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Inter-operator and inter-device agreement and reliability of the SEM Scanner
Marta Clendenin1, Kindah Jaradeh1, Anasheh Shamirian1
1Bruin Biometrics, LLC, 10960 Wilshire Blvd, Ste 950, Los Angeles, CA 90024, USA.
The SEM Scanner demonstrates high reliability and good agreement for pressure ulcer prevention. This medical device shows promise for objectively assessing tissue damage in clinical settings.
Area of Science:
- Medical device evaluation
- Pressure ulcer prevention technology
- Biomedical engineering
Background:
- Pressure ulcers pose a significant healthcare challenge.
- Current methods for pressure ulcer detection and prevention have limitations.
- Objective tools are needed to assess tissue damage.
Purpose of the Study:
- To evaluate the inter-rater and inter-device agreement of the SEM Scanner.
- To assess the reliability of the SEM Scanner in a clinical context.
- To determine the SEM Scanner's utility in pressure ulcer prevention programs.
Main Methods:
- Thirty-one volunteers were assessed using the SEM Scanner at sternum, sacrum, and heel sites.
- Three operators used three devices, collecting multiple readings per site.
- Inter-operator and inter-device agreement and reliability were statistically analyzed.
Main Results:
- Over 3000 SEM Scanner readings were collected.
- Good agreement was observed between operators (mean differences -0.01 to 0.11).
- Inter-operator and inter-device reliability exceeded 0.80 across all sites.
Conclusions:
- The SEM Scanner exhibits high reliability and good agreement among operators and devices.
- This medical device shows potential as an objective tool for detecting pressure-induced tissue damage.
- The SEM Scanner could enhance pressure ulcer prevention strategies.
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