Materiovigilance and its significance and MVPI

Materiovigilance

1. Professor, Department of Pharmaceutics
St. Peter’s Institute of Pharmaceutical Sciences,
Hanumakonda, Telangana, India.
Materiovigilance
[email protected];
[phone]

2. Contents
▸Definition of Materiovigilance (What?)
▸History (When?)
▸Location of the office and functional bodies (Where?)
▸Significance of Materiovigilance (Why?)
▸Stake holders (Who)
▸Reporting and functioning (How?)
▸Materials under MVPI (Which?)
▸Conclusion
▸References
1

3. Introduction
Definition:Materiovigilanceisthecoordinatedsystemofidentification,collection,
reporting,andanalysisofanyuntowardoccurrencesassociatedwiththeuseofmedical
devicesandprotectionofpatient'shealthbypreventingitsrecurrences.
MedicalDevicesareapplicablein
Prognostic,
Diagnosticand
TherapeuticPurposes.
2a
What ?

4. Medical Device
2b
What ?
The World Health Organization has defined medical device as any
“Instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similaror
related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the
specific medical purpose(s) of diagnosis, prevention, monitoring, treatment or alleviation of disease, diagnosis, monitoring,
treatment, alleviation of or compensation for an injury, investigation, replacement, modification, or support of the anatomy or of a
physiological process, supporting or sustaining life, control of conception, disinfection of medical devices providing information by
means of in vitro examination of specimens derived from the human body; and does not achieve its primary intended action by
pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function
by such means”

5. History
OnJuly6,2015,attheIndianPharmacopoeiaCommission(IPC),theMateriovigilanceProgramof
India(MVPI)wasformallyinauguratedtomonitorthesafetyofmedicaldevicesinthenation.
3
When ?

6. Location of the office and functional bodies
▸TheMvPIisformallyIntroducedbytheDrugControlGeneralofIndia(DCGI)atIndianPharmacopoeia
Commission(IPC)atGhaziabad.
▸Themedicaldevicemonitoringcentre(MDMC)hasbeenestablishedin12medicalcollegesalloverIndia.
▸TheSreeChitraThirunalInstituteofMedicalSciencesandTechnologyinThiruvananthapuramistobethe
NationalCollaboratingCentrefortheprogramme,whichwillrunincollaborationwiththeCentralDrug
StandardControlOrganization(CDSCO).
▸TechnicalsupportfortheprogrammeistobeprovidedbytheDivisionofHealthcareTechnology,aproposed
WorldHealthOrganizationcollaboratingcentreforprioritymedicaldevicesandhealthtechnologypolicyinthe
NationalHealthSystemsResourcesCentre.
▸IndianPharmacopoeiaCommission(IPC),GhaziabadwillbeworkingasNationalCoordinationCentretocollect
thereportsonadverseevents.
4a
Where ?

7. List of MDMCs
4b
S. No. MDMC Name & Address Status Recognition year
1.Dept. of Oral and Maxillofacial Surgery, Maratha Mandal's NathajiraoG HalgekarInstitute of Dental Sciences & Research
centre Belagavi Karnataka –590010.
Non Government 2019
2.Lady HardingeMedical College Department of Pharmacology, C-604 Shaheed Bhagat Singh, Road, DIZ Area, Connaught
Place, New Delhi, Delhi 110001 .
Government 2019
3.Department of Pharmacology, Hamdard Institute of Medical Sciences & Research Jamia Hamdard, New Delhi -110062 . Non Government 2019
4.School of Tropical Medicine Department of Clinical & Experimental Pharmacology,108 Chitta Ranjan Avenue, Kolkata –
700073.
Government 2019
5.Yashoda Super Speciality Hospital H1,26,27, Kaushambi, Near, H-1 Metro, Kaushambi, Ghaziabad, Uttar Pradesh 201001 .Non Government 2019
6.Frontier Lifeline Hospital Pvt Ltd, R30-C, Ambattur Industrial Estate Road, Mogappair, Chennai, Tamilnadu-600101 . Non Government 2019
7.Dr SampurnanandMedical College, Residency Road, Near Sriram Excellency Hotel, Opposite Petrol Pump, Sector-D, Shastri
Nagar, Jodhpur, Rajasthan 342003.
Government 2019
8.Dept. of Pharmacology, All India Institute of Medical Science, Patna, Bihar-801507. Government 2019
9.Dept. of Pharmacy Practice, St. James College of Pharmaceutical Sciences, Chalkudy, Thrissur, Kerala-680307. Non Government 2019
10.Biomdicalwing, District Hospital Mavelikkara, Near mavelikaraPandalamRoad, Thazhakkara, Mavelikara, Alappuzha, Kerala
690102.
Government 2019

