IPC Rolls Out PPE Adverse Event Reporting Form

Mumbai, 17 Oct 2020: 

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.

This portal which would serve the purpose as an India specific tool has been developed in consultation with Central Drugs Standard Control Organisation (CDSCO) to ensure that safe medical devices are available in the country.

IPC has been keenly working on the development of resource material and reporting tools as the National Coordination Centre (NCC) for MvPI which was launched in 2015. 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. Pharmabiz