11 July 2012
The Medicines and Healthcare products regulatory Agency (MHRA) has issued a medical device alert about standing aids manufactured by ArjoHuntleigh. The warning relates to all standing aids manufactured by the company – including the Encore, Chorus and Sara Plus devices. The alert has been prompted by a recent incident where a patient suffered a severe impalement injury. Standing aids are often used by elderly people to support them and encourage independent standing. Hospital patients also use standing aids during physiotherapy sessions, for example, if recovering from surgery.
The alert follows a Field Safety Notice issued by the manufacturer on 14 May 2012. The notice was given after a serious injury happened where a ‘supportive knee pad had been removed from the standing aid’, but a ‘support bracket holding the proactive knee pad support had not been removed’. A metal bracket was then exposed, and a patient fell on it causing a severe injury.
The alert raises concerns about possible impalement injuries where a support bracket is left exposed, contrary to the instructions of the manufacturer. The manufacturer has now amended the instructions to highlight the importance of removing the bracket completely. This is in addition to the original warning to remove the support bracket assembly if the proactive (knee) pad is not required.
The alert offers advice to all those involved in the use and maintenance of these hoists, in particular equipment store managers, nursing home managers, moving and handling co-ordinators, occupational therapists, physiotherapists, and care staff. It has set a deadline for a system to be in place to take action by 17 August 2012.
If you would like to speak to one of our experienced product liability
or defective medical devices
lawyers, particularly if you have suffered an injury because of a defective medical product, then please contact Jill Paterson
, a partner in the firm’s nationally recognised product liability team, on 020 7650 1219
for a free and friendly initial consultation.
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