AACC calls FDA’s proposed method to improve glucose meters a ‘burden’

The American Association for Clinical Chemistry 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The FDA’s draft guidance proposed that prescription blood glucose meters be categorized with a complexity rating that would necessitate operation by health care providers with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. The American Association for Clinical Chemistry (AACC) said in an online statement that such a change would be detrimental to patient outcomes.

"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,” 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 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."

James H. Nichols

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.