Colm Burke (Fine Gael) | Oireachtas source

I thank the delegates for their presentations. I wish to briefly touch on one or two issues. On the issue of the defective devices, a system know as RAPEX was set up under the toys directive, which provides that if a defective item is identified in a country, that country has an obligation to notify the other 27 member states. The RAPEX system is a fast-track procedure for ensuring the market becomes aware of defective toys. Is a similar procedure or structure available or in place in respect of medical devices?

My second question relates to the Irish Medical Devices Association. Following a meeting of 27 November 2012, more than 12 months ago, it wrote to the Irish permanent representative at the time and expressed concern that the product scrutiny as structured in the Commission proposal would not increase patient safety. It expressed that concern in 2012. What is its position on the Commission's proposal and what is being talked about among the member states? Is the medical devices industry happy with the progress that is being made or does it still have some concerns that need to be dealt with? We are taking those concerns on board as we have a large number of people employed in the medical devices industry. The delegates may have touched on this but I would like further clarification.

The third issue on which I wish to touch is that of insurance. It comes back to the issue of breast implants. I introduced a Private Members' Bill that provided for placing an obligation on all people involved in medicine to have adequate insurance. The Department intends to move forward with that proposed legislation over the next six to nine months. On the current structure in place covering medical devices, the people involved in plastic surgery in Ireland, in particular Peter Meagher, are concerned about the number of people coming from abroad, providing a service and not having adequate cover. They are also concerned that we do not have the power to close the operations of those practitioners if they are not providing a structured service. They carry out the procedure but provide no backup support in the event of anything going wrong and, as a result, our health service has to deal with those difficulties afterwards. How far advanced are we in ensuring that in respect of everyone who provides medical care in this country - we are talking about the use of medical devices - there is a structure in place and adequate insurance cover and supervision in place? I understand the legislation in place does not cover all that area. How long will it take the Department to come on board with regard to that amending legislation?