Tuesday, 23 July 2019

Questions (1166)

Louise O'Reilly


1166. Deputy Louise O'Reilly asked the Minister for Health the data available to the HSE regarding the safety of titanium ions in the blood; and his views on whether children should have blood tests to check for such levels in the blood during their treatment with a device (details supplied). [31930/19]

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Written answers (Question to Health)

Titanium is a commonly used material in a range of medical devices. Medical device manufacturers must ensure the safety and biocompatibility of any materials used in the device, taking into consideration the amount of time that they may remain in contact with a patient’s body.

Before an implantable medical device can be placed on the Irish market, the product undergoes assessment by a notified body, who must assess whether the medical device conforms to the essential requirements of the medical device legislation including those relating to material safety and biocompatibility.

Ongoing monitoring of the levels of titanium ions in patients with Magec Spinal Rods remains under discussion. The Department and the Health Products Regulatory Authority are not aware of any current recommendation in place in Ireland for such testing.