AHA comments on blood glucose monitoring test systems guidance

The Food and Drug Administration’s draft guidance on blood glucose monitoring test systems for prescription point-of-care use would appropriately improve the safety and efficacy of the devices while recognizing their vital role in hospitals and health systems, AHA said in comments submitted yesterday. “Blood glucose testing remains one of the most commonly performed initial diagnostic screening tests in the acute and post-acute care settings, and ensuring safe and effective use of these devices is essential,” AHA wrote. “…If finalized, this guidance would provide automatic Clinical Laboratory Improvement Act waiver status to BGMS for POC use, eliminating the previous requirements under ‘high complexity’ testing and, ultimately, benefiting the patients for whom we care.” With respect to disinfectant products for BGMS, AHA urged FDA to consider compiling a finite list of universally acceptable disinfectant products that would apply to all medical devices or classes of device. “This commonsense approach will limit waste and confusion and decrease the potential for hospital staff to apply the improper disinfectant to a specific device,” the association said.