BS EN 60601-2-52-2010 Part 2-52: Particular requirements for basic safety and essential performance of medical beds

A review and explanation of the new Standard for healthcare beds

INTRODUCTION

Carebase are a supplier of healthcare beds and have been providing aa range of beds into the community sector for 15 years.We are the UK partner to Hermann Bock GmbH ,who are one of the leading manufacturers of electric height adjustable beds.

With the ratification of the BS EN 60601-2-52-2010 Standard, Carebase feel it is critically important that our customers and potential customers are fully informed and aware of the implications of the new Standard. We are therefore offering this guide free to any persons involved in purchasing or specifying healthcare beds.

The object of this particular standard is to establish particular basic safety and essential performance requirements for medical beds.

This particular standard is the realization of much work in aligning IEC 60601-2-38, EN 1970, and the third edition of IEC 60601-1. It represents the current thinking in basic safety and essential performance of a medical bed as used to alleviate illness of patients and disability of disabled persons. It takes account of international incidence reporting of accidents occurring in the environment of the bed.

This guide is not meant to be a replacement for the full Standard documentation which can be purchased from an official source such as the BSI (link at the back of the guide)

It aims to highlight the key points in the Standard and where particular attention is required.

THE STANDARD

FACT

The HSE has made a number of successful prosecutions of health care providers in relation to bed and siderail incidents. This has resulted in substantial fines of upto £250,000 and serious reputa-tional damage.

AREAS COVERED

• Testing • Areas of use• Siderails• Mattress• Hoist clearance• Marking & Identification• Safe working load and maximum patient weight• Stability• Ergonomic • Operating speed and time• Emission and Noise• Labelling

Note:Compliance with a British Standard cannot confer immunity from legal obligations.

KEY POINTS

• The dimensional requirements of this particular standard are based on anthropometric data based on patients ranging in physical size from a 146 cm tall female to a 185 cm tall male.

• The siderail height should be at least 22cm above the mattress height.

• Introduction of a new long-term siderail test with 30.000 cycle.• Introduction of a new long-term test with 3.000 cycles with 10 kg• There should be a minimum tensile strength for the siderail to

withstand a force of 500N.• Fall tests with the operating unit are to be carried out with no

fault after 1,000 falls from a height of 0.5 m• Mattress gaps should be less than 12cm when pressure is applied

at the edge of the mattress.• The adjustable height range of the bed should be a minimum of

40cm to 80cm.• Every bed should come with the suppliers confirmation of

compliance with the Standard, preferably independently tested by a body such as BSI or TUV.

• The NEW Standard is in force from 1st April 2013 and all beds sold subsequently should comply from that date.

• Beds sold prior to 1st April 2013 that met the existing Standard, EN1970, up until that date, may continue to be used unless the Standards body deems the risk level unacceptable.

TESTING EQUIPMENT USED - CONE TOOL

The Standard specifies the eaxct dimensiosn of testing equipment. This should not generally be required by end users or purchasers.

Carebase provide a full specific audit usintg the correct testing equipment, alternatively we can supply a simple tool for testing the measurements.

1. Intensive care in a hospital, where 24hr medical supervision and constant surveillance is necessary. The provision of a life-support system/device is important in order to maintain the patient´s vital functions.

2. Acute care in a hospital or other medical institution, where medical supervision and surveillance are necessary. Mostly where medical devices that support the maintenance and enhancement of the patient´s conditions are provided.

3. Long term care. Medical supervision and surveillance is necessary. This includes nursing care homes, rehabilitation centres and elderly homes.

4. Care at home. Where a medical device for the relief of an injury or disability is used.

5. Ambulant care which is offered under medical supervision in a hospital or other medical institution. A medical device for the patient´s needs with diseases, injury or disability is provided for treatment, diagnosis and supervision.

AREAS OF USE

A suggested height adjustment range of at least 40cm-80cm for the mattress platform itself. This is part of the Standard for Application area 4 - domestic use.

When determining the adjustable height range of the bed, consideration should be given to regional anthropometrics for both caregiver and/or operator and/or patient/resident.

Attention should be paid to:– patient/resident falling from the bed, where a low height minimizes injuries;– ease of patient/resident entry and egress;– transfers to and from a wheelchair;– caregiver’s and/or operator’s safe working height in order to minimize back problems.

ERGONOMIC

1. Introduction of a new long-term test with 30.000 cycles (up and down) followed by a static load in order to evaluate the robustness and reliability of the side rails.

2. Introduction of a new long-term test with 3.000 cycles with 10 kg applied load in the longitudinal and transverse direction in order to simulate the shaking and bounce on the side rails by a patient.

3. Increase of the pressure test from 5kg to 25 kg in order to test the gaps of the side rails.

4. Due to an increase in the numbers of incidents the measurements of the gaps for the side rails have been changed. The essentials are: − Distance head part – side rail always < 60mm C1− Distance between rails < 120mm A1− Distance foot part – side rail either < 60mm or > 318mm− Distance between splitted side rails (middle gap) either <60 mm or 318mm C2

The investigations of incidents with entrapment in full-length side rails that fulfil the standard EN 1970 or IEC 60601-2-38 regarding the measurement A , show that seven incidents were registered. Four of these incidents occurred between the lower bar and the mattresssupport platform , the other three occurred between the upper (or middle) bar and the lower bar of the siderail.

IMPORTANT NOTE - USE FOR CHILDREN

The Standard is designed for beds for individuals upto 145cm or 12 years.The UK Medical Devices body has recommended that siderails used for children’s beds have a gap of 60mm and not 120mm.This follows specific incidents including a fatality and a considerable number of reports of entrapment.

