Paul Murphy (Dublin South West, RISE)
Link to this: Individually | In context | Oireachtas source

790. To ask the Minister for Health the number of halo traction chairs currently available for use in Children’s Health Ireland at present; and if there are plans to increase their availability given the urgent need for such equipment. [36846/24]

Paul Murphy (Dublin South West, RISE)
Link to this: Individually | In context | Oireachtas source

791. To ask the Minister for Health if Children’s Health Ireland has used non-CE marked halo gravity traction chairs in the treatment of children with scoliosis; and to confirm the compliance of this practice with Medical Device Regulations (EU) 2017/745. [36847/24]

Paul Murphy (Dublin South West, RISE)
Link to this: Individually | In context | Oireachtas source

792. To ask the Minister for Health if Children’s Health Ireland has notified parents of any failure to comply with medical device regulations regarding the use of non-CE marked halo gravity traction chairs; and the steps taken to rectify this issue. [36848/24]

Paul Murphy (Dublin South West, RISE)
Link to this: Individually | In context | Oireachtas source

793. To ask the Minister for Health if the current halo gravity traction treatment beds in use at Children’s Health Ireland are CE-marked and compliant with the Medical Device Regulations (EU) 2017/745; and if any audits or inspections have been conducted to ensure this compliance. [36849/24]

Paul Murphy (Dublin South West, RISE)
Link to this: Individually | In context | Oireachtas source

796. To ask the Minister for Health the details on the procurement of the halo gravity traction chairs currently in use or which have been in use over the past several years at Children’s Health Ireland, including the brand, make, model, and supplier of the chairs; and whether these chairs were procured in compliance with Medical Device Regulations (EU) 2017/745, in tabular form. [36852/24]

Paul Murphy (Dublin South West, RISE)
Link to this: Individually | In context | Oireachtas source

797. To ask the Minister for Health the number of children who have undergone halo gravity traction in Children’s Health Ireland (CHI) hospitals since January 2000, including the length of treatment for each child, broken down by year and across all hospitals within the CHI network, in tabular form. [36853/24]

Stephen Donnelly (Wicklow, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

I propose to take Questions Nos. 790, 791, 792, 793, 796 and 797 together.

As this is an operational matter, I have referred the question to the HSE for their attention and direct response to the Deputy.

Paul Murphy (Dublin South West, RISE)
Link to this: Individually | In context | Oireachtas source

794. To ask the Minister for Health if Children’s Health Ireland has reported any adverse incidents related to the use of halo gravity traction chairs or beds to the Health Products Regulatory Authority; and if so, the follow-up actions taken to investigate and address these incidents. [36850/24]

Stephen Donnelly (Wicklow, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

As the Medical Device Regulator in Ireland my officials reached out to the Health Products Regulatory Authority (HPRA) to see if they were aware of any incidents with regard to halo gravity traction chairs or beds in use at CHI.

Medical devices which are appropriately CE marked may be freely placed on the European market without further national authorisation. The HPRA does not maintain a listing of all medical devices placed on the Irish market. As such the HPRA does not have visibility to the specific halo gravity traction chairs or beds in use at CHI. An initial search of the HPRA’s vigilance database performed based on the limited information currently available has not identified any incidents / serious incidents reported to the HPRA by CHI. If further information can be provided by the Deputy in relation the specific medical devices of interest (i.e. specific device name/model and/or manufacturer name) the HPRA would be in a position to perform a more comprehensive search.

Paul Murphy (Dublin South West, RISE)
Link to this: Individually | In context | Oireachtas source

795. To ask the Minister for Health the steps being taken to ensure that future equipment purchases by Children’s Health Ireland, specifically in the treatment of scoliosis, fully comply with Medical Device Regulations (EU) 2017/745; and whether there are plans to review the procurement process to prevent the use of non-compliant medical devices in the future. [36851/24]

Stephen Donnelly (Wicklow, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

I requested HIQA to carry out an independent review at Children's Health Ireland focused on the end-to end processes around the use of the non-CE spring implants during spinal surgery in Temple Street. I also requested HIQA to examine the controls, oversight processes and governance within CHI on the use of surgical implants / implantable medical devices. The review is well advanced, and I am expecting the final report to be submitted to me in the near future.