8. List of MDMCs
4c
S. No. MDMC Name & Address Status Recognition year
11.Dept. of Pharmacology, Veer Surendra Sai Institute of Medical Sciences and Research (VIMSAR) Pg Chowk, Burla, Odisha 768017.Government 2019
12.Dept. of Pharmacology, SLN Medical College and Hospital, Janiguda, Koraput, Odisha 764020. Government 2019
13.Dept. of Pharmacology, KonaseemaInstitute Of Medical Science AmlapuramAndra Pradesh –533201. Non Government 2019
14.Dept. of Pharmacology, All India Institute of Medical Sciences, Saket Nagar, Bhopal, Madhya Pradesh 462020. Government 2019
15.Mysore Medical College and Research Institute, Irwin Road, Next to Railway Staion, Mysuru, Karnataka 570001 (Affiliated
hospitals: K.R. Hospital; CheluvambaHospital; PKTB Hospital)
Government 2018
16.College of Pharmacy, Sri Ramakrishna Institute of paramedical Sciences, 395,Sarojini Naidu Rd, Sidhapur, Coimbatore641044. Non Government 2018
17.Department of Quality Systems Royal Care Super Speciality Hospital, SF No:554/555, NeelamburVillage, SulurTaluk, CBE,
Tamilnadu-641062
Non Government 2018
18.Department of Biomedical Engineering, National Institute of Mental Health & Neuro Sciences (NIMHANS), Hosur Road,
Lakkasandra, Wilson Garden, Bengaluru, Karnataka 560029.
Government 2017
19.Department of Biomedical Engineering, Sanjay Gandhi Post Graduate Institute of Medical Science, Luknow, Uttar Pradesh. Government 2017
20.Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), DhavantriNagar, Gorimedu, Puducherry-
605006
Government 2017

9. List of MDMCs
4d
S. No. MDMC Name & Address Status Recognition year
1.Narayana Health, NH Health City,258/A, Bommasandra Industrial Area, AnekalTaluk, Hosur Road, Bangalore-560099 (Affiliated
hospitals: Narayana Institute of Cardiac Sciences; MazumadarShaw Medical Center)
Non Government 2016
2.Postgraduate Institute of Medical Education and Research, Room no. 4043, 4th Floor, PGIMER, Sector-12, Chandigarh-160012 Government 2016
3. Department of Pharmacology, Dayanand Medical College and Hospital, Ludhiana, Punjab,141001 Non Government 2016
4.Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), Ansari Nagar East, Gautam Nagar, New Delhi-110029 Government 2016
5.GlocalGroup of hospitals, 3 B 207, Eco-space Business Park action Area II, New town Rajarhat, Kolkata-700156 Non Government 2016
6.Department of Biomedical Engineering, Christian Medical College (CMC), Thorapadi, Vellore-6323004 Government 2016

10. Significance of Materiovigilance (Why?)
▸Byrecognizingunfavorableoccurrencesthatcanendangerpatients,itenhancespatientsafety.
▸ItmotivatesMedicalDeviceManufacturers/Importerstoevaluateandenhanceproduct
performanceanddesign,andtolaunchitemsintothemarketwithafeelingofethicalbusiness.
5
MATERIOVIGILANCEPROGRAMMEOFINDIA(MvPI).
Vision
▸ToimprovepatientsafetyandwelfareofIndianpopulationbymonitoringadverseeventsrelatedtomedicaldevicesand
therebyreducingtheriskassociatedwithuseofmedicaldevices.
Mission
▸SafeguardthehealthofIndianpopulationbyensuringthatthebenefitsofuseofmedicaldevicesoutweightherisks
associatedwithitsuse.

