You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device. Fetal Monitoring We can listen to your babys heartbeat with a Pinard stethoscope or handheld doppler in your pregnancy from 16 weeks onwards. The TGA cannot give advice about an individual's medical condition. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS). ![]() Your OB-GYN is about to use a fetal doppler to listen for your baby’s heartbeat. It is just about the end of your first trimester, 12 weeks or so into your pregnancy. Your report will contribute to the TGA's monitoring of these products. Between the butterflies in your stomach and the beautiful baby in your belly, it might be getting a little crowded down there. In addition to adverse events involving home use fetal dopplers, consumers and health professionals are encouraged to report problems with medical devices. The TGA will regularly review any adverse event reports and the benefit-risk profile of home use fetal dopplers. 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. Expectant mothers are advised to present to a healthcare facility if they are concerned about their baby's wellbeing. The US Food and Drug Administration (US FDA) and the Royal Australian and New Zealand College of Obstetricians and Gynaecologists ( RANZCOG (pdf, 122 Kb)) have published advice on the use of these monitors and DO NOT recommend the use of home doppler devices to detect fetal heartbeat.Ĭlinicians are advised to caution expectant parents about the potential risks of using home fetal dopplers. Your provider may use it if they suspect your baby has a congenital heart. Fetal echocardiogram: This type of ultrasound looks at your baby’s heart size, shape, function and structure. Most Doppler ultrasounds occur later in pregnancy. Without training, the sounds detected from the mother or placenta could easily be misinterpreted as the fetal heartbeat, providing potentially inaccurate reassurance. Doppler ultrasound: This type of ultrasound checks how your baby’s blood flows through its blood vessels. The TGA has become aware of instances where patients have become falsely reassured by the home use fetal dopplers and delayed medical attention. Over the past few years, home use fetal dopplers have become widely available and consumers can use them without training. 1 Commonwealth Scientific and Industrial Research Organisation, Lindfield, NSW, Australia. ![]() S B Barnett D Maulik International Perinatal Doppler Society. Traditionally these devices are used by health professionals in clinical settings. Guidelines and recommendations for safe use of Doppler ultrasound in perinatal applications. The investigations undertaken by the TGA will assist in determining whether the risk of using these devices outweighs the potential benefit.įetal dopplers are handheld devices used to monitor fetal heart rate starting from 10-12 weeks of pregnancy. 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.
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