Are All Home-Based Blood Sugar Tests Equal?
FDA takes steps to eliminate potential risks for people with diabetes
Another manufacturer, Abbott Diabetes Care in Alameda, Calif., "makes substantial investments to monitor and control manufacturing variability," said Jared Watkin, head of technical operations for Abbott. The company has "strict controls in place to ensure consistent quality within each lot and from lot to lot," he said. "Managing diabetes depends on having an accurate understanding of blood glucose levels, so strip accuracy is critical."
Both company spokesmen said they would welcome third party, independent, after-market assessments of their products, which is something that's been proposed to the FDA by the Diabetes Technology Society, a nonprofit organization that focuses on the development and use of technology to fight diabetes.
Watkin said that such assessments could help level the playing field between manufacturers in the United States and those in other countries.
"Research shows that not all strip manufacturers can verify the accuracy of their strips," Watkin said. "Internal tests and third-party published trials show multiple on-market systems fail to meet the [20 percent] performance standards, and there is also evidence of inconsistent adverse event reporting. In addition, foreign-based manufacturers aren't subjected to unannounced audits by the U.S. FDA."
The FDA's draft guidance document addressed this by asking manufacturers to describe their accuracy on their labels. This would allow consumers to better compare devices and judge for
Concerns, however, extend beyond manufacturers and standards.
"We are concerned that many Medicare patients have experienced issues getting the strips they want -- and those recommended by their doctor -- as a result of the competitive bidding program," Watkin said. That program, which started last summer, lowers the cost of blood-testing supplies, but limits where people can go to buy them. "They could unwillingly be getting switched to brands that potentially have lower accuracy," he said.
Dunlap also expressed some worry about people's lack of control over which product they choose and lack of information to make the right choice.
"The expectation that market forces can influence the market depends on a truly free market, and full and complete information," Dunlap said. "Right now, it's difficult to know which devices are more or less accurate."