PMID- 30961573
OWN - NLM
STAT- MEDLINE
DCOM- 20190808
LR  - 20200225
IS  - 1471-2466 (Electronic)
IS  - 1471-2466 (Linking)
VI  - 19
IP  - 1
DP  - 2019 Apr 8
TI  - Comparison of bench test results measuring the accuracy of peak flow meters.
PG  - 74
LID - 10.1186/s12890-019-0837-3 [doi]
LID - 74
AB  - BACKGROUND: The study evaluates and compares the accuracy of nine peak flow 
      meters ("PFMs") and spirometers that are currently available in Europe and have 
      Conformite Europeene ("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(R) and the Mini Wright(R). 
      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.
FAU - VanZeller, Cristiano
AU  - VanZeller C
AD  - Royal London Hospital, London, UK.
FAU - Williams, Andrew
AU  - Williams A
AD  - Guy's Hospital, London, UK.
FAU - Pollock, Ian
AU  - Pollock I
AUID- ORCID: 0000-0001-6964-3424
AD  - St Mary's Hospital, London, UK. ianpollock@doctors.org.uk.
LA  - eng
GR  - N/A/The study was funded by Smart Respiratory Products Limited/
PT  - Comparative Study
PT  - Journal Article
DEP - 20190408
PL  - England
TA  - BMC Pulm Med
JT  - BMC pulmonary medicine
JID - 100968563
MH  - Europe
MH  - European Union
MH  - Forced Expiratory Volume
MH  - Humans
MH  - Lung/*physiology
MH  - Monitoring, Ambulatory/*instrumentation
MH  - Peak Expiratory Flow Rate
MH  - Reproducibility of Results
MH  - Spirometry/*instrumentation/standards
PMC - PMC6454778
OTO - NOTNLM
OT  - Accuracy
OT  - Asthma
OT  - CE
OT  - Peak flow meter
COIS- ETHICS APPROVAL AND CONSENT TO PARTICIPATE: Not applicable. CONSENT FOR 
      PUBLICATION: Not applicable. COMPETING INTERESTS: The authors declare that they 
      have no competing interests. PUBLISHER'S NOTE: Springer Nature remains neutral 
      with regard to jurisdictional claims in published maps and institutional 
      affiliations.
EDAT- 2019/04/10 06:00
MHDA- 2019/08/09 06:00
PMCR- 2019/04/08
CRDT- 2019/04/10 06:00
PHST- 2018/09/16 00:00 [received]
PHST- 2019/03/24 00:00 [accepted]
PHST- 2019/04/10 06:00 [entrez]
PHST- 2019/04/10 06:00 [pubmed]
PHST- 2019/08/09 06:00 [medline]
PHST- 2019/04/08 00:00 [pmc-release]
AID - 10.1186/s12890-019-0837-3 [pii]
AID - 837 [pii]
AID - 10.1186/s12890-019-0837-3 [doi]
PST - epublish
SO  - BMC Pulm Med. 2019 Apr 8;19(1):74. doi: 10.1186/s12890-019-0837-3.