IV fluids prescribing - calculator and guidanceDetailed instructions on safe and appropriate use of the IV fluids calculator as required for UK CA marking.
About this toolkit
This toolkit was first published and the calculator UK CA marked in August 2024 as part of the IV Fluids Prescribing Programme led by the National Waiting Times Board. It will be reviewed annually in line with the post-market surveillance plan drawn up for UK CA marking requirements.
It should be used only by suitably qualified healthcare professionals within NHS Scotland.
Individual NHS Boards should confirm consistency with local procedures and governance processes - e.g. Area Drug and Therapeutics Committee approval.
Key operational contact
Ann Wales - Programme Director, Knowledge and Decision Support. ann.wales3@nhs.scot
Clinical lead
Dr Ross Paterson, Consultant in Intensive Care & Lead for Quality and Safety & Associate Director of Medical Education (Improvement), NHS Lothian. ross.paterson@nhs.scot
As required by UK CA marking, a systematic literature search and critical appraisal process were conducted. This was followed by summarising the evidence on benefits, areas of uncertainty, and potential clinical risks and confirming with clinicians the overall benefits of the calculator and prescribing guidance.
The calculator and static text content and its delivery via the RDS have been approved by the multidisciplinary steering group convened to oversee this development. This reports to the overarching IV prescribing group which in turn is governed by the Modernising Patient Pathways Programme Board within the National Wating Times Centre Board.
As set out in the post-market surveillance plan required for UK CA marking, content will be reviewed annually through a combination of sourcing new evidence and gathering user feedback including any complaints and criticisms. Requests for updates, whether between scheduled review dates or at scheduled review times, will be reviewed by the multidisciplinary steering group and Clinical Lead, and will go through a formal change control process with overall sign-off by InnoScot Health as a registered manufacturer for the calculator as a medical device.
The annual review schedule has been reviewed by the Clinical Lead for this development and by the other clinical experts on the multidisciplinary group. It is based on their knowledge - confirmed by the extensive literature search - of the limited availability of new research evidence in this field and by the commitment to responding in a timely way to user feedback.
The programme lead will receive the automated alerts and will initiate the evidence review and post-marked surveillance report in response to this prompt.
The content of this toolkit has been extensively reviewed by the multidisciplinary steering group and ither end-user representatives.
Sign-off
Signed off by multidisciplinary steering group for development and implementation of the calculator (22/08/2024). This group reports to the overarching national steering group for IV fluid prescribing, which in turn reports to the Modernising Patient Pathways Programme board within the National Waiting Times Centre.
InnoScot Health as registered manufacturer has also approved and signed off all documentation within the technical file required for UK CA marking.
Ongoing development
The multidisciplinary steering group will continue to monitor and support ongoing development.
A hazard log with mitigations and a risk management plan and report were documented as part of the technical file for UKCA marking.
A detailed post-market surveillance plan is in place and approved by Healthcare Improvement Scotland and InnoScot Health as registered manufacturer. This includes both reactive measures - e.g. feedback recieved via the RDS feedback form, clinician emails and steering group discussion on experience within their clinical teams - and proactive measures, including an initial targeted evaluation among junior doctors.
Content has been checked for accessibility in line with the relevant RDS standard operating procedure.
This toolkit does not contain any content from external providers.
All icons are from Flaticon.com, accessed through the licence held Tactuum Ltd for the resources supported by the software platform it provides.
A functional test plan and test report, and a usability and user acceptance test plan and report have been documented and delivered as part of UK CA marking requirements.
Functional testing comprised four rounds of manual and automated testing by Tactuum Ltd, followed by manual testing by the product owner.
Three rounds of usability and user acceptance testing were conducted with a multidisciplinary group of senior clinical leads for IV fluid prescribing and end-user representatives.