Navigation auf zora.uzh.ch

Search ZORA

ZORA (Zurich Open Repository and Archive)

The importance of post marketing quality control

Buehler, Philipp K; Weiss, Markus; Wendel-Garcia, Pedro D; Both, Christian P; Schmidt, Alexander R; Wehren, Martin P; Thomas, Jörg (2023). The importance of post marketing quality control. European journal of anaesthesiology and intensive care, 2(1):e0016.

Abstract

BACKGROUND
A previously published study reported on the nonlinear behaviour for airway pressure and tidal volume of the adjustable pressure-limiting (APL) valve of the Aisys CS2 anaesthesia machine (GE Healthcare, Madison, Wisconsin, USA) during manual bag ventilation. In co-operation with the manufacturer, an adapted APL valve was developed.

OBJECTIVE
To test and characterise the performance of an adapted APL valve and assess its clinical usability.

DESIGN
Two-stage study, consisting of an in-vitro testing of an adapted APL valve in a baby and adolescent lung model, followed by a clinical experience survey of anaesthesia personnel after the official implementation of the new APL valve into clinical routine.

SETTING
Anaesthesia Department at the University Children's Hospital Zurich.

MAIN OUTCOME MEASURES
Airway pressures and inspiratory tidal volumes during opening and closure of the APL valve at different settings. Likert scale assessment of performance expectance, effort expectance, behavioural intention and safety of the APL valve during clinical use.

RESULTS
In contrast to the original APL valve of the GE Aisys CS2, the adapted APL valve showed a nearly linear increase in airway pressures as well as in the tidal volumes measured. Most importantly, the measured pressures never exceeded the set pressures. Based on the experimental findings, all original APL valves of the GE Aisys CS2 were replaced by the adapted APL valve. Two months later, an anonymised and standardised questionnaire was handed out to all employees working with the adapted APL valve. Analysis of the questionnaire indicated that the adapted APL valve is easier and more precise to handle in the daily routine than the original one.

CONCLUSION
The newly adapted APL valve for the GE Aisys CS2 has considerably improved its linearity at lower pressures and supports our institution's bag mask ventilation practices.

Additional indexing

Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > University Hospital Zurich > Institute of Intensive Care Medicine
Dewey Decimal Classification:610 Medicine & health
Language:English
Date:1 January 2023
Deposited On:13 Sep 2023 07:05
Last Modified:26 Dec 2024 04:52
Publisher:Wolters Kluwer
ISSN:2767-7206
OA Status:Hybrid
Free access at:Publisher DOI. An embargo period may apply.
Publisher DOI:https://doi.org/10.1097/ea9.0000000000000016
Download PDF  'The importance of post marketing quality control'.
Preview
  • Content: Published Version
  • Language: English
  • Licence: Creative Commons: Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0)

Metadata Export

Statistics

Citations

Dimensions.ai Metrics

Altmetrics

Downloads

11 downloads since deposited on 13 Sep 2023
10 downloads since 12 months
Detailed statistics

Authors, Affiliations, Collaborations

Similar Publications