Dr. Renjith S. Scientist B, Biomedical Technology Wing Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum

ABOUT THE SPEAKER Dr.Renjith S. is working as Scientist in the Central Analytical Facility (CAF) of the Biomedical Technology Wing of Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), Trivandrum. He currently functions as the Deputy Quality Manager of Testing Services in the Campus. Dr. Renjith completed his M.Sc. in Chemistry with first rank and PV Nair Gold Medal from Kerala University in 2011. Further, he completed his Ph.D. from CSIR-NIIST on the topic “Liquid crystalline conducting materials for energy applications”. Before joining SCTIMST he worked at Common Facility Service Centre, Dept. of Industries and Commerce, Govt. of Kerala as a Chemical Analyst. His research interests include the analytical characterization of biomaterials and medical devices, analytical method validation, surface modification of materials and devices, and ionic liquid-based biomaterials.

 

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Abstract

 

Chemical characterization of polymeric medical devices: Unveiling the identity and risks

 

Dr. Renjith S.
Scientist B, Biomedical Technology Wing
Sree Chitra Tirunal Institute for Medical Sciences and Technology,
Trivandrum – 695012
E-mail: renjithschem@sctimst.ac.in

 

Polymeric medical devices play an inevitable role in day-to-day medical care. Every medical device has to undergo strenuous biological evaluations in line with international standards to ensure patient safety and to avoid undue health risks. Gathering information about the chemical and physical features of medical devices is crucial in this regard. Chemical characterization involves different steps of identification of component materials, their composition and estimation of the amount of extractables, leachables, and degradation products released from the medical device under ambient or accelerated conditions. International standards like ISO 10993-18, provide a framework for the identification and quantification of chemical constituents of a medical device and helps to estimate the associated biological hazards and risks. Chemical characterization would help to establish the equivalence of a material or device with that of an accepted one in clinical use. In the case of a new device or a candidate biomaterial, it would enable to assess the biological safety, in combination with toxicological evaluation.

 

A diverse set of spectroscopic and chromatographic techniques are available for the analysis of polymeric medical devices, which help in the identification of the bulk and surface composition, the quantification of residual contents of monomers, catalysts, and solvents, and the elucidation of chemical structure. There are physicochemical tests that can reveal crystallinity, cross-linking, spatial orientation, tacticity, and molecular mass distribution. There are two strategies to evaluate the safety and risks of polymeric medical devices. If a predicate device is available, the equivalence of product specifications could be established. If the device is new and has no prior similar models, detailed characterization (including the quantification of extractable and leachable components under accelerated conditions) could be done followed by toxicological evaluation.

 

The talk will focus on the step-wise step methodology for the chemical characterization of a medical device as provided by the standard ISO 10993-18. It will also touch upon the toxicological risk assessment and regulatory compliance requirements of polymeric medical devices.

 

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