|
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. |
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.
.