Expert: Substandard diabetes monitors allegedly on the market

From: UPI

CHAPEL HILL, N.C., July 8 (UPI) — Some blood  glucose monitors are not meeting U.S. government accuracy standards once  approved and on the market, a diabetes expert says.

Dr. Richard Kahn, a professor of medicine at the University of North Carolina  and former chief scientific and medical officer of the American Diabetes  Association, wrote in a commentary in Roll Call that it is openly acknowledged,  with much supportive data, some blood glucose monitors do not meet U.S. Food  and Drug Administration accuracy standards.

Almost all of the problems are with low-cost products manufactured overseas,  Kahn said.

This year, the Centers for Medicare & Medicaid Services implemented a  competitive bidding program for durable medical products such as blood glucose  meters with the goal of reducing healthcare costs without sacrificing quality. A  pilot program in nine markets showed it helped reduce medical costs.

However, significant issues have recently surfaced. The problem is that there  is no FDA surveillance system in place to effectively monitor quality after  devices are approved.

To its credit, the FDA has acknowledged the problem and is working to address  it by developing a guidance document for manufacturers and strengthening current  standards, Kahn said.

“However, while the FDA works to address the problem, these inaccurate  monitors are still commercially available, and as of July 1, these inaccurate  monitors will very likely come out ahead under the new Medicare competitive  bidding program,” Kahn wrote.

“With competitive bidding, products are assumed to be of equal quality and  accuracy, and bids are based on cost. In efforts to reduce the cost of care, we  will likely also be reducing the quality of care by providing our nation’s  diabetics with inaccurate technology.”

Congress and the CMS must rethink the new competitive bidding program, Kahn  advised.

“Over the long term, I have great confidence that the FDA will act in the  best interest of patients and put stringent post-market surveillance in place to  ensure products continue to meet FDA standards after approval,” Kahn said. “In  the meantime, anything that will stop the widespread introduction of defective  systems into the marketplace is urgently needed.”