Subjects: Quality and safety
For a science project, Morgan DiSanto-Ranney, a 16 year-old Virginia high school student recently purchased 7 glucose monitors and asked her diabetic father to use them all.
“What I found was that the meters were off from one another by 60 to 75 points,” she told the New York Times.
About the same time, government researchers found that the results from 5 widely-used monitors varied by up to 32%.
Inaccuracies like this expose patients to seizures, loss of consciousness and rarely, death, so the American Association of Clinical Endocrinologists asked the FDA to act on the matter.
“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,” it wrote in a letter obtained by the New York Times.
Nothing happened immediately but as it turned out, Morgan’s mother works for Iowa Republican Senator Charles Grassley, and before long the Iowa Republican had fired off a letter asking the FDA to investigate.
The FDA had for decades punted glucose QA responsibilities to the International Organization for Standardization, whose regulations permit the devices to be off by up to 20%.
Upon receipt of Grassley’s love letter, the FDA began pressing the IOS to tighten its standards, and warned that if it refused to do so, the FDA “may instead promulgate other (higher) performance standards” on its own.
As the matter simmers, glucose monitor manufacturers have warned that more stringent accuracy requirements would force them to jack up prices which would, in turn, discourage their use.
For his part, Morgan’s father has lost faith in his glucose monitors. “He doesn’t use them as much anymore,” sighed the high school student.