The purpose of materiovigilance is to study and follow the incidents that might result from using medical devices

1. Dr KAVITHA S
Assistant Professor
Department of pharmacology
AIMS&RC
Materiovigilance

2. Materiovigilance
Study and follow incidents that might
result from using medical devices.
It enables dangerous devices to be
withdrawn from the market and to
eliminate faults in medical devices
Intention of constantly improving the
quality of devices and providing patients
and users with increased safety.

3. Medical device is defined as any instrument,
equipment, material or other article used on its own or
jointly, including software required for it to function
correctly, which is intended by the manufacturer to be
used on humans for the following purposes :
 for diagnostic, prevention, control, treating
or diminishing an illness
 for diagnostic, control, treating, for diminishing or
compensating an injury or handicap,
 for studying, replacing or modifying part of the
anatomy or a physiological process
 for mastering conception and whose principal
intended action in or on the human body is not
obtained by pharmacological or immunological
means or by metabolism but whose function can be
assisted in such a way.
Materiovigilance

4. ➢Medical Devices come under Schedule R1.
➢At present, provisions related to import,
manufacture, distribution and sale of
medical devices are covered under the
Drugs and Cosmetics Act, 1940 and the
Drugs and Cosmetics Rules, 1945
Materiovigilance

5. ➢ After several horrific cases of malfunctioning
medical devices, like babies being burnt to death due
to short circuits in incubators or hip implants
causing blood poisoning etc.
➢ The Ministry of Health and family Welfare
(MoHFW) has approved a commencement of
“Materiovigilance Programme of India (MvPI)”
vide approval dated 10/02/2015 in an effort to
ensure safety of medical devices.
Materiovigilance

6. Need for MvPI ?
6
24 infants died in the
space of 72 hours in two
government hospitals of
Murshidabad in West
Bengal-Jul 17, 2011
Three-day-old killed after
incubators caught fire in a
hospital in Ahmedabad. -
December 2008
Five newborns
receiving treatment for
jaundice at a
government hospital in
northern India died as a
fire broke out in its
phototherapy unit. Nov
16, 2009
An 8-minute power
cut at a premier
hospital in
Punducherry ended
in the loss of three
lives -09/03/2017

10. Materiovigilance programme of India
MvPI

11. Scope
 To 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 collaborate with other healthcare organisations for
the exchange of information and data management.

12. 1. PGIMER, Chandigarh
2. CMC Vellore
3. AIIMS, New Delhi
4. Dayanand Medical College and Hospital, Ludhiana
5. National Institute of Mental Health And Neurosciences
(NIMHANS), Karnataka
Medical Device Adverse Event
Monitoring Centers (MDMCs)

13. 6. Glocal Group of Hospitals, Kolkata
7. Narayna Hrudalaya Hospital, Bengaluru
8. Jawaharlal Institute of Postgraduate Medical
Education and Research (JIPMER), Puducherry
9. Sanjay Gandhi Post Graduate Institute of Medical
Science, Lucknow
10. Bankura Sammilani Medical College, West Bengal
Medical Device Adverse Event
Monitoring Centers (MDMCs)

14. Programme Communication
CDSCO-Headquarter,
New Delhi
National Coordination Centre
IPC, Ghaziabad
Technical
Support &
Resource
Centre
NHSRC,
New-Delhi
National
Collaborati
on Centre
SCTIMST,
Kerala
AMCs/MDMCs
Healthcare Professionals
CDSCO Zonal / Subzonal
Offices
Medical Device
Industries in India
Steering
Committee
Working
Group
Core
Technical
Committee

15. Roles and responsibilities
▶ Each MDMC under MvPI is assigned with a
coordinator and a Research Associate responsible
for its functioning .
▶ The coordinator is responsible for sending the
consolidated monthly reports of its MDMC to NCC.
▶ The Research Associate is responsible for collection
and follow-up of MDAEs. All MDAE reports have to
be sent to National Coordination Centre (NCC) for
review and analysis.
▶ Feedback to all healthcare professionals involved in
reporting is to be sent by the Coordinator.
Medical Device Adverse Event
Monitoring Centers (MDMCs)

16. 16GNS-IPC, GZB 16
Indian Pharmacopoeia Commission

17. Roles and responsibilities
▶ IPC functions as National Coordination Centre (NCC)
for MvPI.
▶ The main responsibility of NCC is to coordinate with
all partners of the programme.
▶ Organising various meetings like steering committee,
working group, core technical committee meetings etc.
▶ Recognition of new Medical Device Adverse Event
Monitoring Centres (MDMCs) of public and private
hospitals across the country.
Indian Pharmacopoeia Commission
(IPC)

18. Roles and responsibilities contd....
▶ Recruitment and deployment of manpower (All MvPI
staff shall be appointed & work under the
administrative control of NCC-PvPI).
▶ Data collection, collation, analysis and signal
detection and outcome to be communicated to
CDSCO for relevant regulatory actions.
▶ IPC is the sole Custodian for MvPI database.
▶ Publication and dissemination of standard operating
procedures, guidance documents, newsletters,
training manuals etc. with technical support from
NHSRC and SCTIMST.

