Summary Safety Review - Avalon Fetal Monitor - Assessing the potential risk of inaccurate heart rate tracking of unborn babies (fetuses)

Review decision

A Summary Safety Review complements other safety related information to help Canadians make informed decisions about their use of health products. Each summary outlines what was assessed in Health Canada’s review, what was found and what action was taken by Health Canada, if any.


Issued: 2019-10-09

Product

Avalon Fetal Monitor FM20, Avalon Fetal Monitor FM30, Avalon Fetal Monitor FM40 and Avalon Fetal Monitor FM50 manufactured by Philips Medizin Systeme Boeblingen GmbH

Potential Safety Issue

Inaccurate heart rate tracking of unborn babies (fetuses)

Key Messages

  • The Avalon Fetal Monitor is a medical device licensed in Canada for heart rate tracking (monitoring) of the mother and unborn baby or babies (fetus or fetuses). It can be used during labour and delivery.
  • Health Canada's safety review was triggered by Canadian reports related to the use of the Avalon Fetal Monitor that describe possible inaccurate heart rate tracking including outcomes of deaths of fetuses (stillbirths) and the potential need for immediate care at birth.
  • The review did not find enough information to establish a link between the use of the device and poor fetal outcomes.
  • While the Avalon Fetal Monitor Instructions for Use (IFU) contains detailed information regarding the correct use of the device, key instructions are not highlighted. As a result, users may not be aware of certain key steps during the use of the device, which could contribute to inaccurate fetal heart rate monitoring.
  • Health Canada has worked with the manufacturer to update the IFU to ensure that important instructions are appropriately highlighted in order to help further reduce the risk associated with inaccurate monitoring.
  • A Health Product Risk Communication has been published to give healthcare professionals more details about this risk and to communicate the changes that have been approved for the IFU.

Overview

In 2017, Health Canada received incident reports related to the Avalon Fetal Monitor and inaccurate fetal heart rate monitoring, including outcomes of deaths of fetuses (stillbirths) and the potential need for immediate care at birth. As a result, Health Canada conducted a safety review to assess the potential safety risks associated with this device.

The Avalon Fetal Monitor is a continuous electronic fetal monitoring device, which allows healthcare professionals providing obstetrical care to analyze fetal heart rate changes during labour and delivery. Inaccurate monitoring could lead to unnecessary interventions, or failure to identify abnormal fetal heart rate patterns (sign of fetal distress) and the need for intervention.

At the time of the review, Health Canada had not received similar reports with other continuous fetal heart rate monitors currently licensed in Canada.

Use in Canada

  • The Avalon Fetal Monitor is a medical device authorized for sale in Canada to monitor the heart rate of the mother and fetus or fetuses before and during labour and delivery.
  • Continuous electronic fetal heart rate monitoring during labour helps healthcare professionals identify possible fetal distress and provide timely intervention if needed.
  • The Avalon Fetal Monitor has been sold in Canada since 2006 by Philips Medizin Systeme Boeblingen GmbH. There are 4 models available: FM20, FM30, FM40, and FM50.

Safety Review Findings

  • At the time of the review, Health Canada had looked at all incident reports related to the Avalon Fetal Monitor and inaccurate fetal heart rate monitoring. The review assessed reports involving poor fetal outcomes. There were 8 Canadian reportsa of fetal death and 2 reports of a potential need for immediate care at birth. While inaccurate fetal heart rate monitoring was found to have occurred, there was not enough information to confirm the cause of the outcomes, or whether the Avalon Fetal Monitor played a role in the outcomes of these cases.
  • The cause of fetal death during labour and delivery is complex and difficult to identify because many factors may be involved. In these incidents, there was no evidence of device malfunction.
  • There were also international reports of fetal or newborn baby (neonatal) deaths, poor neonatal outcome, and unnecessary caesarean section (C-sections) in cases where the Avalon Fetal Monitor had been used.
  • The review showed that inaccurate fetal heart rate monitoring could be caused by accidental recording of the mother's heart rate. Scientific literature suggests that this could happen with all continuous fetal heart rate monitors that use Doppler ultrasound to track fetal heart rate.
  • In 2009, the manufacturer of the Avalon Fetal Monitor issued a recall to provide more information to help healthcare professionals better recognize potential inaccurate fetal heart rate readings and manage the associated risks. This recall did not involve product removal from the market. This information has since been included into the newer versions of the Instructions for Use.
  • In 2014, the manufacturer put in place additional risk mitigation measures, including introducing new accessory and software updates to help users identify potential inaccuracies. Starting with software version Revision J.3, an audible alarm was added to notify users when the maternal heart rate is potentially being mistaken for the fetal heart rate, or when a fetal heart rate is potentially being mistaken for another fetal heart rate in the case of twins or triplets. Even with these actions, Health Canada received new reports in 2017 related to the Avalon Fetal Monitor and inaccurate fetal heart rate monitoring.
  • Health Canada's review also found that not all Avalon Fetal Monitor units being used in Canada have the latest software version installed.

Conclusions and actions

  • Overall, Health Canada's review of the available information found that inaccurate fetal heart rate monitoring is occurring, but there was insufficient evidence to establish a link between the use of the Avalon Fetal Monitor and the reported incidents. There was no evidence of device malfunction in these incidents.
  • While the Avalon Fetal Monitor Instructions for Use (IFU) contains detailed information regarding the correct use of the device, key instructions are not prominently highlighted. As a result, users may not be aware of certain key steps during the use of the device, which could contribute to inaccurate FHR monitoring.
  • Health Canada has worked with the manufacturer to update the IFU to ensure that important instructions are appropriately highlighted in order to help further reduce the risk associated with inaccurate monitoring. Health Canada has issued a Health Product Risk Communication to increase awareness of how to reduce the risk of inaccurate fetal heart rate monitoring and to communicate the changes that have been approved for the IFU.
  • Health Canada will continue to monitor safety information involving fetal heart rate monitors, as it does for all health products on the Canadian market, to identify and assess potential harms. Health Canada will take appropriate and timely action if and when any new health risks are identified.

Additional information

The analysis that contributed to this safety review included scientific and medical literature, Canadian and international adverse reaction reports, and what is known about the use of this device both in Canada and internationally.

For additional information about Health Canada's assessment, please contact the Marketed Health Products Directorate.

If manufacturers or industry associations require more information at this time, they are encouraged to contact the Therapeutic Products Directorate (hc.tpdgeneral-generaldpt.sc@canada.ca).

Footnotes

  1. Search Medical Device Incidents (https://hpr-rps.hres.ca/mdi_landing.php?lang=en)

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