National patient safety alertMHRA
Medical beds, trolleys, bed rails, bed grab handles patient safety alert over a software fault
The MHRA continues to receive reports of deaths and serious injuries from entrapment or falls relating to medical beds, bed rails, trolleys, bariatric beds, lateral turning devices and bed grab handles.
What to do now
A software, display or alarm problem affects Medical beds, trolleys, bed rails, bed grab handles and lateral.
- If you use this device at home, do not stop treatment without speaking to the team who supplied it.
- Compare the details on the device or its box with the list here.
- Report problems with medical devices to the MHRA Yellow Card scheme.
Why it matters. Software faults can lead to wrong readings, missed alarms or incorrect settings.
Replacements and support
Device safety notices are mainly aimed at hospitals, clinics and suppliers, who are told how to replace, update or check affected devices.
If you use the device at home, the team or company that supplied it is responsible for any replacement or correction.
From the official notice
Published by the Medicines and Healthcare products Regulatory Agency (NatPSA/2023/010/MHRA). Quoted as issued.
Summary
The MHRA continues to receive reports of deaths and serious injuries from entrapment or falls relating to medical beds, bed rails, trolleys, bariatric beds, lateral turning devices and bed grab handles.
The risk
Date of Issue: 30 August 2023
Reference No: NatPSA/2023/010/MHRA
This alert is for action by: All those responsible for the use, purchase, prescription and maintenance of medical beds, trolleys, bed rails, bed grab handles and lateral turning devices including all Acute and Community healthcare organisations, care homes, equipment providers, Occupational Therapists and early intervention teams.
Advice for healthcare professionals
When: Begin as soon as possible and complete by 1 March 2024
Update your organisation’s policies and procedures on procurement, provision, prescribing, servicing and maintenance of these devices in line with the MHRA’s updated guidance on the management and safe use of bed rails.
Develop a plan for all applicable staff to have training relevant to their role within the next 12 months with regular updates. All training should be recorded.
Review the medical device management system (inventory/database) for your organisation or third-party provider for devices within your organisation, including those which have been provided to a community setting (for example, the patient’s own home). Keep this system up to date.
Implement maintenance and servicing schedules for the devices in the inventory/database, in line with the manufacturer’s instructions for use and/or service manual. Prioritise devices which have not had regular maintenance and servicing. If this is outsourced, compliance with the schedule should be monitored.
Review patients who are children or adults with atypical anatomy as a priority. Ensure the equipment they have been provided with is compliant with BS EN 50637:2017 unless there is a reason for using a non-compliant bed. Record this on the risk assessment and put in place measures to reduce entrapment risks as far as possible.
Review all patients who are currently provided with bed rails or bed grab handles to ensure there is a documented up-to-date risk assessment. Complete risk assessments for patients where this has not already been done and for each patient who is provided with bed rails or bed grab handles.
Implement systems to update risk assessments where the equipment or the patient’s clinical condition has changed (for example, reduction/improvement in weight or mobility), and also at regular intervals.
Open the MHRA notice
Questions
Why has Medical beds, trolleys, bed rails, bed grab handles and lateral been recalled?
A software, display or alarm problem affects Medical beds, trolleys, bed rails, bed grab handles and lateral. Software faults can lead to wrong readings, missed alarms or incorrect settings.
How do I know if my product is affected?
The notice describes the affected product rather than listing codes. Compare the product name, pack size and where you bought it with the official notice.
What should I do now?
If you use this device at home, do not stop treatment without speaking to the team who supplied it. Compare the details on the device or its box with the list here.
Who replaces the device?
Device safety notices are mainly aimed at hospitals, clinics and suppliers, who are told how to replace, update or check affected devices. If you use the device at home, the team or company that supplied it is responsible for any replacement or correction.