Safety recommendation
HSSIB recommends that NHS England and the Medicines and Healthcare products Regulatory Agency work together to develop an effective mechanism for sharing medical device related incident data, including where devices function as designed.
Response:
In your letter you reference your investigation looking into ‘Risks to medication delivery using ambulatory infusion pumps: design and usability in inpatient settings’, where you made a joint recommendation to NHS England and the MHRA. The recommendation reads as follows: Safety recommendation R/2023/009: HSSIB recommends that NHS England and the Medicines and Healthcare products Regulatory Agency work together to develop an effective mechanism for sharing medical device related incident data, including where devices function as designed. You also detailed a round table regarding the sharing of medical device incident information which you felt should reflect ‘mechanism for sharing’. You raise concerns that our response does not indicate clear timelines for prioritisation and investment to address this recommendation.
At the roundtable and in subsequent communications both NHS England and the MHRA discussed the commitment to work together in order to explore further the feasibility and requirements of an application programming interface (API) between NHS England and the MHRA data collection platforms to streamline exchange of reports on patient safety events. At the meeting it was discussed that this was dependent upon the identification of resources in order to pursue this with a third party who would have the technical capability. The MHRA explained that while a discovery phase for this work had been undertaken by a third party, further resourcing was required for the additional work required for implementation. The MHRA has previously sought the required resource funding via a grant application which in 2022 was unsuccessful.
The development of an API to streamline Learn From Patient Safety Events (LFPSE) and Yellow Card reporting is unfortunately not straightforward and will require significant external resource in terms of funding and technical ability which neither organisation is currently in a position to provide. It will also require careful user engagement and research, plus service and content design. This is necessary to ensure that any additional data requirements do not impede recording by increasing the burden on staff to input data or introduce other unintended consequences of a significant extension to LFPSE data capture.
The MHRA and NHS England will continue to work together to identify opportunities for further grant applications. An application for UKRI funding has just been submitted and we are also discussing making a joint Spending Review bid. If successful this will enable a third-party supplier to be engaged to undertake the required Alpha phase and testing for the ongoing work to ensure a single, consistent approach to reporting which meets the requirements for both NHS England, MHRA, and users of the LFPSE service. The MHRA and NHS England are continuing to work together to progress this recommendation. We have recently begun developing a plan for a joint working group and through this group a further grant application for resource, options for improved sharing of existing data, and the future ways in which incident data can be shared more effectively, will be taken forward.
In your letter you mention the 10 year ambition to work towards better linkage between incident reporting data and the Yellow Card system. While we support this ambition, it is important to recognise the very different requirements of each system (incident data and Yellow Card). We were unable to create any linkage whilst the National Reporting and Learning System (NRLS) was the primary incident reporting mechanism utilised by most NHS Trusts. The introduction and widespread adoption of the Learn From Patient Safety Events (LFPSE) service offers better technical options to undertake this exploration. From July 2024 this will be the sole reporting mechanism for all providers of NHS care in England.
In response to your final point regarding prioritisation of a mechanism for sharing, unfortunately we are unable to provide HSSIB with a current estimation of feasibility, the reasons for this being detailed within this letter. These include the need to identify financial resource, technical resource and the outcomes of this work, which at this point in time we cannot predict. We will, however, continue to work together through the planned working group to explore this.
Response received on 12 February 2024 and updated on 26 June 2024.