INNOVATION DESIGN: MEDICAL DEVICE TESTING BEFORE DEPLOYMENT FOR RESEARCH STUDIES
2024
Testing New Medical Devices for Infections
publication
Author Information
Author(s): Ashcraft Alyce, Owen Donna, Brashear Jessica
Primary Institution: Texas Tech University Health Sciences Center
Hypothesis
How can we validate a device for point of care infection assessment?
Conclusion
Both tested devices failed to meet expected performance standards.
Supporting Evidence
- The study involved a collaborative team from Nursing, Clinical Laboratory Sciences, and Electrical Engineering.
- One device provided expected results on 33% of runs, while the other only had expected results on 16%.
Takeaway
The study looked at two devices meant to test for infections, but neither worked well enough.
Methodology
The study involved a collaborative team testing two devices against a standard protocol for validation.
Limitations
The validation process revealed operational differences but did not specify all mechanical issues.
Digital Object Identifier (DOI)
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