OG Status:

Fully open

Issue date

August 2012

Author Section:

Operational Strategy Division (OPSTD), Public Services Sector (PSS) - Health and Social Care Services Unit (HSCSU)

Target audience:

FOD and LA Inspectors

• Summary
• Introduction
• Action
• Background
• Risk Management System
  • Risk Assessment
  • Additional control measures
  • Maintenance
  • Training
• Organisation
  • Resources
  • Recording & Reporting
    • Liaison with other regulators
    • Legal considerations
    • Defined standards
    • Established standards
• Further information
• Appendices

Summary

This SIM provides advice to Inspectors who regulate health and social care services. It deals with the management of the risks to people who use bed rails.

Introduction

Analysis of accident data continues to highlight the serious issue of injuries involving bed rails. The term 'people who use care services' is used to describe patients, residents and others who use care services.

Bed rails (also known as bed side-rails, cot-sides, safety sides and bed guards) are used extensively to protect vulnerable people from falling out of bed. There are several causes of injury, the most serious being entrapment by the head, neck or chest.  This may lead to death from asphyxiation. Injuries also arise from a person attempting to climb over the rails, and falling, or striking their head against the rails.

Between 2001 and 2009 there were 21 RIDDOR reported bed rail related deaths in the UK, as well as numerous injuries.

Action

Inspectors should use this SIM as a guide in assessing whether the care provider is adequately managing the risks from using bed rails.

Background

Failings associated with bed rail use include:

• Poorly fitting bed rails allowing parts of the body to become trapped, eg between the bed rail and the headboard or bottom rail and bed base. This can arise from using a bed rail that is not designed for use with a particular bed type or is poorly fitted;
• Poor bed rail design, for example, over-sized spacing between the rails;
• Poorly fitting mattresses that do not fit snugly between the bed rails, leaving gaps between the side of the mattress and the bed rail;
• Mattresses that are too thin or easily compressible at the edges for certain bed rail types, allowing occupants to slide under the bed rail;
• Loose fitting bed rails allowing movement away from the side of a mattress, or up or down the bed. This can create dangerous gaps;
• Use of overlays such as pressure relieving mattresses which reduce the effective height of the bed rail;
• Use of light (eg pressure relieving) mattresses which fail to keep certain types of divan bed rails in position, or inadequate securing devices;
• Lack of maintenance; and,
• Inadequate assessment of whether bed rails are suitable for the individual.

The risks are well known and publicised. Enforcement action should be considered where there are failings to assess or control the risks. Enforcement action should have a positive impact on dutyholders in these sectors.

There are numerous examples of successful enforcement action. In May and June 2011 the owners of separate care homes were fined £70,000 and £65,000 respectively following fatalities involving bed rails.

Risk Management System

Inspectors should look at the following elements of the risk management system:

Risk Assessment

Risk assessment should consider:

• Whether bed rails are required – is alternative equipment more appropriate? Other methods of bed management may be appropriate for some people, for example, those who are likely to try and climb over bed rails. Inspectors should be aware of the guidance on the priorities for enforcement of Section 3 HSWA, which includes a bed rail example;
• Whether the bed rail is suitable for use in combination with the bed, mattress and occupant. For example, is the occupant's head or body small enough to pass through the bed rail bars? Are there gaps that could entrap? Is there adequate advice and instruction eg from the supplier?
• Is the bed rail fitted correctly to the bed and secure? Different bed rails or fittings may be required for different types of beds. Electric profiling beds often have integrated bed rails that may overcome this issue.
• Are there any gaps that allow the occupant to become trapped? BS EN 60601-2-52:2010 (replaced BS EN 1970:2000 on 1st April 2013) specifies requirements and dimensions for bed rails intended for use by adults. Particular attention should be paid to the gap between the bed rail and headboard / footboard and between the bottom rail and the bed base. The British Standard sets dimensional requirements that may need to be improved upon (eg. reduced) depending on the risks presented by the bed occupant and the combination of equipment used, for example, where someone could pass between the lower rail and the bed base board. [Note: the new British Standard introduces a requirement for new equipment to be designed to limit the gap between the bedrail and headboard to 60mm or less. The old British Standard allowed an opening of greater than 250mm (where assessment allowed). Care providers should be aware of the changes to the British Standard for new equipment with a view to achieving this new standard. If this cannot be achieved with older equipment, they should ensure individual assessment considers whether a gap of greater than 250mm is safe]

HSL have produced a simplified risk assessment procedure that can be used by care providers. The risk assessment procedure is included in Appendix 1.

