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SCTIMST inks MoU with Tynor
Orthotic to boost orthotic devices
The main objective of this Institute-Industry
collaboration is to develop a cluster of orthoses for catering to clinical
conditions such as osteoarthritis and diabetic foot ulcer.
Development of orthotic devices may soon receive a
boost with a Kerala based scientific institution collaborating with a Mohali
based private manufacturer for co-development of such devices catering to
clinical conditions such as osteoarthritis and diabetic foot ulcer.
Sree Chitra Tirunal Institute for Medical Sciences
and Technology, Trivandrum, Kerala (SCTIMST), an Institute of National
Importance under the Department of Science and Technology, Government of India,
has signed an MoU with Tynor Orthotics Private Limited (Tynor), Mohali, to set
up an Orthotics and Rehabilitation R&D vertical to promote indigenous device
development in this sector towards the goal of ‘Aatmanirbhar Bharat’, a high
priority target of the Govt of India.
Tynor, a manufacturer and exporter of high quality
and affordable orthopedic appliances and fracture aids in India, will
collaborate with SCTIMST for the co-development of Orthotic devices and to
promote joint research programs in Orthotics and Rehab.
Tynor has funded SCTIMST for Research and
Development of two off-loading devices in patients with diabetic foot ulcers and
osteoarthritis. The project is planned for one year with Tynor contributing Rs
27 lakhs to the program.
The main objective of this Institute-Industry
collaboration is to develop a cluster of orthoses for catering to clinical
conditions such as osteoarthritis and diabetic foot ulcer.
SCTIMST has done considerable amount of R&D work in
biomedical devices over the last 30 or more years and has established itself as
a pioneer in this field. This collaboration with an Industry leader for
co-development of ortho-rehab devices in the country is a commendable step.
Tynor has planned to set up India’s first R&D
Center in Orthopedic Appliances, Fracture Aids, Walking Aids, Compression
Garments, and Footcare Products. This center has been named TORNADO (Tynor Ortho
Research N Appliance Development Organization) and aims to bring about
technology and innovation-based disruption at the scale of a tornado.
This will be a novel center in which a
Cross-Functional Team consisting of experts from Engineering, Orthopedics,
Biomedical Sciences, Design shall be brought together to brainstorm and develop
products as per the requirements of the Indian patient. Industry-academia
collaboration is the key to achieve this feat.
https://www.biospectrumindia.com/news/74/17228/sctimst-inks-mou-with-tynor-orthotic-to-boost-orthotic-devices.html.
IPC Rolls Out PPE Adverse Event
Reporting Form As Part Of MvPI For Patient And Health Worker Safety
In order to collect information on Medical Devices
Adverse Event (MDAE) in India, the Indian Pharmacopoeia Commission (IPC) has
rolled out personal protective equipment (PPE) adverse event reporting form as
part of the Materiovigilance Programme of India (MvPI) for patient and health
worker safety.
It has simultaneously rolled out MDAE reporting
form to be used voluntarily by manufacturer, importer, distributor of medical
devices, healthcare professionals and anyone with direct or indirect knowledge
of MDAE.
Duly filled MDAE reporting form can be sent to IPC
via email at mvpi.ipcindia@gmail.com or can be communicated through helpline
number 1800 180 3024 to report adverse event. Till now, MvPI has set up 50
exclusive centres under it to collect and disseminate reporting of adverse
events due to medical devices at the point of care besides the over 311 adverse
drug reaction monitoring centres (AMCs) across the country.
IPC which is the national coordinating centre for
MvPI has also sent circulars to all the 50 MDAE reporting centres in the country
to keep a check on serious adverse events (SAEs) due to faulty ventilators or
personal protective equipment used by the healthcare staff and patients to
tackle COVID-19.
PPE includes protective clothing, helmets, goggles,
or other garments or equipment designed to protect the wearer's body to minimize
exposure to specific hazards.
PPE also includes respirators, gloves, aprons, fall
protection, and full body suits, as well as head, eye and foot protection. Using
PPE is only one element in a complete hazard control program that would use a
variety of strategies to maintain a safe and healthy environment.
MDAE reporting form launched by IPC will help
generate independent, evidence-based recommendations on the safety of medical
devices and to communicate the findings to all key stakeholders. The reporting
form includes adverse event details, severity of the event, date, location,
device category, model of the device available with the organisation, its use
after the event, name of medical device, manufacturer, brand name, model number,
serial number, batch number etc.
MvPI which was launched in 2015 to ensure safety of
medical devices is currently being coordinated by the IPC at Ghaziabad. IPC
functions as the NCC for MvPI and Sree Chitra Tirunal Institute of Medical
Sciences and Technology (SCTIMST) in Thiruvananthapuram acts as its
collaborating centre. Technical support is being provided by the National Health
System Resource Centre (NHSRC) in New Delhi.
In order to help IPC facilitate baseline study of
products available with medical devices companies in India and assure patient
safety, the Union health ministry has also directed medical device manufacturers
to register at medical devices information sharing portal through hyperlink -www.mvpi.co.in.
http://pharmabiz.com/NewsDetails.aspx?aid=132828&sid=1
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