Users of mobile hoists, designed to assist in lifting and moving people with disabilities, are urged to be vigilant following reports of collapse during use due to incorrect assembly.

Since January 2009, the Medicines and Healthcare products Regulatory Agency (MHRA) has received reports of minor injuries and one fatality following the collapse of the Smart mobile hoist during use.

Incorrect assembly will cause the hoist mast to collapse, dropping the sling and the person in it to the floor.

Carers and users are advised to obtain new labelling and updated instructions for use which can be found on the manufacturer, Molift's website (external link). All Smart hoists made prior to week 11, 2009 are affected. Manufacturing dates can be found near the base of the hoist with the serial number.

Molift is also fitting a label to any new hoists that illustrates the correct method of assembly.

MHRA Director of Device Technology and Safety, Clive Bray said, "The MHRA is advising that all Smart mobile hoist users familiarise themselves with the revised instructions for use.

"We continue to encourage people to report incidents involving medical devices to the MHRA via our website."

A Medical Device Alert (MDA/2009/057) has been issued to nurses, care staff and maintenance staff as well as back care and manual handling advisors, who may use or maintain this hoist.

Notes

1. 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 judgments 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.

2. In general, a medical device cannot be marketed in the UK without carrying a CE Mark of Conformity. A CE mark is applied by the manufacturer to denote that the device meets the relevant regulatory requirements and performs as intended. For all but the very lowest risk devices, such as non-medicated bandages, an EC Certificate of Conformity must be obtained from an independent certification organisation, called a Notified Body, before the CE marking can be affixed. The MHRA is responsible for designating UK Notified Bodies and regularly audits them to ensure that they continue to perform to the required standards.

3. Adverse incidents relating to medical devices can be reported to the MHRA website. Information and printed incident report forms are available from: the MHRA Adverse Incident Centre on 020 7084 3080 or email: aic@mhra.gsi.gov.uk

4. The Medical Device Alert (MDA/2009/057) can be found on the MHRA website.

5. To identify the hoist, there is a label near the base of the hoist mast that has the serial number. This label can be in one of two styles (see figures in PDF). One is in the format 03 10 XX where 03 is the year of manufacture, 10 is the week, and the last two digits are a sequential number. The other style is a number that appears below the bar code.

Hoists that need the new label have serial numbers in the range 02 37 XX to 09 10 XX or 10000 to 12099.

Source
MHRA