A senior coroner has warned that more babies could die unless “action is taken”, following the deaths of three infants who had received contaminated feed while being cared for in hospital.
Three-month-old Aviva Otte died in January 2014 after being given contaminated feed at St Thomas’ Hospital, south London.
In June that year, one-month-old Oscar Barker and nine-day-old Yousef Al-Kharboush died after a similar, but separate contamination incident.
Following an inquest, Dr Julian Morris said he was concerned that St Thomas’ Hospital was not legally required to report the first incident and called for a change in the law.
All three babies, who had been born prematurely, were fed through an intravenous drip, a method known as “total parenteral nutrition” (TPN).
Aviva, the first child to die, was given TPN that was made by NHS pharmacists at St Thomas’ Hospital.
Oscar, who died at Addenbrooke’s Hospital, Cambridge and Yousef, who also died at St Thomas’ Hospital, received feed manufactured by private company ITH Pharma which supplied to several trusts.
The bacteria Bacillus cereus was found to be the contaminant in the cause of all three deaths.
In his conclusion, the senior coroner for Inner South London said he was worried that a lack of regulation around medicines such as Aviva’s feed might lead to future deaths.
Aviva’s TPN was made in St Thomas’ hospital’s pharmacy – which is known as a “Section 10″ setting. Hospital pharmacists will typically make bespoke medicines for highly dependent patients with niche needs.
Such medicines are not subject to the same regulatory process as those produced by private manufacturers. This means that any problems with them do not need to be reported to the Medicines and Healthcare Products Regulatory Agency (MHRA) or to other trusts.
Dr Morris said this concerned him, as it meant the “industry in general” was not being warned of any “adverse” issues with these medicines.
In a letter to Health Secretary Wes Streeting he wrote: “In my opinion, action should be taken to prevent future deaths and I believe you have the power to take such action.”
He also said that although issues must be reported to the NHS and the healthcare regulator the Care Quality Commission (CQC), “the threshold or necessity for such reporting appears unclear and, in essence, up to the trust”.
He added: “There may be times when section 10 entities reach conclusions which would assist the wider industry and help to assist both other trusts and commercial organisations.”
Dr Morris also highlighted that Bacillus cereus is resistant to some cleaning methods and that sporicides – disinfectants that kill microbial spores – can be required to achieve decontamination.
He said St Thomas’ Hospital knew this prior to the outbreak later that year but did not pass on its findings.
ITH Pharma was fined £1.2m by a crown court in 2022 after providing TPN from which 19 premature babies became infected across nine hospitals in 2014, including Oscar and Yousef.
The company pleaded guilty to a number of regulatory offences in 2022.
A spokesperson said the company welcomed the coroner’s recommendations and it “recognised the importance of sharing information and learning” across the industry.
“Any information that had been shared with ITH and the MHRA as a result of a previous outbreak in the NHS five months prior to the ITH incident could have been of real value in taking steps to prevent future possible incidents.”
Guy’s and St Thomas’ NHS Foundation Trust said following Aviva’s death, it ceased TPN production and began to outsource it.
Dr Sara Hanna, a medical director at Guy’s and St Thomas’ NHS Foundation Trust, said it extended its “deepest condolences” to the families of Aviva and Yousef.
“We are considering the coroner’s findings carefully and continue to ensure we are doing everything possible to provide the very highest quality of care for all of our patients, but particularly for our most vulnerable patients,” Dr Hanna added.
Recipients of the coroner’s letter, which also include NHS England, the MHRA and the CQC must respond to his report by 8 January next year.
