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Coroner expresses concern after man dies after being impaled on an Arjo Encore hoist

Coroner to issue Regulation 28 report after accidental death verdict

5 November 2014

A Coroner presiding over the inquest into the death of a man who was impaled on an Arjo Encore hoist at Pilgrim Hospital, Boston, is to issue a Regulation 28 report on the device.

The inquest concluded that the man’s death was the result of a tragic accident which had happened because of the misuse of the lifting device. He died in April 2012 after being impaled on the knee guard of the hoist as he was being treated in the hospital. 

The medical director of Pilgrim Hospital has said that more training will take place at the hospital to prevent such incidents happening again. 

A Regulation 28 report is written by a Coroner if he or she believes there is a risk of other deaths happening  in the same way.  The report is sent to, for example, the manufacturers of medical devices, who have to reply to the Coroner within 56 days to say what action they plan to take to reduce the risk of other deaths occurring.

The Medicines and Healthcare Products Regulatory Agency (MHRA) issued an urgent field safety notice about the ArjoHuntleigh Encore hoist in 2012. 

The field safety notice in gave instructions about what action should be taken to ensure that the hoist was used safety, including the instruction that the safety correction action notice should be circulated to all users of the hoist, and be included in all user manuals for the device. 

Senior coroner for South Lincolnshire Prof Robert Forrest said: 

“It concerns me that, in spite of a hazard warning being issued about the Arjo devise, it is still in use in the UK.

“If not a total recall, maybe there could be a modification to make them safer. Evidence given at the inquest shows significant training is now in place in the United Lincolnshire Hospitals NHS Trust (ULHT), but I would hope this is taking place in other trusts.”

Medical device lawyer Michelle Victor said:

“This tragic event shows how vital it is that hospital staff are fully informed about any safety notices that have been issued by the regulatory bodies that relate to particular medical devices or pieces of equipment, and the instructions on how to use a device are clear and comprehensive.”  

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