Materiovigilance

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

1. MATERIOVIGILANCE Dr. Yash N. Panchal Junior Resident Pharmacology Department AMC MET Medical College 24/09/2021 1

2. Outline of Presentation Medical devices Drug vs Medical devices Classification and regulation of Medical devices Materiovigilance Global perspective of Materiovigilance MvPI Non-reported events 2

3. What is Medical Device ?? 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 : 3

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 4

5. Drug vs Medical device 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 5

6. Classification of Medical devices USFDA classification 6

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8. Licensing of Medical devices 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). 8

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 9

10. Licensing of Medical devices in India 10

11. Medical device rules, 2017 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 11

12. Notified Medical Devices 12

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14. Materiovigilance 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. 14

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 15

16. Aim and Objectives of Materiovigilance 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 16

17. Global perspective of Materiovigilance 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 17

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 18

19. MDAEs reporting in USA 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 19

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22. Med Watcher Mobile Application 22

23. Med Watch 3419 Form 23

24. MDA Guidelines VIGILANCE SCHEME ADVERSE EVENT REPORTING SCHEME For manufacturers For Health care professionals Mandatory Voluntary 24

25. Need for MvPI (Materiovigilance Programme of India ) 25

26. New-born killed after incubator caught fire due to short circuit 26

27. 5 New-born charred to death in photo-therapy unit, receiving treatment for jaundice 27

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29. MvPI MoHFW ( Ministry Of Health & Family Welfare ), GoI (Government Of India ) approved MvPI on 10 th February 2015 with an effort to ensure safety of medical devices. MvPI was launched by DCGI ( Dr. G.N. Singh ) on 6 th July 2015 at IPC ( Indian Pharmacopoeia Commission ), Ghaziabad IPC function as National Co-ordination center 29

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32. Scope & Objectives of MvPI 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 32

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 33

34. Partners of MvPI 34

35. Programme Communication 35

36. MDMCs (Medical device adverse event monitoring center ) 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 36

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. 37

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39. SCTIMST (Sree Chitra Tirunal Institute Of Medical Science & Technology 39

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 40

41. IPC (Indian Pharmacopoeia Commission) 41

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 42

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, newsle tters, training manuals with technical support from NHSRC 43

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 44

45. Committee under IPC,NCC 45

46. NHSRC (National Health System Resource Centre 46

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 47

48. CDSCO (Central Drug Standard Control Organization ) 48

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 49

50. Reporting Criteria 50

51. Who Can Report ? 51

52. What to report ? 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 52

53. How to report 53

54. MDAE Reporting Form 54

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60. Time Frame of Reporting 60

61. What is serious event ?? 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 61

62. Key achievements of MvPI 62

63. Some of Reported Adverse Events under MvPI 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 63

64. Not-reportable incidents or events 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. 64

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 . 65

66. Recall/ Field safety corrective action of Medical device 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. 66

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68. References 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. 3 rd ed. : Paras Medical Books Postgraduate Pharmacology 1 st 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 68

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