Counterfeiting Medical Devices: A Global Threat
Safety of Medical devices
The safety of patients is constantly and seriously threatened by counterfeit medical devices. Counterfeit medical supplies violates patients' rights, diminishes the value of the brand, and costs original equipment manufacturers revenue. The objective and purpose of medical treatment can be completely defeated by fake or inferior equipment. When a counterfeit product is used in the life sciences sector, particularly medical devices, it puts the patient at risk and has an impact on the manufacturer through potential brand damage, the expense of removing these counterfeit products from the supply chain, and additional work to prevent future problems. Therefore, it is imperative that producers of medical devices make sure their supply chain, packing, and labeling are tight and carefully traced until the point of use. Both the manufacturer and the consumer are safeguarded by anti-counterfeiting techniques. Manufacturers can include deterrents to each of components of packaging to prevent counterfeiting like hologram, UV identifying code, a 2D barcode with special numbering or serialization, or concealed text written with magnetic or security ink. To make sure the functional quality and effectiveness of these medical devices, proper adaptive and regulatory measures are needed to be in place.
Albiani R.combating counterfeit medical devices: A Case Study, https://bpp.msu.edu/magazine/combating-counterfeit-medical-devices-a-case-study-march2021/
Bansal, D., Malla, S., Gudala, K., & Tiwari, P. (2013). Anti-counterfeit technologies: a pharmaceutical industry perspective. Scientia Pharmaceutica, 81(1), 1-14.
Biesman, B. S., & Patel, N. (2014). Physician alert: beware of counterfeit medical devices. Lasers in surgery and medicine, 46(7), 528-530.
Combat Counterfeiters: The battle against counterfeit medical devices, Medtech dive July 12, 2019, Retrieved from https://www.medtechdive.com/press-release/20190712-combat-counterfeiters-the-battle-against-counterfeit-medical-devices
de Bruijn, A. C. P., & Hermsen, H. P. H. (2009). Counterfeit medical devices-A risk indication. RIVM letter report 360060001.
Ghosh D., Fake oximeter gang busted in Kolkata, May 27, 2021, Retrieved from https://timesofindia.indiatimes.com/city/kolkata/fake-oximeter-gang-busted/articleshow/82985482.cms
Glass, B. D. (2014). Counterfeit drugs and medical devices in developing countries. Research and Reports in Tropical Medicine, 11-22.
Global operation targets rise in counterfeit COVID-related medical items. (2020). Reactions Weekly, 1798(1), 2. https://doi.org/10.1007/s40278-020-76739-3
Hana O., "Fake thermometers that only show 37°Csold online, worth more than S$14,000seized, woman busted”.The Independent Singapore News and Media. Retrieved from https://theindependent.sg/fake-thermometers-that-only-show-37c-sold-online-worth-more-than-s14000-seized-woman-busted.
Hubbard D., RAM Medical Pleads Guilty to Importing, Reselling Contaminated Surgical Equipment https://patch.com/new-jersey/wayne/medical-device-distributor-pleads-guilty-to-importingf3536683f0
Interpol. The global operation sees a rise in fake medical products related to COVID-19. Internet Document : 19 Mar 2020. Available from: URL: https://www.interpol.int/en/News-and-Events/News/2020/Global-operation-sees-a-rise-in-fake-medical-products-related-to-COVID-19
Kambli R.Battle against Counterfeit Medical devices, Nov 5, 2019, Retrieved from https://www.expresshealthcare.in/medtech/battle-against-counterfeit-medical-devices/414905
MAUDE – Manufacturer and User Facility Device Experience. Published by USFDA. Available from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE /search.CFM (Accessed on 20.12. 2019).
Medical Device and diagnostics, Central Drugs Standard Control Organization, Ministry of Health & Family Welfare, Government of India, Retrieved on May 3,2023,https://cdsco.gov.in/opencms/opencms/en/Medical-Device-Diagnostics/Medical-Device-Diagnostics
Medical Device Distributor Pleads Guilty For Importing, Reselling Counterfeit And Contaminated Surgical Hernia Mesh, https://www.justice.gov/archive/usao/nj/Press/files/RAM%20Medical%20Plea%20News%20Release.html
Millar A. Medical device network. Counterfeit medical devices: on the rise during Covid-19? New York, NY. November29.2021. Retrieved from https://www.medicaldevice-network.com/features/counterfeit-medical-devices-covid-19.
Mori, M., Ravinetto, R., & Jacobs, J. (2011). Quality of medical devices and in vitro diagnostics in resource‐limited settings. Tropical Medicine & International Health, 16(11), 1439-1449.
Pasricha N., Countering the counterfeit medical devices, Published on Dec 20,2022.https://www.healthcareradius.in/features/equipment-devices/countering-the-counterfeit-medical-devices
Perapadan P.S.Substandard, fake medical products increased by almost 47%from 2020 to 2021 during pandemic: report. March 29, 2022, Retrieved from https://www.thehindu.com/news/national/substandard-fake-medical-products-increased-by-almost-47-from-2020-to-2021-during-pandemic-report/article65270728.ece
Stevens, W. G., Spring, M. A., & Macias, L. H. (2014). Counterfeit medical devices: The money you save up front will cost you big in the end. Aesthetic Surgery Journal, 34(5), 786-78
The world’s biggest medical device recalls. Medical device Network. April 30, 2019, Retreived from https://www.medicaldevice-network.com/features/biggest-medical-device-recalls
U-Nica.The Rise of Counterfeit Medical Devices. U-NICA Americas Inc. August 19, 2022, Retrieved from https://www.u-nica.com/blog/rise-of-counterfeit-medical-devices.
US Food and Drug Admin., What is a Medical Device Recall?, https://www.fda.gov/medical-devices/medicaldevice-recalls/what-medical-device-recall
Wang, J. V., Hattier, G., Rohrer, T., Zachary, C. B., & Saedi, N. (2020). Experiences with counterfeit aesthetic medical devices and injectables: a national survey. Dermatologic Surgery, 46(10), 1323-1326.
What is a Medical Device Recall? Published by USFDA. Available from: https://www.fda.gov/medical-devices/medical-devicerecalls/what-medical-device-recall (Accessed on 01.12. 2018)
WHO. Over 8% of medical devices in circulation are counterfeit: WHO. Available from: http://www.news-medical.net/news/20100128/Over-825-of-medical-devices-in-circulation-are-counterfeit-WHO.aspx Accessed October 4, 2013.
Copyright (c) 2023 Manvi Aggarwal, Arti Thakkar, Jyoti Sinha
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.