Blood glucose meters are a key tool that many of the 19 million Americans with diabetes use to manage their conditions. The devices are also used in hospitals—causing increasing concern by government regulators because they aren't cleared for use in critically ill patients. Because of this, the U.S. Food and Drug Administration in January released draft guidance for blood glucose meters. It proposes separate performance and accuracy criteria for over-the-counter blood glucose meters used at home and for prescription blood glucose meters used in hospitals.
AACC supports the FDA’s draft guidance, Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use, but recommends revisions to make sure that new requirements do not increase healthcare system costs and regulatory burden. The FDA recognizes that blood glucose meters have become a key tool for managing some hospital patients, but the agency is concerned critically ill patients may have physiological variables that can impede meter accuracy. The draft guidance recommends addressing this concern by categorizing prescription meters as “moderate complexity,” allowing only qualified healthcare providers to use them. But after reviewing the draft guidance, AACC suggests that blood glucose meters not be categorized as moderate-complexity devices.
"Although we support the agency's objective, reclassifying prescription-use blood glucose monitors will add to the regulatory burden for healthcare providers by increasing their personnel documentation, proficiency testing, and method performance certification requirements under CLIA'88," says James H. Nichols, PhD, medical director of clinical chemistry at Vanderbilt University Medical Center and chair of AACC's Government and Regulatory Affairs Committee. "We do not believe that this will improve patient outcomes. In fact, we are concerned that the opposite may occur if glucose meters are suddenly removed from critical-care settings, where they are effectively used to measure and manage glucose levels, thus contributing to better patient outcomes."
AACC suggests the FDA instead set new performance criteria for prescription meters “high enough to improve patient care, but not so high that they encumber the use and production of these devices with no benefit to patients,” according to a statement.
For a comprehensive look at the FDA’s draft guidance, read the May issue of CLN. Read AACC’s press release explaining its recommendations for revising the draft guidance.