Carebase offer specially designed siderails for use with children.

SIDERAILS

Key1 Area of TOOL representing neck diameter (60 mm).2 Area of TOOL representing chest breadth (318 mm).3 Area of TOOL representing head breadth (120 mm).4 MATTRESS SUPPORT PLATFORM5 HEAD BOARD6 FOOT BOARD7 Mattress8 SIDE RAIL

Example of MEDICAL BED with segmented or split SIDE RAIL

Example of MEDICAL BED with single piece SIDE RAIL

Entrapment test. The large end of the cone tool shall not sink below the mattress surface by 50 % or more of its 120 mm diameter.

The requirement for siderail height to be at least 22cm above the mattress support platform in at least 50 % of the length of the mattress support platform.

Medical beds designed to have replacement mattresses shall be marked with a warning and a risk assessment for such mattresses should be carried out if the 22cm is not reached.

MATTRESS

There should be at least 15cm clearance for the use of mobile hoists

HOIST CLEARANCE

Locations identified as trapping zones fingers should have distances between moving parts which shall always be either less than 8 mm or more than 25 mm.

GAPS

The manufacturer’s identification must be on the bed and the removable parts.The medical bed shall be marked with the name or trademark and address of the manufacturer and the means to allow traceability.

MARKING & IDENTIFICATION

There is a new test for end to end stability. The bed and bed lift shall be capable of withstanding a uniformly distributed static load equal to two times the safe working load or 4 000 N, whichever is greater, in the most disadvantageous position on the mattress support platform in a horizontal position.

STABILITY

SAFE WORKING LOAD & MAXIMUM PATIENT WEIGHTThe medical bed shall be marked with the corresponding maximum patient weight and safe working load of the bed. The minimum SWF is 1700N.

The bed should be able to be moved with reasonable force and over thresholds without any instability or damage.

MOVEMENT FOR TRANSPORT

There are a number of electrical safety elements to the Standard.

Power cables should have a length (min 2.5 m) and strain relief.

The power cord shall have a moulded-on plug or other means to withstand the ingress of water during the cleaning process for which the bed is intended.

The bed shall be equipped with a means to keep the power supply cord clear of any moving bed part or mechanism, when the bed is in use, transport or not in use to avoid a damage of the power cord.

The power cord shall be adequately protected against damage from contact with moving part(s) or from friction at sharp corners and edges within the bed.

The ingress of water protection on motors on beds should be at least to IP4 level.

Specific tests are required for beds described as machine washable.

ELECTRIC REQUIREMENTS

A lifting pole should be able to withstand a test of at least 750N

ACCESSORIES

Handset test - a new fall test with the operating unit should be carried out with no fault after 1,000 falls from a height of 0.5 m.

HANDSET TEST

The use of third party siderails or mattresses ill-suited to the bed. It is difficult to ensure compliance when different beds and siderails are used.

The use of alternating mattresses. These often cause the height of the mattress to be above the 22cm required. Additional siderails may be required and a risk assessment should be carried out.

The use of ill-fitting mattresses that leave a gap between siderails and the bed platform.

Low beds that do NOT comply with the 80cm height level. The desire to have a bed with a low entry point has resulted in the supply of beds that do not come upto 80cm which is the requirement of the standard for domestic use and a strong recommendation in other application areas.

Note the 80cm relates to the mattress platform height not including the mattress.

Siderails that are not designed for the bed and may leave unsafe gaps.

Siderails raised at one end only. This will potentially alter the strength of the siderail and will not meet the standard in reference to the height.

Beds are not marked with the manufacturers details to hide the source of supply. This means that the required element of traceability in the Standard is not met.

COMMON AREAS CAUSING NON COMPLIANCE

Specific issues relating to children and those below 145cm height.

The use of standard adult beds for children will automatically mean that the siderail gaps will be incorrect. There have been a number of notices from the MHRA regarding this issue. There is a case of a fatality at an NHS hospital with a young adolescent whose head became trapped between adult siderails.

The use of “cot” inserts that do not meet the tensile strength requirement of the Standard. Some suppliers will offer inserts that are not sufficiently secured to the side of the bed or do not provide the stability and tensile strength required in the Standard.

Legal advice and Health & Safety advice to Carebase suggest that the Standard should be applied to healthcare beds for children in all respects other than where different anthromorphic data suggests otherwise - i.e with siderail gaps.

SPECIFIC ISSUES RELATING TO CHILDREN

CONCLUSION

• Carry out assessments with actual product to be used• Take account of each situation and specific requirements• Risk assess carefully • Comply with all relevant sections of the Standards • Ensure suppliers have proper independent certification• Involve all stakeholders as far as possible• Document the process of product selection and risk assessment

thoroughly

Given the level of risks that the can exist around the bed, it is vital that any purchaser ensures that product that they buy complies with the new Standard and that they have evidence of compliance.

** DON’T TAKE A RISK - MEET THE STANDARD **

All Carebase Bock beds and cots meet the new Standard and are tested by TUV, the highly respected German Standards Institute. We are able to provide a certificate of compliance with every bed purchased.

Links

BSI http://www.bsigroup.co.ukTUV http://www.tuv.comMHRA http://www.mhra.gov.ukNSPA http://www.npsa.nhs.ukHSE http://www.hse.gov.uk

For further information about the Standard, further copies or any other Carebase products please contact us.

Tel: 01609 785360web: www.carebase.netemail: info@carebase.net