J Korean Med Assoc.  2019 Sep;62(9):480-485. 10.5124/jkma.2019.62.9.480.

Medical device adverse effects

Affiliations
  • 1Department of Rehabilitation Medicine, Dongguk University Hospital, Dongguk University College of Medicine, Goyang, Korea. bskwon@dumc.or.kr

Abstract

This study aimed to describe adverse effects or reactions by medical devices. There may be unexpected effects caused by medical devices that can often be harmful to the patient. This is defined as a medical device adverse event or adverse effect (MDAE). We should prevent the recurrence of MDAEs by reporting them to regulatory authorities and device manufacturers. This reporting requires that manufacturers check the manufacturing process and update the medical device. However, it is difficult for both patients and medical persons to recognize and report MDAEs because adverse effects can be ambiguous to them in many cases. In addition, many medical persons lack an understanding of the role of this reporting. In Korea, the Ministry of Health and Welfare enacted laws and regulations for MDAE reporting in 2005. However, the number of MDAEs reported was still very small. The Ministry of Food and Drug Safety started the Medical Device Safety Monitoring Center project in 2011, with the purpose of promoting MDAE reporting. Since the Medical Device Safety Monitoring Center project began, the number of reported MDAEs rapidly increased from 137 in 2010 to 6,078 in 2017. Medical persons and device manufacturers should be encouraged to voluntarily report MDAEs and provide useful information. Korea is an important member of the International Medical Device Regulators Forum and leader of the Asia-Pacific Economic Cooperation Regulatory Committee. There should be medical device vigilance with global cooperation.

Keyword

Equipment and supplies; Mandatory reporting; Safety management

MeSH Terms

Equipment and Supplies
Equipment Safety
Humans
Jurisprudence
Korea
Mandatory Reporting
Recurrence
Safety Management
Social Control, Formal

Reference

1. National Law Information Center. Medical Device Act [Internet]. Sejong: Korea Ministry of Government Legislation;2019. cited 2019 Jul 21. Available from: http://www.law.go.kr/법령/의료기기법.
2. Korea Health Industry Development Institute. Medical device industry statistics [Internet]. Cheongju: Korea Health Industry Development Institute;2019. cited 2019 Jul 21. Available from: http://khiss.go.kr/geo?menuId=MENU00322.
3. Oh IG. Warning alarm: implant medical device. Medical Newspaper. 2018. 11. 26. cited 2019 Jul 21. Available from: http://www.bosa.co.kr/news/articleView.html?idxno=2094776.
4. Lee KM, Baek NK, Seo JH. A study on the system improvement policy according to the status analysis of medical device control system in Korea. J Korea Saf Manag Sci. 2010; 12:37–52.
5. Jang HJ, Choi YD, Kim NH. Design for a medical devices safety information reporting system for the hospitals. J Inst Electron Inf Eng. 2015; 52:140–147.
Article
6. US Food and Drug Administration. MedSun: Medical Product Safety Network [Internet]. Silver Spring: US Food and Drug Administration;2018. cited 2019 Jul 21. Available from: https://www.fda.gov/medical-devices/medical-device-safety/medsun-medical-product-safety-network.
7. International Medical Device Regulators Forum. IMDRF Strategic Plan 2020 [Internet]. [place unknown]: International Medical Device Regulators Forum;2015. cited 2019 Jul 21. Available from: http://www.imdrf.org/docs/imdrf/final/procedural/imdrf-proc-151002-strategic-plan-2020.pdf.
8. Asia-Pacific Economic Cooperation. APEC concept note: roadmap to promote regulatory convergence for medical device vigilance [Internet]. Singapore: Asia-Pacific Economic Cooperation;2015. cited 2019 Jul 21. Available from: https://www.apec.org/-/media/Files/Groups/LSIF/2016/ConceptNote_Roadmap-to-Promote-Regulatory-Convergence-for-Medical-Device-Vigilance.pdf.
9. Ministry of Food and Drug Safety. Guideline of medical device adverse event abroad [Internet]. Cheongju: Ministry of Food and Drug Safety;2018. cited 2019 Jul 21. Available from: https://www.mfds.go.kr/brd/m_99/view.do?seq=41572.
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