---

To: Local Authority Health and Safety Enforcement Managers, Health and Safety Regulators, Regulators of Health and Social Care Services and Others

This circular provides advice to Health and Safety Regulators (for clarity and convenience referred to as Inspectors) who are involved in the regulation of health and social care activities. The circular deals with the management of the risks to people who use care services associated with bed rail use.

---

Background

1. Analysis of accident data has continued to highlight the serious issue of injuries involving bed rails to service users for consistency the term ‘people who use care services’ has been used to describe patients, residents and any others in health and social care premises.

2. Bed rails, also known as bed side-rails, cot-sides, safety sides, and bed guards, are used extensively in the health and social care sectors to protect vulnerable people from falling out of bed. There are several causes of injury involving bed rails, the most serious being as a result of entrapment by the head or neck. This may lead to death from asphyxiation. Injuries also arise from a patient attempting to climb over the rails, or when a restless person strikes their head against the rails.

3. For the period April 2001 to March 2005 RIDDOR statistics identified at least 10 fatal accidents and a number of major injury incidents in which the use of bed rails was implicated.

Nature of the problem

4. There are a number of failings associated with bed rail use that may result in an accident to people who use care services, the commonest of these are:

• Poorly fitting bed rails that may result in parts of the body becoming trapped, e.g. between the mattress and the bedrail. This could arise from using a bed rail that is not designed for use with a particular bed type.
• Poor bed rail design, for example very large spacing between the rails
• Movement of the bed rail away from the side of a divan mattress
• Use of mattress overlay which reduces the effective height of the bed rail
• Use of an air mattress which is too light to keep the bed rail assembly in position on a divan bed
• Bed rails in poor condition due to a lack of maintenance

Legal considerations

5. The health and safety of people who use care services is covered by the general requirements of Section 3 of the Health and Safety at Work Etc Act 1974, (HSW s.3) and by the risk assessment requirements of the Management of Health and Safety at Work Regulations (Reg 3) (MHSWR reg.3). The Provision and Use of Work Equipment Regulations 1998 (PUWER) also set out requirements for work equipment including suitability and maintenance, and instruction and training. HSE and LA Inspectors enforce these requirements.

6. Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 1995 Regulation 3 (RIDDOR), requires that where a person not at work suffers a major injury (as defined in schedule 1 to the regulations) or fatal injury out of or in connection with work must be reported to the relevant enforcing authority. Guidance on understanding the meaning of the phrase “Arising out of or in connection with work” is given in regulation 2(2)(c) of RIDDOR. Accidents involving service users and bed rails will generally be classed as ‘arising out of or in connection with work’ and will be reportable if they meet the above criteria.

Role of intermediaries

7. CSCI is the single, independent inspectorate for all social care services in England. Further information on their role with regard to health and safety of people who use care services can be found in SIM 07/2006/14 Better Regulation: Regulatory Bodies Inspecting Social Care [155kb] .

8. In Scotland, the Scottish Commission for the Regulation of Care (the Care Commission) was set up under the Regulation of Care (Scotland) Act 2001 to establish a unified system of registration and regulation for social care services in Scotland including early education and independent and private health care. The Care Commission (CC) carries out regular inspections (at least twice a year for 24-hour care providers and annually, as a minimum, for others) to make sure that services meet the required minimum standards. Both HSE and CC have legitimate interest in matters concerning regulation in the care sector. However, because workplace health and safety is a reserved matter, HSE/LA inspectors in Scotland remain responsible for the regulation of risks to service users arising out of or connected with work. A protocol, which will clarify the roles and responsibilities of HSE and CC is being developed.

