METROLOGICAL SUPPORT OF PULSE OXIMETERS
Article Sidebar
Main Article Content
Abstract
The experience of the International Medical Device Regulators Forum in the use of products for oxygen therapy based on the study of guidelines, international and European regulations on medical devices is considered. Emphasis is placed on issues related to the metrological support of pulse oximeters. The global situation with the pandemic increases the relevance of selected topics. Continuous monitoring of blood oxygen saturation is one of the most important elements in the diagnosis and treatment of COVID-19. Despite the fact that the use of pulse oximeters does not require special medical knowledge, calibration and special maintenance, it is still necessary to control their reliability and accuracy of measurement. The study of pulse oximeter MD300M in accordance with the requirements of DSTU 8893:2019 "Metrology. Pulse oximeters. Calibration Method” 2020. Analysis of MD300M pulse oximeter calibration results revealed that this pulse oximeter was calibrated by the saturation and pulse measurement channel, as the maximum deviation of the measured saturation value from the pulse oximeter calibration measure does not exceed the pulse oximeter measurement documentation specified in the operating documentation. The discreteness of the MD300M pulse oximeter and the discreteness of the reference device MPPO-2, which are specified in the passports for the respective devices, have the greatest influence on the measurement uncertainty.
Article Details
References
Juliana, N., Azmani, S., IdroseS., Amirfaiz, N., Roslan, A. (2017). Reliable monitoring of oxygen saturation via pulse oximetry: Which site to choose? Journal of Fundamental and Applied Sciences, No. 9, рр. 122–129. doi: 10.4314 / jfas.v9i4S.54.
Putu, Anna Andika, Rahmawati, Triana, Ridha, Mak M. (2019). Portable Pulse Oximeter. JEEMI, vol. 1, no. 1, pp. 28–32. doi: 10.35882/jeeemi.v1i1.6.
Sidhartha, G., Dwarakanath, M.L., Vineeth, K.C., Sukruth, R. (2021). IoT Based Pulse Oximeter. International Journal for Research in Applied Science & Engineering Technology, vol. 9, is. VIII, рр. 2946–2951.
Milner, Q.J., Mathews, G.R. (2012). An assessment of the accuracy of pulse oximeters. Association of Anaecthetists, vol. 67 (4), рр. 396-401. doi: 10.1111 / j.1365-2044.2011.07021.
Choi, Byung-Moon, Kang, Bong Jin, Yun, Ho-Yong, Bokyoung, Jeon, Bang, Ji-Yeon, Noh, Gyu-Jeong (2019). Performance of the MP570T pulse oximeter in volunteers participating in the controlled desaturation study: a comparison of seven probes. Anesth Pain Med, vol. 15. no. 3, рр. 371–377. https://doi.org/10.17085/apm.20028.
Jyotirmoy, Das, Amit, Aggarwal1, Naresh, Kumar Aggarwal (2010). Pulse oximeter accuracy and precision at five different sensor locations in infants and children with cyanotic heart disease. Indian Journal of Anaesthesia, vol. 54, iss. 6, рр. 531–534.
Podmasteryev, K.V., Dunaev, A.V., Kozyura, A.V., Zherebtsov, E.A. (2012). Metrological support of biomedical devices and technologies for functional diagnostics. Metrology in biomedical engineering. Biotechnosphere, no. 5–6 (23–24), pp. 92–96.
Sotova, B.I., Boriskina, M.O. (2013). Study of metrological reliability of pulse oximeters by statistical methods. News of TulGU. Technical science, vol. 6. (1), pp. 3–10.
Konopelko, L.A., Rumyantsev, D.V., Suvorov, V.I. (2003). Metrological support of pulse oximeters. Scientific Instrumentation, vol. 13, no. 3, pp. 44–45.
Tverytnykova, E., Drozdova, T., Demidova, Yu. (2020). Environmental management as a component of an integrated management system for gas condensate and oil processing enterprises. Advanced information systems, vol. 4, no. 1, рр. 133–138. doi: 10.20998/2522-9052.2020.1.06.
Tverytnykova, E, Demidova, Yu., Drozdova, T. (2021). Management system of occupational safety at ukrainian enterprises: international and european dimension. Advanced information systems, vol. 3, no. 1, рр. 45–53. doi: 10.20998/2522-9052.2021.1.06.
Kushnir, K. (2019). Problems of Metrological Provision of Activities of Primary Medical-Sanitary Assistance Bodies. Metrology and instruments, no. 3. рр.67–71. doi: 10.33955/2307-2180(3)2019.67-71.
WHO (2019). Technical specifications for oxygen concentrators. Geneva: World Health Organization; available at: http://www.who.int/medical_devices/publications/tech_specs_oxygen-concentrators/en/.
Amene, Mulueta M., Bradley, Beverly, Karlstrom, Jonas, Hemmi, Andrew. (2019). WHO-UNICEF technical specifications and guidance for oxygen therapy devices. Geneva: World Health Organization and the United Nations Children's Fund. WHO medical device technical series, 132 р.
Technical (2020) Technical and Regulatory Aspects of the Use of Pulse Oximeters in Monitoring COVID-19 Patients. Pan American Health Organization, 18 c.
WHO (2020). Priority medical devices list for the COVID-19 response and associated technical specifications. Interim guidance 19 NOVEMBER 2020, 176 р.
WHO (2020). Technical and Regulatory Aspects of the Use of Pulse Oximeters in Monitoring COVID-19 Patients. Interim guidance 7 August 2020, 18 р.
Technical regulations (2013) Technical regulations on medical devices, approved by the resolution of the Cabinet of Ministers of Ukraine №753 of 02.10.2013, available at: https://zakon.rada.gov.ua/laws/show/753-2013-%D0%BF/.
Resolution (2015) Resolution of the Cabinet of Ministers № 374 About the statement of the list of categories of legally regulated means of measuring equipment which are subject to periodic verification, available at: https://zakon.rada.gov.ua/laws/show/374-2015-%D0%BF#Text.
DSTU 8893:2019 (2020), Metrology. Pulse oximetry. Method of verification, Kyiv, 10 р.