This is not a question but excerpts from an article read from the New York Times. It is a statement brought forth by the American Association of Clinical Endocrinologist regarding the FDA [Federal Drug Administration] needing to tighten the standards for glucose meters used by hospitals and by patients at home. For decades the US standard has followed international standards that allow glucose testing devices to be wrong by as much as 20%. Such a wide error rate can leave patients vulnerable to severe medical problems, including seizures, unconsciousness, and comas. Let’s face it folks, 20% is a large margin of error; a 60 mg/dl reading could be 48 mg/dl or 72 mg/dl, where the former is an unhealthy level.
One or two actions for change must take place; the International Organization for Standardization [ISO] can act quickly and broadly for tightening the rules, and/or the FDA can move through their cumbersome and time-consuming processes to get manufacturers to adhere to tighter policy/guidelines on meter accuracy. In either case, we diabetics, and those approximate 6 million undiagnosed diabetics, deserve accurate meters. Write to your elected officials to get the FDA to act on its own if ISO neglects to adhere for tighter standards.Your health depends on it.