Journal of the Korea Academia-Industrial cooperation Society (한국산학기술학회논문지)

The Korea Academia-Industrial cooperation Society (한국산학기술학회)
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Research on Safety and Quality Regulatory Policy for Assistive Products

보조기기 안전·품질관리 방안 연구

  • 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)
  • 김혜원 (국립재활원 공공재활의료지원과) ;
  • 김동아 (국립재활원 공공재활의료지원과) ;
  • 서원산 (국립재활원 공공재활의료지원과) ;
  • 김장환 (한서대학교 의료복지공학과) ;
  • 고명한 (한서대학교 대학원 재활과학과) ;
  • 손병창 (나사렛대학교 재활공학과) ;
  • 이진복 (한서대학교 의료복지공학과)
  • Received : 2018.10.18
  • Accepted : 2018.12.07
  • Published : 2018.12.31
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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.

본 연구는 사용자군이 사회적 약자임과 동시에 광범위한 규모로 취급되고 있는 장애인보조기기의 바람직한 품질관리체계 모델을 제시하고자 진행되었다. 보조기기는 의료기기법과의 충돌 문제로 인해 독립적인 제품군으로 분류할 수 없고 법적 기반이 미비하여 독자적인 품질관리 체계를 가지지 못한다. 품목 별로 필요할 때마다 기존의 여타 품질관리 체계에 선별적으로 편입시켜 문제를 해결해왔다. 외국의 사례에서도 독자적인 품질관리 제도는 발견할 수 없었다. 이러한 문제를 합리적으로 극복하기 위해 보조기기를 기존의 품질관리 체계를 반영하는 방법으로 분류할 것을 제안하였다. 해당 분류마다 적절한 품질관리 방법들을 공식화하여 이해가 용이하고 예측가능한 행정이 되도록 고려하였다. 치밀한 품질관리를 위한 행정 과정도 제안하여 보조기기임에도 안전품질관리 체제에 누락되는 일이 없도록 하였다. 이 개선안 제안은 보조기기의 정체성 확립을 통해 보조기기 품질관리의 사각지대를 해결하여 장애인 등의 사용자에게 제품의 안전과 기본적인 기능을 제공하고 더 나아가 해당 산업을 활성화 시키는 단초가 될 수 있을 것이다.

Keywords

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Fig. 1. Process of Classification

Table 1. Assistive Products Classification

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Table 2. Certification systems of the leading country

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Table 3. Examples of Assistive Products Safety Quality Management by National Rehabilitation Center

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Table 4. Modified Classification System for Assistive Products

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Table 5. Examples of Safety Quality Management for Assistive Products for Seniors by SeniorFriendly Industry Promotion Act

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Table 6. Safety & Quality Control of Assistive Products

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