Leading diabetes associations recommend overhaul of European,US medical device safety

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Northerner

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The European Association for the Study of Diabetes and the American Diabetes Association have made recommendations for a comprehensive evaluation of diabetes medical device safety to involve regulators, manufacturers, health care providers and the associations.

The position statement, published simultaneously in Diabetologia and Diabetes Care, comes after a review by the joint Diabetes Technology Committee of the systems in place for assessing the safety of insulin pumps from a clinical perspective.

“Pumps are used by an increasing proportion of people with diabetes,” John R. Petrie, MD, PhD, of the Institute of Cardiovascular and Medical Sciences, University of Glasgow, told Endocrine Today.

Worldwide, approximately 1 million patients are currently receiving continuous subcutaneous insulin infusion, according to a news release. Although most have type 1 diabetes, some patients with type 2 diabetes also use pumps.

http://www.healio.com/endocrinology...overhaul-of-european-us-medical-device-safety
 
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