A senior coroner has warned that more babies could die if “action is not taken” after the deaths of three babies who received contaminated food while in hospital care.

Three-month-old Aviva Otte died after being given contaminated food at St Thomas’ Hospital in south London in January 2014.

In June that year, one month old Oscar Barker and nine days Yousef Al-Kharboush Died after a similar, but separate contamination incident.

Following the inquiry, 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, born prematurely, were fed milk through an intravenous drip, known as “total parenteral nutrition” (TPN).

Aviva, the first child to die, was given TPN which was made up by NHS pharmacists at St Thomas’s Hospital.

Oscar, who died at Addenbrooke’s Hospital, Cambridge, and Joseph, who died at St Thomas’ Hospital, received feed manufactured by a private company. ITH Pharma Which supplied to many trusts.

The bacteria Bacillus cereus was found to be the contaminant causing all three deaths.

In his conclusion, The senior coroner for Inner South London said he was concerned that a lack of regulation of medicines such as Aviva Feed could lead to future deaths.

Aviva’s TPN was created in the pharmacy of St Thomas’s Hospital – known as “Section 10″ settingHospital pharmacists will usually create special medications for highly dependent patients with specific needs.

Such drugs are not subject to the same regulatory process as drugs produced by private manufacturers. This means there is no need to report any problems with them to the Medicines and Healthcare products Regulatory Agency (MHRA) or other trusts.

Dr. Morris said this concerns him, because it means “the industry in general” is not being warned about any “adverse” problems with these drugs.

In a letter to Health Secretary Wes Streeting he wrote: “In my opinion, action must be taken to prevent future deaths and I believe you have the power to take such action.”

They also said that although issues should be reported to the NHS and the health care regulator the Care Quality Commission (CQC), “the threshold or requirement for such reporting appears to be vague and, in essence, up to belief”.

He added: “There may be times when section 10 institutions will reach conclusions that will assist the wider industry and help assist both other trusts and commercial organisations.”

Dr. Morris also highlighted that Bacillus cereus is resistant to some cleaning methods and decontamination may require sporicides – disinfectants that kill microbial spores.

He said St. Thomas Hospital knew this before the outbreak later that year but did not forward its findings.

ITH Pharma was fined £1.2 million by the Crown Court in 2022 after providing TPN which infected 19 premature babies in nine hospitals, including Oscar and Joseph, in 2014.

The company admitted the crime in 2022 for multiple regulatory offences.

A spokesperson said the company welcomed the coroner’s recommendations and that it “recognized the importance of sharing information and learning” across the industry.

“Any information shared with ITH and the MHRA as a result of a previous outbreak in the NHS five months before the ITH incident could have been of real value in taking steps to prevent potential future incidents.”

Guy’s and St Thomas’ NHS Foundation Trust said that after Aviva’s death, it stopped producing TPN and began outsourcing it.

Dr Sarah Hannah, medical director of Guy’s and St Thomas’ NHS Foundation Trust, said she expressed her “deepest condolences” to the families of Aviva and Joseph.

Dr. Hanna said, “We are carefully considering the coroner’s findings and continue to ensure that we are doing everything possible to provide the highest quality care for all of our patients, especially our most vulnerable patients. Trying.”

Recipients of the coroner’s letter, which also includes NHS England, the MHRA and the CQC, have until January 8 next year to respond to their report.

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