July 19, 2009
FDA may increase standards for meters
An endocrinologist group has asked the U.S. Food and Drug Administration to increase standards for home glucose monitors, an FDA doctor said.
The American Association of Clinical Endocrinologists wrote the FDA in May asking that the standards be tightened.
We think this technology is not up to par for some of the protocols we see out there like hospital treatment of critically ill patients, said Dr. Alberto Gutierrez, deputy director of the agency's in vitro diagnostics office.
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 doctors' letter said.
One concern is hospitals have begun using home meters that are not as accurate as sophisticated meters that cost much more.
The FDA follows international standards for meters that allow the blood sugar reading to be off by as much as 20 percent. The FDA pressured the international standards agency to lessen the amount of deviation allowed in the meter.
The U.S. agency may set its own standards if the international group does not, the report said.