I propose to take Questions Nos. 325 and 348 to 352, inclusive, together.
As this is a service matter, it has been referred to the Health Service Executive for attention and direct reply to each Deputy. However, the Department is in a position to provide some information ahead of this direct reply, as follows.
The Department of Health was made aware of the matter relating to the monitoring of fetal heart rates in late January 2018 and immediately asked the HSE to examine the issue as a matter of urgency.
In 2009 a Field Safety Notice (FSN) was issued with new advice and guidance in relation to using these monitors and the known risks in relation to reading the fetal heartrate. The Health Products Regulatory Authority advise that it was confirmed to the manufactor that all relevant hospitals had received this notice in 2009, and that in 2011 a software upgrade had been applied to the machines.
In addition, there was a software revision applied to all these devices in Ireland and Philips Healthcare confirmed to the HPRA in November 2011 that the software revision had been completed in all Irish centres. The HPRA monitored the completion and effectiveness of these communications and the software revision.
The HPRA confirmed that all hospitals acknowledged receipt of the FSN, and that by 2011 all Avalon fetal monitors in Irish hospital had the software updates installed. The National Women and Infant’s Health Programme has requested updates from the hospitals that were affected by the FSN 2009.
Avalon Fetal monitors are CE marked medical devices on the market in Europe. [A medical device that has been approved will bear a CE mark. This indicates it meets the basic requirements for safety and effectiveness under European law].
These medical devices were not recalled in Europe or USA as a result of this issue. The use of the word ’recall’ is US Food and Drug Administration [FDA] terminology used in communications for either a device correction or a removal, depending on the action being taken in the United States.
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.
The HSE advises that hospitals where the monitors were located are as follows, Coombe Women and Infants University Hospital, Portlaoise Hospital, Regional Hospital Mullingar, University Hospital Limerick, National Maternity Hospital, Sligo University Hospital, Rotunda Hospital, South Tipperary General Hospital, St Luke's General Hospital Kilkenny, Cork University Maternity Hospital and Wexford General Hospital.
Risk Assessment Team
Due to the nature and complexity of this issue and the level of assurance currently available in relation to actions taken to date, a Risk Assessment Team has been established will be responsible for assessing the nature of any potential risk to patient safety and to determine the appropriateness of actions taken by the manufacturer and the health service to date. If deficits are identified, the Risk Assessment Team will advise on any actions required to safeguard the safety of patients. These actions will include but may not be limited to;
1. Understanding the nature of any patient safety risks identified in the FSN.
2. 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.
3. Determining whether the actions taken were appropriate in order to address potential risk.
4. 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 membership of the Risk Assessment Team, which is Chaired by the Director of the National Women and Infants Health Programme, includes both the Clinical Director and the Director of Midwifery for the Programme, a representative of the Health Products Regulatory Authority [HPRA], the HSE’s National Medical Device Equipment Advisor and the National Director for Quality Assurance and Verification.