Written question asked by Lord Walton of Detchant (Crossbench), in the House of Lords. It was answered by Earl Howe (Conservative) on Monday, 26 March 2012.

Health: In-vitro Diagnostic Tests

Question: To ask Her Majesty's Government whether the use of in-vitro diagnostic tests in the National Health Service has led to any serious issues or problems; and, if so, to which regulatory authority any such incidents have been reported.

Answer: The Medicines and Healthcare products Regulatory Agency (MHRA) is the executive agency of the department charged with protecting and promoting public health and patient safety by ensuring that medicines, healthcare products and medical devices meet appropriate standards of safety, quality, performance and effectiveness, and that they are used safely. One way in which they achieve this is by investigating reports of adverse incidents involving medical devices and, where appropriate, instigating corrective actions to reduce the risk of recurrence. In 2011, the MHRA received 740 reports of adverse incidents related to in-vitro diagnostic medical devices (IVDs). Of these, 510 were received from manufacturers, 105 from medical device users (including National Health Service laboratories) and 125 from other sources (eg other organisations and members of the public). Four deaths and 41 serious injuries related to IVDs were reported to the MHRA. There is an exemption in the IVD Directive (98/79/EC) for health institutions, which means that they are not obliged to report adverse incidents with IVDs that are manufactured in-house. The MHRA has not received any reports on in house manufactured IVDs.

Secondary information