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Interaction between Objective Performance Measures and Subjective User Perceptions in the Evaluation of Medical Devices: A Case Study—ADDENDUM

Published online by Cambridge University Press:  02 July 2019

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Abstract

Type
Addendum
Copyright
Copyright © Cambridge University Press 2019 

The authors wish to clarify that this study was an investigation into technology testing, comparing objective and subjective evaluation, and was not primarily designed to establish the relative efficacy of the systems used in the study. The “new device” tested as part of this study was the Acuset device used in conjunction with a standard tube giving set, and did not test the full Safeguard IV system, which the authors have been advised now comprises a flow controller designed to function with a non-standard drip set, and other components. To avoid doubt, the full Safeguard IV system was not supplied to the authors and was not used in this study.

No conclusions about the relative performance of the full Safeguard IV system can be made, as this system was not compared with the roller clamp device. The study was not a clinical trial but rather a bench top study, conducted in a clinical setting, involving nurses and no patients. The main conclusion from the paper was that user opinion regarding a new medical device is influenced by more than just objective performance measures.

References

1.Haydock, MD, Mittal, A, Wilkes, CF, et al. (2015) Interaction between Objective Performance Measures and Subjective User Perceptions in the Evaluation of Medical Devices: A Case Study. International Journal of Technology Assessment in Health Care 31, 297303. doi: 10.1017/S0266462315000586.Google Scholar