Materiovigilance, Medical device safety, and MvPI (Materiovigilance Programme of India)

1. Dr. Yash N. Panchal
Junior Resident
Pharmacology Department
AMC MET Medical College
24/09/2021
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2. • Medical devices
• Drug vs Medical devices
• Classification and regulation of Medical devices
• Materiovigilance
• Global perspective of Materiovigilance
• MvPI
• Non-reported events
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3. • As per WHO,
Medical device can be defined as any apparatus, appliance,
instrument, implement, implant, machine, material, reagent for in
vitro use, software or other related article,
Used or intended to be used by manufacturer,
Alone or in combination,
In or on human body,
For 1 or more of the following
medical purposes of :
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4. 1- Diagnosis, prevention, monitoring, treatment of any disease
2- Diagnosis, prevention, monitoring, treatment of any injury
3- Investigation, modification, replacement of anatomy or
physiological process supporting or sustaining life
4- Aids for person with disabilities
5- Device incorporating human tissue in it
6- In-vitro diagnostic tool
7- Device for in-vitro fertilization or assisted reproductive
technologies
8- Control of conception
9- Disinfection of substances
10- Disinfection of medical devices
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5. DRUG MEDICAL DEVICE
Chemistry and Pharmacology Biomedical engineering , compatibility
Safety and Efficacy Safety and Performance
GMP QMS
Local and Systemic toxicity Bio - compatibility
Long product lice cycle Short product life cycle
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6. USFDA classification
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8. USFDA REGULATIONS
• For class I , manufacturer self certificate the conformity for medical devices
• For class II and III , prior investigation is done by higher notified body
(USFDA).
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9. CDSCO Classification
CLASS RISK EXAMPLES
A Low risk Cotton wool, Surgical
dressing, Thermometer
B Low-Moderate risk Hypodermic needle, Suction
equipment
C Moderate-High risk Lung ventilator, Bone fixation
plate
D Very high risk Heart valve, Pacemaker, MRI
Machine
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10. Licensing of Medical devices in India
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11. • Provisions related to import, manufacturing, labelling, distribution and sale of medical devices
( including IVDs – In-vitro diagnostic tools ) in India
• With intention of effective and safe use of medical devices across India
• On approval by MoHFW,
was notified by DCGI on 31/1/2017
• Effective since 1/1/2018
• Available on cdsco.gov.in
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14. • Vigilance means Close monitoring
• Is Close monitoring of Medical devices
to look for occurrence of adverse event
related to use of the medical device
during post – marketing phase by
system of its identification, collection,
reporting and reacting to it.
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15. • 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 device and providing
patients and users with increased safety
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16. AIM
To improve the protection of health safety of the patients by reducing the
reoccurrence of an adverse event
OBJECTIVES
• To capture and record MDAE
• To analyze the risk-benefit ratio of
the use of medical device
• To generate evidence based data on the safety
of medical devices
• To promote effective communication with different stakeholders regarding safety
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17. USA first initiated PMS of medical devices
by USFDA modernization act 1970, under section 522
Subsequently, Canada, European union,
Japan, Australia also brought out
regulatory guidelines and initiated
PMS of medical devices
Global harmonization task force (GHTF) was formed in 1993 by government
and industry representative of these countries to bring harmony in
regulatory guidelines related to medical devices
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18. In 1999 AHWP was formed by voluntary group of industry representatives of
Asia to promote regulatory harmonization related to medical devices across
Asia in accordance with GHTF guidelines
International medical device regulatory forum (IMDRF) was build upon
commendable work of GHTF in 2011, to accelerate harmonization of
regulatory guidelines on medical devices
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19. • Mandatory for all the stakeholders to report any of adverse events they come across
• 1- Med watch 3500A form – available on USFDA website
2- Med watcher Mobile application
• Annual summary report of death or serious adverse events to be submit
3419 FDA form
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24. VIGILANCE SCHEME ADVERSE EVENT
REPORTING SCHEME
For manufacturers For Health care professionals
Mandatory Voluntary
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26. New-born killed after incubator caught fire
due to short circuit
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27. 5 New-born charred to death in photo-therapy
unit, receiving treatment for jaundice
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29. • MoHFW ( Ministry Of Health & Family Welfare ), GoI (Government Of
India ) approved MvPI on 10th February 2015 with an effort to ensure
safety of medical devices.
• MvPI was launched by DCGI ( Dr. G.N. Singh ) on 6th July 2015 at IPC (
Indian Pharmacopoeia Commission ), Ghaziabad
• IPC function as National Co-ordination center
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32. • To create nationwide system for vigilance on Medical devices related
adverse events
• To capture and records suspected medical device associated adverse
events
• To identify new signal and analyse it via surveillance system
• To analyse risk-benefit ratio of medical device
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33. • To generate evidence based information on safety of medical devices
• To support regulatory agencies in decision making process on safety of
medical devices
• To communicate the safety of information on use of medical devices to
various stakeholders with aim to minimize the risk
• To collaborate with other national centers for exchange of information and
data management
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34. CDSCO,
NEW DELHI
IPC,
GHAZIABAD
NHSRC
SCTIMST MDMCs
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36. • Each MDMC under MvPI is assigned with Research associate and
Co-Ordinator
• Research associate :
1- Collect, scrutinize and check for the completeness of reported
MDAE form
2- Involved in causality assessment
3- All reported adverse events at MDMC can be send at IPC for further
review and analysis
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37. • Co-Ordinator :
1- Sends monthly consolidated report of all reported adverse event at
MDMC to IPC
2- Sends feedback to reporters and NCC IPC
3- Organize educational webinar on materiovigilance related activities
for health care professionals
• Currently 101 MDMCs has been identified by IPC pan India.
