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Glucose Meters: Here Today, Gone Tomorrow?
Mark J Rice1, Douglas B Coursin
11Department of Anesthesiology, Vanderbilt University, Nashville, TN. 2Departments of Anesthesiology and Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI.
Critical Care Medicine
|November 21, 2015
Summary
Blood glucose meters have accuracy issues in critically ill patients. Regulatory bodies like the U.S. Food and Drug Administration and Centers for Medicare and Medicaid Services are addressing these concerns, leading to a temporary moratorium on their use.
Area of Science:
- Clinical Chemistry
- Medical Device Regulation
- Critical Care Medicine
Background:
- Blood glucose meters (BGMs) have a long history of hospital use, but accuracy concerns have persisted.
- These accuracy limitations are particularly critical in the care of critically ill patients, potentially leading to erroneous treatment decisions.
Purpose of the Study:
- To review the historical use of BGMs in hospitals.
- To examine current issues and regulatory changes impacting BGM use in critically ill populations.
Main Methods:
- Analysis of recent guidance from the U.S. Food and Drug Administration (FDA) and Centers for Medicare and Medicaid Services (CMS).
- Review of recent scientific publications and communications from regulatory agencies.
- Interpretation of regulatory guidance to provide an overview of the current situation.
Main Results:
- The FDA and CMS are moving to eliminate the use of current BGMs for critically ill patients due to accuracy concerns.
- CMS has implemented a temporary moratorium on the prohibition of BGM use in this patient group, without a specified end date.
Conclusions:
- Healthcare providers must understand the accuracy and interference limitations of BGMs.
- Awareness of the evolving regulatory landscape concerning BGMs in critical care is essential for appropriate patient management.
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