IDEAS home Printed from https://ideas.repec.org/a/eee/hepoli/v125y2021i7p941-946.html
   My bibliography  Save this article

The establishment of the Korean medical device safety information monitoring center: Reviewing ten years of experience

Author

Listed:
  • Choi, Soo Jeong
  • Nam, Ki Chang
  • Choi, Sooin
  • Kim, Jin Kuk
  • Lee, You Kyoung
  • Kwon, Bum Sun

Abstract

Medical devices may revolutionize healthcare delivery but can lead to serious adverse events for treated patients and users. While reporting of adverse events related to medical devices is an essential starting point for post-market surveillance, underreporting of medical device adverse events is a global problem. Korea introduced a voluntary medical device adverse event reporting system in 2010, called the Medical Device Safety Information Monitoring Center, which has led to an increase in adverse event reports. For 10 years, the Medical Device Safety Information Monitoring Center has analyzed medical device adverse events systematically and has provided active feedback to the manufacturers and education on safe use. Recently, the Medical Device Safety Information Monitoring Center contributed to harmonization of international medical device vigilance through the sharing of adverse events. This experience of Korea might contribute to improvements in medical device vigilance, which is a critical prerequisite for improving medical device policies and regulations.

Suggested Citation

  • Choi, Soo Jeong & Nam, Ki Chang & Choi, Sooin & Kim, Jin Kuk & Lee, You Kyoung & Kwon, Bum Sun, 2021. "The establishment of the Korean medical device safety information monitoring center: Reviewing ten years of experience," Health Policy, Elsevier, vol. 125(7), pages 941-946.
    • Handle: RePEc:eee:hepoli:v:125:y:2021:i:7:p:941-946
    DOI: 10.1016/j.healthpol.2021.04.017
    as

    Download full text from publisher

    File URL: http://www.sciencedirect.com/science/article/pii/S0168851021001159
    Download Restriction: Full text for ScienceDirect subscribers only
    File URL: https://libkey.io/10.1016/j.healthpol.2021.04.017?utm_source=ideas
    LibKey link: if access is restricted and if your library uses this service, LibKey will redirect you to where you can use your library subscription to access this item
    ---><---

    As the access to this document is restricted, you may want to search for a different version of it.

    References listed on IDEAS

    as
    1. Zippel, Claus & Bohnet-Joschko, Sabine, 2017. "Post market surveillance in the german medical device sector – current state and future perspectives," Health Policy, Elsevier, vol. 121(8), pages 880-886.
    Full references (including those not matched with items on IDEAS)

    Most related items

    These are the items that most often cite the same works as this one and are cited by the same works as this one.
    1. Claus Zippel & Sabine Bohnet-Joschko, 2021. "Rise of Clinical Studies in the Field of Machine Learning: A Review of Data Registered in ClinicalTrials.gov," IJERPH, MDPI, vol. 18(10), pages 1-14, May.
    2. Shatrov, Kosta & Blankart, Carl Rudolf, 2022. "After the four-year transition period: Is the European Union's Medical Device Regulation of 2017 likely to achieve its main goals?," Health Policy, Elsevier, vol. 126(12), pages 1233-1240.
    3. Semjonova Nadezhda, 2020. "Economic Tendencies of the European and Latvian Medical Device Market," Economics and Business, Sciendo, vol. 34(1), pages 297-310, February.

    Corrections

    All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:eee:hepoli:v:125:y:2021:i:7:p:941-946. See general information about how to correct material in RePEc.

    If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.

    If CitEc recognized a bibliographic reference but did not link an item in RePEc to it, you can help with this form .

    If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.

    For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: Catherine Liu or the person in charge (email available below). General contact details of provider: http://www.elsevier.com/locate/healthpol .

    Please note that corrections may take a couple of weeks to filter through the various RePEc services.

    IDEAS is a RePEc service. RePEc uses bibliographic data supplied by the respective publishers.