Metrology part 2: Procedures for the validation of major measurement quality criteria and measuring instrument properties

Pierre Squara, Thomas W. L. Scheeren*, Hollmann D. Aya, Jan Bakker, Maurizio Cecconi, Sharon Einav, Manu L. N. G. Malbrain, Xavier Monnet, Daniel A. Reuter, Iwan C. C. van der Horst, Bernd Saugel

*Corresponding author for this work

Research output: Contribution to journalReview articlepeer-review

2 Citations (Scopus)
67 Downloads (Pure)

Abstract

A measurement is always afflicted with some degree of uncertainty. A correct understanding of the different types of uncertainty, their naming, and their definition is of crucial importance for an appropriate use of the measuring instruments. However, in perioperative and intensive care medicine, the metrological requirements for measuring instruments are poorly defined and often used spuriously. The correct use of metrological terms is also of crucial importance in validation studies. The European Union published a new directive on medical devices, mentioning that in the case of devices with a measuring function, the notified body is involved in all aspects relating to the conformity of the device with the metrological requirements. It is therefore the task of scientific societies to establish the standards in their area of expertise. After adopting the same understandings and definitions (part 1), the different procedures for the validation of major quality criteria of measuring devices must be consensually established. In this metrologic review (part 2), we review the terms and definitions of validation, some basic processes leading to the display of an indication from a physiologic signal, and procedures for the validation of measuring instrument properties, with specific focus on perioperative and intensive care medicine including appropriate examples.

Original languageEnglish
Number of pages11
JournalJournal of clinical monitoring and computing
Early online date2020
DOIs
Publication statusPublished - 18-Mar-2020

Keywords

  • Statistics
  • Critical care
  • Perioperative medicine
  • Hemodynamic monitoring
  • Cardiovascular dynamics

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