Browse > Article
http://dx.doi.org/10.5762/KAIS.2018.19.12.805

Research on Safety and Quality Regulatory Policy for Assistive Products  

Kim, Hye-Won (Department of Public Rehabilitation Service, National Rehabilitation Center)
Kim, Dong-A (Department of Public Rehabilitation Service, National Rehabilitation Center)
Seo, Won-San (Department of Public Rehabilitation Service, National Rehabilitation Center)
Kim, Jang-Hwan (Department of Biomedical Engineering & Welfare Technology, Hanseo University)
Ko, Myeong Han (Department of Rehabilitation Science, Graduate School, Hanseo University)
Son, Byung-Chang (Department of Rehabilitation Technology, Nazarene University)
Yi, JinBok (Department of Biomedical Engineering & Welfare Technology, Hanseo University)
Publication Information
Journal of the Korea Academia-Industrial cooperation Society / v.19, no.12, 2018 , pp. 805-813 More about this Journal
Abstract
The research was conducted with the purpose of providing effective safety and quality control system for assistive products for handicapped those are used extensively. Assistive products couldn't be classified independently due to collision with the act of medical device and lack in legal basis. The issues about safety and quality have been solved by other legal frames on a case by case basis. We couldn't find any abroad case of independent safety and quality control policy. For the practical solution, this article suggested hybrid classification system mixed with existing policies. Each classified branches are allocated to the appropriate policy of safety and quality control so those are ease of understanding and prospect. And also a delicacy process was suggested not to leave off any assistive products. Through these suggests of the improvement it is expected that blind areas of safety and quality control for assistive products for handicapped could be solved and identity of assistive products could be established to provide product safety for handicapped and boost relevant industries.
Keywords
Assistive Technology; Assistive Products; Consumer Products for the Handicapped; Safety Regulation; Classification System; Quality Management;
Citations & Related Records
연도 인용수 순위
  • Reference
1 Article 3 of the Act on the Support for Assistive products for Persons with Disabilities, No. 13662, 2015.
2 JB Yi, J. H. Kim, J. K. Lee, B. C. Son, Legal Improvement & Complement for Assistive Products Safety Control System Buildup, National Rehabilitation Center, 2017.
3 M. Gagnon-Roy, A. Bourget, S. Stocco, A. L. Courchesne, N. Kuhne, et al, Assistive Technology Addressing Safety Issues in Dementia: A Scoping Review, The American Journal of Occupational Therapy, Vol. 71, Iss. 5, pp. 1-10, 2017. DOI: https://dx.doi.org/10.5014/ajot.2017.025817
4 M. Claudine, T. Anthea, The Acceptability of Assistive Technology to Older People, Ageing and Society, Vol. 25, Iss. 1, pp. 91-110, 2005. DOI: https://dx.doi.org/10.1017/S0144686X0400248X   DOI
5 Medical Devices Act, No. 15486, 2018.
6 Article 10 of the Act on the Support for Assistive products for Persons with Disabilities, No. 13662, 2015.
7 Attached Table 4 of the Enforcement Rules of the Electrical Appliances and Consumer Products Safety Control Act, No. 303, 2018.
8 Attached Table 6 of the Enforcement Rules of the Electrical Appliances and Consumer Products Safety Control Act, No. 303, 2018.
9 Article 72 of the Act on Welfare of Persons with Disabilities, No. 15270, 2017.
10 Paragraph 2, Article 69 of the Act on Welfare of Persons with Disabilities, No. 15270, 2017.
11 Subparagraph 1, Paragraph 2, Article 26 of the Enforcement Rules of the National Health Insurance Act, No. 594, 2018.
12 A. Nilsson, K. S. Vreede, V. Haglund, H. Kawamoto, Y. Sankai, J. Borg, Gait training early after stroke with a new exoskeleton . the hybrid assistive limb: a study of safety and feasibility, Journal of NeuroEngineering and Rehabilitation, 11:92, 2014. DOI: https://dx.doi.org/10.1186/1743-0003-11-92   DOI
13 Subparagraph 1, Paragraph 4, Article 25 of the Medical Care Assistance Act, No. 586, 2018.
14 Attached Table 2 of the Public Notice on Designation of Assistive Products, No. 2016-15, 2016.
15 J. B. Kang, J. H. Woo, J. Y. Kong, Y. H. Lee, T. Y. Kim, A Study on Support and Vitalizing of the Assistive Devices, pp. 121-122, Korea Disabled people's Development Institute, 2016. ISBN 978-89-6921-210-1(93300)
16 A. Souza, J. L. Pearlman, R. Cooper, A. Kelleher, B. Gebrosky, et al, Evaluation of scooters using ANSI/RESNA standards, Journal of Rehabilitation Research and Development, Vol. 50, Iss. 7, pp. 1017-1034, 2013. DOI: https://dx.doi.org/10.1682/JRRD.2011.03.0054   DOI
17 National Rehabilitation Center, Report of Assistive Products Safety Control Project, Ministry of Health and Welfare, 2011.
18 M. S. Moon, K. H. Kim, J. C. Ryu, S. M. Lee, Y. H. Lee, G. M. Lee, B. S. Song, Y. C. Kim, M. H. Kim, S. M. Kim, Research for Assistive Technology Industry Vitalizing & Assistive Products Safety Control, p. 285, Korea Workers' Compensation & Welfare Service Korea Orthopedics & Rehabilitation Engineering Center, 2008.
19 Yamada Y, Kurachi K, Standardization of Care and Assistive Products Involving Robot Technology, Studies In Health Technology And Informatics, Vol. 242, pp. 535-541, 2017.