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40. • At Thiruvananthapuram, Kerala
• Act as National Collaboration Centre
• Function :
1- Collect, Collate all the adverse events from all MDMCs
2- Evaluate and outcome and new signal is to discussed with NCC IPC
3- Co-ordinate with IPC and MDMC in case of serious adverse event
for follow up
4- Organize educational webinar and meetings for training activities for
MDMCs
5- Provide research and testing facility for Materiovigilance programme
of India
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42. • Function as National Co-ordination center
• Location- Ghaziabad
• Responsibilities :
1- Main responsibility is to co-ordinate with all the partners of MvPI for
better functioning of programme
2- Recognition of new MDMCs pan India of public and private
hospitals.
3- Recruitment and deployment of manpower (staff of all the partners )
is strictly under the administrative control of NCC IPC
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43. 4- Data collection, collation, analysis and signal detection and outcome
to be communicated to CDSCO for regulatory actions.
5- Reporting all the concerned issues to CDSCO
6- IPC is the sole custodian for the MvPI database.
7- Publication and dissemination of the standard operating procedures,
guidance documents, newsletters, training manuals with technical
support from NHSRC
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44. 8 – Issue of medical device alert for awareness and knowledge
9- Providing financial support to all the partners of MvPI
10- Collaborating with the International authorities for continuous
transfer of information and knowledge on materiovigilance activities
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45. Core technical
committee
Working
group
Steering
committee
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47. • Location – New Delhi
• Responsibilities :
1- The Healthcare Technology division of NHSRC act as technical
support partner for MvPI
2- Provide Technical support to NCC IPC in publication of the Standard
operating procedures, Newsletters, Medical device alerts, Training
manuals
3- Lend support to NCC IPC in the recognition of the new MDMCs
4- Lend technical support to SCTIMST on materiovigilance related
activities
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49. • Is the National Regulatory Authority and ensures safety, efficacy,
and quality standards of Medical devices
• Responsible for taking appropriate regulatory decisions/ related
actions based on the recommendations by NCC IPC
• Collaborate with international agencies for exchange of information
and data on Materiovigilance related activities
• Audit/Inspection of the Medical device manufacturing/Storage site
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50. AE has occurred
Manufacturer'
s device is
suspected
cause
AE lead to
adverse
consequence
s
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51. Pharmacist
Health care
professional
Nurses
Biomedical
engineer
Importer
Manufacturer
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52. • All type of adverse events :
known or unknown ,
frequent or rare ,
serious or non serious can be reported
• According to article 10 of European Medical Device Directive (EMDD)
1- Any inaccuracy in the labelling
2- Any inaccuracy in the instruction for the uses
3- Malfunction of devices is to be reported
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60. • Within 15 calendar days of
becoming aware; with action to
be taken in defined time period
Serious
adverse event
• Within 30 calendar days of
becoming aware; with action to
be taken in defined time period
Non-serious
adverse events
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61. Serious adverse event means any noxious, untoward medical
occurrence that leads to,
I – a death or
II – a serious deterioration in the health of user that either
(A)- resulted in life threatening illness
(B)- resulted in a permanent impairment of a body structure
(C) - resulted in – patient prolonged hospitalization
III – foetal distress, foetal death or congenital abnormality
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62. MvPI
Recognitio
n of 101
MDMCs
MDAE form
(Version
1.1) has
been
formed
Reference
manual for
medical
devices
> 4500
MDAEs
reported till
now
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63. Medical
Device
Adverse Event Serious/
Non-serious
Reporter
Surgical gloves Allergic reaction Non-serious Surgeon
Dialysis Machine Hypertension and
cramps due to low
conductivity
Serious Technician
Canula Multiple ecchymosis
lesion on forearm with
purpura
Non-serious PV-Associate
Pacemaker Arrythmia Serious Clinician
Hip Implant Pain associated with
limb dystrophy
Serious Industry
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64. • The regulated countries, along with India, defined not-reportable events
as :
1- If the deficiency of a device is found by the user before its use and no
serious injury has occurred.
2- If the root cause of the adverse event is due to a patient’s pre-existing
condition.
3- If the shelf life or service life of the device was exceeded before its use by
a patient.
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65. 4- If the deficiency had a negligible likelihood of causing death or serious
injury and had been established and documented as acceptable after risk
assessment.
5- If the side effects are expected and foreseeable from the manufacturer’s
labelling, are clinically well known and are documented in the device master
record, with an appropriate risk assessment.
6- If the adverse event was caused by abnormal use.
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66. • FDA uses the term “recall” when a manufacturer takes a correction or
removal action to address a problem with a medical device that violates
FDA law
1 - Return of a medical device to the manufacturer or its representative.
2 - Device modification.
3 - Device exchange.
4 - Advice is given by the manufacturer regarding the use of the device.
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68.  Meher, B.R., 2018. Materiovigilance: an Indian perspective. Perspectives in clinical research, 9(4), p.175.
 Kumar, P., Kalaiselvan, V., Kaur, I., Thota, P. and Singh, G.N., 2016. Materiovigilance programme of India
(MVPI): A step towards patient safety for medical devices. Eur J Biomed Pharm Sci, 12, pp.497-501.
 Maiti Rituparna.2020. Postgraduate Topics in Pharmacology. 3rd ed. : Paras Medical Books
 Postgraduate Pharmacology 1st Edition 2020 by Sougata Sarkar
 Chauhan, P.R.A.T.I.B.H.A., Zareen, A.A.L.I.A. and Iqbal, M.K., 2019. Current Status of Materiovigilance
Globally–An Utter Overview with clinical case perusal. Int J Pharm Pharm Sci, 11(10), pp.1-8.
 www.fda.gov
 www.cdsco.gov.in
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