MHRA safety guidance, Insulin pumps and continuous glucose monitoring (CGM) equipment, October 2024, Version 1.0

Circulation

DL1 NHS Incidents and alerts Safety Officers

DL2 Local authority Incidents and alerts Safety Officers

DL3 Specialist Liaison Group

DL4 Product Specialists

DL5 General List

MHRA has published the attached safety guidance document and it applies across the UK. This guidance is aimed at patients, their families, care givers and representatives (end users).  In Scotland, end users of diabetes management equipment should inform the health team managing their care about any issues involving Insulin pumps and continuous glucose monitoring (CGM) equipment.  They may also fill in a Yellow card report.  Healthcare professionals should continue to report adverse incidents to their local incident reporting and learning system and to IRIC.

A PDF version of the guidance is attached. You can also view a web version on the MHRA website.

Onward cascade
As the nominated person for your organisation, you need to identify managers and staff in your organisation who need to know or be aware of this document and cascade it onward to them. The cascade should include all contractors and private or independent service providers who provide affected care, staff, equipment, buildings or other services or facilities for the direct care of patients or service users. In the meantime, our suggested onward cascade is as follows:

Adverse Incidents

Incidents and near-misses should always be reported to local incident management systems (often referred to as Datix, Ullyses, SHE, etc.). However, IRIC also needs to be informed about incidents and near-misses when they involve:

• Medical devices (e.g. infusion pump, central line, hoist, care bed, x-ray machine, ventilator)
• In vitro diagnostic devices or IVDs (e.g. blood analyser, reagent, SARS-CoV-2 test kit)
• Estates and facilities (e.g. electrical installations, window restrictors, nurse call systems)
• Social care equipment (e.g. mobile wheeled commode, powered rise and recline chair)
• Personal protective equipment or PPE (e.g. visors, FFP3 respirators, aprons)

We need incident reports so we can work with manufacturers and our partners to stop the same thing happening again. Health and care professionals can also report safety concerns about equipment and devices when an incident or near-miss has yet to occur. Information about how to report an incident to IRIC can be found here: https://www.nss.nhs.scot/health-facilities/incidents-and-alerts/report-an-incident/  

Enquiries
If you have any enquiries in relation to this document please email nss.iric@nhs.scot quoting the alert reference number in the message subject line, or call the IRIC Helpline 0131 275 7575. Alternatively, if you have received this message from someone in your own organisation, please direct all enquiries to them and they will liaise with IRIC as required.

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Incident Reporting & Investigation Centre (IRIC)

NHSScotland Assure

NHS National Services Scotland

Tel: 0131 275 7575 | nss.iric@nhs.scot 

IRIC operates incident learning and prevention systems for health and care technologies (medical devices, IVDs, estates, facilities, social care equipment and PPE). Find out more in CEL43 (2009), explore our educational content on Turas Learn or visit our website to: report an incident, find our safety alerts, or watch our short Intro to IRIC video

We are NHS National Services Scotland. We offer a wide range of services and together we provide national solutions to improve the health and wellbeing of the people of Scotland. Find out more in our NSS Strategic Framework 2024-2026

FAC406-272, 8B(ii), Rev 4

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