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

Autor: Jung-Tzu Chang, Chun-Feng Chu, Wen-Ye Lin, Shu-Ping Lin
Jazyk: angličtina
Rok vydání: 2017
Předmět:
RNA viruses
Blood Glucose
Contact time
Sanitization
Physiology
Disinfectant
lcsh:Medicine
Pathology and Laboratory Medicine
0302 clinical medicine
Medicine and Health Sciences
Public and Occupational Health
030212 general & internal medicine
lcsh:Science
Disinfection methods
Multidisciplinary
Organic Compounds
Monosaccharides
Pulp and paper industry
Blood Sugar
Body Fluids
Chemistry
Infectious Diseases
Blood
Medical Microbiology
Filoviruses
Viral Pathogens
Physical Sciences
Viruses
Anatomy
Pathogens
Ebola Virus
Disease transmission
After treatment
Research Article
Biotechnology
medicine.medical_specialty
Materials science
Polymethyl methacrylate
Infectious Disease Control
Carbohydrates
030209 endocrinology & metabolism
Microbiology
03 medical and health sciences
Blood Glucose Self-Monitoring
medicine
Humans
Microbial Pathogens
Blood glucose meters
Hemorrhagic Fever Viruses
Organic Chemistry
lcsh:R
Chemical Compounds
Organisms
Biology and Life Sciences
Surgery
Health Care
Disinfection
Glucose
Medical Devices and Equipment
lcsh:Q
Preventive Medicine
Zdroj: PLoS ONE, Vol 12, Iss 7, p e0180617 (2017)
PLoS ONE
ISSN: 1932-6203
Popis: 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.
Databáze: OpenAIRE
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