Medical Device Alert: Locomotor lifting slings for adults and children manufactured by Select Healthcare (UK) Ltd (MDA/2009/041)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2009/041 or 2008/012/011/301/001.

Technical aspects
Ed Ball or Maurice Rand
Medicines & Healthcare products Regulatory Agency
Centre for Assistive Technology
241 Bristol Avenue
Bispham
Blackpool
FY2 0BR

Tel: 01253 596 000
Fax: 01253 596 177

E-mail: ed.ball@mhra.gsi.gov.uk or maurice.rand@mhra.gsi.gov.uk

Clinical aspects
Jonathan Plumb
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3128
Fax: 020 7084 3111

E-mail: jonathan.plumb@mhra.gsi.gov.uk

How to report adverse incidents
Please report via our website http://www.mhra.gov.uk
Further information about CAS can be found at https://www.cas.dh.gov.uk/Home.aspx

Alerts in Northern Ireland will continue to be distributed via the NI SABS system.
Enquiries and adverse incident reports in Northern Ireland should be addressed to:

Northern Ireland Adverse Incident Centre (NIAIC)
Health Estates
Estate Policy Directorate
Stoney Road
Dundonald
Belfast
BT16 1US

Tel: 02890 523 704
Fax: 02890 523 900

E-mail: NIAIC@dhsspsni.gov.uk

http://www.dhsspsni.gov.uk/index/hea/niaic.htm

How to report adverse incidents in Northern Ireland
Please report directly to NIAIC, further information can be found on our website http://www.dhsspsni.gov.uk/niaic
Further information about SABS can be found at https://sabs.dhsspsni.gov.uk

Enquiries and adverse incident reports in Scotland should be addressed to:

Incident Reporting and Investigation Centre
Health Facilities Scotland
NHS National Services Scotland
Gyle Square
1 South Gyle Crescent
Edinburgh
EH12 9EB

Tel: 0131 275 7575
Fax: 0131 314 0722

E-mail: iric.nss@nhs.net

http://www.hfs.scot.nhs.uk/online-services/incident-reporting-and-investigation-centre-iric/

Enquiries in Wales should be addressed to:

Dr Jane Ludlow
Senior Medical Officer
Medical Device Alerts
Welsh Assembly Government
Cathays Park
Cardiff
CF10 3NQ

Tel: 029 2082 3505 / 3922

E-mail: Haz-Aic@wales.gsi.gov.uk

Potential for straps to detach in use if safety-critical stitching is missing. This can cause the occupant to fall from the sling with the potential for serious injury or death.

The MHRA has received a report where a webbing strap detached from a sling because the safety-critical stitching was missing. The occupant fell from the sling and subsequently died.

Select Healthcare (UK) Ltd has now updated its instructions for use to include details of the inspections to be carried out prior to each use of the sling. The cleaning and storage instructions have also been updated. The full range of instructions for use are available from Select Healthcare (UK) Ltd on 01933 411 729 or the company’s website www.selecthealthcare.co.uk (external link).

Select Healthcare (UK) Ltd has been requested to issue a Field Safety Notice. However, they cannot trace all slings, especially where they have been passed on to second or subsequent users.

1. Trace all Locomotor slings manufactured by Select Healthcare (UK) Ltd.
2. Obtain copies of the revised instructions for use from the manufacturer.
3. Inspect all slings in line with the manufacturer’s updated instructions.
4. Remove any faulty slings from use.
5. Ensure regular inspections are made before use and every six months, in accordance with the latest instructions for use.

This MDA has been distributed to:

• NHS trusts in England (Chief Executives)
• Care Quality Commission (CQC) (Headquarters)
• HSC Trusts in Northern Ireland (Chief Executives)
• NHS Boards in Scotland (Chief Executives)
• OFSTED (Directors of Children’s Services)
• Primary care trusts in England (Chief Executives)
• Social services in England (Directors)

Onward distribution
Please bring this notice to the attention of all who need to know or be aware of it. This may include distribution by:

Trusts to:
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:

• All wards
• Back care/manual handling advisors
• Clinical governance leads
• Equipment store managers
• Health and safety managers
• Laundry services and contractors
• Maintenance staff and contractors
• Nursing executive directors
• Occupational therapists
• Physiotherapists
• Risk managers

Care Quality Commission (CQC) (England only) to:
Headquarters for onward distribution as appropriate to:

• Care homes providing nursing care (adults)
• Care homes providing personal care (adults)
• Domiciliary care providers
• FECs registered as care homes
• Hospices
• Hospitals in the independent sector
• Independent treatment centres
• Nursing agencies

OFSTED to:
Directors of children’s services for onward distribution to:

• Educational establishments with facilities for the disabled
• Residential special schools

Primary care trusts to:
CAS liaison officers for onward distribution to all relevant staff including:

• Back care/manual handling advisors
• Community hospitals
• District nurses
• Equipment store managers
• Laundry services and contractors
• Maintenance staff and contractors
• Occupational therapists
• Physiotherapists
• Risk managers

Social services to:
Liaison officers for onward distribution to all relevant staff including:

• Back care/manual handling advisors
• Care at home staff
• Care management team managers
• Community care staff
• Day centres (older people, learning disabilities, mental health, physical disabilities, respite care, autistic services)
• Equipment store managers
• In-house domiciliary care providers (personal care services in the home)
• In-house residential care homes
• Laundry services and contractors
• Loan store managers
• Maintenance staff and contractors
• Occupational therapists
• Palliative care team

Change of address or removal from address list for Care Quality Commission:
National Contact Centre
Care Quality Commission
St Nicholas Building
St Nicholas Street
Newcastle-upon-Tyne
NE1 1NB

Tel: 03000 61 61 61

E-mail: enquiries@cqc.org.uk

Richard Paine
Select Healthcare (UK) Ltd
Unit 2
Albert Road
Rushden
Northants
NN10 0BU

Tel: 01933 411 729
Fax: 01933 410 213
E-mail: info@selecthealthcare.co.uk