Urgent recall notice was issued for monitoring equipment at maternity units - HSE confirms

Conor Ganly


Conor Ganly

Urgent recall notice was issued for monitoring equipment at maternity units - HSE confirms

File photo courtesy of Pixabay

The HSE has confirmed that it is investigating the use of equipment used to monitor foetal and maternal heart rates at maternity units but has declined to say which hospitals may be subject to the review.

In a statement the HSE said a number of communications have been received by the HSE in recent weeks in relation to an urgent - medical device recall dating back nearly decade.

The notice was dated 20th November 2009.  The HSE says this Field Safety Notice (FSN) relates to concerns about 'Avalon Fetal Monitors' in use in Irish hospitals and in particular "the potential safety concerns" that led to its issuing. 

The HSE says these communications have been directed to the HSE, the Department of Health and the Health Products Regulatory Authority (HPRA) in Ireland. On the 31st January 2018 the Department of Health’s, National Patient Safety Office wrote to the HSE on the matter and on the 7th February 2018 correspondence was received from HIQA.

As a result the HSE decided to investigate further.

"In order to obtain assurance in relation to the actions taken in response to the FSN in 2009, a decision has been taken by the HSE to establish a Risk Assessment Team to undertake an assessment of any potential current safety concerns and the status of any potential risks between 2009 and the present in relation to CTG monitoring.                                          

"Due to the nature and complexity of this issue and the level of assurance currently available in relation to actions taken to date, the Risk Assessment Team 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 National Risk Assessment Team will advise on any actions required to safeguard the safety of patients," said a statment. 

The HSE said these actions will include but may not be limited to;

- 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. 

The HSE said the Risk Assessment Team met for the first time last week. It will provide a Report to the HSE's National Director Acute Hospital Services Operations following the conclusion of its work.

"Where issues requiring an immediate or urgent response are identified, these will be immediately escalated to the National Director Acute Hospital Services Operations by the Chair of the Risk Assessment Team," concluded the statement.

The HSE declined to say which hospitals the equipment was used in but RTÉ has reported that the equipment was in use in Portlaoise and other hospitals.