Demonstration of disinfection procedure for the development of accurate blood glucose meters in accordance with ISO 15197:2013

Abstract

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.

Fig 1. Product images and the principal materials for the 5 systems evaluated in this study.

^a Product images are reprinted from [http://www.btm-medical.com/en/product-list.php?id=38] under a CC BY license, with permission from the Biotest Medical Corp., original copyright 2013. ^b Full name of the principal types of materials: acrylonitrile butadiene styrene (ABS), polymethyl methacrylate (PMMA), polycarbonate (PC). ^c Distributor is given if different from manufacturer (according to the manufacturer’s labeling).

Fig 2

The analyses of elemental composition of the three principal materials of the 5 BGMs before and after multiple disinfection cycles were shown in (a), (b), and (c). The quantification of chemical elements before and after multiple disinfection cycles was statistically analyzed and shown in (d). Six samples of each material were tested (N = 6, value = mean ± SD.).

Fig 3. System accuracy plots for the 5 systems before disinfection.

The solid lines indicate the system accuracy criteria per ISO 15197:2013. The results demonstrate that the difference between each individual glucose result falls within the acceptance limit.

Fig 4. System accuracy plots for the 5 systems after disinfection.

The solid lines indicate the system accuracy criteria per ISO 15197:2013. The results demonstrate that the difference between each individual glucose result falls within the acceptance limit.

Fig 5. The proposed disinfection procedure for BGM cleaning.

Reprinted from [http://www.btm-medical.com/en/product-list.php?id=38] under a CC BY license, with permission from the Biotest Medical Corp., original copyright 2013.