You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device. The TGA cannot give advice about an individual's medical condition. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS). Your report will contribute to the TGA's monitoring of these products. Personalize your experience by entering your babys due date, reviewing.
In addition to adverse events involving home use fetal dopplers, consumers and health professionals are encouraged to report problems with medical devices. Baby Doppler Sonoline B Models of fetal heart rate monitors with speaker outputs. 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 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. Without training, the sounds detected from the mother or placenta could easily be misinterpreted as the fetal heartbeat, providing potentially inaccurate reassurance. 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. Traditionally these devices are used by health professionals in clinical settings. 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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