- 期刊
勞工醫院血糖機驗證如何符合ISO 15197:2013之要求
How to Verify Blood Glucose Meters at Laborers' Hospitals to Meet the Requirements of ISO 15197:2013
摘要
在醫療儀器的研發及科技的進步，使用血糖機測定血糖更為簡便與快速。醫院使用血糖機檢驗血糖值在門診病患與病房床邊(bedside)血糖分析有增加之趨勢。血糖機有縮短血糖檢驗作業時間(Turnaround Time；TAT)及檢驗流程簡單化的優點，使得血糖機檢驗的重要性日益增加。ISO 15197:2013為最新的國際認證血糖機之標準，歐盟國家針對小型血糖機驗證之規範，主要目的是希望規範所有市售的血糖機，確保血糖機分析結果的可靠性，可以在糖尿病病患的自我血糖值監測(Self-Monitor of Blood Glucose；SMBG)，提供更精確與準確的數據，臨床醫師在治療病患上可以做好良好的血糖監控。ISO 15197:2013的驗證包括：精密度評估、準確度評估、相關性比對評估、使用者評估、干擾性評估、線性評估、血球容積比干擾性評估、高海拔評估，以符合實驗室認證要求與提升醫療品質及病人安全。
並列摘要
Thanks to the advancements in R&D of medical devices and technologies, measuring blood glucose using blood glucose meters has become a convenient and efficient way. There has been an increasing trend for hospitals to use blood glucose meters to test patients' blood glucose level at outpatient clinics and bedside for blood glucose analysis. The advantages of blood glucose meters include the ability to shorten the turnaround time (TAT) of blood glucose test and to simplify the testing procedures. Therefore, examination using blood glucose meters has become increasingly important. ISO 15197:2013 is the latest international certification standard for blood glucose meters, and it is the EU countries' requirement for verification of small blood glucose meters. Its main purpose is to regulate all of the blood glucose meters available on the market and to ensure the reliability of analysis results of blood glucose meters. It provides patients with diabetes with more precise and accurate data on their Self-Monitor of Blood Glucose (SMBG) and enables clinical physicians to implement good blood glucose monitoring when treating patients. The verification items of ISO 15197:2013 include: precision assessment, accuracy assessment, correlation comparison assessment, user assessment, interference assessment, linearity assessment, hematocrit interference assessment and high altitude assessment to meet the laboratory certification requirements and improve medical quality and patient safety.