Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, what steps the NHS is taking to prevent technological faults in equipment used in heart operations from causing harm or fatality.

Medical devices cannot be placed on the market in the United Kingdom without being CE marked by the manufacturer in accordance with the safety, quality and performance requirements of the relevant EC Directives (Medical Device Directive, Active Implantable Medical Device Directive or In Vitro Diagnostic Directive). Medical devices used for heart operations, such as pacemakers, aortic valves, transcatheter aortic valve implantation and stents fall into the highest risk category and as such have to meet the most stringent regulatory requirements set out in the Directives. Conformity against these requirements has to be assessed and certified by a third party independent certification organisation known as a notified body, which is designated by EC member states regulatory authorities as competent to carry out this function.