Concern continues over the accuracy of glucose meters used in critically ill patients, as deaths and serious adverse events associated with certain meters are still being reported in the U.S. FDA MAUDE database and in peer-reviewed medical journals. Substances commonly found in the whole blood of critically ill patients often interfere with glucose measurement accuracy in these meters, which, though currently used in hospitalised critically ill patients, were originally designed for self-monitoring at home.

This webinar will present a new, regulatory-compliant risk evaluation protocol in critically ill patient care settings. It will detail the methodology, data analysis, and complex and extensive clinical risk analysis undertaken in an international, multi-site study to substantiate the performance of a glucose meter in critically ill patients.

Learned Objectives

1. Review the history of patient safety issues associated with glucose meter use in hospitals.
2. Describe the risk that unevaluated and non-qualified glucose meters pose to critically ill patients.
3. Examine whether a glucose meter can be equivalent to a central laboratory,
   definitive reference method.
4. Demonstrate the advanced analytical and statistical risk models needed to establish
   glucose meter effectiveness.
5. Determine whether improved glucose meter technology can improve patient outcomes.
6. Establish that a glucose meter can meet the FDA’s 2016 final guidance.

Featured Speaker



Andrei Malic, PhD
Director, Medical and Scientific Affairs Nova Biomedical

Who should attend?
• POC coordinators
• Laboratorians
• Critical care nurses

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