Dr. Tony Holohan:

When we hear about something, the biggest issue is if the risk tells us that a service might be unsafe and needs an immediate intervention. We have responded in those kinds of situations. Clearly we escalate the issue immediately in those situations where there has been a failure for people who have gone through a service and have been exposed, of which there are examples but I will not waste the Deputy's time by talking through them, and where patients have to be identified through a look-back to be offered some service to help mitigate what is happening. The next level down is when an individual case does not have wider safety ramifications but which still has to be brought to the Minister's attention. This case is in the category, at the time in 2016, of something that could potentially cause a difficulty. Every population based programme such as screening and immunisation carries with it the risk of publicity arising from how errors are reported if there are cases. This is a well-known and internationally recognised phenomenon. Any screening programme or immunisation programme carries with it that potential.