Update for General Practitioners: Home fetal heart monitors (dopplers)
In 2022, Queensland Health raised concerns about the use of home fetal heart monitors (dopplers) with the Therapeutic Goods Administration (TGA). This was in response to a retrospective audit conducted by the Queensland Maternal and Perinatal Quality Council.
The audit identified 4 clinical incidents which saw parents who were concerned about a lack of fetal movement being falsely reassured about their baby’s heart rate by using a fetal doppler at home. The 4 clinical incidents included 3 stillbirths and 1 baby dying shortly after birth.
Outcomes since the Queensland Maternal and Perinatal Quality Council audit
To determine if the risk of using home fetal doppler devices outweighed the devices' potential benefit, the TGA reviewed all home-use dopplers included in the Australian Register of Therapeutic Goods (ARTG).
On 4 September 2024, the TGA, in the published the findings of their review stated, “All home-use fetal dopplers that were intended to be used without the supervision of a healthcare professional have been removed from the Australian Register of Therapeutic Goods (ARTG).” [1]
Home-use fetal doppler devices will no longer be available for purchase as these products may deter people from seeking necessary medical attention even if they are concerned about their baby’s wellbeing. This also includes Baby Movement Apps.
How can GPs assist?
- Caution expectant parents about the potential risks of using home fetal dopplers or Baby Movement Apps.
- Advise expectant parents to contact their midwife or doctor and present to a maternity facility for timely review if they are concerned about their baby’s wellbeing.
- Include the risks of home fetal doppler/Baby Movement App use in messaging around decreased fetal movements during antenatal appointments and when clinicians are in contact with concerned expectant parents.
- Display this poster in your practice to help spread the message to parents that relying on a doppler can be a risk.
More information for GPs
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Australian Government Therapeutic Goods Association (2024) Post-market review of home-use fetal dopplers
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Royal Australian and New Zealand College of Obstetrics and Gynaecology (2009) Position Statement on Home Fetal Heart Monitoring
Article sources
- Australian Government Therapeutic Goods Administration. (2024, October 28). Post-market review of home-use foetal dopplers. Therapeutic Goods Administration. https://www.tga.gov.au/how-we-regulate/supply-therapeutic-good/supply-medical-device/medical-device-post-market-reviews/post-market-review-home-use-foetal-dopplers