A Multistep Validation Procedure for Monitoring Compliance of a Large Network of Connected Hospital Glucose Meters to International Quality and Performance Standards

L. Blairon, A. Wilmet, I. Beukinga, M. Tré-Hardy
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Abstract

Abstract The ISO 22870:2016 standard requires validation of point-of-care testing (POCT) instruments before routine use. Although it is a relatively easy task for blood gas analyzers, it is much more involved in connected blood glucose monitoring (BGM) devices because they are used ubiquitously and in large numbers throughout hospital departments. Here we present the model used in order to validate efficiently and effectively compliance of 116 glucose/ketone BGM devices to ISO 22870. In a first step, a “reference” BGM was established and fully evaluated in comparison to our criterion-standard laboratory method. The 115 remaining connected and hospital-wide distributed BGM devices were then correlated against the “reference” BGM. We spiked donated blood samples with increasing amounts of glucose derived from a diluted oral glucose solution and tested it with the reference StatStrip BGM device and with a cobas 8000 glucose laboratory comparison method. Every connected BGM device was then compared with the BGM reference device using the same sample preparation methodology. The ISO 15197, POCT 12-A3, and Food and Drug Administration performance acceptance criteria were used for comparing the BGM reference results with the laboratory criterion-standard results and for comparing BGM reference results with the connected hospital BGM devices. Repeatability and interassay precision were assessed with aqueous controls. We show that it is possible to validate compliance of a large number of connected POCT BGM devices to ISO 22870 efficiently and effectively using only 1 operator. The StatStrip BGM device performances were excellent and met the ISO 15197, POCT 12-A3, and Food and Drug Administration criteria.
监测大型联网医院血糖仪网络是否符合国际质量和性能标准的多步骤验证程序
ISO 22870:2016标准要求在常规使用前对护理点检测(POCT)仪器进行验证。虽然对于血气分析仪来说,这是一项相对容易的任务,但它更多地涉及到连接血糖监测(BGM)设备,因为它们在整个医院部门中无处不在且大量使用。在这里,我们提出了用于有效验证116葡萄糖/酮BGM设备符合ISO 22870的模型。首先,建立了一个“参考”BGM,并与我们的标准实验室方法进行了比较。然后将115个剩余的连接的和医院范围内分布的BGM设备与“参考”BGM相关联。我们在捐献的血液样本中加入越来越多的从稀释的口服葡萄糖溶液中提取的葡萄糖,并使用参考StatStrip BGM设备和cobas 8000葡萄糖实验室比较方法进行测试。然后使用相同的样品制备方法将每个连接的BGM装置与BGM参考装置进行比较。使用ISO 15197、POCT 12-A3和美国食品药品监督管理局性能验收标准将BGM参考结果与实验室标准标准结果进行比较,并将BGM参考结果与连接的医院BGM设备进行比较。用水溶液对照评价重复性和测定间精密度。我们表明,仅使用一个操作员就可以有效地验证大量连接的POCT BGM设备是否符合ISO 22870。StatStrip BGM装置性能优异,符合ISO 15197、POCT 12-A3和美国食品药品监督管理局标准。
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