이식형 의료기기의 추적 및 회수 관리를 위한 통합전산관리시스템 설계

Abstract

Medical implant devices are one of the targets of the US’s Food & Drug Administration (FDA) for tracking in case of a serious adverse event since they are directly connected to the lives of patients. The US law stipulates that the public health agency shall order implantable device makers to track their product down to the patient level if a serious adverse event has occurred or defects have been discovered; in reality, however, the agency can pass on the responsibility for tracking or recalling faulty devices to the manufacturers or use mass media. This article proposes an efficient tracking and recall management system and examines four main virtual scenarios based on such. This research seeks to suggest a system that enables FDA to perform accurate and prompt tracking and recall management for patients’ enhanced safety