At present the FDA allows an error rate of blood glucose meters at 20%….
The American Association for Clinical Chemistry (AACC) has responded to the FDA’s recent draft proposal to reclassify usage guidelines for prescription blood glucose meters, saying that the changes would limit opportunities to monitor blood glucose in critical care scenarios.
The organization supports the FDA’s initiative to enhance patient care but recommends improving clinical protocols in critical care rather than increasing regulatory requirements for the equipment.
The FDA’s draft guidance proposed that prescription blood glucose meters be categorized with a complexity rating that would necessitate operation by health care providers with appropriate qualifications. AACC said in an online statement that such a change would be detrimental to patient outcomes.
James H. Nichols, PhD, medical director of clinical chemistry at Vanderbilt University Medical Center and chair of AACC’s Government and Regulatory Affairs Committee, said that, "Although we support the [FDA’s] objective, reclassifying prescription-use blood glucose monitors will add to the regulatory burden for health care providers by increasing their personnel documentation, proficiency testing, and method performance certification requirements," said in a press release. "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 said in a press release that, overall, the FDA could benefit patients the most by increasing performance criteria for prescription blood glucose meters, but not to an extent that would limit or encumber use of the devices. Previously, AACC worked with the FDA in a March 19 webinar that outlined new blood glucose meter guidelines.
Publishers Comment: Improving the accuracy of blood glucose meters can have a major impact on those that are pro-active in doing basal bolus insulin treatment. The more accurate the meters are, the better control we will see for our patients. It will also bring the artificial pancreas closer to reality.