Medical device bodies welcome CDSCO order on self-reporting adverse effects

Medical device associations have flagged the need to ensure systematic reviews while welcoming the Central Drugs Standard Control Organisation’s (CDSCO) move to urge all licensed medical device manufacturers to use the Materiovigilance Programme of India (MvPI) portal to self-report adverse events related to the devices.

In a circular dated May 15, the drug regulator stated that medical device manufacturers need to take appropriate action for timely reporting of adverse events related to medical devices to MvPI.

The MvPI is an initiative taken by the CDSCO along with the Indian Pharmacopoeia Commission (IPC), with the objective of improving the protection of the health and safety of patients, healthcare professionals, and others by reducing the likelihood of recurrence of any adverse event associated with the use of medical devices.

Speaking on the need for reporting severe adverse events, Pavan Choudary, chairman, Medical Technology Association of India (MTaI), said that prompt reporting of adverse events allows for rapid identification and rectification of potential device failures, mitigating risks to patients.

“This process would help healthcare providers (HCPs) and regulatory agencies track the performance of medical devices in real-world settings, ensuring that any issues are addressed before they can cause widespread harm,” he added.

Rajiv Nath, forum coordinator, Association of Indian Manufacturers of Medical Devices (AIMED), said that while reporting of adverse events is necessary for events that can lead to death or serious injury requiring surgical intervention, it should also not lead to witch hunts and should enable a systematic review for ensuring patient safety. “Only then will manufacturers be motivated to self-report,” he said.

“Many times a serious adverse event may not necessarily be due to a manufacturing defect but due to incorrect or abnormal usage or abuse of the medical device, for which one cannot blame the manufacturer but seek better instructions for use (IFU) or product familiarisation training,” he added.

Highlighting the need to create awareness about self-reporting of adverse effects, Choudary added that as medical devices are a nascent sector, more awareness initiatives need to be conducted to inform and encourage the industry, HCPs, and patients to report any adverse events.

Nath added that ensuring the quality, safety, and performance of medical devices is the core commitment we all should be driven by. “We have to create a trust-based robust system with strict protocol and check-back mechanisms,” he said.