Medical Device Alert: Posture (hip) belts for use on paediatric seating systems and buggies (MDA/2009/033)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2009/033 or 2008/009/005/061/006.

Brian Mather or Jonathan Smith
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:
brian.mather@mhra.gsi.gov.uk
jonathan.smith@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@shs.csa.scot.nhs.uk
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

The belt has been manufactured from material that is too thin and this could slip through the buckles when the belt is in use. Consequently the occupant could slide down in the seat and suffer positional asphyxiation.

R82 in Denmark has identified five batches of hip belts that have straps that were manufactured from webbing material that is too thin. The effects of this will only become apparent to the user or carer if the belt extends to its maximum adjustment and the occupant loses postural support or slips down in their seat.

R82 has issued a Field Safety Notice intended to inform users of the need to obtain replacement belts. The response has not been adequate despite follow up by the manufacturer. Also, the FSN does not include the labelling detail and R82 do not have traceability to users where the belt has been supplied as an accessory or replacement part or where the buggy or seating system has been passed on to second or subsequent end users.

General information on the use of posture belts is also given in the MHRA’s Medical Device Alert MDA/2008/037.

• Trace all affected posture belts.
• Contact R82 UK to obtain replacement belts.
• Arrange for the new belts to be fitted in accordance with the original instructions for use supplied with each seating system.

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:

• Equipment store managers
• Health and safety managers
• Maintenance staff and contractors
• Occupational therapists
• Paediatric departments
• Physiotherapists
• Rehabilitation engineers
• Risk managers
• Wheelchair and seating service managers

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

• Domiciliary care providers
• Hospices
• Hospitals in the independent sector

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

• Children’s services
• Educational establishments with facilities for disabled children
• Residential special schools

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

• Community children’s nurses
• Equipment stores managers
• Health and safety managers
• Maintenance staff and contractors
• Occupational therapists
• Paediatric departments
• Physiotherapists
• Rehabilitation engineers
• Risk managers
• Wheelchair and seating service managers

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

• Children’s disability services
• Equipment stores managers
• In-house domiciliary care providers (personal care services in the home)
• Maintenance staff and contractors
• Occupational therapists
• Wheelchair and seating service managers

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

Ms Sandy Evans
R82 UK Ltd
Unit 4DA Coombswood Business Park East
Coombswood Way
Hailsowen
West Midlands
B62 8BH

Tel: 0121 561 2222
Fax: 0121 561 5437
E-mail: sev@r82.com