Clinicians, Patients and Device Manufacturers Discuss Options for Verifying the Performance of Meters and Strips Post FDA-Clearance
Diabetes experts met this week in Bethesda, Md., to identify new measures to ensure the safety of patients using potentially inaccurate self-monitoring blood glucose (SMBG) systems. This meeting comes on the heels of recent evidence demonstrating that some monitors fail to consistently meet accuracy standards post-FDA clearance. On Sept. 9, the U.S. Food and Drug Administration (FDA), clinical experts and device manufacturers, at a meeting convened by the Diabetes Technology Society (DTS), discussed the need for improving post-market surveillance and quality assurance.
During the meeting, DTS presented a plan to develop a mandatory post-market surveillance program that could provide independent assessment of FDA-cleared SMBG systems to ensure they maintain accuracy standards. The program would be led by a diverse steering committee and implemented in several labs across the U.S. and outside of the U.S. This program could deliver performance verification information to the FDA and generate information to assist patients, healthcare providers and payers with product selections. Next steps for the program include:
- Forming a steering committee of regulators, clinicians, payers, advocates, industry and patients to develop program protocols
- Consulting with the FDA to ensure regulatory compliance and validity of the program
- Seeking funding for the program
- Collaborating with the entire diabetes community to achieve the mutual goal of patient safety
"The Diabetes Technology Society thanks everyone, particularly the FDA, for their participation in this critically important meeting," said David Klonoff, M.D., President of the Diabetes Technology Society and Clinical Professor of Medicine at the University of California, San Francisco. "As a community, we need to seize this opportunity to work together to establish and implement a mandatory post-market surveillance program that will help ensure the safety of diabetes patients."
This meeting was convened following a May forum where diabetes experts reviewed post-market studies and found that some SMBG systems did not meet accuracy standards post-FDA clearance. Meter inaccuracy poses a significant health threat to patients that use these meters to guide treatment decisions including the proper dose of insulin.