title: Inter-operator and inter-device agreement and reliability of the SEM Scanner.
abstract: OBJECTIVE
  The SEM Scanner is a medical device designed for use by healthcare providers as part of pressure ulcer prevention programs. The objective of this study was to evaluate the inter-rater and inter-device agreement and reliability of the SEM Scanner.
  
  
  METHODS
  Thirty-one (31) volunteers free of pressure ulcers or broken skin at the sternum, sacrum, and heels were assessed with the SEM Scanner. Each of three operators utilized each of three devices to collect readings from four anatomical sites (sternum, sacrum, left and right heels) on each subject for a total of 108 readings per subject collected over approximately 30 min. For each combination of operator-device-anatomical site, three SEM readings were collected. Inter-operator and inter-device agreement and reliability were estimated.
  
  
  RESULTS
  Over the course of this study, more than 3000 SEM Scanner readings were collected. Agreement between operators was good with mean differences ranging from -0.01 to 0.11. Inter-operator and inter-device reliability exceeded 0.80 at all anatomical sites assessed.
  
  
  CONCLUSIONS
  The results of this study demonstrate the high reliability and good agreement of the SEM Scanner across different operators and different devices. Given the limitations of current methods to prevent and detect pressure ulcers, the SEM Scanner shows promise as an objective, reliable tool for assessing the presence or absence of pressure-induced tissue damage such as pressure ulcers.
authors: Bruin Biometrics, LLC, 10960 Wilshire Blvd, Ste 950, Los Angeles, CA 90024, USA. Electronic address: mclendenin@bruinbiometrics.com.
authors: Marta
authors: M
authors: Clendenin
authors: Bruin Biometrics, LLC, 10960 Wilshire Blvd, Ste 950, Los Angeles, CA 90024, USA. Electronic address: kjaradeh@bruinbiometrics.com.
authors: Kindah
authors: K
authors: Jaradeh
authors: Bruin Biometrics, LLC, 10960 Wilshire Blvd, Ste 950, Los Angeles, CA 90024, USA. Electronic address: ashamirian@bruinbiometrics.com.
authors: Anasheh
authors: A
authors: Shamirian
authors: Bruin Biometrics, LLC, 10960 Wilshire Blvd, Ste 950, Los Angeles, CA 90024, USA. Electronic address: srhodes@bruinbiometrics.com.
authors: Shannon L
authors: SL
authors: Rhodes
mesh_terms: D000328:Adult; D004864:Equipment and Supplies / Q000592:standards*; D006801:Humans; D015588:Observer Variation; D003668:Pressure Ulcer / Q000175:diagnosis*; D015203:Reproducibility of Results
keywords: Medical device; Pressure ulcer; Reproducibility