Gary Gannon (Dublin Central, Social Democrats)
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422. To ask the Minister for Health to outline the statutory obligations on hospitals to report adverse incidents or deaths potentially related to medical devices, including pacemakers and Holter monitors; and if these obligations were met by CHI Crumlin in the case of a child (details supplied); and if she will make a statement on the matter. [23020/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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The delivery of high quality, safe services is a priority within the Irish healthcare system. An integral part of this is the appropriate and timely reporting of adverse events when they do occur, including those that relate to medical devices. It is vital that our health services take steps to ensure adverse events are appropriately reviewed and responded to so that care and experiences for patients and their families can continuously improve. The HSE has systems and procedures in place to respond when an adverse incident occurs. The HSE’s Incident Management Framework is applied to the management of such incidents and is the mechanism for incident investigations in the HSE. The focus of the Framework is on understanding how and why an incident occurred and using this knowledge to improve safety.

In relation to the specific case referred to by the Deputy I have asked the HSE to respond directly.