The TGA has urged healthcare professionals to advise caution about the use of home-use foetal heart monitors, following reports they have been associated with baby deaths.
The Therapeutic Goods Administration has issued a safety alert about home-use foetal heart monitors, warning baby deaths had been associated with their use.
The handheld devices designed to detect or monitor a baby’s heartbeat during pregnancy were cancelled from the Australian Register of Therapeutic Goods (ARTG) following a regulatory review completed in September 2024.
The review confirmed that the lack of specialised training to use these devices could result in false reassurance of the health of a baby, the TGA reported.
However the TGA said this week that there appeared to be ongoing illegal sales online of both new and second-hand devices.
“Medical devices which are not included in the ARTG cannot be advertised or supplied in Australia unless subject to a relevant approval, authorisation or exemption,” the regulator said in the safety alert.
“There are criminal and civil penalties for non-compliance in relation to the supply of therapeutic goods or their advertising.”
The TGA reaffirmed there were no home-use foetal heart monitors approved for supply in Australia, and that adverse outcomes relating to the use of the devices continue to be reported to the TGA.
“Using a home-use foetal heart monitor to check a baby’s heartbeat may seem reassuring but it can be dangerously misleading,” the TGA said.
“We have received reports of instances where they have provided false reassurance, leading to delayed medical attention and deaths.
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“These devices are not a substitute for professional care. We advise consumers to exercise extreme caution when considering using home-use foetal heart monitors to check their baby’s wellbeing.”
The TGA advised healthcare professionals to caution expectant parents about the potential risks associated with home-use foetal heart monitors and/or baby movement apps.
“Specifically, that home-use foetal heart monitors used without specialised training required to operate these devices could result in false reassurance of the health of a baby,” it said.
Expectant parents should be advised to contact their midwife or doctor and present to a maternity facility or care service for timely review if they are concerned about their unborn baby’s well-being.
“Include the risks of home-use foetal heart monitors/baby movement apps in messaging around decreased foetal movements during antenatal appointments and when healthcare professionals are in contact with concerned expectant parents,” the TGA said.
See the full safety alert here.
