Banned pregnancy devices are leading to deaths around Australia as they continue to be illegally traded, the Therapeutic Goods Administration has warned.
Following a review in September last year, the TGA removed all home-use foetal heart monitors from the Australian Registry of Therapeutic Goods, meaning they are no longer approved for sale or advertising in Australia.
But new and second-hand devices continue to be sold illegally, the TGA said, and warned that the information provided by such devices can be “dangerously misleading”.
“We have received reports of instances where they have provided false reassurance, leading to delayed medical attention and deaths,” the TGA said in a statement.
“These devices are not a substitute for professional care.”
Home-use foetal heart monitors are handheld devices used to detect or monitor the heartbeat of a baby during pregnancy.
They are commonly used by health professionals during pregnancy checkups, but in recent years had become widely available to the public.
Following the ban, the TGA has urged people concerned about their unborn baby’s wellbeing to seek “immediate” attention from their midwife or doctor.
Untrained use of an illicit monitor can provide falsely reassuring data.
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Medical professionals have also been urged to remind parents-to-be of the dangers associated with the devices.
Criminal and civil penalties apply for selling therapeutic goods excluded from the ARTG.
People can report a problem related to a medical device online here.
