Date of Issue: 30 August 2023
Reference No: NatPSA/2023/010/MHRA

Risks of entrapment or falls (BS EN 50637:2017)

It’s important to be aware of the National Patient Safety Alert issued by the MHRA (Medicines and Healthcare products Regulatory Agency) regarding the risk of death from entrapment or falls associated with medical beds, bed rails, and related equipment.

MHRA Medical Patient Bed states that young patients and adults with smaller body anatomy should now be using beds or cots compliant with BS EN 50637:2017, which is based on the international standard for medical beds. This standard outlines specific requirements for medical beds and cots designed for young patients or patients with atypical anatomy to minimise entrapment risks. Older beds that do not comply with this standard may pose a higher risk of entrapment.

Actions required:

When: Begin as soon as possible and complete by 1 March 2024

1. Update policies and procedures on procurement, provision, prescribing, servicing and maintenance in line with the MHRA’s updated guidance on the management and safe use of bed rails.
2. Develop a plan for all applicable staff to have recorded training relevant to their role, with regular updates.
3. Review the medical device management system, including those which have been provided to a community setting (for example, the patient’s own home). Keep this system up to date.
4. Implement maintenance and servicing schedules for these devices, in-line with the manufacturer’s instructions or service manual. Prioritise devices which have not had regular maintenance and servicing.
5. 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.
6. 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.
7. 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 as required