CURRENT STATUS OF MATERIOVIGILANCE GLOBALLY-AN UTTER OVERVIEW WITH CLINICAL CASE PERUSAL

  • PRATIBHA CHAUHAN Department of Pharmacology, School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi 110062, India
  • AALIA ZARREEN Department of Pharmacology, School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi 110062, India
  • MOHAMMAD KASHIF IQUBAL Department of Pharmaceutics, School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi 110062, India

Abstract

Today’s medical devices are the lifesaving tool and these tools are very frequently used globally since long ago. With the increase in the number of medical devices and their uses, there is an increase in the number of adverse events related to such devices. That is why Materiovigilance is an important tool for the identification, collection, reporting, and analysis of any aversive catastrophe related to the use of medical devices and protection of a patient’s life by fending its reiteration. Post marketing surveillance of medical devices has been initiated in many countries, like the United States of America has started a program under the name Medical Device Reporting (MDR), France, Australia and the United Kingdom have also come up with their own programs. Apart from this India has also initiated the Materiovigilance program by Drug Controller General of India (DCGI) at the Indian Pharmacopoeia Commission (IPC) in Ghaziabad in 2015. In this article we have discussed about the risks associated with the use of different classes of medical devices and the need of Materiovigilance program. This article also discusses the adverse events associated with the medical devices, the reporting criteria of those adverse events and the different clinical events of the medical devices.

Keywords: Medical device, Materiovigilance, Regulations, Clinical case studies

Downloads

Download data is not yet available.

