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

P Squara, TWL Scheeren, HD Aya, Hanneke Bakker, M Cecconi, S Einav, MLNG Malbrain, X Monnet, DA Reuter, ICC van der Horst, B Saugel

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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
Pages (from-to)27-37
Number of pages11
JournalJournal of Clinical Monitoring and Computing
Volume35
Issue number1
DOIs
Publication statusPublished - Feb 2021

Bibliographical note

Funding Information:
This project was endorsed by the European Society of Intensive Care Medicine. All definitions are reproduced from the reference 1 with permission. However, the only authentic versions are those of the documents of the Joint Committee for Guides in Metrology.

Funding Information:
BS has received honoraria for consulting, honoraria for giving lectures, and refunds of travel expenses from Edwards Lifesciences Inc. (Irvine, ca., USA). BS has received honoraria for consulting, institutional restricted research grants, honoraria for giving lectures, and refunds of travel expenses from Pulsion Medical Systems SE (Feldkirchen, Germany). BS has received institutional restricted research grants, honoraria for giving lectures, and refunds of travel expenses from CNSystems Medizintechnik GmbH (Graz, Austria). BS has received institutional restricted research grants from Retia Medical LLC. (Valhalla, NY, USA). BS has received honoraria for giving lectures from Philips Medizin Systeme Böblingen GmbH (Böblingen, Germany). BS has received honoraria for consulting, institutional restricted research grants, and refunds of travel expenses from Tensys Medical Inc. (San Diego, ca., USA). XM is a member of the medical advisory board of Pulsion Medical Systems, member of Getinge, and gave some lectures for Cheetah medical. MLNGM is member of the medical advisory Board of Getinge (former Pulsion Medical Systems) and Serenno Medical. He consults for Baxter, Maltron, ConvaTec, Acelity, Spiegelberg and Holtech Medical. TWLS received research grants and honoraria from Edwards Lifesciences (Irvine, CA, USA) and Masimo Inc. (Irvine, CA, USA) for consulting and lecturing and from Pulsion Medical Systems SE (Feldkirchen, Germany) for lecturing. TWLS is associate editor of the Journal of Clinical Monitoring and Computing but had no role in the handling of this paper. PS received grants from Sorin for patents fees and was reimbursed for patent fees maintenance by Medtronic. He received consultant honorarium and was reimbursed for travel expenses from Medtronic. The other authors declared no conflicts of interest.

Publisher Copyright:
© 2020, The Author(s).

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