Regulatory body 'recalls home foetal monitor'

28 Jan 2008

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a caution regarding the use of foetal monitor Baby Beets Fetal Doppler.

Following concerns that the product does not reach the required safety and quality standards outlined by the Medical Devices Regulations, the MHRA has urged women in the UK not to use the monitor.

At present the device is available online from legitimate foetal monitor manufacturers, however, there is no supporting evidence to indicate that the product is safe and free from causing potential risk to mother and baby.

Clive Bray, director of device technology and safety at the MHRA 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."

Foetal monitors can transmit the sound of the baby's heartbeat through a speaker or earphones after approximately 12 weeks into the pregnancy.

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