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Comparison of bench test results measuring the accuracy of peak flow meters
BACKGROUND: The study evaluates and compares the accuracy of nine peak flow meters (“PFMs”) and spirometers that are currently available in Europe and have Conformité Européene (“CE”) marking. The CE marking is a manufacturer’s declaration that their product complies with European health regulations...
Autores principales: | , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6454778/ https://www.ncbi.nlm.nih.gov/pubmed/30961573 http://dx.doi.org/10.1186/s12890-019-0837-3 |
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author | VanZeller, Cristiano Williams, Andrew Pollock, Ian |
author_facet | VanZeller, Cristiano Williams, Andrew Pollock, Ian |
author_sort | VanZeller, Cristiano |
collection | PubMed |
description | BACKGROUND: The study evaluates and compares the accuracy of nine peak flow meters (“PFMs”) and spirometers that are currently available in Europe and have Conformité Européene (“CE”) marking. The CE marking is a manufacturer’s declaration that their product complies with European health regulations and it is a requirement for marketing medical devices in Europe. METHODS: The nine devices were selected as they all had received or were in the process of receiving CE approval in Europe and were readily obtainable. The devices were bench tested following the ISO 23747:2015 accuracy guidelines for medical devices measuring peak flow. All standards, including accuracy, from these guidelines must be met to obtain CE marking. This study was performed with a certified piston pump testing apparatus. The apparatus chosen was the pulmonary waveform generator manufactured by Piston Medical Ltd. Using predefined flow (time) and volume (time) waveforms, peak flow meters and spirometers were tested for validation and calibration. Three CE guideline tests were utilised, and standards require that all three tests are passed for the device to obtain certification. RESULTS: Of the nine devices that were tested, two passed and seven failed. The devices that passed the tests were the Smart Peak Flow® and the Mini Wright®. CONCLUSIONS: A high percentage of devices failed accuracy testing in this study. This is a concern as the CE marking is a manufacturer’s certification documenting the accuracy, reliability and safety of devices. Of the seven devices that failed all have the CE marking. All tested devices are on the market in Europe based upon studies conducted by each of the manufacturers. The data used to obtain CE certification of these devices, however, are not in the public domain. |
format | Online Article Text |
id | pubmed-6454778 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-64547782019-04-19 Comparison of bench test results measuring the accuracy of peak flow meters VanZeller, Cristiano Williams, Andrew Pollock, Ian BMC Pulm Med Research Article BACKGROUND: The study evaluates and compares the accuracy of nine peak flow meters (“PFMs”) and spirometers that are currently available in Europe and have Conformité Européene (“CE”) marking. The CE marking is a manufacturer’s declaration that their product complies with European health regulations and it is a requirement for marketing medical devices in Europe. METHODS: The nine devices were selected as they all had received or were in the process of receiving CE approval in Europe and were readily obtainable. The devices were bench tested following the ISO 23747:2015 accuracy guidelines for medical devices measuring peak flow. All standards, including accuracy, from these guidelines must be met to obtain CE marking. This study was performed with a certified piston pump testing apparatus. The apparatus chosen was the pulmonary waveform generator manufactured by Piston Medical Ltd. Using predefined flow (time) and volume (time) waveforms, peak flow meters and spirometers were tested for validation and calibration. Three CE guideline tests were utilised, and standards require that all three tests are passed for the device to obtain certification. RESULTS: Of the nine devices that were tested, two passed and seven failed. The devices that passed the tests were the Smart Peak Flow® and the Mini Wright®. CONCLUSIONS: A high percentage of devices failed accuracy testing in this study. This is a concern as the CE marking is a manufacturer’s certification documenting the accuracy, reliability and safety of devices. Of the seven devices that failed all have the CE marking. All tested devices are on the market in Europe based upon studies conducted by each of the manufacturers. The data used to obtain CE certification of these devices, however, are not in the public domain. BioMed Central 2019-04-08 /pmc/articles/PMC6454778/ /pubmed/30961573 http://dx.doi.org/10.1186/s12890-019-0837-3 Text en © The Author(s). 2019 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Research Article VanZeller, Cristiano Williams, Andrew Pollock, Ian Comparison of bench test results measuring the accuracy of peak flow meters |
title | Comparison of bench test results measuring the accuracy of peak flow meters |
title_full | Comparison of bench test results measuring the accuracy of peak flow meters |
title_fullStr | Comparison of bench test results measuring the accuracy of peak flow meters |
title_full_unstemmed | Comparison of bench test results measuring the accuracy of peak flow meters |
title_short | Comparison of bench test results measuring the accuracy of peak flow meters |
title_sort | comparison of bench test results measuring the accuracy of peak flow meters |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6454778/ https://www.ncbi.nlm.nih.gov/pubmed/30961573 http://dx.doi.org/10.1186/s12890-019-0837-3 |
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