Monday 16 September 2019

HSE launch review following foetal monitor safety concerns in Irish hospitals

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The HSE have opened a review into potential safety concerns about foetal monitors used in a number of Irish maternity hospitals.

A spokesperson for the HSE confirmed to that a review was to take place in relation to a 'Field Safety Notice' issued in 2009 for one type of foetal monitors used in Irish hospitals.

The HSE review will look at what actions were taken in relation to the notice, issued for Avalon Fetal Monitors.

The HSE are setting up a Risk Assessment Team to look at both current safety concerns and any risks between the date of the notice and the present day with regard to Cardiotocography (CTG) monitoring.

In a statement to the HSE say that 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 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.

RTE report that the recall was sent to 11 hospitals, including the Midland Regional, where five babies died in similar circumstances between 2006 and 2013.

One of the babies who died in the Midland Regional was Mark Molloy, who passed away in 2012.

The report into his death, known as a systems analysis review, contains the CTG trace of baby Mark, which charts some of his final moments.

It highlights the failure of hospital staff to act on signs of foetal distress and fully assess all sections of the CTG reading.

Speaking on Morning Ireland this morning, Mark Molloy's father Mark said: "The consequences of this could be really significant, There are families out there who thought they had closure on what happened to their loved ones. This could open up all sorts of wounds for them and the bigger picture for the HSE... it could be huge.

"From our own perspective we are getting pulled back in again into something that we handed over to senior HSE personnel four years ago. We're just going to have to see where this goes."

The Risk Assessment Team met for the first time last week but no date for the completion of the review has been announced.

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