心導管室UDI醫療衛材管理系統的設計與評估

Design, Development and Evaluation of a Unique Device Identification System for Managing Medical Supplies in the Cardiac Catheterization Room

研究背景：心導管室使用的醫療衛材種類繁多且昂貴。而傳統醫療衛材的管理仰賴護理人員人工清點及輸入模式進行，但此管理模式易因故而發生錯誤，進而影響醫院營運成本及病人安全。近年來，衛生福利部頒布了「醫療器材單一識別系統（UDI）」，給予醫療衛材單一識別碼方便追蹤及管理，此特性配合資訊系統或許可以做為簡化心導管室醫療衛材的管理模式。研究目的：設計並建置整合UDI編碼的心導管室醫療衛材管理平台，並配合流程改善，簡化人工管理的步驟以提升管理效率、減少錯誤並提升病人安全。研究方法：首先，分析目前心導管室醫療衛材管理流程問題，並探討合適的簡化流程。其次，採「螺旋式開發模型（Spiral Model）」方式建置及優化平台。在結果評值方面，以管理步驟數變化、計價管理耗時及計價異常發生率。研究結果：結果顯示，計價步驟由14簡化至9個，並可於手術過程中並行。在計價管理耗時方面，單一病人的耗時由497秒縮至37秒，每月平均總計價耗時由75,918秒降至5,900秒（約1.6小時）。在計價異常發生率方面，由2021年的0.45%顯著降至2023年的0.05%（p < 0.001）。此外，此系統有過期品主動提醒功能，阻絕使用過期品之風險，確保病人安全。結論：心導管室導入此系統有效簡化了管理流程及時間，並減少了人工管理帶來的虧損與病安風險。未來，本系統將延伸至醫院其他類似系統，並持續朝向智能化與數據共享化邁進，為醫院帶來更為顯著的經濟效益與醫療品質保障。

Background: Various medical devices and consumables are used in cardiac catheterization laboratories, many of which are costly. In conventional management procedures, medical devices and consumables are counted and recorded manually by healthcare professionals, such as nurses. However, these procedures are susceptible to human error, which can increase hospital operating costs and compromise patient safety. In recent years, the Ministry of Health and Welfare has implemented the unique device identification (UDI) system to improve the traceability and management of medical devices and consumables. Integrating the UDI system with hospital information systems may simplify workflow processes and improve the management efficiency of cardiac catheterization laboratories. Aims: This study aims to develop an integrated UDI and hospital information system platform as well as improve management processes to simplify workflow, enhance management efficiency, reduce errors, and improve patient safety in cardiac catheterization laboratories. Methods: We analyzed problems associated with management processes in a cardiac catheterization laboratory and proposed solutions to improve these processes. Further-more, we developed and refined the information platform using a spiral model. To evaluate the effectiveness of the improvements, we analyzed changes in the number of process steps, the time required to complete management tasks, and the incidence of management process errors. Results: The number of management process steps reduced from 14 to 9, and the management process was successfully completed during surgery. The time required to manage a single patient decreased from 492 to 37 s, while the average total management time per month decreased from 75,918 to 5,900 s (approximately 1.6 h). The incidence of management process errors decreased from 0.45% in 2021 to 0.05% in 2023 (p < 0.001). Additionally, the system provided warnings for expired products, which prevented the use of expired medical devices and consumables, thereby improving patient safety. Conclusion: Implementing this information system in the cardiac catheterization laboratory reduced the time required and the number of process steps for managing medical devices and consumables while minimizing the risk of human errors. In the future, this system may be extended to other departments with similar management requirements and further developed to support intelligent management and data sharing, thereby improving hospital operational efficiency and healthcare quality.