FDA Catches Heat For Plans To Raise Standards For Hospital Glucose Meters
This article was originally published in The Gray Sheet
An FDA draft guidance issued earlier this year on hospital glucose meters has attracted an unusual amount of attention, including criticism from clinicians, companies and others who worry it could cut off access to point-of-care glucose testing in patient cases where it is needed. The agency says it is taking appropriate measures to address a safety issue, and that some of the criticism is misdirected.
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FDA says it has become aware of large data sets that raise new questions about the level of accuracy that blood glucose meters can deliver in an intensive-care hospital setting using capillary blood samples. An advisory panel will be tasked March 30 with considering the issue and its impact on assessing risk-benefit of the devices in the hospital environment.
The US agency finalized two closely watched guidance documents for blood glucose systems used in the hospital and at home. The guidance focusing on hospital point-of-care systems included a key revision of proposed accuracy standards from a 2014 draft guidance that had been broadly maligned as too tough.
During a recent panel discussion on bolus insulin calculator apps, experts called on FDA to establish some oversight, but said precise steps should vary depending on whether the app is intended to incorporate new data sources.