India Proposes Template for Reporting Medical Device Adverse Events

The Indian Pharmacopoeia Commission has released a proposed template for manufacturers or medical personnel to report adverse events involving medical devices.

The form contains sections for patient information, details about the device, the incident date and location and the seriousness of the event. Details on the incident should include a description of the device’s deficiency or malfunction, and a clarification of the hazards and the associated risks to patients or users, IPC says.

IPC issued a draft version of the form as part of the Materiovigilance Programme of India, which was launched earlier this year by India’s health ministry to collect and monitor adverse events for devices. The system was designed by the Central Drugs Standard Control Organization and the Sree Chitra Tirunal Institute of Medical Sciences and Technology (IDDM, June 5).

Comments on the draft form are due to pvpi.ipcindia@gmail.com by Jan. 3. Access the proposed template here: www.fdanews.com/12-15-IPC-Form.pdf. — Jonathon Shacat