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FDA Warns People with Diabetes and Health Care Providers Against the Use of Devices for Diabetes Management Not Authorized for Sale in the United States

FDA Warns People with Diabetes and Health Care Providers Against the Use of Devices for Diabetes Management Not Authorized for Sale in the United States

An FDA Safety Communication

Nathan E Botts 0 11053 Article rating: No rating

The U.S. Food and Drug Administration (FDA) is warning health care providers and people with diabetes of risks associated with use of devices for diabetes management unauthorized for sale in the U.S., whether used alone or along with other devices. These unauthorized diabetes management devices have not been reviewed by the FDA to ensure they provide a reasonable assurance of safety and effectiveness for their intended use. Use of unauthorized devices could result in inaccurate glucose level readings or unsafe insulin dosing, which can lead to injury requiring medical intervention or death.

Why are wearables not better targeted toward the people who might need them the most?

Why are wearables not better targeted toward the people who might need them the most?

Analysis of the J.C. Herz article at Wired.com

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SUBJECTIVE: Abstract from the article titled, "Wearable Are Totally Failing The People Who Need Them Most" posted on Wired Magazine: "As the Internet of Things becomes an actual thing, more steps are being counted, more sleep patterns are being logged, more activities are being appified. What isn’t appearing in the data is much common sense or ambition. Instead, developers continue flocking to a saturated market filled with hipster pet rocks, devices that gather reams of largely superficial information for young people whose health isn’t in question, or at risk."

Medical Device Failure

Medical Device Failure

How Data Can Help Us Prevent It

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From the Healthcare Triage YouTube video page:

You can directly support Healthcare Triage on Patreon: http://vid.io/xqXr If you can afford to pay a little every month, it really helps us to continue producing great content.Things sometimes go wrong with airbags, food and drugs, prompting recalls. It can also happen with medical devices, though you'd think lifesaving devices like heart defibrillators or artificial hips would be closely monitored.

But the data needed to systematically and rapidly identify dangerous medical devices are not routinely collected in the United States. Why not? It wouldn't be that hard to do.

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