Concern Over Foetal Monitors Used in Irish Hospitals

15.02.2018

The Health Service Executive is to review safety concerns relating to certain foetal monitors being used in several Irish maternity hospitals.

The HSE has established a Risk Assessment Team to identify any past or current safety concerns following a product recall of the monitors in 2009. It follows concerns raised about the potential impact of the recall on the deaths of a number of babies at the Midland Regional Hospital, Portlaoise.

In 2009, Philips, the manufacturers of Avalon Foetal Monitors, issued a Field Safety Notice (FSN) due to the receipt of a high volume of complaints that certain models of the machine were taking inaccurate readings. The company warned that if hospitals did not put corrective action in place there was potential to cause injury or death to mothers and babies.

The recall was sent to 11 Irish hospitals, including the Midland Regional Hospital, Portlaoise, which featured as part of an RTÉ investigation in 2014 concerning the deaths of five babies. In all five cases there were issues with the interpretation of foetal traces.

Now the HSE has formed a committee to establish if appropriate action was taken in response to the 2009 recall and if any safety concerns exist for mothers attending hospitals where particular models of the foetal monitors are still in use.

The review will look at four areas;

-       Understanding the nature of any patient safety risks identified in the FSN.

-       Undertaking an assessment of the actions taken following the issue of the FSN in 2009 and since then. This will include consideration of the technological and human factors issues that may have impacted on cardiotocograph (CTG) interpretation.

-       Determining whether the actions taken were appropriate in order to address potential risk.

-       Determining if there are any current safety risks and the status of risk in the period from November 2009 to the present and if there are, to advise on further actions required in order to ensure patient safety.

The six-member team is expected to produce a report when it concludes its work, a timeframe for which is not yet known.

RTÉ. February 12. Irish Independent. February 12.