IPC To Sensitize Manufacturers About SAEs

Mumbai, 5 Dec 2020:

In order to foster the habit of reporting serious adverse events (SAEs) related to medical devices, the Indian Pharmacopoeia Commission (IPC) on behalf of the Materiovigilance Programme of India (MvPI) has circulated a notice on programme communication of MvPI to sensitize manufacturers about the movement of information between the key stakeholders.

This is also aimed to ensure continuous transfer of data, information and knowledge related to known or unknown, serious and non-serious, frequent or rare serious adverse events.

The notice on programme communication of MvPI also specifies about committees constituted by the union health ministry to give proper direction for efficient functioning of the programme.

After 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, the union health ministry launched Materiovigilance Programme of India on July 6, 2015 at IPC Ghaziabad in an effort to ensure safety of medical devices.

In addition to protection of health and safety of patients, Materiovigilance program reduces the likelihood of recurrence of the harmful incidents elsewhere thereby improving quality of health products.

IPC has been keenly working on the development of resource material and reporting tools as the National Coordination Centre (NCC) for MvPI. Other reporting tools and reference documents for manufacturers available on IPC website are an updated 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.

The notice stipulates use the ‘Medical Device Adverse Event (MDAE) reporting form’ which is available at www.ipc.gov.in to report any adverse event. Research Associates from Medical Device Adverse Event Monitoring Centres (MDMCs) after filling the MDAE form would submit it to the National Collaboration Centre (NCC)- MvPI (mvpi@sctimst.ac.in). NCC-PvPI helpline 1800-180-3024 (Toll free) also provides assistance in medical device adverse event reporting.

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 mvpi@sctimst.ac.in and copy to mvpi.ipcindia@gmail.com.

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.

Under MvPI clinician, biomedical engineers, clinical engineers, hospital technology managers, pharmacists, nurses, technicians can report medical device SAEs. Medical device manufacturers/CDSCO notified medical device manufacturers/ medical device importer traders can also report adverse events specific for their product to NCC- MvPI at SCTIMST, Thiruvananthapuram.

The key objectives of MvPI are to create a nation - wide system for patient safety monitoring, analyse the benefit-risk ratio of medical devices, to generate evidence based information on safety of medical devices, to support CDSCO in the decision-making process on use of medical devices, to communicate the safety information on use of medical devices to various stakeholders to minimise the risk, to emerge as a national centre of excellence for Materiovigilance activities, to collaborate with other healthcare organisations for the exchange of information and data management.Pharmabiz