고령친화 의료기기의 안전관리방안 연구

= A Study on Safety Management for Senior-Friendly Medical Devices

• 저자[authors] 임경민,송동진
  

• 학술지명[periodical name] 의공학회지
  

• 권호사항[Volume/Issue] Vol.39 No.6[2018]
  

• 발행처[publisher] 대한의용생체공학회
  

• 자료유형[Document Type] 학술저널
  

• 수록면[Pagination] 256-267
  

• 언어[language] Korean
  

• 발행년[Publication Year] 2018
  

초록[abstracts]

[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.]