The current medical device regulatory framework provides for mandatory reporting of all incidents by the manufacturer to the Health Products Regulatory Authority (HPRA) when the incident occurs in Ireland. Incidents which should be reported to the HPRA are any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which, directly or indirectly, might lead to or might have led to the death of a patient, or user or of other persons or to a serious deterioration in their state of health.
User / healthcare professional reporting is not mandatory in Ireland but is strongly encouraged by the HPRA. The HPRA has an online incident user report form on their website to facilitate user reporting.
No incidents have been reported to the HPRA in relation to the MAGEC Rods.
As the first part of the question relates to the policy of Our Lady's Children Hospital regarding reporting medical device safety incidents we have sent this to the HSE for direct reply to the Deputy.