Medical Device Link . Regulatory Guidelines For Biocompatibility Safety Testing

Biomaterials and medical devices constitute an extremely diverse, heterogeneous category of items. Because the use of these products normally entails their direct or indirect contact with patients, there is an obligation on the part of manufacturers to establish the safety of their products before they are marketed. Medical device safety evaluation assesses the risk of adverse health effects due to normal use and likely misuse of a device. Since adverse health effects could result from exposure to the materials from which a device is made, preclinical assessment of the toxic potential of such materials or components is needed to minimize the potential hazard to the patient. A thorough biocompatibility safety testing program will typically comprise in vivo studies supplemented by select in vitro assays. Photo: Northview Biosciences, Inc. Until recently, the regulations governing the manufacture and sale of medical devices varied greatly among countries. Since January 1995, medical devices to be marketed in the European Union (EU) have been required to comply with EU Medical Devices Directive 93/42/EEC, which specifies requirements for safety assessment issues. The purpose of the directive is to promote a single European market for trade in medical devices, while ensuring that users and patients are not exposed to unnecessary risks. At present, safety assessments of medical devices are guided by the toxicological and other studies recommended in the International Organization for Standardization (ISO) 10993-1/EN 30993-1 standard. At present, 17 parts of the standard are either accepted or under preparation. Tests that may be used in an evaluation of medical device biocompatibility include procedures for cytotoxicity, skin sensitization, dermal irritation and intracutaneous reactivity, acute systemic toxicity, subchronic toxicity, mutagenicity, implantation, hemocompatibility, chronic toxicity, and carcinogenicity. This article is an introduction to a relatively new and rather complicated field in toxicology—the toxicological testing of medical devices. The guidelines for