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Health Ministry Okays Plan To Monitor
Medical Devices; Vigilance Cells To Be Set Up Nationwide
After several horrific cases of malfunctioning medical de
vices, like babies being burnt to death due to short circuits in incubators or
hip implants causing blood poisoning, the health ministry has approved a materio
vigilance programme in an effort to ensure safety of medical devices.
Despite being a $3.1 billion market for medical devices,
India has no system for registering adverse events caused by medical devices or
for tracking the safety record of medical devices and is dependent on data from
the developed countries The proposed plan, to be coordinated by the Indian
Pharmacopoeia Commission in Ghaziabad, envisages a nation-wide programme,
involving district hospitals, medical colleges and corporate hospitals.
The biotechnology wing of the Sree Chitra Thirunal Institute
of Medical Sciences and Technology in Thiruvananthapuram is to be the national
collaborating centre for the programme, which is to be run in collaboration with
the Central Drug Standard Control Organisation (CDSCO).
Technical support for the programme is to be provided by the
Division of Healthcare Technology, a proposed World Health Organisation
collaborating centre for priority medical devices and health technology policy
in the National Health Systems Resources Centre.
The Materio Vigilance Programme of India (MvPI) is meant to
enable safety data collection in a systematic manner so that regulatory
decisions and recommendations on safe use of medical devices for India could be
based on data generated here.
The programme is meant to monitor medical device associated
adverse events (MDAE), create awareness among health care professionals about
the importance of MDAE reporting in India and to monitor the benefit-risk
profile of medical devices. It is also meant to generate independent, evidence
based recommendations on the safety of medical devices and to communicate the
findings to all key stakeholders.
The Pharmacovigilance Commission is supposed to meet every
three months to examine the reported adverse events and confirm the events to be
reported to the drug committee. Based on these reports, a decision will be taken
on whether any change is required in the labeling of the devices, or whether a
recall or a ban on the product is called for.
To begin with, MvPI cells are to be established in 10 medical
colleges. These will be funded by the government to report online. The programme
will be along the lines of the existing pharmacovigilance programme and
haemovigilance programme.
(Ref:
http://economictimes.indiatimes.com/industry/healthcare/biotech/
healthcare/health-ministry-okays-plan-tomonitor-medical-devices-vigilance-cellsto-be-set-up-nationwide/articleshow/46579794.cms)
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