flexibility for these materials. A low modulus implies greater flexibility and is often correlated with lower hardness (Shore scale A and/or D). However, many structural medical […]