Chemistry and Technology of Polymeric Materials Used In Medical Device
Before 10/4 After 10/4
Member $249 $349
Non-Member $425 $525
Student/Emeritus $40 $50
Course Description: The course begins with an overview of the FDA systems, terminology and guidance documents for: classifications of devices, for obtaining FDA approvals, and for pre-clinical testing including biocompatibility and biodurability testing. Included by example in the foregoing and throughout the course are a broad range of medical devices which are manufactured wholly or substantially from elastomeric and plastic polymeric materials. These include medical latex items such as: gloves, catheters, condoms; urethane, silicone, polyamide, and polyolefin catheters; thermoplastic elastomeric blood tubing; syringes and associated accessories; UHMW and polyurethane orthopedic implants; plastic bottles, packaging and closures; and others. Key properties, chemical characteristics, and testing and analytical methods related to requisite performance characteristics of materials used in a range of products are discussed. Finally, the course reviews methods of material modification through chemical backbone modifications, surface treatments, incorporation of nano materials to achieve properties such as: anti-microbial properties, electrical conductivity, improved blood compatibility, and/ or improved biodurabilty.
Those who should attend include: This is intended as an introductory course for Materials, Quality and Engineering personnel who have limited knowledge of rubber and plastic materials used in medical devices. The course may also be useful to management or sales professionals new to the medical device field. There are no suggested technical pre-requisites for this course, one should need only have a general knowledge of rubber and plastics terminology to benefit to derive a significant benefit.
Instructor: Dave Russell, Akron BioMaterials Inc.