OTTAWA, ON, Nov. 29, 2023 /CNW/ –
Abstract
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Product: Unauthorized blood glucose (sugar)-reading smartwatches
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Concern: Unauthorized smartwatches that declare to observe blood glucose ranges could give false blood glucose readings, which may result in a harmful well being scenario, notably for individuals with diabetes
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What to do: Don’t use blood glucose-reading smartwatches that aren’t licensed by Well being Canada. Seek the advice of a healthcare skilled when you have used any of those merchandise and have well being considerations. Use solely blood glucose-measuring units listed on Well being Canada’s Medical System Energetic License Itemizing (MDALL).
Concern
Well being Canada is warning individuals with diabetes and fogeys/caregivers of individuals with diabetes that varied social media and on-line retail platforms are selling unauthorized blood glucose-reading smartwatches. These units haven’t been assessed for security and effectiveness and should pose critical well being dangers to shoppers as a result of they could give false blood glucose readings or they could not present well timed alerts, which may result in errors in diabetes administration.
Well being Canada has licensed units to be inserted beneath the affected person’s pores and skin that can be utilized with their smartwatch or smartphone to observe blood glucose ranges. Licensed units might be discovered by looking Medical Units Energetic Licence Itemizing (MDALL). Well being Canada has not licensed any smartwatches that may independently monitor blood glucose ranges.
If a false blood sugar studying is used to make diabetes remedy choices or an essential alert just isn’t supplied in time, critical errors can happen reminiscent of:
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taking too little insulin, which may result in excessive blood sugar (referred to as hyperglycemia),
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taking an excessive amount of insulin, which may result in low blood sugar (referred to as hypoglycemia), and
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failing to deal with low or excessive blood sugar.
These critical errors can result in well being penalties requiring medical remedy, reminiscent of hyperglycemic emergencies, extreme low blood sugar, lack of consciousness, seizure, coma, and loss of life.
Well being Canada will take vital motion to cease the sale and commercial of unauthorized blood glucose-reading smartwatches in Canada. The Division’s compliance and enforcement strategy is to mitigate the danger to Canadians utilizing essentially the most acceptable degree of intervention, in accordance with our Compliance and enforcement coverage for well being merchandise.
What it’s best to do
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Don’t use blood glucose-reading smartwatches that aren’t licensed by Well being Canada.
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Seek the advice of a healthcare skilled when you have used any of those merchandise and have well being considerations.
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Speak to your healthcare skilled about which blood glucose monitoring system is best for you. You’ll be able to search Well being Canada licensed medical units at Medical Units Energetic Licence Itemizing (MDALL).
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Report any well being product-related unintended effects or complaints to Well being Canada.
Additionally out there in French
SOURCE Well being Canada (HC)
View unique content material: http://www.newswire.ca/en/releases/archive/November2023/29/c6987.html
