|
Abstract
Advances in science,
technology and medicine have produced a huge variety
and number of medical devices, which have become an
important part of healthcare delivery today. The term
“Medical devices” as generally defined, covers very
simple, low risk ones like contact lenses and syringes
to critical life-saving and life-supporting devices
like artificial heart valves and hemodialysers; the
numbers are increasing rapidly every year, with the
development of new advanced materials and
technologies. However, poorly designed or manufactured
devices have the potential to cause harm and injury to
patients and care givers.
Current international experience in the use of
medical devices has clearly shown that the optimum
assurance of medical device safety has several
essential elements:
Absolute safety cannot be
guaranteed
It is a risk management
issue
It is closely aligned with
device effectiveness and performance
It must be considered
throughout the life span of the device
It requires shared
responsibility amongst the stakeholders
Medical devices are
manufactured using a wide variety of technologies and
are different from drugs. Consequently, ensuring the
safety of the public in the use of medical devices
requires an entirely different system from the current
national and international practices that are being
applied for ensuring the safety of drugs and
cosmetics.
The present approach under the Drugs and Cosmetics
Act, is very similar to the FAILED approach taken by
USA in 1976 under their Food and Drugs Act. They had
to make many amendments from 1990 onwards to make
their system practical and workable. Most importantly,
the present approach is NOT IN CONFORMITY with the
recommendations of the Global Harmonizing Task Force.
Hence, in taking this approach, the medical devices
industry in the country is going to be burdened and
things made more difficult for them to compete
internationally.
The talk will explain these points and the draft
Medical Devices Regulatory bill that has been placed
on the DST web site for feedback. |
|
DR.
G.S. Bhuvaneshwar
Head, Biomedical Technology Wing,
Sree Chitra Tirunal Institute for Medical
Sciences and Technology, Trivandrum. |
About Speaker
Dr. G. S.
Bhuvaneshwar is the Head, Biomedical Technology Wing,
Sree Chitra Tirunal Institute for Medical Sciences &
Technology, Trivandrum. He obtained his B.Tech
(Electronics) and M.S. (Biomedical Engineering)
degrees from IIT Madras and PhD (Biomedical
Technology) from Sree Chitra Tirunal Institute for
Medical Sciences & Technology, Trivandrum.
He joined Sree Chitra in 1976 and has been associated
with the Biomedical Technology Wing right from its
inception.
He has received several awards including the
Distinguished Alumnus Award (2001) of IIT Madras,
shared FIE foundation award (1995) for the development
of Chitra Heart Valve and NRDC-Awards for meritorious
invention for Chitra Heart Valve (1994) and Spictra
Membrane Oxygenator (2006).
Main
research interests are in the development of
cardiovascular devices and blood compatibility of
materials. His major contributions are in the
development of medical devices such as tilting disc
heart valve prosthesis (TTK-CHITRA HEART VALVE — TTK
Health Care Ltd, Chennai), Hydrocephalus Shunt System
(CEREDRAIN - Hindustan Latex Ltd, Trivandrum), Hollow
Fiber Membrane Oxygenator (SPICTRA — SIDD Lifesciences
Ltd., Chennai) and Woven Arterial Prosthesis
(developed in collaboration with South India Textile
Research Assn, Coimbatore. Technology transfer to TTK
Healthcare Ltd, Chennai in progress). He has two US,
one European and 5 Indian patents and has authored 25
research papers and a book chapter.
A quality system conforming to ISO17025 for biomedical
testing services has been implemented in the
Biomedical Technology Wing of the institute under his
leadership and accredited by COFRAC of France. The
wing is currently in the process of implementing a
major expansion programme for providing greater
support to the medical devices industry in the areas
of testing, R&D and GMP. |
