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인공지능 기반 신생혈관성 나이관련황반변성 진단보조소프트웨어 사용자 인터페이스 개선 연구
구원미(Wonmi Gu),김소영(Soyoung Kim),김영은(Young Eun Kim),박성희(Sunghee Park),김문수(Moonsu Kim),임화경(Hwakyung Lim),허태영(Tae-Young Heo),김도윤(Doyun Kim),민정기(Jung Kee Min),홍석수(Seoksu Hong),윤재석(Jaesuk Yun) 대한약학회 2024 약학회지 Vol.68 No.2
With the recent development of Software as a Medical Device (SaMD), the significance of reducing use errors in medical devices is increasing. In this study, we conducted a formative evaluation of Artificial Intelligence (AI)-based software for ophthalmic image detection and diagnosis. The software automatically displays the presence or absence of neovascular age-related macular degeneration using fundus images to assist medical personnel in making diagnostic decisions. We aimed to find ways to reduce the number of use errors in formative evaluations. For this purpose, we conducted usability testing by performing tasks based on use scenarios for usability formative evaluations with intended users in their intended use environments, and then modified the user interface to reduce use errors. The initial formative evaluation revealed errors in utilizing the capture and dragand- drop functions for uploading fundus images, checking analysis results, and perform logout procedures. To reduce use errors, we improved the function by relocating the capture icon, displaying a hand-shaped cursor during dragging, inserting a fundus position guide, and eliminating the drag-and-drop function. We have also enhanced the design to present analytics results in a more intuitive manner and added a separate logout button to reduce the risk of use error. As a result, the number of use errors in the formative evaluation decreased from six to one in the summative evaluation. The development of ophthalmic image detection and diagnosis assistant software that reflects these improvements is expected to enhance user safety, usability, and reduce use errors.
인체세포ㆍ조직이용 의료제품 등의 규제에 관한 국내외 규정 비교 및 안전관리 개선방안 연구
이지훈(Jihoon Lee),최수경(Soo Kyung Choi),김주희(Juhui Gim),박미영(Miyoung Park),박수현(Soo Hyun Park),최진희(Jinhee Choi),임화경(Hwakyung Lim),노혜민(Hyemin Noh),이윤희(Yun hee Lee),윤재석(Jaesuk Yun) 대한약학회 2018 약학회지 Vol.62 No.3
Over the past several decades, human-derived cells, tissues, and cell- and tissue-based therapies have contributed to essential body function regeneration in the absence of effective alternative medicine substitute. This study reviewed strength and weakness of the regulation related to human-derived cells, tissues based pharmaceutical products compared to the US regulation, and suggested points for improvement classified into three categories. First, it is necessary to supplement regulations and guidelines on donor eligibility for pharmaceutical products. Second, there is a need to integrate regulations related to classify pharmaceutical product into biologics, device, and combination products. Finally, there is a need to develop and supplement the traceability of biological traces and the regulations for biological monitoring systems of pharmaceutical products. Collectively, it would be necessary to revise the regulations and the guidelines for the approval, manufacture, management and tracking of human cell/tissue derived pharmaceutical products by collecting opinions from researchers, industry, and clinical health care workers with a systematic long-term goal.