It has been reported that the deaths of two children at Great Ormond Street Hospital prompted an urgent investigation following concerns that the children may have been treated with a “faulty” surgical glue, called histoacryl glue.
A recall notice was issued earlier this year after some batches of the glue were identified to harden less rapidly than expected.
Five children were treated with affected batches of the glue at St Ormond Street, and very sadly, two of those children later died.
The hospital has said that the use of the “faulty” glue was not thought to be the sole or main factor in the harm to patients, an investigation was launched nonetheless to consider the way in which safety notices are distributed.
It is reported that a partial recall of the glue was issued by the manufacturer on 3rd March. On 26th April, the procurement team at Great Ormond Street received an email from the manufacturer directly addressing the product recall and listing affected batch numbers. The last procedure using the glue had taken place three days earlier.
Following their investigation, the hospital said
“The investigation found that whilst the passage of glue through the intended vessel may have been contributory in some instances of harm, it was unlikely to be the sole or main factor. Both patients who died had serious and complex medical conditions and the procedure to correct these always carries a high degree of risk, which is discussed extensively with the families before any treatment takes place.”
The hospital’s investigation found that:
“there was no formal policy or process in place in the trust for the management of field safety notices (FSNs) issued by companies. These are mostly managed on a local level, as companies communicate directly with their customers.”
The papers added:
“The lack of clear governance around FSNs poses a risk to patients and needs to be urgently addressed.”
The trust has since created “clear guidance to staff on how alerts should be distributed and what action should be taken once an alert is received,” the documents state.
Comment
Whilst it appears that the apparent delay in acting on the original recall notice in March was responsible for the deaths of these two children, the ensuing investigation has highlighted a worrying concern that patient safety is at risk through the lack of policies and procedures which ought to be in place to deal with recalls such as this.
Clearly, Great Ormond Street is taking necessary action to put in place clear guidance to avoid this happening again. But it begs the question; how many more hospitals have no clear governance in place for this situation and how many more patients are at risk?
The investigation and resulting report should be seen as fair warning to other hospitals across the country to ensure their own policies and procedures are robust and suitable.
How can Nelsons help?
Danielle Young is a Senior Associate in our expert Medical Negligence team.
If you have any questions in relation to the subjects discussed in this article, then please get in touch with Danielle or another member of the team in Derby, Leicester or Nottingham on 0800 024 1976 or via our online form.
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