Lin Shu-Ping, Lin Wen-Ye, Chang Jung-Tzu, Chu Chun-Feng
Graduate Institute of Biomedical Engineering, National Chung Hsing University, Taichung, Taiwan R.O.C.
Research Center for Sustainable Energy and Nanotechnology, National Chung Hsing University, Taichung, Taiwan R.O.C.
PLoS One. 2017 Jul 6;12(7):e0180617. doi: 10.1371/journal.pone.0180617. eCollection 2017.
Despite measures to reduce disease transmission, a risk can occur when blood glucose meters (BGMs) are used on multiple individuals or by caregivers assisting a patient. The laboratory and in-clinic performance of a BGM system before and after disinfection should be demonstrated to guarantee accurate readings and reliable control of blood glucose (BG) for patients. In this study, an effective disinfection procedure, conducting wiping 10 times to assure a one minute contact time of the disinfectant on contaminated surface, was first demonstrated using test samples of the meter housing materials, including acrylonitrile butadiene styrene (ABS), polymethyl methacrylate (PMMA), and polycarbonate (PC), in accordance with ISO 15197:2013. After bench studies comprising 10,000 disinfection cycles, the elemental compositions of the disinfected ABS, PMMA, and PC samples were almost the same as in the original samples, as indicated by electron spectroscopy for chemical analysis. Subsequently, the validated disinfection procedure was then directly applied to disinfect 5 commercial BGM systems composed of ABS, PMMA, or PC to observe the effect of the validated disinfection procedure on meter accuracy. The results of HBsAg values after treatment with HBV sera and disinfectant wipes for each material were less than the LoD of each material of 0.020 IU/mL. Before and after the multiple disinfection cycles, 900 of 900 samples (100%) were within the system accuracy requirements of ISO 15197:2013. All of the systems showed high performance before and after the series of disinfection cycles and met the ISO 15197:2013 requirements. In addition, our results demonstrated multiple cleaning and disinfection cycles that represented normal use over the lifetime of a meter of 3-5 years. Our validated cleaning and disinfection procedure can be directly applied to other registered disinfectants for cleaning commercial BGM products in the future.
尽管采取了减少疾病传播的措施，但当在多个个体上使用血糖仪（BGM）或由护理人员协助患者使用时，仍可能存在风险。应证明血糖仪系统在消毒前后的实验室和临床性能，以确保为患者提供准确的读数和可靠的血糖（BG）控制。在本研究中，首先根据ISO 15197:2013，使用包括丙烯腈丁二烯苯乙烯（ABS）、聚甲基丙烯酸甲酯（PMMA）和聚碳酸酯（PC）在内的血糖仪外壳材料测试样品，证明了一种有效的消毒程序，即擦拭10次以确保消毒剂在污染表面的接触时间为1分钟。经过包含10000次消毒循环的实验台研究后，化学分析电子能谱显示，消毒后的ABS、PMMA和PC样品的元素组成与原始样品几乎相同。随后，将经过验证的消毒程序直接应用于对5个由ABS、PMMA或PC组成的商用BGM系统进行消毒，以观察经过验证的消毒程序对血糖仪准确性的影响。用乙肝病毒血清和消毒剂擦拭处理后，每种材料的乙肝表面抗原（HBsAg）值均低于每种材料的检测限0.020 IU/mL。在多次消毒循环前后，900个样品中的900个（100%）符合ISO 15197:2013的系统准确性要求。所有系统在一系列消毒循环前后均表现出高性能，并符合ISO 15197:2013的要求。此外，我们的结果表明，多次清洁和消毒循环代表了血糖仪3至5年使用寿命内的正常使用情况。我们经过验证的清洁和消毒程序未来可直接应用于其他注册消毒剂，用于清洁商用BGM产品。
