Materiovigilance is a coordinated system for monitoring of any undesirable performance or characteristic fluctuations in medical devices. Materiovigilance is a system which is capable of identification, collection, reporting and reacting to medical device adverse events with field safety corrective actions or device recall during post marketing phase of medical devices.

Materiovigilance Programme of India started in 2015 under the Ministry of Family & Healthcare.

Sri Aurobindo Medical College and PG Institute [SAMC & PGI] is also a Medical Device Adverse Event Monitoring Centre [MDMC], Since Jan-2022.

Enclosures :

•  1. Recognition letter for MDMC Click Here to View

Materiovigilance Reporting forms Links :

•  1. Medical Device Adverse Event Reporting Form Click Here to View
•  2. Medical Device Adverse Event Reporting Form (Hindi Version) Click Here to View
•  3. Personal Protactive Equipement Adverse Event Reporting Form Click Here to View

MDMC Personal:

1. MDMC Coordinator- Dr. Pooja Reddy

2. MDMC Deputy Coordinator – Dr. Anuja Jha

3. Materiovigilance Associate – Mr. Jitendra Patidar

Objectives:

1. 1. To generate awareness about medical device related adverse events among healthcare providers and consumers.
2. 2. To identify and report medical device related adverse events.
3. 3. To carryout Causality Assessment of Medical Device Related Adverse Events.
4. 4. To strengthen the Materiovigilance Programme of India.

Scope of the Committee:

The committee shall be responsible for planning, implementing and monitoring of various activities of the Materiovigilance Programme of India (MvPI).

Roles:

1. 1. Coordinator: The Materiovigilance Coordinator oversees the MDMC's entire operation. Key responsibilities include:

a. Management & Supervision: Leading all MvPI activities at the MDMC.

b. Adverse Event Reporting: Ensuring accurate and timely collection, documentation, and reporting of Medical Device Associated Adverse Events (MDAEs).

c. Data Quality: Validating reports before submission.

d. Awareness & Education: Promoting adverse event reporting within their institution.

e. Compliance & Liaison: Ensuring adherence to MvPI guidelines and acting as a primary contact.

2. 2. Deputy Coordinator: The Deputy Materiovigilance Coordinator supports the Coordinator, ensuring continuous operation. Their duties often mirror the Coordinator's, including:

a. Assistance & Support: Aiding the Coordinator in all MvPI tasks.

b. Operational Continuity: Maintaining smooth MDMC functioning, especially in the Coordinator's absence.

c. Reporting & Data Entry: Assisting with report processing and data management.

d. Awareness Activities: Helping with educational and awareness programs.

3. 3. Members: Will primary work as subject experts and will also do the sensitization of healthcare professionals. They will give suggestions for better and effective functioning of the programme and work as facilitators.
4. 4. Role of Materiovigilance Associate

a. MV Associate will be responsible for interacting with all healthcare professionals and consumers for collecting and reporting of medical device related adverse events and verify completeness of reporting form.

c. Documentation of relevant documents about the materiovigilance.

d. Submission of the complete medical device related adverse event form to Indian Pharmacopoeia Commission under given timelines.

e. Sensitization programmes about MvPI among the healthcare professionals and spread awareness regarding importance of Materiovigilance.

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Contact Details

Email: [email protected]

Mobile: +91 7223099647 (Materiovigilance Associate)

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