Federal officials may soon require improvements for the glucose monitors used by more than 11 million diabetics in the United States.
The rise in the use of home glucose monitors, even by hospitalsFood 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....
In June, the agency pressed the international group that sets the standards to tighten them. If the group refuses to act, the agency “may instead recognize other (higher) performance standards” on its own, according to a June letter from Dr. Margaret A. Hamburg, the agency commissioner.
A change in the international standards is the easiest and best option, officials said. The International Organization for Standardization, which sets the standards, can act quickly and broadly. But the F.D.A. can change the rules itself through a more time-consuming and cumbersome process.
Officials said they would keep pushing until monitor accuracy improves, a promise that diabetes doctors cheered...
(sorry for the bizarre use of fonts this started in a test run of Safari and I still haven't been able to get it cleaned up.)