NHS Supply Chain
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.
NHS Supply Chain
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 22 February 2021
MEDUSA (UK Injectable Medicines Guide) advisory board
It is recommended that the MEDUSA (UK Injectable Medicines Guide) advisory board, in conjunction with other relevant multi-professional organisations, develops validated national drug libraries for smart infusion pumps.
MEDUSA (UK Injectable Medicines Guide) advisory board
We consider that the concept of producing a national drug library for Smart pumps which would be freely available to all is an important step forward for improved patient safety. We took this opportunity to consult widely over the feasibility of producing a National drug library for Smart infusion pumps hosted by the Medusa Injectable medicines guide website. We consider that until the following points are resolved a course of action described in the actions section below is not achievable.
- Identification of a long-term financial sponsor.
- Continuing financial support to allow employment of appropriately qualified staff (clinical and IT) to implement the actions described in the actions section below.
- Sign up from all multidisciplinary NHS organisations involved in the manufacturer, prescribing, preparation and administration of IV infusions in the UK is required before the project commences.
- The support of Smart Infusion pump manufacturers (both current and future) is required. The NHS needs to be able to evaluate all the drug library information they currently hold and all future amendments in order to create and update a relevant drug library.
- The agreement of all organisations involved in infusion therapy that this work needs to continue indefinitely to ensure that any library hosted by the Medusa website is continuously reviewed and reflects current practice is required. Assurance of ongoing funding is essential: an out-of-date library would pose significantly higher patient safety risks than no library at all.
- The Medusa advisory board and NHS supplies need to work closely together to ensure that Safety recommendation R/2020/104: (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) is implemented in a way which is compatible with the drug library.
ACTIONS: PHASE ONE ACTIONS
Drug library; ADULT patients
Encourage local adoption of the standard list of infusion concentrations for adult patients currently hosted by the Intensive Care Society (ICS) and reflected in the relevant Medusa monographs. https://medusa.wales.nhs.uk/docs/2020-12%20ICS%20standard%20concentrations%20list%20v4.1.pdf
Encourage appropriate updating of locally used Smart pump drug libraries, drug guidelines and prescribing systems to match this list.
Explore local barriers to the adoption of the standard list and after appropriate consultation make necessary amendments. Update Medusa monographs as necessary to reflect any changes.
Work with all Smart pump manufacturers selling pumps in the UK to encourage them to share with Medusa the infusion concentrations which are adopted by organisations which use their pumps. This will allow for a recommendation of further standard concentrations which can be adopted by virtue of them being used by a defined majority.
Work with relevant NHS specialties to endorse the recommendation of majority use concentrations so as to expand the ICS list to ultimately include all infusions given to adults in all disciplines. Encourage local adoption of the expanded list.
Continuously review the list to ensure that it reflects best practice.
Host the updated list on the Medusa website. Each concentration to be referenced to the organisations which endorse it.
Continuously update Medusa monographs as necessary to reflect any changes.
Ensure that all infusion pump manufacturers and organisations in the UK who use Smart infusion pumps are alerted to agreed changes and are encouraged to make any relevant local amendment or report back as to why an amendment is unacceptable.
As the list is expanded encourage local adoption of additions/deletions and appropriate updating of locally used pump drug libraries and prescribing systems. Explore any barriers to a change of local practice
Ensure all relevant organisations, publications and Smart pump manufacturers involved in infusion therapy are actively involved in the updating of the drug list and are encouraged to publicise its use.
Drug library; PAEDIATRIC patients (including neonates)
A similar approach to the one described above for adult patients is required to create and maintain a paediatric drug list. The starting point is the standard infusion concentrations published by the Neonatal Joint RCPCH/NPPG Standing Committee on Medicines (April 2021). https://www.rcpch.ac.uk/resources/standardising-intravenous-infusion-concentrations-children-uk
Medusa IT actions
Develop Medusa IT to ensure that agreed standard infusion concentrations are listed on Medusa as a summary table (referenced to the NHS organisations which endorse them) which can be easily accessed by all Medusa users and Smart infusion pump manufacturers. Ensure that the list is compatible with infusion pump manufacturers systems.
Develop Medusa IT to allow comparison and evaluation of locally used infusion concentrations to help to inform future change.
Collaboration with Smart infusion pump manufacturers, NHS supplies and Medusa
Facilitate the establishment of a standing committee to include all parties involved in the manufacture, supply and implementation of the use Smart infusion pumps.
Development of ready to administer preparations
Work with manufacturers to encourage production of ready to administer infusions which reflect the agreed adult and paediatric concentrations listed on Medusa.
PHASE TWO ACTIONS
It is recognised that in conjunction with phase one actions an agreed list of upper infusion rates needs to be developed for infusions which are only available as one concentration and hosted on Medusa. It is recommended that SMART infusion pumps should be loaded by the manufacturer with these before delivery. and signed off as acceptable by the relevant organisation before use in clinical areas.
PHASE THREE ACTIONS
Extend upper infusion rate list to include infusions available as more than one concentration.
TIMELINE: Dependent on obtaining relevant funding an appropriate timescale for each action can be estimated.
Response received 24 June 2021