Great Ormond Street Hospital investigates ‘faulty’ surgical glue

Great Ormond Street Hospital is investigating after patients were treated with a “faulty” surgical glue.

Two of five children treated with the affected batches of Histoacryl glue at the central London hospital later died.

A recall notice for some batches of the glue was issued earlier this year after they were found to harden less rapidly than expected.

The hospital said it may have caused some instances of harm but was unlikely “to be the sole or main factor”.

Great Ormond Street Hospital said in a statement: “First and foremost, our thoughts are with the families of the children affected.

“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 lack of clear governance around FSNs (field safety notices) poses a risk to patients and needs to be urgently addressed.”

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 hospital trust received an email from B Braun that listed affected batch numbers.

The last procedure that used a batch of the affected glue took place three days earlier, the hospital said.

Some information related to the investigation was also documented in the trust’s board papers, as reported in the Health Service Journal.

The papers said: “The lack of clear governance around FSNs (field safety notices) poses a risk to patients and needs to be urgently addressed.”

The Great Ormond Street Hospital for Children NHS Foundation 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 a Great Ormond Street Hospital 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.