A risk assessment team has been put in place to look at how hospitals responded to a safety notice issued by the manufacturers at that time, warning that some were failing to monitor the baby’s heartbeat and instead recording only the mother’s, while audio warnings were also faulty.
The monitor in question, the Avalon Foetal Monitor made by Philips, was in use in 11 hospitals and continues to be used in Ireland. It was in use at the Midland Regional Hospital in Portlaoise during a period when there were a number of baby deaths that led to an inquiry.
In one of the most high-profile cases, that of baby Mark, son of campaigning parents Roisín and Mark Molloy, his death in 2012 was partly due to his distress not being detected because his mother’s heart rate was monitored instead of his.
Following yesterday’s revelations by the RTÉ Investigation Unit, the Molloys said they had raised the safety notice with the hospital during their fight to learn the truth of what happened to their baby but had been assured that questions around this issue had been cleared up.
Opposition politicians yesterday called on the HSE and Mr Harris to make full statements, explaining why there appeared to be fresh concerns and why previous responses to the safety notice were now being questioned.
Fianna Fáil health spokesman Billy Kelleher said there could be no further delays in getting to the bottom of the issue.
“We need to know why it has taken nine years since the initial product recall, and a further four years since the reporting of the deaths of five babies at Portlaoise Hospital, for the HSE to begin an investigation into the use of these foetal monitors,” said Mr Kelleher.
Labour health spokesman Alan Kelly said: “We need much more detail from Minister Harris regarding this investigation and whether there are any live concerns about the use of these monitors today.”
Sinn Féin TD Louise O’Reilly said the revelations were extremely worrying.
“It is hard to understate the seriousness of this issue,” she said.
Mr Harris said the HSE is going to meet the monitor manufactures this week but described the risk assessment as a “precautionary look back” and said there was no actual recall of the monitor but that instead guidance had been issued on how to ensure its proper functioning.
“I’m informed by the HSE that they put in place a number of measures to make sure that that guidance was followed, including mandatory training for staff,” he said.
“What I would say to any woman going into our maternity services today is that all of the hospitals have been reissued with the guidance. So this is about guidance, so that those using those monitors know how to correctly interpret the results.”
Under the terms of reference issued by the HSE, the risk assessment will look at the patient risks that led to the safety notice in 2009, what actions were taken as a result and whether any risks currently remained.
It said in a statement: “If deficits are identified, the National Risk Assessment Team will advise on any actions required to safeguard the safety of patients.”