9. In Wales the Care Standards Act 2000 and The Children Act 1989 (as amended) provide the National Assembly for Wales with the authority to register and inspect establishments and agencies in Wales that provide social care. The Care Standards Inspectorate Wales (CSIW), an operationally independent part of the Assembly regulates social care, early years and private and voluntary health care services. CSIW conduct regular (usually annual) inspections measuring services against National Minimum Standards produced by the Welsh Assembly Government. The National Minimum Standards address patient safety issues as well as the health and safety of care staff. A memorandum of understanding between HSE, LA’s and CSIW is being developed. CSIW will take the lead in enforcement in relation to any issue relating to the safety of people who use care services within the Care Standards Act and associated regulations; this will include the management of risks from hot water. Social Services Inspectorate for Wales will merge with CSIW to create the Care and Social Services Inspectorate (CSSIW) in April 2007.

Medicines and Healthcare Products Regulatory Agency

10. The Medicines and Healthcare Products Regulatory Agency (MHRA) an executive Agency of the Department of Health has considerable expertise on bed rail use. There has been confusion over whether bed rails are medical devices or not under the Medical Devices Regulations 2002 (Enforced by MHRA). Bed rails can be medical devices, dependent on the manufacturers intended purpose and whether they are an accessory to a CE marked medical/adjustable bed. MHRA should be contacted via their adverse incident center aic@mhra.gsi.gov.uk, (Tel 020 7084 3080) in the event of a serious bed rail incident as they may wish to be involved in any Investigation. For incidents in Scotland, the Independent Reporting and Investigation Center (IRIC) of Scottish Healthcare Supplies should be contacted via iric@shscsa.scot.nhs.uk, (Tel 0131 275 7575).

11. MHRA has published and distributed advice on the safe use of bed rails throughout the health and social care sector. Currently the main MHRA guidance is contained in Device Bulletin DB2006 (06) ‘Safe use of bed rails’ (issued within Scotland by Scottish Healthcare Supplies (SHS) under SAN(SC) 07/08). This document updates and replaces the previous MHRA guidance provided in DB 2001(04) Advice on the safe use of bed rails, (distributed within Scotland in September 2001 by SHS). It should be noted that the 2001 Bulletin was published by the MHRA when they were known as the Medical Devices Agency (MDA).

12. MHRA has issued other information on bed rails:

• Medical Device Alert MDA/2007/009 – Bed rails and grab handles.
• MHRA Safe use of Bed Rails Poster (issued in Scotland under SAN(SC07/08))
• MHRA Medical Device Alert MDA/2004/007 – Bed rails: twin bar designs. Scottish Version is SAN (SC) 04/06
• MHRA Bed Rail ONE LINERS July 2006
• Scottish Healthcare Supplies documents

Risk management system

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

Risk Assessment

13. In summary, a risk assessment should be completed which takes account of the following best practice guidance:

• Is alternative equipment more appropriate – are bed rails actually required? Other methods of bed management may be appropriate for some people who use care services. It should be remembered that the actual decision whether or not to use bed rails is a clinical decision and therefore one in which health and safety inspectors should not become involved. However if a decision is taken that bed rails are required, and they are not provided, then there may be a contravention of HSW Act s.3.
• Is the bed rail chosen 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? Is there a gap between the bed rail and the side of the mattress that will allow the occupants body to pass through or trap their head? Has suitable advice and instruction been sourced from the bed rail supplier or manufacturer?
• Is the bed rail fitted correctly to the bed and is it secure? Note that different fittings may be required for different types of beds such as hospital or divan. Electric profiling beds have integrated bed rails that may overcome this issue.
• Are there any gaps present when the bed rail is fitted to the bed that potentially will allow the occupant to become trapped? BS EN 1970:2000 ‘Adjustable Beds for Disabled Persons’ specifies requirements and dimensions for bed rails intended for use by people over 12 years old.
• Is there a regular ‘in use’ check made by a responsible person, to ensure that the bed rails remain properly adjusted and continue to be suitable for the patient?
• If either the bed, mattress, occupant or bed rail is changed, the risk assessment should be carried out again.

Maintenance

14. Significant numbers of incidents are caused by a lack of maintenance. This can lead to problems such as loose fixings, missing clamps and worn or bent components. Bed rail assemblies should be included on a planned preventative maintenance schedule. Individual bed rails should be traceable and records should be kept of inspections and maintenance.

