Medical device testing using standardized animal models has long been conducted using muscle, vaginal, penile, oral (cheek pouch), and subcutaneous tissue to evaluate local irritation effects.
EPL pathologists are extensively experienced in the evaluation of the irritation potential of solid devices made from a variety of materials, as well as injectibles and leachables. Beyond experience with these standard irritation tests, our pathologists also evaluate a wide variety of cardiac and vascular devices, including leads, valves, stents, grafts, sealers and drug-eluting and assist devices for efficacy and safety in a number of different species. Occasionally, other tissues such as brain or bone may be the intended target tissue. Many of these studies have grading criteria and scoring systems developed specifically for the study in which analysis of inflammatory cell infiltrates, tissue reactions, and any changes to or degradation of the device are noted.
Guidance documents for the product safety testing and evaluation of medical devices and constituent materials are provided in the ISO-10993 Guidelines, “Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing” and in conjunction with the FDA Bluebook Memorandum G95-1 explaining FDA’s approach to use of the ISO-10993 testing scheme.
