In January, the U.S. Food and Drug Administration (FDA) released draft guidance proposing separate performance and accuracy criteria for over-the-counter blood glucose meters used in the home and prescription blood glucose meters used in hospitals. AACC supports FDA’s initiative to improve the quality of these devices and enhance patient care, but recommends revising this draft guidance to ensure that it does not unnecessarily increase the regulatory burden and costs on the healthcare system.
Blood glucose meters are best known in their over-the-counter form for helping many of the 19 million Americans with diabetes to manage their condition. These devices have also become essential for managing care for other groups of patients in hospitals in recent years, as studies have uncovered a connection between high blood sugar and poor outcomes. FDA has become increasingly concerned about this practice, however, because blood glucose meters aren’t cleared for use in critically ill patients, who may present with physiological variables that could interfere with the accuracy of these devices.
FDA’s draft guidance “Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use” suggests remedying this issue by categorizing prescription blood glucose meters as moderate complexity, which means that only qualified healthcare providers would be able to use them. The guidance also describes the studies manufacturers should conduct to demonstrate that prescription blood glucose meters can perform with an acceptable level of precision in different hospitalized patient groups and in the presence of interfering substances and common medications.
After reviewing the draft guidance, AACC recommends that blood glucose meters not be recategorized as moderate complexity devices.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,” said 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 improving the clinical protocols followed by the personnel performing blood glucose monitoring rather than increasing the regulatory requirements associated with using these devices. Overall, AACC recommends that FDA set its new performance criteria for prescription blood glucose 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.
The association also intends to continue working with FDA to prepare healthcare professionals for the implementation of this guidance, as it did with the March 19 AACC webinar, “New Blood Glucose Meter Guidance Unveiled: A Discussion With the FDA,” which featured FDA division director Courtney Lias, PhD.