The Health Information and Quality Authority (HIQA) has published its terms of reference for an independent statutory review into governance and oversight of the use of surgical implants and implantable medical devices in Children’s Health Ireland (CHI), including at CHI Temple Street.

The terms of reference have been developed following a request by the Minister for Health for HIQA to conduct a review under section 8(1)(c) of the Health Act 2007.

HIQA’s independent statutory review will be conducted in two phases, reviewing compliance at CHI and CHI Temple Street against relevant National Standards for Safer Better Healthcare.

Sean Egan, HIQA’s Director of Healthcare Regulation, said: “It is essential that children and their families, as well as the wider public, can be assured that surgical services are safe, and that appropriate governance structures are in place.

“This review aims to determine the end-to-end processes around any use of non-CE spring implants during spinal surgery in CHI at Temple Street. It will also assess the controls, oversight processes and governance arrangements in place within all CHI hospitals and services for the use of such implants and medical devices, including internal governance processes in meeting regulatory requirements. Furthermore, we will report on any potential opportunities for wider system learnings and system-wide improvements.

“Throughout the review, HIQA will engage with the families impacted by surgical practices at CHI Temple Street. Their experiences will inform our findings and will be reflected in our recommendations for improvement of children’s services.”

Following completion of the review, a report of the findings and conclusions a will be provided to the Minister for Health and published on www.hiqa.ie. Read the full terms of reference below.

Terms of Reference:

The following terms of reference have been determined for the conduct of this review:

1. To make an assessment of the governance, leadership and management arrangements in place within CHI for the use of use of surgical implants / implantable medical devices, including processes around regulatory requirements and notifications, and consideration of the controls and oversight processes.
    
2. To monitor compliance with the National Standards for Safer Better Healthcare, in accordance with Section 8(1)(c) of the Health Act 2007 as amended. In doing so, HIQA may use existing information available to it, as relevant.
    
3. To conduct the assessment of compliance in 2 phases, in the following order:
   • Phase 1: The end-to-end processes around the use of the non-CE spring implants during spinal surgery in CHI at Temple Street. It is intended to conclude this phase of the review as quickly as possible in the interest of providing answers to the Minister for Health no later than the end of 2023.
   • Phase 2: The controls and oversight processes and governance within CHI on the use of surgical implants / implantable medical devices, including processes around regulatory requirements and notifications.
      
4. In assessing the quality and safety of services, HIQA will: 
   • assess the extent to which the governance arrangements support a child-centred approach to care and the provision of safe and effective care, as they relate to the use of surgical implants / implantable medical devices in the provision of care, including assessment of arrangements for:
     • how the needs of children and families using the services are being met
     • monitoring and evaluation arrangements for quality improvement and sharing learning 
     • protecting children using the services from the risk of harm
        
5. In assessing the capacity and capability of the services, HIQA will:
   • assess the effectiveness and sustainability of the governance, and management and accountability arrangements in place within CHI as they relate to the use of surgical implants / implantable medical devices in the provision of care, including assessment of arrangements for:
     • controls and oversight processes 
     • risk management and reporting, including identification, assessment and mitigation of risks to service users
     • regulatory requirements and notifications processes
        
6. On conclusion of phase 1 and no later than the end of 2023, HIQA will brief the Minister for Health on initial interim phase 1 relevant findings. In doing so, HIQA will ensure it will not undermine, interfere or inhibit phase 2 of this review. 
    
7. On conclusion of phase 2, a report of the findings and conclusions across both phases of the review will be provided to the Minister for Health. This report will be published in order to promote quality, safe use of surgical implants / implantable medical devices for the benefit of the health and welfare of the public. 
    
8. Where relevant, HIQA may make recommendations in this report for the purpose of further quality improvement which will reflect current best practice and the future vision for services in line with standards, policy and legislation. In the interests of wider service improvement, national recommendations may be made where HIQA considers appropriate.

Ends.

Further information:

Marty Whelan, Head of Communications & Stakeholder Engagement
085 805 5202, mwhelan@hiqa.ie

Notes to Editor:

• The review will be conducted under section 8(1)(c) of the Health Act 2007, as amended, which outlines HIQA’s powers to monitor compliance with nationally mandated standards and advise the Minister for Health and the Health Service Executive (HSE) accordingly.