Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what steps his Department has taken to assess the accuracy of spirometry breathing tests.

In order for spirometers to be placed on the market they need to meet the requirements of the EU Medical Devices Directive 93/42/EEC. This requires that their manufacturer will be assessed by a third party certification body (Notified Body) who will check that the metrology requirements for the devices, including their accuracy, have been met. The Medicines and Healthcare products Regulatory Agency (MHRA) does not perform this function itself.

Once on the market, manufacturers are responsible for the safety and performance of medical devices on the United Kingdom market. We would ask manufacturers to investigate if we became aware of any potential safety or performance issues. Safety issues or adverse incidents can be reported to the MHRA via their Yellow Card Scheme.