Post-market review of home-use foetal dopplers

We have published a safety alert regarding baby deaths associated with home-use foetal dopplers.

Home-use foetal dopplers

Foetal dopplers are handheld devices used to detect or monitor the heartbeat of a baby during pregnancy.

These are commonly used by health professionals during prenatal visits. In recent years, foetal dopplers for home-use have become widely available for members of the public.

Background

We received reports where expectant parents may have been falsely reassured by using home-use foetal dopplers and delayed seeking medical attention.

Untrained users could mistake the sounds of the mother's heartbeat or placental sounds for the baby's heartbeat.

This could potentially delay expectant parents from seeking necessary medical care.

In response to the reports, we reviewed all home-use foetal dopplers included in the Australian Register of Therapeutic Goods (ARTG).

The purpose of the review was to determine whether the risk of using these devices outweighed the potential benefit.

Overview

We required all sponsors of home-use foetal dopplers included in the ARTG to provide information to the TGA about their product, including:

• Advertising material
• Labelling information including the Instructions for Use (IFU)
• Complaint and adverse event information
• Risk-benefit analysis, and
• Clinical data supporting the use of their device.

During the review, the TGA followed guidelines from The Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG). 

We also sought expert advice from the Advisory Committee for Medical Devices (ACMD). 

The ACMD advised that the overall risk of inaccurately using the device outweighs the benefits and recommended limiting the supply of the device to appropriately trained health professionals.

All regulatory decisions taken during this post-market review were made on an individual device basis and were based on the evidence submitted by sponsors and manufacturers, and expert advice.

Outcomes and actions

All home-use foetal dopplers that were intended to be used without the supervision of a healthcare professional have been removed from the ARTG. 

The review confirmed that the lack of specialised training to use these devices could result in false reassurance of the health of a baby.

Where a foetal doppler device is cancelled from the ARTG, they are not being recalled from the market. 

The cancellation means home-use devices will no longer be available for purchase.

For consumers

If you are concerned about your unborn baby’s wellbeing, seek immediate attention from your midwife or doctor.

Important
DO NOT rely on home-use foetal heart monitors to check your baby’s heartbeat. Home-use foetal dopplers used without specialised training to operate these devices could result in false reassurance of the health of a baby.

For healthcare professionals

Healthcare professionals are advised 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. 

We urge consumers and health professionals to report any suspected adverse events where a home-use foetal doppler may have been a contributing factor.

Regulatory decisions

During the post-market review, some sponsors decided to discontinue supplying their products to the Australian market. 

A sponsor may do this at any time and a reason for their withdrawal from the market is not required to be provided to us.

We decided to cancel all remaining home-use foetal dopplers supplied in Australia.

The below table reflects the status of ARTG entries for devices included in the post‑market review.

Note: An ARTG entry may be cancelled in two ways: (1) The sponsor (the supplier within Australia) may voluntarily cancel the entry or (2) the TGA may cancel the entry. The sponsor can cancel their entry at any time and is not required to provide a reason to the TGA.

Clinical-use foetal doppler devices

Foetal doppler devices intended for clinical-use remain available for clinical settings. These devices are operated by qualified healthcare professionals who are trained to accurately interpret results and respond appropriately.

As part of the post-market review, we also examined the instructions for use (IFUs), advertising materials, labelling, and technical documentation for clinical-use doppler devices.

Following this review, the intended purpose of these devices, as included on their public ARTG certificates, has been updated to clearly state that these devices are for hospital or clinical use only.

Baby Movement Apps

We are aware that there are a range of apps and other software on the market for use as recording diaries, or for monitoring baby movements or kicks during pregnancy.

If the app or software claims to monitor or diagnose foetal health or wellbeing, this could be considered a medical device and would require ARTG inclusion to be legally supplied in Australia.

Apps that only allow users to log or count baby movement are unlikely to meet the definition of a medical device and would therefore not be regulated by the TGA.

Although not all of these products are considered medical devices, consumers should be aware that relying on movement data they have logged in these apps may give them a false sense of reassurance, potentially delaying them from seeking timely medical attention.

If they are worried of have concerns, expectant mothers should contact their healthcare provider or go to a healthcare facility.

Reporting problems

To report adverse events or any other concerns involving home-use foetal dopplers or monitoring apps, we encourage consumers and health professionals to report problems with medical devices. 

Your report will contribute to the TGA's monitoring of these products. See the TGA Incident Reporting and Investigation Scheme (IRIS).

Concerns about illegal advertising or supply of foetal dopplers can be reported here: Report a perceived breach or questionable practices.

The TGA cannot give advice about an individual's health or medical condition. We recommend talking to a doctor is you are worried about an adverse event.