Consumers and health professionals are advised that the TGA is currently undertaking a review of the safety signals, benefits, and harms associated with home-use fetal heart monitors. The investigations undertaken by the TGA will assist in determining whether the risk of using these devices outweighs the potential benefit.
Fetal dopplers are handheld devices used to monitor fetal heart rate starting from 10-12 weeks of pregnancy. Traditionally these devices are used by health professionals in clinical settings.
Over the past few years, home use fetal dopplers have become widely available and consumers can use them without training. The TGA has become aware of instances where patients have become falsely reassured by the home use fetal dopplers and delayed medical attention. Without training, the sounds detected from the mother or placenta could easily be misinterpreted as the fetal heartbeat, providing potentially inaccurate reassurance.
The US Food and Drug Administration (US FDA) and the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) have published advice on the use of these monitors and DO NOT recommend the use of home doppler devices to detect fetal heartbeat.
Clinicians are advised to caution expectant parents about the potential risks of using home fetal dopplers. Expectant mothers are advised to present to a healthcare facility if they are concerned about their baby’s wellbeing.
The TGA is urging consumers and health professionals to report any suspected adverse events where a home fetal doppler may have been a contributing factor.
The TGA will regularly review any adverse event reports and the benefit-risk profile of home use fetal dopplers.
In addition to adverse events involving home use fetal dopplers, consumers and health professionals are encouraged to report problems with medical devices