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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.

SUBMITTER: Lin SP

PROVIDER: S-EPMC5500346 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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

Lin Shu-Ping SP Lin Wen-Ye WY Chang Jung-Tzu JT Chu Chun-Feng CF

PloS one 20170706 7

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 disinfecta ...[more]

PMID: 28683148

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Project description:IntroductionSufficiently high analytical quality of blood glucose monitoring systems (BGMS) is a prerequisite for efficient diabetes therapy. In this study we assessed system accuracy, measurement repeatability, intermediate measurement precision, user performance, and the influence of hematocrit on two CE-marked blood glucose monitoring systems. For one BGMS, measurement accuracy using venous samples was additionally investigated.MethodsStudy procedures were based on the International Organization of Standardization (ISO) 15197:2013/EN ISO 15197:2015 ("ISO 15197"). User performance included data from 100 subjects who used one test strip lot, whereas for all other analyses three different reagent system lots were used. For system accuracy assessment, 100 capillary samples were measured in duplicate with each of three reagent system lots per system, resulting in 600 results per system.ResultsCareSens S Fit and CareSens H Beat both fulfilled the ISO 15197 accuracy criteria with 97.5-100% of each test strip lot's results falling within ± 15 mg/dL or ± 15% of the results of the comparison method and 100% of results in consensus error grid (CEG) zone A for all three lots. User performance evaluation revealed sufficient accuracy in the hands of lay users although some handling errors were documented by study staff. Assessment of measurement repeatability and intermediate measurement precision is given by standard deviation (SD) (glucose levels < 100 mg/dL) and by coefficient of variation (CV) (glucose concentrations ≥ 100 mg/dL). SD was ≤ 4.1 mg/dL and CV ≤ 4.2% for measurement repeatability and SD was ≤ 2.2 mg/dL and CV ≤ 2.6% for intermediate measurement precision. In case of hematocrit influence, both BGMS complied with all three tested lots with the defined criteria.ConclusionBoth BGMS analyzed in this study fulfilled the required accuracy criteria of ISO 15197. They showed high precision, good performance in the hands of lay users, and the influence of hematocrit was acceptable in the labeled range.

Project description:INTRODUCTION:The international standard ISO 15197:2013 requires a user performance evaluation to assess if intended users are able to obtain accurate blood glucose measurement results with a self-monitoring of blood glucose (SMBG) system. In this study, user performance was evaluated for four SMBG systems on the basis of ISO 15197:2013, and possibly related insulin dosing errors were calculated. Additionally, accuracy was assessed in the hands of study personnel. METHODS:Accu-Chek® Performa Connect (A), Contour® plus ONE (B), FreeStyle Optium Neo (C), and OneTouch Select® Plus (D) were evaluated with one test strip lot. After familiarization with the systems, subjects collected a capillary blood sample and performed an SMBG measurement. Study personnel observed the subjects' measurement technique. Then, study personnel performed SMBG measurements and comparison measurements. Number and percentage of SMBG measurements within ± 15 mg/dl and ± 15% of the comparison measurements at glucose concentrations < 100 and ≥ 100 mg/dl, respectively, were calculated. In addition, insulin dosing errors were modelled. RESULTS:In the hands of lay-users three systems fulfilled ISO 15197:2013 accuracy criteria with the investigated test strip lot showing 96% (A), 100% (B), and 98% (C) of results within the defined limits. All systems fulfilled minimum accuracy criteria in the hands of study personnel [99% (A), 100% (B), 99.5% (C), 96% (D)]. Measurements with all four systems were within zones of the consensus error grid and surveillance error grid associated with no or minimal risk. Regarding calculated insulin dosing errors, all 99% ranges were between dosing errors of - 2.7 and + 1.4 units for measurements in the hands of lay-users and between - 2.5 and + 1.4 units for study personnel. Frequent lay-user errors were not checking the test strips' expiry date and applying blood incorrectly. CONCLUSIONS:Data obtained in this study show that not all available SMBG systems complied with ISO 15197:2013 accuracy criteria when measurements were performed by lay-users. TRIAL REGISTRATION:The study was registered at ClinicalTrials.gov (NCT02916576). FUNDING:Ascensia Diabetes Care Deutschland GmbH.

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

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

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