FDA May Raise Standards for Diabetes Monitors

[bgdavis]

http://www.nytimes.com/2009/07/19/he...itor.html?_r=1

The rise in the use of home glucose monitors, even by hospitals, is pushing the action by the Food and Drug Administration, which for decades has followed international standards that allow the devices to be wrong by as much as 20 percent. Such a wide error rate can leave patients vulnerable to severe problems, including seizures, unconsciousness and coma.

Officials said they would keep pushing until monitor accuracy improves, a promise that diabetes doctors cheered. In a May letter, the American Association of Clinical Endocrinologists formally asked that the agency act on the issue.
“Because of the highly variable quality of the meters and the glucose testing strips in widespread use, the safety of our patients who depend upon those meters is threatened,” the letter said.

[We Hope]

Re: FDA May Raise Standards for Diabetes Monitors

A 1997 guidance document wanted to have the standards tightened to 10%:

http://web.archive.org/web/200801231.../ode/gluc.html

The consensus document expressed the following performance goals: a) "The goal of all future Self Monitoring Blood Glucose (SMBG) systems should be to achieve a variability (system plus user) of 10% at glucose concentrations of 30-400 mg/dL 100% of the time. However, the panel is aware that the accuracy required for clinical management has not been rigorously defined.", b) "With current systems, SMBG measurements should be within 15% of the results of the reference measurements.", c) "Approximately 50-70% of individuals who receive some sort of formal training are capable of obtaining a result within 20% of the reference method; however, performance may deteriorate over time.""

http://www.accessdata.fda.gov/script...UDE/search.CFM

Going to FDA and searching the MAUDE database where adverse experiences with medical devices are reported found the following:

http://www.accessdata.fda.gov/script...estTimeout=500

14 records meeting your search criteria returned - DeviceName: " Glucose Oxidase, Glucose " ReportDateFrom: " 01/01/2009 " ReportDateTo: " 06/30/2009 "

http://www.accessdata.fda.gov/script...estTimeout=500

Glucose Dehydrogenase, Glucose from 01/01/2009 to 06/30/2009 search.

"500 records meeting your search criteria returned . The number of records meeting your search criteria is greater than the system can return and is incomplete. It is not possible to retrieve the missing records. Please narrow your search."

When you search for meter reports, you need to search for them under the chemical method the meter uses for reading a blood sample; as you see there are more than 500 reports involving meters using the glucose dehydrogenase method and this represents the most recent six month period.

No idea why it's taken 10+ years to decide to act on this.

Kathy