Safety recommendation
It is recommended that NHS Supply Chain develops an agreed specification that defines an open standard format for the sharing of event log data, thus allowing dose error reduction systems (DERS) to be evaluated to establish patient safety benefits.
Response:
Thank you for sharing the Healthcare Safety Investigation Branch (HSIB) report into the Procurement, usability and adoption of ‘smart’ infusion pumps.
As you are hopefully already aware NHS Supply Chain is actively engaged in the development of essential specifications as part of the ongoing service development within our Clinical and Product Assurance (CaPA) team. As part of this work all future procurement frameworks will be adopting the essential specification principles, including technical requirements, to ensure products procured are not only value for money, but fit for purpose safe and represent Health and Care Professional as well as patient and carer need.
Fundamental to this is our understanding that regulatory requirements for market placement are merely a baseline for market access and that a much more holistic approach to product selection and product review is required which is informed by our wider system partners, including HSIB colleagues.
In the report, HSIB notes that:
“..the infrastructure needed to implement smart pump technology requires the use of software to upload the drug library to the smart pumps, download data logs associated with usage (including alerts where DERS has prevented an ‘error’), and monitor the status of each smart pump in the system (including which version of the drug library it is using). The investigation also identified that maintaining the IT infrastructure required specialist staff. Smart pumps need to be connected to a trust’s IT network. This can be achieved by using a hardwired connection (where the device is plugged into a port in the wall) or a Wi-Fi network. Both methods required specialist IT provision.”
On this basis, we are content to pursue, as part of future framework renewals and the associated essential specification design, the recommendation for an open standard format for the sharing of event log data. As our work on essential specifications is constantly evolving, we will seek to identify the correct technical content to ensure the HSIB recommendation is integrated into the essential specification design and work with the supplier community to implement these changes at the earliest opportunity, with the re-procurement timetable currently planned to go live in June 2022.
We also recognise the need for a system-wide approach to the management of these risks and so feel dutybound to highlight the need for the endorsement and adoption of essential specification by commissioning partners within NHS England and NHS Improvement to ensure this is also applied to procurement that takes place outside NHS Supply chain (direct procurement) along with the provision of associated clinical guidance to embed this change and ensure consistency of procurement and clinical practice across the Health and Care system.
Whilst implementing the recommendation as part of work on essential specifications is a commitment we are pleased to make, system preparedness and purchasing of the right products outside of the remit of NHS Supply Chain will also therefore be critical additional factors to the mitigation of the risk of under or over dosing linked to Dose Error Reduction Systems (DERS). We would therefore suggest discussion for this recommendation to be fully implemented agreement with NHS England & NHS Improvement Patient Safety Team, National Clinical leaders and responsible commissioners in order to address the procurement of “smart” infusion pumps outside the NHS Supply Chain remit.
With this in mind we suggest a call be convened by HSIB with relevant partners to develop a joint delivery plan, to deliver fully on the report recommendation for which the NHS Supply Chain Clinical and Product Assurance team are more than happy to attend to support the formulation of a cross-partner action plan. In the meantime, please see the attached action plan internally for NHS Supply Chain.
SUMMARY: The development of an essential specification for infusion pumps is already in development working in collaboration with HSIB colleagues and wider system partners (Medicines and Healthcare products Regulatory Agency (MHRA), NHS England and NHS Improvement) This will ensure the recommendations made, are embedded within the content and so implemented as part of the framework re-procurement which is planned to go live in June 2022.
As provider organisations also may choose to procure the products directly from suppliers and/or via an alternative route we would suggest that in order to be confident that the recommendations are implemented system wide further agreement will be required with the regulator and NHS England and NHS Improvement partners to ensure future guidance reflects the recommendations outlined in the report for which NHS Supply Chain would like to offer their support as appropriate.
ACTION: Confirm requirements of essential specification for relevant category strategy. TIMELINE: March 2021.
ACTION: Engage with supplier market to confirm availability of products that meet essential specification requirements and ability to meet associated demand. TIMELINE: April 2021.
ACTION: Finalise essential specification and confirm endorsement of content with wider partners including NHS England & NHS Improvement clinical leads. TIMELINE: July 2021.
ACTION: Collaborate with wider partners as necessary to inform updates to existing clinical guidance as necessary. TIMELINE: July 2021.
ACTION: Include essential specification in next re-procurement activity. TIMELINE: May 2022.
ACTION: Launch new framework for ‘smart infusion pumps’. TIMELINE: May 2022.
Response received on 22 February 2021.