The deaths of two children at Great Ormond Street Hospital have prompted an urgent investigation amid fears they may have been treated with a “faulty” surgical glue.
Five children were treated with affected batches of histoacryl glue at the renowned hospital in London, two of whom later died.
A recall notice for some batches of the glue was issued earlier this year after some batches of the product were identified as hardening less rapidly than expected.
While it is not thought the use of the product was the “sole or main factor” in patients being harmed, the hospital trust still launched an investigation into the way safety notices are distributed.
Great Ormond Street Hospital said in a statement: “First and foremost, our thoughts are with the families of the children affected.
“A comprehensive serious incident investigation has been carried out to determine the impact of the faulty glue on all patients treated with it.
“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 said a partial recall of the glue was issued by the manufacturer, B Braun, on 3 March.
On 26 April, the procurement team at the trust received an email from B Braun that directly addressed the product recall for the first time. This email listed affected batch numbers.
The last procedure that used a batch of the affected glue took place on 23 April, the hospital said.
Some information related to the investigation was also reported in the trust’s board papers, as reported in the Health Service Journal (HSJ).
The trust’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.
According to a report to the hospital’s public board meeting on 29 September, titled “Faulty batch of Histoacryl glue potentially impacting patient treatment outcomes”, the adhesive has been used for more than 30 years in the endovascular treatment of brain arteriovenous malformations – a tangle of blood vessels with abnormal connections between arteries and veins.
Additional reporting by Press Association
