Human Factors Engineering 을 적용한 인공호흡기 환자중앙감시장치 사용자 인터페이스 설계

Abstract

As the medical device and use environment get complicated and diverse, Human Factors Engineering that is defined as designing the device considering human capacities, limits and use environment related to device use has become the important discipline in medical device industry. So far Human Factors Engineering (Usability Engineering) guidance has been issued by International Standard Organization(ISO) and regulatory authorities such as FDA, MHRA, MFDS. But these guidance only present extensively applicable methodologies and process. For this reason, it is hard to find the specific case applying Human Factors Engineering to medical device design process. This paper presents the application for Human Factors Engineering to Ventilator Central Monitoring System User Interface Design. For that application, modified design process was developed consisting of 7 steps: user requirement identification, user research, hazard analysis, user interface implementation, verification, final user interface and validation; The process was developed by adding Human Factors activities based on IEC 62366 to the FDA presented medical device design process. The requirements for design the user interface were collected by physician consultant review, investigating home and abroad regulation or standard and design practice/guidance. The requirements that need to be reflected to design implementation, identified by previous activities, were transformed to design input, and reflected to design implementation through Requirement Traceability Matrix(RTM). The design was implemented using software prototyping tool. For verification that assure implemented user interface comply with design input, PCA analysis and Heuristic Evaluation were performed. The verification results were managed by RTM in order to apply to design input. The RTM document reviewing activity was performed for validation. The result for review showed that the final user interface reflected all requirement identified in user requirement, user research, hazard analysis, verification activities.