The Science Journal of the American Association for Respiratory Care

2008 OPEN FORUM Abstracts

THE 50+ REQUIREMENTS THAT YOU CAN USE TO DOCUMENT THAT A SPIROMETER BEING CONSIDERED FOR PURCHASE ACTUALLY COMPLIES WITH THE ATS-ERS 2005 SPIROMETRY STANDARD

Alan J. Moore1, Michael H. Lang1



Since the publication of the ATS-ERS Task Force standardisation of Lung Function Testing series 2 paper "Standardisation of Spirometry" in 2005, equipment manufacturers have had sufficient time to document the compliance or otherwise of their products with the standard requirements and to make known that information as required by the standard.

To date most manufacturers/vendors of spirometers claim that their products meet the requirements of the 2005 standard. A survey of web site and downloadable brochures from a range of manufacturers revealed claims such as 'Meets or exceeds ATS/ERS: 2005 Guidelines & all COPD Guidelines', 'Complies with the new ATS and ERS standards', 'ATS - ERS Standards', 'Complies with the latest ATS and ERS recommendations', 'Parameters and standards: ERS; ATS; NLHEP', 'Standard compliance: ATS/ERS 2005* , ECCS, OSHA, SSD, MDD (Independent validation report available)', 'Complying with all aspects of the ATS/ERS 2005 recommendations for spirometry'. But how many of these claims are actually true ?

We determined 52 requirements set out in the standard in addition to testing devices against the 24 Volume and 26 Flow-Time Waveforms. Of these 52 requirements, 45 could be ascertained by simple observation and/or measurement with an ordinary ruler. The other 7 requirements required the use of a specialist pulmonary waveform generator.

We set out to determine whether, in addition to passing the 24 Volume and 26 Flow-Time waveform tests, it was possible for the smaller pocket/desktop spirometers currently available to truly meet the requirements of the 2005 standard. We tested the MicroMedical Microlab and Microloop devices against the 52 requirements. We were able to confirm that the MicroMedical Microlab complied with all 52 requirements and that the Microloop, which does not have a built in printer but downloads to personal computer via a docking station, complied with all requirements except those specific to hard copy printout.

Our study shows that it is possible for even small pocket/desktop spirometers to truly comply with the high requirements and the true spirit and intention of the 2005 Spirometry standard.

We recommend that all those considering purchase of spirometers should document similar high levels of proof of compliance with the 2005 standard by self documentation and insistence on vendors providing proof from independent testing before committing to purchase.