Training

15. 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, also may remove and replace bed rails. These employees should also be given information and instruction in the correct fitting and adjustment of bed rails. (Equipment suppliers may be able to provide training on use of their equipment).

Health and Safety Laboratory (HSL) research

16. HSL have produced a simplified risk assessment procedure that can be used by healthcare providers/users of bed rails and by Inspectors. The risk assessment procedure is included in the appendix to this document along with dimensional requirements from BS EN 1970:2000.

Determining the risk gap

17. Determining appropriate enforcement action requires HSE Inspectors to reference the HSE Enforcement Management Model (EMM), Version 3.0 [133kb] This is a fully open government document available at the HSE website.

Actual risk

18.  A judgment of actual risk will need to be based on the vulnerability of the population and the risk control measures already in place. In a worst-case scenario of badly maintained bed rails, lack of risk assessment and poor management arrangements (including information and training) there is a risk of serious personal injury with likelihood possible to single casualties.

Benchmark

19.  Where all elements of the risk control system are in place, the permitted level   of risk or injury is nil/negligible.

Risk gap

20. This should be determined using Table 2.1 of the EMM. 

Established standards

21. The following standards have been identified as ‘Established’ using the criteria set out in Table 3 of the EMM.

1. HS(G) 220 Health and Safety in care homes – issued 12/01(file 357) recommends that if bed rails are used they should:
   • Be compatible with the bed
   • Be compatible with the person using the care service
   • Be fitted to the bed correctly to prevent entrapment.
   • Be maintained in working order
   • Have properly engaged locking mechanisms.
   • A new risk assessment will need to be carried out if the bed, mattress or bed rail change or the needs of the person using the care service change.
2. MHRA Device Bulletin DB2006 (06) ‘Safe use of bed rails’.
3. BS EN 1970:2000 ‘Adjustable Beds for Disabled Persons’. Contains a clause that specifies requirements and dimensions for bed rails. Note that this standard covers beds that are intended for use by people over 12 years old.
4. BS 4886:1998 ‘Specification for Hospital Bedsteads’. Specifies requirements for bed rails for hospital beds.
5. BS EN 60601-2-38: 1997 Revision 1, ‘Medical Electrical Equipment – Part 2. Particular requirements for the safety of electrically operated hospital beds’

Initial enforcement expectation

22. Initial enforcement expectation is derived from Table 5.1 using the risk gap and standards criteria.

Local factors

23. Inspectors should take into account previous advice from other relevant regulatory authorities.

Strategic factors

24. The potential risks presented by bed rails to vulnerable people using the care service are well   known and publicised. There are public interest implications to consider when determining appropriate action. Strong enforcement action should be considered where failings of risk management give rise to significant risk to vulnerable people. Inspectors should also consider that enforcement action will have a positive impact on dutyholders in the industry in general.

25. A relevant example of successful enforcement action against a Health Care Provider demonstrates the potential serious nature of injuries involving bed rails. A company responsible for running a large number of nursing homes was fined £175,000 following a fatality involving bedrails.

Feedback

26. The Health and Social Care Services Unit would welcome information about any incidents, campaigns or iniatives on this issue.  Contact should be made using the general Health Services Communities email account: hscsu@communities.hse.gov.uk

