Philips made monitors at the centre of new investigation at maternity units.
The Department of Health, the HSE and a number of State-funded health agencies have refused to say which hospitals may have used faulty maternity unit monitors which are now the subject of an investigation.
The investigation into into the use at such units at 11 hospitals was ordered by the Department of Health after 'communications' were directed to itself, the HSE and the Health Products Regulatory Authority (HPRA). The investigation is examining the use of Philips made foetal CTG monitors used to check the heartbeats of mother and baby during labour.
The company issued a warning about the machines in 2009 because of the risk to mothers and babies.
The Department of Health declined to reveal which hospitals were subject to a review by a HSE Risk Assessment Team when contacted by the Leinster Express. In a statement the Minster for Health said the review ordered was prudent.
“The decision by the HSE to put in place a precautionary lookback, to check that monitors are being correctly used in our hospitals, is a sensible and prudent decision.
"It is right and proper that the HSE would take precautionary steps to ensure there is no patient safety risk.
"A huge amount of work has been done in recent years to improve maternity services in this country, including the establishment of the National Women and Infants Health Programme, which is now implementing the National Maternity Strategy,” said a statement.
The HSE confirmed the background and details of its investigation but also declined to say which hospitals had or are are still using the equipment.
The Department of Health has received correspondence from the health watchdog the Health Information and Quality Authority about the monitors. However, HIQA also refused to say which hospitals were involved.
It told the Leinster Express it has requested a copy of the HSE report being compiled into the matter and will 'consider it carefully' when received.
It did confirm the terms of reference for the major investigation it carried out into Portlaoise hospital in 2014 were very specific and did not include a review of equipment.
The Dublin Midlands Hospital Group indicated that the equipment was used at Portlaoise.
"Portlaoise Hospital has been active in relation to addressing the issues as raised and have agreed and established processes for managing clinical equipment. The current national Risk Assessment Process underway will provide an overview and update in that regard," said a statement.
The HPRA, which is the competent authority for medical devices in Ireland, also declined to comment. However, the HSE’s Risk Assessment Team confirmed that it met by teleconference on Monday afternoon (February 12).
The HSE said the team received an update from the HPRA on the interactions with the manufacturer of the Cardiotocography (CTG) monitor and steps taken to address concerns.
"The HPRA have advised that a software revision was applied to all these devices in Ireland and Philips Healthcare confirmed this to the HPRA in November 2011. This software revision was completed in all Irish centres. The HPRA monitored the completion and effectiveness of these communications and the software revision.
"It should be stressed that these medical devices were not recalled in Europe or USA as a result of this issue. The use of the word ’recall’ is FDA terminology used in communications for either a device correction or a removal depending on the action in the USA.
"The HPRA has monitored the incident and complaint rates nationally, on a European level and internationally and at no time identified the need for additional regulatory action," said a statement.
The following Irish public hospitals provide Maternity Care services:
Coombe Women's Hospital | National Maternity Hospital, Holles Street | Rotunda Hospital
South and South East
Cork University Maternity Hospital | Kerry General Hospital, Tralee | South Tipperary General Hospital | St Luke's General Hospital Kilkenny | Waterford Regional Hospital | Wexford General Hospital
West and North West
Galway University Hospitals | Letterkenny General Hospital | Mayo General Hospital, Castlebar | Portiuncula Hospital, Ballinasloe|Sligo General Hospital
University Maternity Hospital, Limerick
Cavan / Monaghan Hospital Group | Our Lady Of Lourdes Hospital, Drogheda
Midland Regional Hospital Mullingar | Midland Regional Hospital Portlaoise