A Serious Incident Investigation has taken place at Great Ormond Street Hospital to determine the impact of the “faulty” glue on all patients treated with it.
The adhesive is used in the endovascular treatment of brain arteriovenous malformations and it was recalled after some batches were found to be hardening less rapidly than expected.
Five children were treated with affected batches of histoacryl glue; two of whom sadly died, prompting an investigation. It is not thought that the glue was the only or main factor in patients being harmed, however, the trust is investigating the way into which safety notices were distributed.
A statement from the hospital said that 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 main or sole 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 investigation found that there was “no formal policy or process in place in the trust for the management of field safety notices issued by companies”. There is concern that this lack of governance “poses a risk to patients and needs to be urgently addressed”.
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