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 of the review

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.

Information for consumers

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

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.

Information 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. 

The TGA is urging 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.

Baby Movement Apps

There are apps and other software on the market for recording diaries or monitoring baby movements or kicks during pregnancy. These products are widely available for download by consumers. It may look like a diary, but these digital products are intended to prevent foetal harm through monitoring foetal movement. As such they are considered to be medical devices. These must be included in ARTG.

There is a risk of false reassurance to consumers once the movements are recorded in such an app. While the developer may not claim to take action, this false reassurance may lead people to not seek medical attention right away.

Expectant mothers should go to a healthcare facility if they are worried.

Reporting problems

In addition to adverse events involving home-use foetal dopplers, 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 medical condition. We recommend talking to a doctor is you are worried about an adverse event.