Coroner Calls for Action After Infant Deaths Linked to Contaminated Hospital Feed

A senior coroner has issued a warning, stating that additional infant fatalities are possible if “action is taken” to address the issue, after three babies died from contaminated feed administered during their hospital care. In January 2014, three-month-old Aviva Otte passed away subsequent to receiving contaminated feed at St Thomas’ Hospital in south London. That same year, in June, Oscar Barker, aged one month, and Yousef Al-Kharboush, aged nine days, also died following a contamination incident that was similar yet distinct. Subsequent to an inquest, Dr Julian Morris expressed apprehension that St Thomas’ Hospital lacked a legal obligation to report the initial incident and advocated for legislative reform. The three infants, all born prematurely, were nourished via an intravenous drip, a procedure referred to as “total parenteral nutrition” (TPN). Aviva, the initial fatality, received TPN prepared by NHS pharmacists located at St Thomas’ Hospital. Oscar, whose death occurred at Addenbrooke’s Hospital in Cambridge, and Yousef, who also died at St Thomas’ Hospital, were given feed produced by ITH Pharma, a private firm that supplied multiple trusts. Bacillus cereus bacteria was identified as the contaminant responsible for all three fatalities. The senior coroner for Inner South London, in his concluding remarks, voiced concern that insufficient regulation pertaining to medications like Aviva’s feed could result in subsequent deaths. Aviva’s TPN was prepared within St Thomas’ Hospital’s pharmacy, designated as a “Section 10” setting. Hospital pharmacists commonly formulate customized medications for patients with critical dependencies and specialized requirements. These types of medicines are exempt from the regulatory scrutiny applied to products from private manufacturers, implying that any issues encountered with them are not mandated for reporting to the Medicines and Healthcare Products Regulatory Agency (MHRA) or other trusts. Dr Morris indicated that this situation was a source of worry for him, as it implied that the “industry in general” was not receiving alerts regarding any “adverse” problems associated with these medications. In correspondence addressed to Health Secretary Wes Streeting, he penned: “In my opinion, action should be taken to prevent future deaths and I believe you have the power to take such action.” He further noted that while problems are required to be reported to the NHS and the Care Quality Commission (CQC), the healthcare regulator, “the threshold or necessity for such reporting appears unclear and, in essence, up to the trust”. He additionally stated: “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 additionally emphasized that Bacillus cereus exhibits resistance to certain cleaning techniques and that sporicides—disinfectants designed to eliminate microbial spores—may be necessary for effective decontamination. He stated that St Thomas’ Hospital possessed this knowledge before the subsequent outbreak that year but failed to disseminate its findings. In 2022, ITH Pharma incurred a £1.2 million fine from a crown court for supplying TPN that led to the infection of 19 premature infants across nine hospitals in 2014, among them Oscar and Yousef. The company admitted guilt to several regulatory infractions in 2022. A company spokesperson conveyed that ITH Pharma welcomed the coroner’s recommendations and “recognised the importance of sharing information and learning” throughout 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 reported that subsequent to Aviva’s death, it discontinued TPN manufacturing and initiated outsourcing for its production. Dr Sara Hanna, a medical director at Guy’s and St Thomas’ NHS Foundation Trust, stated that the trust offered 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 further commented. The entities that received the coroner’s letter, including NHS England, the MHRA, and the CQC, are required to submit their responses to his report by January 8 next year.