November 25, 2015

Thanks NY Times, Please Consider Diabetes Testing too.

The New York Time has a Piece titled,  "F.D.A. Targets Inaccurate Medical Tests, Citing Dangers and Costs" up this week. It is a good bit about the accuracy of medical lab tests.

I am thankful for attention to patient safety driven by quality testing. That applies at home as well as the lab. So I sen this to the reporter. Fee free to join me in asking for equal attention to the test people with diabetes do at home.

Thank you Mr. Pear for your article on lab test it certainly worrying and starting a conversation on the quality and safety of lab tests.
An equally concerning issue is the accuracy of home testing devices regulated by FDA. Diabetes test systems are currently required to be accurate to +/- 20%. Level lower than much of the rest of the world. 
While FDA has suggested new, more accurate standards, many devices fail to preform to the existing regulatory standard for which they were approved.* FDA has acknowledged this problem. However there is no process to remove underperforming systems form the market. 

Worse Medicare bidding has disputed the market, driving price, not safety or quality. Research shared at the American Diabetes Association scientific sessions showed that the ‘savings’ Medicare achieved were more than offset by increased hospitalizations and mortality.# 
I look forward to reading more of the dialog on medical testing you have started and hopefully it will expand to help the 30 million Americans with diabetes stay safe. 
*“Blood Glucose Meter Accuracy Problems Acknowledged By FDA, Industry And Clinicians.” ‘Medical Devices Today’, 27 May 2013. Web. 8 June 2013.

#“CMS Competitive Bidding Hurts Medicare Beneficiaries With Diabetes,” ‘EndocrinologyAdvisor’ 18 June 2015.

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