Journal of Biomedical Engineering Research (대한의용생체공학회:의공학회지)

The Korean Society of Medical and Biological Engineering (대한의용생체공학회)
권호 표지
DOI QR코드

DOI QR Code

A Study on Safety Management for Senior-Friendly Medical Devices

고령친화 의료기기의 안전관리방안 연구

  • Lim, Kyeongmin (Department of Biomedical Engineering, Jungwon University) ;
  • Song, Tongjin (Department of Biomedical Engineering, Jungwon University)
  • 임경민 (중원대학교 생체의공학과) ;
  • 송동진 (중원대학교 생체의공학과)
  • Received : 2018.11.30
  • Accepted : 2018.12.14
  • Published : 2018.12.31
Download PDF
⟨ Previous Next ⟩

Abstract

The number of items and the market size of the senior-friendly medical devices are rapidly increasing, and it is necessary to come up with a safety management plan for senior-friendly medical devices. We searched and analyzed the definition and policy of senior-friendly medical device, and classified medical device items of the Ministry of Food and Drug Safety, calculated market sizes and manufacturing export import results by classification, and investigated the current state of senior-friendly industry and the fields of its culture. In order to prepare a safety management plan, we reduce the number of items that need to be managed intensively by extracting 69 items for administration, that are substantially harmful to the elderly. As specific safety management plans of items for administration, we propose plans for introductions of readability-enhanced labeling, QR codes for cautions and manuals, universal design mandatory, UDI code system with considering a balanced viewpoint of the industry development.

Keywords

표 1. 국내 의료기기 시장규모와 고령친화 의료기기 시장규모 비교 Table 1. A comparison between medical device domestic market size and senior friendly medical device domestic market size

OOSCB@_2018_v39n6_256_t0001.png 이미지

표 2. 고령친화 의료기기 생산·수출·수입 실적 Table 2. Results of manufacturing·export·import on senior-friendly medical device

OOSCB@_2018_v39n6_256_t0002.png 이미지

표 3. 고령친화 의료기기 품목별 생산실적 (상위품목 5개) Table 3. Results of manufacturing on senior friendly medical device items (top 5 items)

OOSCB@_2018_v39n6_256_t0003.png 이미지

표 4. 고령친화 의료기기 품목별 수출실적 (상위품목 5개) Table 4. Results of exports on senior friendly medical device items (top 5 items)

OOSCB@_2018_v39n6_256_t0004.png 이미지

표 5. 고령친화 의료기기 품목별 수입실적 (상위품목 5개) Table 5. Results of imports on senior friendly medical device items (top 5 items)

OOSCB@_2018_v39n6_256_t0005.png 이미지

표 6. 고령친화 의료기기 품목별 시장규모 Table 6. Market sizes on senior friendly medical device items

OOSCB@_2018_v39n6_256_t0006.png 이미지

표 7. 고령친화 의료기기 관리대상품목 Table 7. Senior friendly medical devices items for administration

OOSCB@_2018_v39n6_256_t0007.png 이미지

References

  1. M.J. Yoon, H.S. Hwang, 2014 The Elderly Statistics, Daejeon, Korea: Statistics Korea, 2014, pp. 1-73.
  2. K.T. Jung, Trends in Senior-Friendly Industry Market, Chungbuk, Korea: Korea Health Industry Development Institute, 2015, pp. 1-16.
  3. K.H. Kim, Status and Prospects of Senior-Friendly Industry Market, Chungbuk, Korea: Korea Health Industry Development Institute, 2012, pp. 1-36.
  4. H.N. Phang, "The Baby Boom Generation : Who are they?," Korea Labor Institute, vol. 71, pp. 5-9, 2011.
  5. J.Y. Seo, H.J. Park, Medical device R&D strategies for the elderly, Seoul, Korea: Science and Technology Policy Institute, 2010, pp. 1-114.
  6. K.J. Park, G.H. Ryu, and S.H. Lee, et al., "The Development for guideline of raw matrials on technical document of Medical Device," J. Biomed. Eng. Res., vol. 31, no. 6, pp. 434- 437, 2010.
  7. Y.W. Kim, C.M. Shin, and K.J. Park, et al., "Preparation of guidance documents item by item for one-step evaluation and approval for Medical Devices," J. Biomed. Eng. Res., vol. 31, no. 4, pp. 280-284, 2010.
  8. J.M. Park, Survey on Safety Status of Health Aid and Medical Devices for the Elderly, Seoul, Korea: Korea Consumer Agency, 2010, pp. 1-28.
  9. S.T. Joo, Result of a general crackdown of high-demand food in Lunar New Year's Day and special inspection on illegal advertisement of medical devices, Chungbuk, Korea: Ministry of Food and Drug Safety, 2016, pp. 1-37.
  10. S.H. Kim, Results of special inspection, such as illegal advertisement of medical device, Chungbuk, Korea: Ministry of Food and Drug Safety, 2016, pp. 1-4.
  11. J.K. Lee, Field Survey and Analysis of Senior-Friendly Industry, Chungbuk, Korea: Korea Health Industry Development Institute, 2014, pp. 1-154.
  12. Ministry of Food and Drug Safety Notification No. 2016-79.
  13. Ministry of Food and Drug Safety Notification No. 2010-91.
  14. I.K. Song, Statistics on manufacturing, export, and import of medical device, Seoul, Korea: Korea Medical Devices Industry Association, 2013.
  15. I.K. Song, Statistics on manufacturing, export, and import of medical device, Seoul, Korea: Korea Medical Devices Industry Association, 2014.
  16. I.K. Song, Statistics on manufacturing, export, and import of medical device, Seoul, Korea: Korea Medical Devices Industry Association, 2015.
  17. H. Hwang, Statistics on manufacturing, export, and import of medical device, Seoul, Korea: Korea Medical Devices Industry Association, 2016.
  18. K.S. Kim, Final Report on Academic Services for the Construction of Senior-Friendly Industrial Complex in Hwasungun, Jeonnam, Korea: Hwasun-gun, 2013, pp. 1-282.
  19. M.T. Jung, A Study on the Promotion Plan of Senior-Friendly Industry in Gyeongsangbuk-do, Daegu, Korea: Korea Institute for Industrial Economics & Trade, 2012, pp. 1-273.
  20. H.J. Park et al., Research for Feasibility Analysis on Study of Healthcare Robot (Medical Device Field), Trend Analysis, and Long-term Planning, Gyeongnam, Korea: Korea Testing Laboratory, 2016, pp. 1-220.
  21. J.Y. Seo, Trends and Prospects of Senior-Friendly Medical Devices, Daejeon, Korea: Biotech Policy Research Center, 2015, pp. 1-11.
  22. N. Super, Final report, Washington, D.C., U.S.: White House Conference on Aging, 2015, pp. 1-83.
  23. Y. Kim, Market Analysis of Medical Devices in Japan, Seoul, Korea: Korea-Japan Cooperation Foundation for Industry and Technology, 2014, pp. 1-16.
  24. K.M. Kim et al., Status of Silver Industry in Japan and Business Opportunities, Seoul, Korea: Korea Trade-Investment Promotion Agency, 2010, pp. 1-98.
  25. J.R. Kim, Planing and Analysis of R&D for Aging Society, Gyeonggi, Korea: Ministry of Science, ICT and Future Planning, 2016, pp. 1-4.
  26. Senior-Friendly Industry Promotion Act.
  27. http://www.motie.go.kr, accessed on Oct. 1, 2016.