While the Avalon Fetal Monitor Instructions for Use (IFU) contained detailed information regarding the correct use of the device, some important instructions were not prominently emphasized. In order to help further reduce the risk associated with inaccurate monitoring, Health Canada has worked with the manufacturer to improve the IFU to ensure that important instructions are appropriately highlighted.
Healthcare professionals are advised that changes have been made in the Avalon Fetal Monitor IFU to highlight the following important instructions:
• Check the mother’s pulse periodically during monitoring and compare this with the FHR signal. Beware of mistaking a “doubled” maternal heart rate (MHR) for FHR.
• Always confirm fetal life before using the monitor.
• The simultaneous monitoring of MHR (preferably, the maternal ECG) and the fetal heart rate is encouraged.
• Whenever possible make use of the cross-channel verification (CCV) feature.
Additionally, healthcare professionals are advised that starting with software version Revision J.3, an audible tone is provided to help users identify potential coincidence between all monitored heart rates.
Read Health Canada’s full advisory here.