CAJ | 학술논문

医疗器械进家是发展趋势，但家是一个不可控的环境，在家使用是有风险的，这些风险来自使用者、使用环境和器械之间的交互作用，它可能极大地影响到使用者与病人的安全。本文简要介绍美国FDA在监管家用医疗器械上的发展过程，重点介绍FDA《家用医疗器械设计要素》指南。《设计要素》的核心是通过合理设计最大程度规避风险，“把风险设计至器械之外”。指南提出了设计居家用器械时需要考虑的六个方面：环境、用户、器械本身、人因工程、标记及上市后事项。
의료기계진가시발전추세，단가시일개불가공적배경，재가사용시유풍험적，저사풍험래자사용자、사용배경화기계지간적교호작용，타가능겁대지영향도사용자여병인적안전。본문간요개소미국FDA재감관가용의료기계상적발전과정，중점개소FDA《가용의료기계설계요소》지남。《설계요소》적핵심시통과합리설계최대정도규피풍험，“파풍험설계지기계지외”。지남제출료설계거가용기계시수요고필적륙개방면：배경、용호、기계본신、인인공정、표기급상시후사항。
Technology going home is an inevitable trend, however, the home is an uncontroled environment, and the use of medical devices in the home also presents unique chalenges and potential safety risks. These risks result from interactions among the user, the use environment, and the device, and can greatly affect user and patient safety. This article mainly introduces the FDA’s Guidance document ‘Design Considerations for Devices Intended for Home Use’. This guidance provides recommendations for minimizing the risks associated with home use devices by considering the user, the use environment, the device or system, human factors, and labeling. This guidance also provides recommendations regarding postmarket considerations.