The head of the Health Service Executive has said that three interventions and three periods of review of the maternity unit at Portiunucula University Hospital over the last decade are "indicative of a systemic concern".
Chief Executive Bernard Gloster made the comment after external reviews were ordered into the delivery of nine babies at the hospital, in Ballinasloe, Co Galway, including two who were stillborn.
Seven babies had hypoxic ischaemic encephalopathy (HIE), resulting in six of them being referred for neonatal hypothermic treatment, also referred to as neonatal cooling.
HIE is a reduction of oxygen or blood supply to the brain around delivery and it can occur before, during or after birth.
"Can I say upfront, without the outcome of those reviews, there is no question that three interventions and three periods of review over a 10-year period in a unit like this is indicative of a systemic concern," Mr Gloster said.
The reason why failures are happening at the facility is the "question which the outcome of the case reviews that are due shortly will point to, and that's a question we have to address.
"But first and foremost is the care of the women and their children who are the subject of review and the care and support and confidence of the 800 women who are currently booked to that unit," he told RTÉ's Morning Ireland.
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Mr Gloster said that he, his officials and clinical leaders have "scrutinised" every day as to whether it is safe for Portiuncula University Hospital's units to continue to operate and for women to continue to have their babies delivered there.
"The level of assurance we have in the context of both the team that have gone there last Monday, the willingness to make it as good as it can be by the staff on the unit, and the openness of everybody ... I am absolutely satisfied that the level of assurance has fundamentally increased and that will be sustained until the outcome of these reviews.
"I can assure you that any change in my level of assurance - first and foremost the women affected ... are the people who will know about that ... and there will be no hiding from that."
Earlier this week, HSE official Tony Canavan insisted that the hospital is "safe".
Mr Golster said it was an "important element of a safe healthcare system" that "when things go wrong, and they do, that we identify them, that we're open in our disclosure about them, and that we correct them".
Portiuncula University Hospital serves east Galway, Roscommon, Westmeath, north Tipperary and Offaly.
Women attending the maternity unit and who have questions can contact the HSE on 1800 807 008.
