The Therapeutic Goods Administration (TGA) has issued a warning regarding the illegal trade of banned pregnancy devices, particularly home-use foetal heart monitors, which have been linked to fatalities across Australia. After conducting a review in September of the previous year, the TGA removed these devices from the Australian Register of Therapeutic Goods, prohibiting their sale and advertising due to safety concerns.
Despite their ban, both new and used foetal heart monitors are still being unlawfully sold, leading the TGA to caution that the data these devices provide can be “dangerously misleading”. Reports suggest that some individuals have received false reassurance from these monitors, resulting in delays in seeking necessary medical attention, which in some cases has tragically led to deaths. The TGA emphasised that these monitors should not replace professional medical care.
Foetal heart monitors are typically used by healthcare professionals during pregnancy check-ups but have gained accessibility for personal use in recent years. In light of their ban, the TGA strongly advises that anyone worried about their unborn child’s health should immediately consult a midwife or doctor, rather than relying on unregulated devices.
The use of these illicit devices can lead to incorrect readings, fostering a false sense of security. Medical professionals are also encouraged to inform expectant parents about the potential dangers associated with these monitors.
It’s important to note that selling therapeutic products excluded from the ARTG can result in both criminal and civil penalties. Individuals are urged to report any issues related to medical devices through the TGA’s online platform.