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Ref: MDA/2010/019
Device
All types of Oxford slings and standing harnesses manufactured by
Joerns Healthcare Ltd for use with hoists and stand aids.
Problem
Action
Unclear instructions for use.
The MHRA has received various incident
reports where occupants have been injured
as a result of incorrect use or inadequate
inspections of slings before use.
• Obtain copies of the revised instructions for
use (IFU) from the manufacturer.
• Ensure users are aware of the revised IFU
and that procedures are in place to ensure
that they are followed in future.
Action by
All those involved in the provision,
prescription, use and maintenance of these
slings and harnesses. In particular:
equipment store managers, nursing home
managers, nurses, moving and handling staff,
occupational therapists, care staff and
maintenance staff and contractors.
CAS deadlines
Contact
Action underway: 23 March 2010
Action complete: 10 May 2010
Manufacturer
Customer Services Department
Joerns Healthcare Ltd
Tel: 01384 446 622
Fax: 01384 446 601
E-mail: info@joerns.co.uk
Device
All types of Oxford slings manufactured by Joerns Healthcare Ltd are affected by this issue, including:
Quickfit/universal sling
Quickfit deluxe sling
Access/toileting sling
Long seat sling
Full back sling
Full back disposable sling
Comfort sling
Comfort disposable sling
Standing harness
Silkfit sling
Standing sling
Transport sling
Prior to 2007, when Joerns Healthcare took over manufacture, these slings and standing harnesses were
manufactured by Oxford Ltd, Parker Baths Ltd and Sunrise Medical Ltd and may be labelled accordingly.
Problem
The manufacturer has now changed the instructions for use (IFU) to include details of pre-use checks
including sling choice, sling position, checks of critical stitching elements and occupant transfer method to
reduce the risk of further incidents.
Joerns Healthcare Ltd issued a Field Safety Notice (FSN) in November 2009 and placed the updated IFU on
its website (www.joerns.co.uk). However, the manufacturer cannot be sure that all relevant people received
their FSN, so the MHRA has issued this alert.
Distribution
This MDA has been distributed to:
• NHS trusts in England (Chief Executives)
• Care Quality Commission (CQC)
• HSC trusts in Northern Ireland (Chief Executives)
• NHS boards in Scotland (Chief Executives)
• NHS boards and trusts in Wales (Chief Executives)
• OFSTED
• Primary care trusts in England (Chief Executives)
• Social services in England (Directors)
• Social services in Scotland (Chief Executives)
Onward distribution
Please bring this notice to the attention of all who need to know or be aware of it. |
