The use of an appropriate flush fluid with arterial lines

We acknowledge that clear labelling of fluid bags and packaging of fluids is very important. Current packaging requirements for licensed medicines (such as the saline solutions in the reference case) in the UK are set out in Schedule 24 of the Human Medicines Regulations (HMR) 2012. Our Best Practice guidance on Labelling and Packaging of Medicines is intended to support safe use alongside the regulatory framework and provides guidance to Marketing Authorisation Holders (MAHs) on the content, design and layout of the presented information. Whilst MHRA guidance on labelling does not specifically include information relating to fluids for infusion presented in flexible infusion bags, the general advice is applicable. In addition, the European Medicines Agency produces guidance on labelling requirements; it should be noted that EU decisions are required to be applied in Northern Ireland and harmonisation of fluid bag labelling across the UK is desirable to ensure conformity. There is limited evidence that risk minimisation measures related to changes in labelling, such as colour, font size, Tallman lettering, or symbols/icons mitigate selection errors as described in the reference case. Furthermore, unintended consequences of labelling changes have not been explored. Labelling designs are global and without international support it would be difficult to deliver a UK specific labelling change especially when labelling requirements have been met. It is anticipated that above uncertainties complicate achieving a consensus on label changes amongst international regulators and manufacturers especially as, following discussion with international regulators, it appears that this safety issue was not recognised in their local reporting systems. Barcode scanning has been shown to be effective in reducing the number of medication errors in a scheme initiated by the Department for Health and Social Care (DHSC). The saline solutions used in the reference case carry barcodes as part of their label which can be used for scanning of the medicine in schemes such as scan4safety. To improve patient safety, we will therefore be exploring options to ensure that manufacturers provide adequate space for Unique Device Identifier (UDI) barcodes (ACTION) on the labels of fluid bags used as medical devices. There is currently no specific guidance regarding the labelling of fluid. Any new MHRA guidance will need to be aligned with the requirements of the new UK Medical Devices Regulation (MDR), when implemented. Response received on 7 November 2022.

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.

Following the report, the Association of Anaesthetists has convened a multidisciplinary working party to produce recommendations to address the findings of this report. The working party has been convened and aims to report and produce guidelines within 12 months from the first meeting to address the key findings of this report. Response received on 20 October 2022.

We welcome this report, which highlights the risks associated with blood sampling from arterial line systems used in adult critical care. We welcome the opportunity to consider what role we can play in providing oversight of the assurance that healthcare providers have to ensure they safely manage the risks of contamination by the flush fluid when using an arterial line to take a blood sample. The recommendation made to us is dependent on the recommendation made to the Association of Anaesthetists and we will work to meet our recommendation when new national guidance is available. Actions planned to deliver safety recommendation: Review recommendations made by the Association of Anaesthetists once existing national guidance has been reviewed. Other dependencies identified: Dependent on Association of Anaesthetists meeting their recommendation. We have been advised by the Association of Anaesthetists that the guideline working party has not yet met, and generally it will take 6-9 months for the guidelines to be written following the first meeting. Consider how oversight of governance and assurance arrangements to reflect the recommendations can be incorporated into the new regulatory model for the critical care core service. Consider whether there are implications for other areas of healthcare core services, given the wider use of arterial lines. All three actions supported by: Chief Inspector of Hospitals National Professional Advisor for Surgery Policy lead for the critical care core service Response received on 3 November 2022.