11. Stake holders of Materiovigilance
6b
Who ?

12. Stake holders of Materiovigilance
▸Roleofhealth-careserviceproviders
▸Roleofmanufactures
▸RoleofresearchassociateandcoordinatoratMDMC
▸TheresponsibilityofNationalCollaboratingCentre(SreeChitraThirunalInstituteofMedicalSciencesandTechnology)
▸TheresponsibilityofNationalCoordinatingCentre(NCC)
▸Theresponsibilityoftechnicalsupportandresearchcenter(TSRC)
▸TheresponsibilityofCDSCO.
▸Policymakersatalllevelsofhealthcare,particularlythoseconcernedwithmedicaldevicepolicy
6a
Who ?
Professional staff at IPC, National Health System Resource Centre (NHSRC), Central Drugs Standard Control Organization
(CDSCO), New Delhi, (CDSCO), MDMC and the whole citizens of India would serve as stakeholders of the programme

13. Whom to Report
7a
How ?
▸The‘MedicalDeviceAdverseEvent(MDAE)reportingform’isavailableatwww.ipc.gov.in
▸ThefilledMDAEreportingformcanbedirectlysentbythereportertoNCC-MvPIvia
email:[email protected]/[email protected]
EventmonitoringCentre(MDMC)/AdverseDrugReactionMonitoringCentre(AMC).
▸Atollfree(18001803024)numbertoreportadverseeventassociatedwithuseofmedical
devicestoNCC-MvPIonweekdaysfrom9:00am–5:30pm.

14. Flow Diagram for MDAE Reporting
14
7b

15. Reporting and functioning
OrganizationalstructureofMateriovigilanceprogramofIndia
7c
How ?
Central Drugs Standard Control Organisation(CDSCO), New Delhi
National Regulatory Authority ( NRA)
Indian Pharmacopoeia Commission, Ghaziabad.
National Coordinating Centre (NCC)
National Health System Resource Centre (NHSRC)
Technical Support and Research Centre(TSRC)
The Sree Chitra Thirunal Institute of Medical Sciences and Technology, Thiruvananthapuram
(National Collaborating Centre)
Medical Device Adverse Event Monitoring Centre (MDMC)Ipc.gov.in
Toll free helpline
1800-180-3024

16. Brief schematic representation of medical devices
-
related reporting.
*Concept developed based on the research of Tase et al. (2021)
16
7d

17. Reporting and functioning
8
How ?

18. Medical Device ADE Reporting Form
10

19. Information required for the reporting of MDAEs
11
How ?
Type/category of information Details
General information Date and type of report (initial/follow-up/final/trend)
Reporter details
Type of reporter (manufacturer/importer/health professionals/users/others) with their
contact information
Device category
Device type (therapeutic/diagnostic/preventive/others), invasive/non-invasive, single
use/reusable, sterile/non-sterile
Device details
Device name, manufacturer’s name, address and contact information, supplier or
purchaser, license number, specification, batch/lot/model, quantity of device used,
manufacturing and expiry date, period of validity (i.e., shelf life), date of sale
Event description
Event date, implant date, serious/non-serious, description of the event, device
operator
Patient information
Patient initial, age, gender, weight and BMI, relevant medical history, and patient
outcomes (recovered/not recovered)
Causality assessment
Investigation or action taken, root cause analysis (RCA) of problem, challenge, and
dechallenge-related information
Manufacturer’s investigation and action takenDevise risk analysis report, corrective/preventive action taken, device history review

20. Information required for the reporting of MDAEs
11a
How ?
Type/category of information Details
General information Date and type of report (initial/follow-up/final/trend)
Reporter details
Type of reporter (manufacturer/importer/health professionals/users/others) with their
contact information
Device category
Device type (therapeutic/diagnostic/preventive/others), invasive/non-invasive, single
use/reusable, sterile/non-sterile
Device details
Device name, manufacturer’s name, address and contact information, supplier or
purchaser, license number, specification, batch/lot/model, quantity of device used,
manufacturing and expiry date, period of validity (i.e., shelf life), date of sale
Event description
Event date, implant date, serious/non-serious, description of the event, device
operator
Patient information
Patient initial, age, gender, weight and BMI, relevant medical history, and patient
outcomes (recovered/not recovered)
Causality assessment
Investigation or action taken, root cause analysis (RCA) of problem, challenge, and
dechallenge-related information
Manufacturer’s investigation and action takenDevise risk analysis report, corrective/preventive action taken, device history review
Guidance document MvPIversion 1.2

21. Reporting timeframes
▸Any SAE like deaths, serious injuries, malfunction, etc. to be
reported within 15days of identification,
▸Non-serious events reporting to be done within 30 days of
occurrence.
11b

22. Penalties to the violators
▸Five lakhs rupees fine or one-year imprisonment or both for
the manufacturer, importer, and seller
11c

