Medical Devices Regulator Issues Alert Over Walking Frames

Main Category: Medical Devices
Also Included In: Seniors / Aging
Article Date: 02 May 2008 - 16:00 PDT

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Adults and children are being urged to be vigilant by the Medicines and Healthcare products Regulatory Agency (MHRA) if using walking frames manufactured by Trulife Limited. The problem concerns the plastic height adjustment clips that can fail, causing the user to fall.

Standard models of walking frames manufactured by Trulife Limited from 02 April to 07 November 2007 with plastic height adjustment clips are affected. This includes models with or without wheels and walking frames with arm support troughs. Standard model product codes begin with RJ or RM. People should check if their walking frame is affected by finding the identification label on one of the front legs which stipulates the manufacturer's name, date and product code.

Clive Bray, Director of Device Technology and Safety at the MHRA said, "Following investigations by the MHRA, the manufacturer has agreed to replace all plastic clips on frames already in use. They will arrange for either one of their engineers to modify the walking frames on site, return of the product to the factory to be modified or supply replacement clips with fitting instructions.

"People should continue to report any faulty medical devices to the MHRA by calling our Adverse Incident Hotline on 0207 084 3080 or http://www.mhra.gov.uk."

A Medical Device Alert (MDA) has also been issued today to all those involved in the provision and maintenance of walking frames to trace these particular models and to contact Trulife Limited to arrange for them to be modified. These include nurses, physiotherapists, occupational therapists and managers of equipment stores.

Notes

1. Any separately purchased made to measure walking frames are not affected.

2. In April 2007 Trulife Limited changed the metal clips used to set height adjustment on all their walking frames to a plastic clip. The MHRA has investigated reports of incidents where the plastic clips have either snapped in use or did not engage correctly causing the frame to collapse and the user to fall. In November 2007 Trulife Limited changed back to using the original design of metal adjustment clips.

3. The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem. We encourage everyone -the public and healthcare professionals as well as the industry - to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action.

MHRA