Mr. Sean Egan:

HPRA has a role around vigilance in the use of products and medicines in hospitals, and in community settings as well. From our perspective, a product arrives at a hospital and the organisation itself must create the safety systems for its use and practice. A lot of that relates to the governance of the various interventions that are brought into play. There is a requirement for the hospital itself to carefully manage the use of medicines or other products in practice, and to have systems around audit and training and making sure the appropriate people are using the products in the appropriate way. HIQA has a role in terms of overseeing that governance. Our specific focus is on medicines and infection prevention and control. As part of that, we look at the governance within the organisations to ensure that anything that may be product-related or that relates to ensuring safety is properly governed and assessed and that the appropriate controls are in place from the top-down of the organisation.