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Spirometer calibration checks: is 3.5% good enough?

Meredith C McCormack1, David Shade, Robert A Wise

  • 1Division of Pulmonary and Critical Care Medicine, Johns Hopkins University, 1830 East Monument Street, Baltimore, MD 21205, USA. mmccor16@jhmi.edu

Chest
|May 15, 2007
PubMed
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Current spirometry calibration checks within 3.5% miss subtle errors. More stringent quality control rules for spirometer calibration are needed to ensure accurate performance and detect drift over time.

Area of Science:

  • Pulmonary Function Testing
  • Medical Device Calibration
  • Quality Control in Healthcare

Background:

  • Current spirometry calibration standards require daily checks within 3.5% of inserted volume.
  • These standards do not mandate the evaluation of calibration trends over time.
  • Suboptimal spirometer performance may go undetected under existing guidelines.

Purpose of the Study:

  • To evaluate current spirometry calibration guidelines.
  • To identify superior quality control rules for detecting suboptimal spirometer performance.
  • To determine the most effective method for ensuring spirometer accuracy.

Main Methods:

  • Reviewed daily calibration checks from seven volume spirometers over 4 to 11 years.
  • Applied current guidelines and candidate quality control rules to historical calibration data.

Related Experiment Videos

  • Assessed the efficacy of different criteria (e.g., +/- 2% deviation, consecutive deviations) in identifying spirometer errors.

    • Main Results:

    • 98% of 7,497 calibration checks met the 3.5% criterion, masking issues in specific spirometers.
    • Spirometers 3 and 5 exhibited systematic errors and drift, undetected by the 3.5% rule.
    • A +/- 2% criterion and a rule for four consecutive 1% deviations effectively identified suboptimal performance, with higher out-of-control rates in affected devices.

    Conclusions:

    • The standard +/- 3.5% calibration check is insufficient for detecting subtle spirometer errors.
    • More stringent quality control rules, including trend analysis, are necessary for accurate spirometry.
    • Revised guidelines for volume spirometer calibration are recommended to improve device performance monitoring.