Dáil Éireann Debate, Thursday - 21 September 2023
275. Deputy Paul Murphy asked the Minister for Health his views on the allegations in a media report in relation to spinal surgeries at Temple Street Children's Hospital (details supplied); and if he will make a statement on the matter. [40901/23]
View answerMy Department was notified of this issued on the 4th August 2023, while the surgeries where these springs were used, according to the information currently available, happened in 2020 and 2022. An external investigation is under way into the use of these springs, as well as a clinical review of the three patients, two of whom have since had the springs removed. This investigation needs to establish all the facts, in the end-to-end process, about how these springs came to be procured and ultimately used in surgeries.
The HPRA has issued clear statements about the regulatory processes for medical devices that are in place to protect patients and about the processes available for the exceptional circumstances where a non-CE device is being considered. The HPRA has confirmed that it has not had any applications to the processes for exceptional circumstances for approval for the use of non-medical grade products, which are sold or supplied not intended for medical use, for clinical use in surgery.
This is a very serious matter and while there is some information circulating, we must await the outcome of the investigation before we can draw conclusions. We need the full facts established. I have asked for this investigation to be completed as quickly as possible, there is also a clear need to ensure that there is a robust governance in place for it and I have also asked my officials and the HSE to reflect on this and advise me how this can best be achieved.