23. Materials under MVPI
12
Which ?
1.ClassAitemshavelowrisk:Surgicaldressing,alcoholswabs,thermometers,
nasopharyngealswabs,tonguedepressors,umbilicalocclusiondevice,bolstersuture,
Nasopharyngealcatheter.
2.ClassBitemsposelow-to-moderaterisk:Atrioventricularshunt,transcervicalendoscope,
oximetercatheter,hypodermicneedles,suctionequipment,hematologyreagentkits,
disinfectants,intravenouscatheter,rectalcatheter,fistulaadapter.
3.ClassCdevicesposemoderate-to-highrisk:Uterineballoontherapydevice,veinablation
device,intraocularlenses,lungventilator,bonefixationplate,biliarystents,bonecement,
Imagingcatheter.
4.ClassDitemshavehighrisk:Coronarystent,cardiacstents,implantabledefibrillator,
cochlearimplants,heartvalve,copperT.

24. CONCLUSION
24
1.MvPIisavitalpartofIndia'shealthcaredeliverysystem,ensuringmedicaldevicesafety
andeffectivenesswhileraisingthestandardofcare.
2.AMateriovigilancesystemthatiseffectiveinprotectingthepublic'shealthand
enhancingthequalityofhealthcaremaybeestablishedbyprioritizingtransparencyand
utilisingstate-of-the-arttechnology.
3.Involvementofallthestakeholdersrangingfrompatientstohealth-careservice
providersimprovisestheMateriovigilanceandhelpsincontrolandpreventionof
medicaldevicesrelatedadverseevents.
13

25. References
➢ 1.RadhadeviN,BalamuralidharaV,KumarTMP,RaviV.RegulatoryguidelinesformedicaldevicesinIndia:Anoverview.AJP.2014;6(1).
➢ 2.Indianpharmacopoeiacommission.Guidancedocument:MateriovigilanceprogrammeofIndia(MvPI)Version1.2,2017:1–58.
➢ 3.HodaF,VermaR,ArshadM,SiddiquiAN,KhanMA,AkhtarM,etal.Materiovigilance:concept,structureandemergingperspectiveforpatient’ssafetyinIndia.DrugRes.
2020;70(09):429–436.doi:10.1055/a-1195-1945.
➢ 4.KalaiselvanV,SaxenaR.IntraoculardevicesassociatedadverseeventsreportingsysteminIndia.IndianJOphthalmol.2020;68(11):2343–2345.doi:10.4103/ijo.IJO_298_20.
➢ 5.ChauhanP,ZarreenA,IqubalMK.Currentstatusofmateriovigilanceglobally—anutteroverviewwithclinicalcaseperusal.IntJPharmPharmSci.2019;11(10):1–8.doi:
10.22159/ijpps.2019v11i10.34716..
➢ 6.PandeyN,ImranM.Materiovigilance:currentstatusinIndiaanalogoustoitsglobalstatus.JPADR.2020;1(2):24–31.doi:10.53411/jpadr.2020.1.2.4.
➢ 7.TaseA,BuckleP,NiMZ,HannaGB.Medicaldeviceerrorandfailurereporting:Learningfromthecarindustry.JPatientSafRiskManag.2021;26(3):135–141.doi:
10.1177/25160435211008273.
➢ 8.JoshiD,SharmaI,GuptaS,SinghTG,DhimanS,PrasharA,etal.Aglobalcomparisonofimplementationandeffectivenessofmateriovigilanceprogram:overviewofregulations.
EnvironSciPollutResInt.2021;28:59608–59629.doi:10.1007/s11356-021-16345-5.
➢ 9.RadhadeviN,BalamuralidharaV,PramodKumarTM,RaviV.RegulatoryguidelinesformedicaldevicesinIndia:Anoverview.AsianJPharm.2012;6:10–7.
➢ 10.HigsonGR.MedicalDeviceSafety:TheRegulationofMedicalDevicesforPublicHealth.London:IOPPublishing;2002.
➢ 11.GuptaSK.MedicalDeviceregulations:Acurrentperspective.JYoungPharm.2016;8:6–11.
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26. 15
THANK You!
Any questions?
You can find me at
[email protected] &
contact me at [phone]
Dr. Rajasekhar Reddy Poonuru
Professor, Department of Pharmaceutics
St. Peter’s Institute of Pharmaceutical
Sciences, Hanumakonda