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Wednesday 28 September 2016 Instagram
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Heart device may harm unborn babies

Heart device may harm unborn babies

A device which checks the heartbeat of unborn babies may pose a danger to expectant mothers and their children, a watchdog has warned.

The Medicines and Healthcare products Regulatory Agency (MHRA) has confiscated 113 of the Baby Beets Fetal Doppler monitors from shops.

It is also advising other stores which may have the devices on sale to pull them from shelves as the system may not reach required safety and quality standards.

The MHRA said energy emitted by the monitors could expose mothers and babies to potential risk, and anyone who has brought one should refrain from using it.

The regulator cannot find evidence the monitors' safety and performance have been properly assessed in accordance with Medical Devices Regulations.

It added the product also incorrectly claims to have CE marking, which indicates it has met European safety requirements.

MHRA director of device technology and safety, Clive Bray, said: "The MHRA is currently assessing certain safety aspects of the product.

"It must be stressed that initial indications are that the health risk to a pregnant woman and/or their baby is small.

"However, as a precautionary measure, I strongly urge anyone using this product to immediately discontinue use."

MHRA

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Your comments: (Terms and conditions apply)
"Hi, this and a lot of the cheap Chinese dopplers are risky, but please do not mix this unit up with Baby Beats - the fully registered, tested and UK-made medical quality doppler" - Mike Brampton, www.babybeats.co.uk

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