References

1. Rani S, Singh K. Materiovigilance: an emerging discipline. Int J Sci Res 2018;7:15-6.
2. Materiovigilance in EU. Lambda therapeutic research ltd; 2019. https://www.lambda-cro.com/materiovigilance-in-eu/ [Last accessed on 26 Oct 2018]
3. Madhusudhan SK, Shashikala GH. Evaluation of knowledge, awareness, and practice of pharmacovigilance among practicing doctors. Asian J Pharm Clin Res 2016;9 Suppl 3:283-6.
4. Sivadasan S, Sellappan M. A study on the awareness and attitude towards pharmacovigilance and adverse drug reaction reporting among nursing students in a private university, Malaysia. Int J Curr Pharm Res 2015;7:84-9.
5. Kumar P, Kalaiselvan V, Kaur I, Thota P, Singh GN. Materiovigilance programme of India (MVPI): A step towards patient safety for medical devices. Eur J Biomed Pharm Sci 2016;12:497-501.
6. Gupta P, Janodia MD, Jagadish PC, Udupa N. Medical device vigilance systems: India, US, UK, and Australia. Med Devices (Auckl) 2010;3:67.
7. Meher BR. Materiovigilance: an Indian perspective. Perspect Clin Res 2018;9:175-8.
8. Johnson JA. FDA regulation of medical devices. Congressional research service; 2016. p. 1-45.
9. https://www.globalbsg.com/iwe-event/2nd-annual-pharmacovigilance-drug-safety-summit/ [Last accessed on 22 Nov 2018].
10. McCulloch P. The EU’s system for regulating medical devices. Br Med J 2012;345:1-2.
11. Medicines and Healthcare products regulatory agency. Annual Report Accounts 2010/11;1-71. Available from: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/247348/1195.pdf [Last accessed 22 Nov 2018].
12. Postmarket surveillance under section 522 of the federal food, drug, and cosmetic act. Guidance for Industry and Food and Drug Administration Staff. USFDA; 2016. p. 1-22. Available from: https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm268141.pdf [Last accessed 12 Dec 2018]
13. Jankar BB, Devesh D, Gosavi. Adverse drug reaction of lithium carbonate-a review. J Crit Rev 2017;4:1-6.
14. Dieffaga T, Sanogo M, Maiga S. P360: materiovigilance and improvement of the maintenance of the biomedical equipment by the implementation of strategies for the use of equipment: case study of the hospital Gabriel Touré of Mali. Antimicrob Resist Infect Control 2013;2 Suppl 1:P360.
15. Wathoni N, Alfauziah TQ, Rantika N. Evolution of contraceptive implants: a review. Int J Appl Pharm 2018;10:16-22.
16. Principles of medical devices classification. The global harmonization task force; 2006. Available from: http://www.imdrf.org/docs/ghtf/final/sg1/technical-docs/ ghtf-sg1-n15-2006-guidance-classification-060627.pdf [Last accessed on 01 Nov 2018].
17. A guidance document for medical devices. Central drugs standard control organization; 2018. Available from: http://www.cdsco.nic.in/writereaddata/Guidance%20Document%20ipv.pdf [Last accessed on 26 Nov 2018]
18. Classification of medical devices and in vitro diagnostic medical devices under the provisions of the medical devices rules. Drugs Controller General, India; 2017. Available from: http://www.cdsco.nic.in/writereaddata/Classification%20wise%20list%20of%20MD%20and%20IVDs17.pdf [Last accessed on 01 Nov 2018].
19. Masurkar P. A need of better pharmacovigilance system in India. Asian J Pharm Clin Res 2017;10:22-4.
20. Classify Your Medical Device. USFDA; 2018. Available from: https://www.fda.gov/medicaldevices/deviceregulationandguidance/overview/classifyyourdevice/ucm2005371.htm [Last accessed on 22 Jan 2019]
21. Medicines and Healthcare products regulatory agency. Available from: https://www.gov.uk/topic/medicines-medical-devices-blood/medical-devices-regulation-safety [Last accessed on 13 Feb 2019].
22. Risk classification of medical devices. New Zealand Medicines and Medical Devices Safety Authority; 2011. Available from: https://medsafe.govt.nz/regulatory/devicesnew/3-7RiskClassification.asp [Last accessed on 01 Nov 2018]
23. Kalaiselvan V, Kumar P, Mishra P, Singh GN. System of adverse drug reactions reporting: what, where, how, and whom to report? Indian J Crit Care Med 2015;19:564-6.
24. Kirschgens LA, Ugarte IZ, Uriarte EG, Rosas AM, Vilches VM. Robot hazards: from safety to security. arXiv preprint arXiv: 1806.06681; 2018. p. 1-10.
25. TGA actions after review into urogynaecological surgical mesh implants. Therapeutic goods administration (TGA). Australian Government, Department of health; 2019. Available from: https://www.tga.gov.au/alert/tga-actions-after-review-urogynaecological-surgical-mesh-implants [Last accessed 10 Jan 2019].
26. Thacker T. Govt plans tweaks in law to make firms liable for defective devices, drugs; 2017. Available from: https://www.livemint.com/Politics/sTQOfekT0SVdqlqo0wu3xL/Govt-plans-tweaks-in-law-to-make-firms-liable-for-defective.html [Last accessed on 21 Feb 2019]
27. Nagaratnam C, Deepika B, Deepalatha C. Drug utilization pattern study in young adult patients of cutaneous adverse drug reactions. Int J Curr Pharm Res 2018;10:13-5.