19. ▶ Reporting all concerned issues to CDSCO
▶ Collaborating with International Authorities
▶ Issue of medical device alert for awareness and
knowledge
▶ Providing financial support to SCTIMST, NHSRC and
MDMCs.
▶ Providing financial support to organise MvPI awareness
program across the country
Roles and responsibilities contd....

20. Sree Chitra Tirunal Institute for Medical Sciences
and Technology (SCTIMST)

21. Roles and Responsibilities
▶ SCTIMST, as the National Collaboration Centre,
shall support the programme in all technical
matters.
▶ Responsible to collaborate with NCC-PvPI for further
follow-up/ analysis in case of Serious Adverse Event
with MDMCs.
▶ Lend Technical support for organising programme,
continuous professional development education on
Materiovigilance as and when considered necessary
by NCC-MvPI.
Sree Chitra Tirunal Institute for Medical
Sciences and Technology (SCTIMST)

22. ▶ To provide research & development/ testing support
facilities to the programme.
▶ To provide technical support in data analysis and
release of medical device alerts.
Roles and responsibilities contd....

23. National Health System Resource Centre
(NHSRC)

24. Roles and responsibilities
▶ The Healthcare Technology Division of NHSRC acts
as a technical support partner for MvPI.
▶ To provide technical support/guidance on
preparation/ review of standard operating procedures,
guidance documents, newsletters, training manuals
etc.
▶ Lend Support to NCC-PvPI in identification of new
MDMC.
▶ Lend Technical support on the activities of National
Collaboration Centre and National Coordination
Centre including training programme.
National Health System Resource
Centre (NHSRC)

25. ▶ Drafting documents for the MvPI related
activities.
▶ Explore possibility of integrating data
mining/ data analytics, to adverse event
reports.
▶ Provide technical advice on setting-up of
online adverse events data collection and
release of medical device alerts via
Email/SMS etc.
Roles and responsibilities contd....

26. ▶ Lend support for creating awareness
program among medical device
manufactures /healthcare organisation.
▶ NHSRC shall also coordinate with other
partners as per need.
Roles and responsibilities contd....

28. Roles and responsibilities
▶ The CDSCO is the National Regulatory
Authority ensure safety, efficacy and quality
standards of pharmaceuticals, medical devices
and vaccines.
▶ Responsible for taking appropriate regulatory
decisions/related actions based on the
recommendation NCC- MvPI.
Central Drugs Standard Control
Organization (CDSCO)

29. ▶ Lend support to NCC-MvPI in sharing
International information Medical Device
Regulators Forum (MDRF), Asian
Harmonization Working Party (AHWP) and
other forums organised by regulatory bodies
of other countries.
▶ Shall convene meetings with the NCC- MvPI,
SCTIMST & NHSRC for monitoring, review
and further advice on medical devices safety.
Roles and responsibilities contd....

30. ▶ Auditing/ inspecting of MDMCs and National
Collaborating Centre from time to time
▶ Providing administrative support to run MvPI.
Roles and responsibilities contd....

31. ▶ Identification and recognition of Ten Medical
Device Adverse Event Monitoring Centres
(MDMCs) across the country.
▶ Constituted steering committee and working
group and conducted two meetings of both.
▶ Medical Device Adverse Event (MDAE) reporting
form developed
▶ Guidance document for Materiovigilance
Programme of India (version 1.0) prepared in
consultation with NHSRC and SCTIMST
The progress made till date

32. ▶ Recruitment of 05 Research Associates
completed & remaining 10 posts are under
process
▶ Interactive meeting held with Medical Device
manufacturers and Associations
▶ Various review meetings held with the MvPI
partners
▶ Till date, NCC has received more than 200
MDAE reports
The progress made till date
contd....

33. Who can Report?
Materiovigilance

34. Clinicians
Nurses
Technicians
biomedical
engineers, clinical
engineers, hospital
technology
manager
Medical device
manufacturers/CDSCO
notified medical
device manufacturers/
medical device
importer - trader
Materiovigilance
Materiovigilance

35. Why to Report?
Materiovigilance

36. What to report ?
Materiovigilance

37. What to report ?
 Dysfunction or any change of the
characteristics and/or performance of a
device
 Inadequacy in the labeling or instructions
 Not only serious incidents but also the
cases where there was a risk of a serious
incident but that incident was avoided due
to the attention and action of the relevant
people
Materiovigilance

38. Materiovigilance

39. Materiovigilance

40. EXAMPLES:
• A batch of out-of-specification blood glucose
test strips is released by manufacturer
• Patient uses strips according to instructions,
but readings provide incorrect values leading
to incorrect insulin dosage, resulting in
hypoglycaemic shock and hospitalization.
Materiovigilance

43. How and Whom to report ?

49. Types of Medical device adverse event
Reports received at NCC-MvPI
*Materiovigilance program of India 49