Thanks to Larry Ellingson for sharing this:  RESOLUTION ON THE IMPORTANCE OF NEED TO DEVELOP MORE STRINGENT ACCURACY REQUIREMENTS FOR BLOOD GLUCOSE MONITORING SYSTEMS WHEREAS, the American Diabetes Association estimated in 2011 that 25.8 million children and adults in the United States have diabetes,1 and WHEREAS, the prevalence of diabetes has increased by 82.2% since

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The following link will take you to  letter from the FDA to diabetes device company. It would appear that medical device reports should have been filed when meter failed to report lows. Here is a little quote that makes it clear why we need to StripSafely: Complaints 618, 779, 728, and 818 describe events in which

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I have been off the grid the last week at CWD’s Friends for Life conference. Sorry I am late to respond to some comments. Much of this was written standing in lines at Disney in my iPhone. Some have asked for information on specific meters. Some information can be found in citations linked here: http://www.stripsafely.com/?page_id=75 – Specifically

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Our friends in New Zealand want to StripSafely too. http://www.nzherald.co.nz/nz/news/article.cfm?c_id=1&objectid=10900924 http://www.stuff.co.nz/waikato-times/news/8946549/Diabetics-challenge-restriction-on-glucose-meters

Dr. Richard Kahn professor of medicine at the University of North Carolina and  formerly chief scientific and medical officer of the American Diabetes Association wrote a commentary in Roll Call titled: Competitive Bidding Puts Diabetes Patients at Risk. In that piece he says: Many of our most vulnerable citizens will assume the test they use is

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WHY People with diabetes are at risk from inaccurate blood glucose strips. The FDA acknowledges that there are substandard strips in the market but has no process to remove them and insure the integrity of blood testing supplies. Our goal is to bring some urgency to the FDA. HOW The diabetes community will bring public

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At a recent public meeting the FDA acknowledged that there are some 510(k) cleared BG meters and strips that do not meet the accuracy standards at which they were approved. There is no clear course of action to insure people with diabetes (PWD) are using blood glucose testing strips that meet regulatory requirements. For PWD using insulin,

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