28. MDR Adverse Event Codes. USFDA; 2018. Available from: https://www.fda.gov/medicaldevices/deviceregulationandguidance/postmarketrequirements/reportingadverseevents/mdradverseeventcodes/default.htm [Last accessed on 19 Dec 2018].
29. Materiovigilance Programme of India (MvPI)-Indian Pharmacopoeia Commission. Available from: http://www.ipc.gov.in/mandates/pvpi/materiovigilance-programme-of-india-mvpi.html [Last accessed on 28 Dec 2018]
30. Kaur I, Kalaiselvan V, Kumar R, Kumar P, Singh GN. Reporting of adverse drug reaction under pharmacovigilance programme of India; 2015.
31. The importance of pharmacovigilance-safety monitoring of medicinal products. World Health Organization; 2002. Available from: http://apps.who.int/medicinedocs/ en/d/ Js4893e/ [Last accessed on 28 Dec 2018]
32. Comparison of the device adverse reporting systems in USA, Europe, Canada, Australia and Japan. Global harmonization task force; 2002. Available from: http://www.imdrf.org/docs/ ghtf/final/sg2/technical-docs/ghtf-sg2-n6r3-2002-comparison-device-adverse-reporting-systems-020521.pdf [Last accessed on 22 Dec 2018]
33. The Medical Devices Regulations. UK Statutory Instruments; 2002. p. 618. Available from: http://www.legislation. gov.uk/uksi/2002/618/introduction/made [Last accessed on 23 Mar 2019]
34. Medical device manufacturers. Guide to inspections of medical device manufacturers, USFDA; 1997. Available from: https://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074899.htm [Last accessed on 26 Dec 2018]
35. Guidance on how to handle information concerning vigilance reporting related to medical devices. Global harmonization task force 1999. Available from: http://www.imdrf.org/ docs/ghtf/final/sg2/technical-docs/ghtf-sg2-n008r4-reporting-guidance-990629.pdf [Last accessed on 27 Dec 2018]
36. Application requirements for participation in the GHTF national competent authority report exchange program. Global harmonization task force; 2009. Available from: http://www.imdrf.org/docs/ghtf/final/sg2/technical-docs/ ghtf-sg2-n38r19-national-competent-authority-report-program-090701.pdf [Last accessed on 16 Jan 2018].
37. Medical device tracking guidance for industry and food and drug administration staff. USFDA; 2014. Available from: https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071775.pdf [Last accessed on 28 Dec 2018].
38. Recalls, suspensions, cancellations, and tampering of medical devices. Australian regulatory guidelines for medical devices (ARGMD) part 3–post-market, therapeutic goods administration; 2011. p. 317-37. Available from: https:// www.tga.gov.au/sites/default/files/devicesargmd-p3.docx [Last accessed on 29 Oct 2018].
39. Recalls, corrections and Removals (Devices). USFDA; 2018. https://www.fda.gov/medicaldevices/deviceregulationandguidance/postmarketrequirements/recallscorrectionsandremovals/default.htm [Last accessed on 18 Nov 2018].
40. Uniform recall procedure for therapeutic goods (URPTG) version 2.1. Therapeutic goods administration; 2019. p. 1-79. Available from: https://www.tga.gov.au/publication/uniform-recall-procedure-therapeutic-goods-urptg-2004-edition [Last accessed on 18 Jul 2019].
41. Parvizi N, Woods K. Regulation of medicines and medical devices: contrasts and similarities. Clin Med (Lond) 2014;14:6-12.
42. Medical Device Overview. USFDA; 2018. Available from: https://www.fda.gov/ForIndustry/ImportProgram/ImportBasics/RegulatedProducts/ucm510630.htm [Last accessed on 22 Nov 2018].
43. Golder S, Wright K, Rodgers M. Failure or success of search strategies to identify adverse effects of medical devices: a feasibility study using a systematic review. Syst Rev 2014;3:1-6.
44. Beydon L, Conreux F, Le Gall R, Safran D, Cazalaa JB. Analysis of the french health ministry’s national register of incidents involving medical devices in anesthesia and intensive care. Br J Anaesth 2001;86:382-7.
45. Laskey W, Awad K, Lum J, Skodacek K, Zimmerman B, Selzman K, et al. An analysis of implantable cardiac device reliability. The case for improved postmarketing risk assessment and surveillance. Am J Ther 2012;19:248-54.
46. Inspection of Medical Device Manufacturers: attachment D: summary of tracking requirements. USFDA; 2018. Available from: https://www.fda.gov/MedicalDevices/DeviceRegulation and Guidance/GuidanceDocuments/ucm149673.htm [Last accessed on 28 Nov 2018].
47. Hefflin BJ, Gross TP, Schroeder TJ. Estimates of a medical device-associated adverse events from emergency departments. Am J Prev Med 2004;27:246-53.
48. Mahajan T, Dubin AM, Atkins DL, Bradley DJ, Shannon KM, Erickson CC, et al. Impact of manufacturer advisories and FDA recalls of implantable cardioverter-defibrillator generators in pediatric and congenital heart disease patients. J Cardiovasc Electrophysiol 2008;19:1270-4.
Statistics
400 Views | 190 Downloads
Citatons
How to Cite
CHAUHAN, P., A. ZARREEN, and M. K. IQUBAL. “CURRENT STATUS OF MATERIOVIGILANCE GLOBALLY-AN UTTER OVERVIEW WITH CLINICAL CASE PERUSAL”. International Journal of Pharmacy and Pharmaceutical Sciences, Vol. 11, no. 10, Oct. 2019, pp. 1-8, doi:10.22159/ijpps.2019v11i10.34716.
Section
Review Article(s)