Appendix: Safe use of bed rails

Assessment of bed side safety rails			If NO, action to be taken
Questions to consider	Yes	No
Patient assessment
1) Have alternative methods of bed management been considered?
2) Has the occupant been assessed for the use of bed rails, inc. mobility, weight, build, size, psychological assessment, etc?
3) Has the occupant been assessed for the use of bed rail covers?
4) Has interaction with other equipment (e.g. hoists) been considered?
5) Has interaction with the work environment (e.g. restricted access) been considered?
6) Has the bed occupant been assessed according to special requirements of patient care?
Procurement
7) Does the supplier or manufacturer provide suitable information regarding its use?
8) Does the manufacturer provide advice on any contra-indications for its use/foreseeable mis-use?
9) Are the bed rails suitable for the bed type(e.g. a bed rail intended for use on a divan bed)?
10) Are spacings between the bed rail, mattress and bed surround appropriate (see diagram) to prevent against the risk of entrapment, in particular: between the end of the bed rail and the headboard; between the mattress and lowest rail of the bed rail when compressed by the bed occupant; and height from top of mattress to the top bed rail.
11) Does the bed rail provide sufficient height protection when used with a pressure-relieving mattress (see diagram)?
12) Have the bed rails been assessed for other types of injury to the bed occupant (e.g. trapping injuries, sharp edges)?
13) Have the bed rails been assessed for the risk of injury to staff (e.g. trapping injuries, sharp edges)?
14) If covers are provided, are they compatible with the bed rails?
15) Does the supplier or manufacturer provide after sales support/maintenance?
16) Have users been consulted?
17) Have bed rails been evaluated, e.g. ease of use?
Fitting and maintenance
18) Have staff been provided with suitable training for each type of bed rail?
19) Have the bed rails been fitted correctly?
20) Are the bed rails secure, rigid and close to the mattress?
21) Are the bed rails in good working order, e.g. do mechanisms for adjusting/gaining access to the bed work correctly?
22) Have covers/bumpers been fitted? If so: are they the correct type for the bed/bed rails? have they been fitted correctly?
23) Are maintenance procedures in place and are they adhered to?

Dimensional requirements of bed rails (from BS EN 1970:2000)

Designator	Description	Requirement mm
A	The greatest dimension in at least one direction between elements inside of the perimeter of the side rail/grab handle in all normal use positions	A ≤120
B	Thickness of normal use mattress as specified by the manufacturer without compression	As specified by the manufacturer
C	Height of the top of the side rail above the mattress without compression and with the bed board in flat position	C ≥ 220
D	Distance between the head end panel/foot end panel/accessories and the side rail grab handle with the bed board in flat position. Applies also if the end panels are extended.	D ≤ 60 or D ≥ 250
E	Distance between segmented side rails with bed board in flat position	E ≤ 60 or 250 ≤ E ≤ 400
F	The greatest dimension in at least one direction of any accessible opening below the side rail, either	If D or E ≥ 250 then:F ≤ 60	If D or E ≤ 60 then: F ≤ 120
G	The length of side rail(s)	G ≥ 2/3 H
H	The distance between the head end panel and the foot end panel without extensions of the panels.	No requirements

Routine inspection of bed rails

Assessment of bed side safety rails			If NO, action to be taken
Questions to consider	Yes	No
1) Has the occupant been assessed for the use of bed rails, inc. mobility, weight, build, psychological assessment, etc?
2) Are the bed rails suitable for the bed type(e.g. a bed rail intended for use on a divan bed)?
3) Are the bed rails suitable for the provision of patient care required?
4) Are the bed rails suitable when used in conjunction with other equipment required for patient care (e.g. hoists, medical equipment, etc.)?
5) Are the bed rails suitable within the present work environment (e.g. restrict access, used correctly)?
6) Have the bed rails been fitted correctly?
7) Are the bed rails secure, rigid and close to the mattress?
8) Are the bed rails in good working order, e.g. do mechanisms for adjusting/gaining access to the bed work correctly?
9) Are spacings between the bed rail, mattress and bed surround appropriate (see diagram) to prevent against the risk of entrapment, in particular: between the end of the bed rail and the headboard; between the mattress and lowest rail of the bed rail when compressed by the bed occupant; and height from top of mattress to the top bed rail.
10) Does the bed rail provide sufficient height protection when used with a pressure-relieving mattress (see diagram)?
11) Have the bed rails been assessed for other types of injury to the bed occupant (e.g. trapping injuries, sharp edges, etc)?
12) Have the bed rails been assessed for other types of injury to staff (e.g. trapping injuries, sharp edges, etc)?
13) Have covers/bumpers been fitted? If so: are they the correct type for the bed/bed rails? have they been fitted correctly?
14) Have the bed rails been inspected and are they maintained in good order?
15) Have staff received training in using the bed rail?