Safety recommendation
HSIB recommends that the Department of Health and Social Care, once post-market surveillance data is available, involves relevant stakeholders including the Association of Anaesthetists’ review and determine appropriate actions that could be taken to further mitigate the risk of blood sample contamination by the flush fluid when using arterial transducer line systems.
Response:
DHSC is grateful to HSIB for their thorough investigation of this issue. Regarding the recommendation of a review once post-market surveillance data is available, it is important to note that there is currently no adverse incident post-market surveillance data indicating a problem with the performance of these devices. This indicates that the devices do work as intended when used correctly and therefore we do not anticipate receiving post-market surveillance data that will necessitate a review of this issue in the near term.
Once a medical device has been placed on the UK market, the manufacturer is required to submit vigilance reports to the MHRA when certain incidents occur in the UK that involve their device. They must also take appropriate safety action when required. MHRA monitor these reports and should post-market surveillance data emerge to signify a problem with the device, they will investigate the issue and explore possible risk mitigating strategies.
DHSC would be happy to assist MHRA with a review relating to contamination by flush fluid with arterial transducer line systems where required, should sufficient adverse post-market surveillance data emerge.
Action planned to deliver safety recommendation:
- Should sufficient adverse post-market surveillance data emerge to trigger an MHRA investigation of the issue, DHSC will support the investigation as required.
Response received on 4 November 2022.