The New Field of Plastics Toxicology - Methods and Results

Abstract

A large number of medical, dental, and pharmaceutical advancements have been made with the use of new plastic materials for a host of items and devices, ranging from artificial heart valves to specialized packaging systems for the storago and delivery of medications. In the past, many of these devices and items received little attention in regard to potential toxicologic effects upon patients. Since present medical devices are not considered to be “new drugs,” there is great confusion as to the types of preclinical tests which should be performed on these items to ensure the safety of the device. A proper program to evaluate the toxicogenic properties of a material to be used in a medical and paramedical application must, of course, consider the end use of the device. In general, however, test results are needed which will indicate that (1) no toxic ingredient from a plastic will be released to tissue, (2) the released ingredient will not produce an allergic response, and (3) the released agent will not be teratogenic, mutagenic, or carcinogenic. For those materials that are parts of prosthetic devices that will have long-term contact with tissues and blood, consideration must also be given to the interaction of cellular components with the material, thereby altering or degrading the polymer. Other tests and studies will be required for plastic items used for the collection, storage, and administration of drug products, as well as various types of biological products. From the various tests employed, a judgment can then be made as to the benefit-to-risk ratio of the specific device or item.