Mohanan PV
Sree Chitra Tirunal Institute for Medical Sciences and Technology
Title: Toxicology of Polymeric biomaterials: A Regulatory Approach
Biography
Biography: Mohanan PV
Abstract
Polymeric biomaterials are widely used in clinical applications such as for drug delivery, tissue engineering, bio-medical sensing, skin grafting, medical adhesives etc etc., Polymeric biomaterials are chosen for different applications depending on their properties. They act as substitutes for soft and hard tissues in the body. The objective of the toxicological studies of polymeric materials, intended for the fabrication of medical devices, is to investigate the potential biological hazards by careful observations for unexpected adverse reactions or events in humans during clinical use of the medical devices. The toxicity/biocompatibility evaluation of polymeric materials assesses the risk of adverse health effects due to normal use and likely misuse of a device. 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. It was well aware that the medical device comprises several components made from different materials; the ideal procedure from a toxicological point of view would be, to evaluate extracts of the components separately. However, in some situations this is not practical, and extracts of the whole device may be used instead. The amount of leachable substances released to the extraction media is related to the surface area and thickness of the product to be extracted. The range of potential biological hazards is wide and may include; short term effects (like acute toxicity, irritation, sensitization, haemolysis and thromobogenicity) and long term effects (such as sub chronic and chronic toxicity, sensitization, genotoxicity, carcinogenicity and effects on reproduction including teratogenicity). Due to the diversity of medical devices, it is recognized that not all the tests identified in a category will be necessary or practical for any given device. It is indispensable for testing that each device shall be considered on its own merits. The details of the toxicity assays will be discussed during the presentation.