Source · HSSIB Patient Safety Investigation
Procurement, usability and adoption of ‘smart’ infusion pumps
Published 26 April 2021
Launched 21 August 2019
Published
HSIB Legacy
Communication and decision making
Medical devices
Although the aim of smart infusion pumps is to improve patient safety, the technology can introduce new risks. This investigation focused on understanding the challenges involved in introducing smart infusion pump technology within NHS hospitals.
Summary
1 recommendation
5 observations
6 learning prompts
1 of 1 responded
Safety Recommendations
R/2020/104
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.
The MEDUSA advisory board deems developing a national drug library for smart pumps unachievable until several pre-conditions, including funding and multi-organisation sign-off, are met. They outline "Phase One Actions" to encourage local adoption of standard lists and work towards expanding them.
Response received 24 June 2021
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 on 24 June 2021.
Safety Observations
Observation 1
Observation
Organisations involved in the development and deployment of smart pumps must adhere to DCB0129 and DCB0160 respectively where health IT is utilised to support the configuration and/or operation of the smart pump.
Observation 2
Observation
Organisations involved in the development and deployment of smart pumps must ensure that their personnel are knowledgeable in clinical risk management. NHS Digital provides a programme of training to support this.
Observation 3
Observation
Examples are needed of where safety cases have been used in the NHS to manage safety proactively, so that their value can be communicated and better understood. The NHS should always show evidence of rigorously considering safety in all procurement, and safety cases are a standard and widely accepted way of doing this.
Observation 4
Observation
A configuration control/management system for drug libraries should be specified within a smart pump safety case.
Observation 5
Observation
There is a need to develop and evaluate ways of training clinicians and pharmacists on the use of safety-critical devices within a hospital to ensure that all staff that may operate the devices are suitably trained. Consideration should be given to mandatory-level medical device training being established at induction for all clinicians.
Learning Prompts
Prompt 1
Learning prompt
National Association of Medical Device Educators and Trainers
Prompt 2
Learning prompt
MEDUSA (UK Injectable Medicine Guide)
Prompt 3
Learning prompt
Specialist Pharmacy Service • Safe Anaesthesia Liaison Group
Prompt 4
Learning prompt
British National Formulary
Prompt 5
Learning prompt
Medicines and Healthcare products Regulatory Agency (MHRA)
Prompt 6
Learning prompt
NHS England and NHS Improvement.