Medical Device Alert: Durewall handling belt supplied in the UK by Prism Medical (MDA/2011/083)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2011/083 or 2010/002/019/261/001

James McVeigh or Brian Mather
Medicines & Healthcare products Regulatory Agency
Centre for Assistive Technology
241 Bristol Avenue
Bispham
Blackpool FY2 0BR
Tel: 01253 596 000
Fax: 01253 596 177
Email: bav@mhra.gsi.gov.uk

How to report adverse incidents
Please report via the MHRA website
Further information about CAS can be found on the CAS website (external link)

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
Health Estates Investment Group
Room 17
Annex 6
Castle Buildings
Stormont Estate
Dundonald BT4 3SQ
Tel: 02890 523 704
Fax: 02890 523 900
Email: 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 the NIAIC website (external link)
Further information about SABS can be found on the SABS website (external link)

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

Enquiries in Wales should be addressed to:
Dr Sara Hayes
Senior Medical Officer
Medical Device Alerts
Welsh Assembly Government
Cathays Park
Cardiff CF10 3NQ
Tel: 029 2082 3922
Email: Haz-Aic@wales.gsi.gov.uk

The instructions for use (IFU) did not provide clear guidance on how to re-thread the buckle nor the checks to be carried out before each use. The cleaning instructions have also been updated.

The manufacturer issued a Field Safety Notice (FSN) (25Kb) for this device on 16 May 2011, but has not had sufficient confirmation from users that they have received and acted on this information.

• Locate all affected handling belts
• Obtain the revised IFU and label from the manufacturer
• Replace the washing label in accordance with the manufacturer’s FSN
• Ensure that all users are aware of the revised IFU and that procedures are in place to inspect and clean these belts in line with the revised IFU
  

This MDA has been sent to:

• NHS trusts in England (Chief Executives)
• HSC trusts in Northern Ireland (Chief Executives)
• NHS boards in Scotland (Equipment Co-ordinators)
• Local authorities in Scotland (Equipment Co-ordinators)
• NHS boards and trusts in Wales (Chief Executives)
• Health and Safety Executive
• Primary care trusts in England (Chief Executives)
• Social services in England (Directors)

Onward distribution
Please bring this notice to the attention of relevant employees in your establishment. Below is a suggested list of recipients.

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

• All wards
• Equipment store managers
• Health and safety managers
• Laundry services and contractors
• Maintenance staff and contractors
• Moving and handling co-ordinators
• Nursing executive directors
• Occupational therapists
• Physiotherapists
• Risk managers

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

• Community hospitals
• District nurses
• Equipment store managers
• Laundry services and contractors
• Maintenance staff and contractors
• Moving and handling co-ordinators
• Occupational therapists
• Physiotherapists
• Risk managers

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

• Day centres (older people, learning disabilities, mental health, physical disabilities, respite care, autistic services)
• Equipment store managers
• Moving and handling co-ordinators
• Occupational therapists
• Risk managers

Independent distribution

Establishments registered with the Care Quality Commission (CQC) (England only)
This alert should be read by:

• Care homes providing nursing care (adults)
• Hospices
• Hospitals in the independent sector
  

Please note: CQC and OFSTED do not distribute these alerts. Independent healthcare providers and social care providers can sign up to receive MDAs directly from the Department of Health’s Central Alerting System (CAS) by sending an email to: safetyalerts@dh.gsi.gov.uk and requesting this facility.

Anette Repenning Raun
Etac AB
Kista Science Tower
SE-164 51 Kista
Sweden
Tel: + 46 371 58 73 30
Fax: + 46 371 58 73 90
Email: anette.raun@etac.com

If you have any comments or feedback on this Medical Device Alert, please email us at: dts@mhra.gsi.gov.uk