Additional control measures

Measures identified by the risk assessment must be implemented. Checks should also be made by a responsible person whenever bed rails are used to ensure that they remain properly adjusted and suitable for the patient. The risk assessment should be reviewed if the bed, mattress, occupant or bed rail changes. Employers and employees need to know what bed rails, beds and mattress combinations are suitable for those they care for.

Maintenance

Significant numbers of incidents are caused by a lack of maintenance. Problems include loose fixings, missing clamps and worn or bent components; these can lead to bed rails moving out of position and becoming unsafe. These must be identified and remedial action taken to prevent injury.

Training

Employers should ensure that all employees who are responsible for selecting, fitting and checking bed rails have received adequate training. Other staff, such as care assistants and domestics who make beds and help clients in and out of bed may also remove and replace bed rails and, if so, will need appropriate information and instruction. All employees who might change mattresses, beds or bed rails should be aware of the correct combinations and the safety implications. Equipment suppliers may be able to provide training on use of their equipment.

Organisation

Resources

Inspectors should be familiar with both MHRA and HSE guidance on safe use of bed rails and should have access to measuring equipment to help assess compliance. In addition, HSL has testing 'cones' to replicate adult head and neck dimensions.

Recording & Reporting

The Health and Social Care Services Unit would welcome information about any incidents, enforcement action, campaigns or initiatives on this issue. Contact via: [email protected]

Liaison with other regulators

Guidance on the roles of other regulators is available on HSE's website.

Bed rails are medical devices / equipment as defined in the Medical Devices Regulations 2002, where their intended purpose is to prevent falls in health and social care. The regulations are enforced by the Medicines and Healthcare products Regulatory Agency (MHRA) and Inspectors should contact them in line with our liaison agreement when investigating bed rail incidents.

MHRA has produced a Device Bulletin DB2006 (06) 'Safe use of bed rails'  (under revision)¹. This is issued within Scotland by Scottish Healthcare Supplies (SHS) under SAN(SC) 07/08.

MHRA has issued other information on bed rails:

• Medical Device Alert MDA/2007/009 – Bed rails and grab handles
• MRHA Guidance on Safe use of bed rails
• MHRA Safe use of Bed Rails Poster (issued in Scotland under SAN(SC07/08))

Legal considerations

Health and Safety at Work Etc Act 1974, Management of Health and Safety at Work Regulations 1999 and Provision and Use of Work Equipment Regulations 1998 all apply. Inspectors should be aware of the guidance on RIDDOR reporting in health and social care.

Defined standards

BS EN 60601-2-52:2010: Medical electrical equipment – particular requirements for basic safety and essential performance of medical beds (Appendix 3). This standard replaces BS EN 1970:2000 (Appendix 2) and BS EN 60601-2-38 on 1st April 2013. The standard details dimensional requirements for bed rail design and supply. The main changes are:

Table 1 – Comparison of BS EN 1970:2000 and BS EN 60601-2-52:2010

Established standards

1. HS(G) 220 Health and Safety in care homes (being revised) provides advice on bed rail safety.Back to reference of footnote 1
2. MHRA Device Bulletin DB2006 (06) 'Safe use of bed rails' (being revised). This includes guidance on safe use of bed rails and the requirement that mattresses fit 'snugly' between the bed rails.

Further information

• MHRA Device Bulletin DB 2006(06) Safe Use of Bed Rails on the MHRA website
• NPSA Bed rails Safer Practice Notice

HSL literature review - 'Entrapment and falls from the use of bed rails' (ERG/08/39).

Appendices

• Appendix 1 - Safe use of bed rails assessment - example
• Appendix 2 - BS EN Dimensional requirements (BS EN 1970:2000) (to be withdrawn 1 April 2013)
• Appendix 3 - BS EN Dimensional requirements (BS EN 60601-2-52:2010) – from April 2013