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Lim, Um, Chang, Kim, Park, and Kim: A Draft Proposal for Korean Classification and Coding System for In Vitro Diagnostic Medical Devices
Original Article
General Laboratory Medicine
Laboratory Medicine Online

Laboratory Medicine Online 2012; 2(3): 148-165.

Published online: 1 July 2012

DOI: https://doi.org/10.3343/lmo.2012.2.3.148

A Draft Proposal for Korean Classification and Coding System for In Vitro Diagnostic Medical Devices

Young Ae Lim, M.D.1, Tae Hyun Um, M.D.2, Yoon Hwan Chang, M.D.3, Hye Ryoun Kim, M.D.4, Joonseok Park, M.D.5, Yonggoo Kim, M.D.6

1Department of Laboratory Medicine, Ajou University School of Medicine, Suwon, Korea.

2Department of Laboratory Medicine, Inje University Ilsan Paik Hospital, Goyang, Korea.

3Department of Laboratory Medicine, Korea Institute of Radiological and Medical Sciences, Seoul, Korea.

4Department of Laboratory Medicine, Chung-Ang University College of Medicine, Seoul, Korea.

5Hanmi Holdings Inc., Seoul, Korea.

6Department of Laboratory Medicine, The Catholic University of Korea College of Medicine, Seoul, Korea.

Corresponding author: Tae Hyun Um, M.D. Department of Laboratory Medicine, Inje University Ilsan Paik Hospital, 2240 Daehwa-dong, Ilsanseo-gu, Goyang 411-706, Korea. Tel: +82-31-910-7283, Fax: +82-31-910-7286, uthmd@hanmail.net

Received 7 November 2011       Revised 21 December 2011       Accepted 23 December 2011

© 2012, Laboratory Medicine Online

(open-access):

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background

The Global harmonization task force (GHTF) recommends a separate regulation system for in vitro diagnostic medical devices (IVDD), because false test results can pose a risk to individual and/or public health. However, in Korea, many reagents for IVDD are not monitored, although IVD analyzers and some reagents are monitored under the Medical Device Act and Pharmaceutical Affairs Act, respectively. Our aim was to propose a draft for a Korean coding and classification system for IVDD.

Methods

For preparing the draft, we reviewed the Korean Current Procedural Terminology for Health Insurance and principles of the coding and classification system for IVDD of the GHTF, the USA, Japan, Canada, Australia, and the EU. The draft was reviewed by consultants from relevant societies, such as Korean Medical Association, Korean Society for Laboratory Medicine, The Korea Association of Medical Technologists, and Korea Association for Diagnostic Laboratory Reagents, and was then publicly discussed at a conference.

Results

IVDD were classified into 4 classes on the basis of the risks they pose to individual (IR) and public health (PR): class 1 (low IR and low PR), class 2 (moderate IR and low PR), class 3 (high IR and/or moderate PR), and class 4 (high IR and high PR). IVD analyzers, reagents and other general laboratory equipments were categorized and coded using the letter D and 7 (2+3+2) digits.

Conclusions

This draft for the Korean IVDD classification and coding system could be used for effective management and regulation of IVDD in Korea.

Keywords: In vitro diagnostic medical devices (IVDD), Classification, Coding, Risk

Figures and Tables

Table 1
In vitro diagnostic medical devices (IVDD) classification system in developed countries
lmo-2-148-i001

*Japan has a separate system for classifying reagents and medical devices for IVDD, and all IVD medical devices are classified into Class I.

Table 2
Proposal for the Korean IVDD categorization and coding system
lmo-2-148-i002

Abbreviations: ESR, erythrocyte sedimentation rate; ABGA, arterial blood gas analysis; HLA, human leukocyte antigen; PNH, paroxysmal nocturnal hemoglobinuria; PCR, polymerase chain reaction.

Table 3
Proposal for the definition of individual and public health risks
lmo-2-148-i003

*Impact of false-positive or false-negative test results.

Table 4
Proposal for the Korean IVDD classification principles
lmo-2-148-i004

Abbreviations: IR, individual risk; PR, public health risk; L, low; M, moderate; H, high.

Notes

This article is available from http://www.labmedonline.org

References

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