Analysis of Polymers, Additives and Contaminates in Medical Devices using Pyrolysis-GCMS

Polymers and additives are used in a variety of subcutaneous and intravascular medical devices, such as sutures and drug delivery systems. These devices typically can be classified as being either absorbable or non-absorbable by the human body. Natural materials, such as silk and catgut, are largely being replaced by synthetic materials. So, the reliability of these devices relies on the quality and proper application of these synthetic compounds. But regardless of their composition, the materials used are foreign to human tissue and will elicit a foreign body reaction to a greater or lesser degree. This poster will show the analysis of several types of implanted medical devices from different manufacturers using pyrolysis-GCMS. Traditionally, pyrolysis has been used as a technique to identify polymers, which will be shown. But in addition, one or more "pre-pyrolysis" steps will be programmed first so that we can analyze for residual monomers, solvents, additives and contaminates, if present. Undesired contaminates or the incorrect quantity of an additive can often lead to product failure or worse.