"FDA" warns against the use of unauthorized devices to manage diabetes

Health and Medical

The US Food and Drug Administration (FDA) today warned patients and health care professionals of the risks associated with using unapproved or unauthorized devices to manage diabetes, including continuous glucose monitoring systems, insulin pumps and automated insulin dosages.

The FDA noted that the use of unapproved or unauthorized devices can result in inaccurate measurements of glucose (glucose) or unsafe insulin doses, which may lead to injury requiring medical intervention or even death.

Millions of Americans use continuous glucose monitoring devices and insulin delivery devices to monitor and treat diabetes. Given the complexity of these devices and the care they provide, it is important that patients are aware of the risks that arise when they are not used as intended or when using unauthorized devices for sale in the United States .

Patients with diabetes may put themselves at risk of serious injury or even death due to devices that have not been approved, said Jeff Schorin, MD, director of the FDA's Center for Devices and Radiological Health.

"Today's warning is part of our ongoing commitment to public health to protect patients and communicate with the public when we recognize problems arising from the use or misuse of medical devices," Schuren said.

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