Such a wide error rate (20%) can leave patients vulnerable to severe problems, including seizures, unconsciousness and coma.
In June 2009, the FDA started pressuring the International Organization for Standardization, which sets the standards,to tighten them. If that group refuses to act, the FDA may instead recognize other (higher) performance standards on its own, according to a June letter from agency commissioner Dr. Margaret Hamburg.
A recent study by government researchers comparing tests from five different popular meters revealed that results varied by as much as 32%. And a similar student project found that almost all of the meters were off from one another by 60 to 75 points.”
