GovWire

1. Summary

The MHRA is the regulator of medicines, medical devices and blood components for transfusion in the UK, a role which includes overseeing investigations into adverse events and promoting the safe use of devices in the UK.

At the MHRA we continue to receive reports of incidents relating to bed rails and associated equipment. These incidents are concerning as some have led to patient harm or death, primarily from entrapment.

This document aims to set out best practice in the provision, prescription, use, maintenance and fitting of bed rails.

This publication has been updated to reflect changes in devices and practices, as well as information gained from the investigation of adverse incidents.

The government has extended acceptance of CE marked devices in Great Britain. For more detail on this see the implementation update on work towards a strengthened future medical devices regime.

Who this guidance is for:

This document is aimed at all users, carers and staff with responsibility for the provision, prescription, use, maintenance and fitting of bed rails. This includes:

• Medical Device Safety Officers (MDSOs) for onward distribution
• medical device trainers
• care home managers and staff
• carers in the community and care-at-home staff
• community equipment stores (CES) and loan store managers
• health and safety or risk managers
• hospice managers and staff
• maintenance staff
• nurses in hospitals and the community
• occupational therapists
• physiotherapists
• those responsible for purchasing beds and bed rails

Scope

This document identifies areas for safe practices, so that policies and procedures can be reviewed and put in place. This includes:

• risk management
• safe use of these devices
• roles and responsibilities
• meeting legal requirements
• training
• planned preventative maintenance

It also identifies areas of good practice, such as:

• assessing if a bed rail is necessary and appropriate
• the need for good communication between bed occupant and carers or staff
• checking compatibility of the bed rail, bed, mattress and the needs of the bed occupant
• taking into account the use environment and possible interaction with any other equipment, accessories or devices present in that environment as part of the risk assessment
• correct fitting and positioning of the bed rails initially and after each period of use
• re-assessing the changing care needs of the bed occupant.

This document is not intended to replace clinical decision making.

2. Introduction

Bed rails are used extensively in hospitals, care homes and peoples own homes to reduce the risk of bed occupants falling out of bed and injuring themselves. For the purpose of this document the term bed rail will be adopted, although other names are often used, for example, bed side rails, side rails, cot sides, and safety sides

At the MHRA we continue to receive reports of adverse incidents involving these devices. The most serious of these have led to injury due to falls and death by asphyxiation as a result of entrapment of the head, neck or chest.

From 1 January 2018 to 31 December 2022, we received 18 reports of deaths related to bed rails and associated equipment, and 54 reports of serious injuries.

Most incidents occurred in community care settings, particularly in nursing homes or the patients own home. Adequate and appropriate risk management should be carried out to prevent the occurrence of such incidents. Healthcare professionals or competent persons should carefully consider the benefits and risks of bed rails before they are used for a patient.

We have also received reports of entrapment in hospitals (acute settings) with side rails on trolleys and stretchers. This guidance should also be followed in acute settings where bed rails are used with trolleys, stretchers and emergency department beds, particularly if the patient is unattended.

Chest or neck entrapment in bed rails is listed (number 11) as a Never Event according to the NHS in 2018. Never Events ^{footnote 1} are serious , largely preventable patient safety incidents that should not occur if the available preventative measures have been implemented by healthcare providers.

Bed Rails

In general, manufacturers intend their bed rails to be used to prevent or reduce the risk of bed occupants falling and sustaining injury. They are not designed or intended to limit the freedom of people by preventing them from intentionally leaving their beds. In addition, they are not intended to restrain people whose condition disposes them to erratic, repetitive or violent movement.

Use of bed rails in these ways can increase the risk of falling. In some cases, the patient may attempt to climb over the bed rail, leading to the potential to fall from a height. Erratic, repetitive or violent movements may also cause the bed rails to break, leading to an increased risk of falling or injury from the broken rail.

To prevent inappropriate or unintended restraint through the use of bedrails, there must be a robust assessment of whether the use of the bed rail will prevent the person from moving freely or make the person feel restricted from moving freely. In all cases the least restrictive options should be explored. The NHS guidance on the Mental Capacity Act ^{footnote 2} has more information on this.

Bed rails must be UKCA, CE or CE UKNI marked as medical devices, to show they meet the requirements of the UK Medical Devices Regulations 2002 (as amended) ^{footnote 3}, in combination with, or as an accessory to, the bed if their intended use meets the definition of a medical device.

Not all beds, bed rails or associated equipment will be classed as medical devices. This will depend on the intended use described by the manufacturer and without a clear medical purpose the definition of a medical device may not be met. In these cases, the product should still meet the requirements imposed by general consumer protection legislation which is outside the scope of this guidance.

Rigid bed rails can be classified into two basic types:

• integral types that are incorporated into the bed design and supplied with it or are offered as an optional accessory by the bed manufacturer, to be fitted later. Examples can include hospital/profiling/adjusting beds see Figure 1 and 3.

Figure 1 - Example of an integral bed rail

• third-party types that are not specific to any particular model of bed. They may be intended to fit a wide range of domestic beds, including divan or metal framed beds from different suppliers. They tend to be fitted under mattresses and use the weight of the mattress to remain in place. See Figure 2.

Figure 2 - Example of a 3rd-party bed rail

Integral type bed rails have been involved in far fewer adverse incidents than third-party types. Usually this is because risks associated with installation and compatibility are reduced, as correct gaps are designed into the bed. Bed rails should meet recognised product standards that include acceptable gaps and dimensions when fitted to the bed (See Legislation and Standards).

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