Last Updated on March 26, 2021 by The Health Master
In order to create awareness on safe use of ocular devices, the Ghaziabad-based Indian Pharmacopoeia Commission (IPC) which is the National Co-ordination Centre (NCC) for Materiovigilance Programme of India (MvPI) will host an international webinar on April 9, 2021 themed safety of medical devices focused on ocular devices.
Ocular devices cover a wide range of design types and applications such as glasses, contact lenses, intraocular lenses, implants, diagnostics, lasers, solutions and surgical instruments.
This will also help address regulatory concerns among the ocular devices manufacturers, regulators, ophthamologists and other healthcare professionals in order to promote the safety of ocular devices manufactured and used in India.
As per the Medical Device Rules 2017, ocular devices are notified in India.
IPC had recently issued safety alert on Perflouro Octane (PFCL), a medical device used in retinal surgery and had directed healthcare professionals in the country to report serious adverse events (SAEs) related to it to the MvPI. It has been keenly working on the development of resource material and reporting tools as the NCC for MvPI.
PFCL is a medical device used in retinal surgery of eye. This device is causing adverse events (blindness/vision loss) in many countries like Spain, Italy, Holland, Chile, Saudi Arabia. In Spain, there are more than 120 cases reported for visual loss after surgery using PFCL.
The Union health ministry launched MvPI on July 6, 2015 at IPC Ghaziabad in an effort to ensure safety of medical devices following several horrific cases of malfunctioning of medical devices, like babies being burnt to death due to short circuits in incubators or hip implants causing blood poisoning.
In addition to protection of health and safety of patients, MvPI reduces the likelihood of recurrence of the harmful incidents elsewhere thereby improving quality of health products.
Reporting tools and reference documents for medical device manufacturers available on IPC website are medical devices adverse event reporting (MDAER) Form (version 1.1), a field safety corrective action (FSCA) form, a reference manual for medical devices and a handbook for MvPI.
MvPI is administered and monitored by the Steering Committee to supervise and give proper direction to the programme and a working group has been constituted to approve major technical issues related to establishment and implementation of programme and giving technical inputs to Central Drugs Standard Control Organisation (CDSCO) for regulatory intervention of medical devices.
IPC on behalf of the MvPI had earlier circulated a notice on programme communication of MvPI to sensitize manufacturers about the movement of information between the key stakeholders.
Adverse events related to medical devices can be reported by downloading the MDAE form available at www.ipc.gov.in and duly filled scanned form can be sent via e-mail on [email protected] and copy to [email protected].
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.
For more details on licensing process of Medical devices, click here
For notifications of Medical Devices, click here