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One premature baby has died and 14 are ill with blood poisoning in six hospitals after apparently being given a batch of liquid food contaminated with Bacillus cereus.
Prof Mark Fielder, Professor of Medical Microbiology, Kingston University, said:
“The recent Bacillus cereus outbreak linked to parenteral feed has left 14 premature babies with septicaemia and sadly one other has lost their life. There is an ongoing investigation to establish exactly how this feed might have become contaminated and in the meantime there has been a product recall to prevent any further infection. Public Health England and the MHRA have acted quickly to both identify the organism responsible and to put measures in place to protect the public. The occurrence of a further three cases, whilst distressing, was to some extent expected as patients who might have earlier received contaminated material develop symptoms. It remains the case that the outbreak is likely to have been contained and very few (if any) further cases will be seen.”
Adam Burgess, head of MHRA’S Defective Medicines Reporting Centre said:
“Organisations who supply aseptically manufactured medicines, which including parenteral nutrition products, all follow the guidelines in EU Good Manufacturing Practice (GMP) to develop procedures on decontamination and microbiological monitoring. There is a specific annex in GMP Guidelines on the manufacture of sterile products.”
Prof Jon Cohen, Emeritus Professor of Infectious Diseases, Brighton & Sussex Medical School, said:
“This incident is not related to the issue of antibiotic resistance, something of course that has had a lot of airtime and with which the public is beginning to become familiar. These bacteria are in fact usually pretty sensitive to antibiotics; the issue here is that the patient’s immune system is so immature that they are not well able to deal with it. It is for that reason that infection with these bacteria is also sometimes seen in patients with leukaemia or transplant recipients whose immune defenses have been reduced by the treatment they are receiving for their underlying disease.”
Statement from St George’s Healthcare NHS Trust:
St George’s Healthcare NHS Trust can confirm that we administered seven of the MHRA identified units of intravenous nutrition to two paediatric patients.
The patients have been identified, their families have been informed and medical assessment has been arranged today. All indications suggest that they are well and appear to have experienced no ill effect.
We currently have one neonatal patient in our care who was transferred to us after being given one of the identified products whilst receiving treatment at another hospital. This baby has been given antibiotics and remains stable. We are continuing to monitor them closely.
Professor Nigel Brown, President, Society for General Microbiology, said:
“This tragic event reminds us how dangerous common bacteria can be if the circumstances are wrong. Thankfully, this Bacillus cereus strain appears to respond to readily available antibiotics.”
Statement from Luton & Dunstable University Hospital:
The Luton and Dunstable University Hospital has withdrawn a manufactured batch of intravenous liquid called parenteral nutrition following the infection of two babies with Bacillus cereus. Parenteral nutrition is a specialised form of liquid food that is given directly into the blood stream by an intravenous tube.
The L&D Hospital identified this bacterium and commenced appropriate antibiotic treatment in the affected babies. The L&D Hospital was alerted by Public Health England to the potential link between the infection with parenteral nutrition following similar cases in other hospitals. The company has since recalled specific batches of the feed. Public Health England and the MHRA (Regulating medicines and Medical Devices) are continuing to assess the situation and advising hospitals of action to take.
Dr Jennifer Birch, L&D’s Clinical Director for Neonatal Intensive care (NICU), said:
“We are informing all of the parents whose babies are being cared for in our Neonatal Intensive Care Unit about this situation. We are reassuring them that the infection does not spread from baby to baby. The two babies who have been infected are being treated with antibiotics and we are using an alternative type of parenteral nutrition.”
“Bacillus cereus is a bacteria found widely in the environment in dust, soil and vegetation. Most surfaces would be likely to test positive for the presence of the bacteria. Bacillus cereus produces very hardy spores and in the right conditions these will grow. The spores can produce a toxin which causes illness.
“The infection came to light here on Tuesday 3rd June. At this hospital we regularly monitor our babies for infection and because our laboratory identified the bacterium, we were able to start antibiotic treatment early on. We are very pleased that both babies are responding well to the treatment.”
Statement from Brighton and Sussex University Hospitals:
Background
Public Health England are investigating a number of cases of Bacillus cereus bacterial infections in the neonatal intensive care units at Chelsea and Westminster NHS trust, Guys and St Thomas NHS trust, The Whittington hospital ,and Royal Alexandra Children’s Hospital in Brighton. This has been declared a PHE Level 3 Incident with the potential of cases being affected outside of London. PHE are working with the MHRA to investigate potential sources of the bacteria.
A spokesperson for Brighton and Sussex University Hospitals said:
“We currently have three babies with confirmed Bacillus cereus bacterial infections being cared forin the Trevor Mann Baby Unit and they are all responding well to treatment.
“It is highly likely that these infections were caused by a feeding product that was contaminated during its manufacturing process outside the hospital and which is no longer being used by the Trust. All our policies and guidelines have been correctly followed.”
Prof Neena Modi, Professor of Neonatal Medicine, Imperial College London, said:
“The vigilance of neonatal staff has identified the source of infection as an unusual consequence of a rare organism surviving despite strict infection control policies, They are to be congratulated for preventing what might have been a major outbreak of serious infection”
Dr Martin Ward Platt, Royal College of Paediatrics and Child Health said:
“Blood poisoning caused by Bacillus cereus is extremely rare. Any baby developing such a serious infection can suffer from fever, pauses in their breathing, and vomiting, amongst other symptoms. It is very important to treat suspected infections as early as possible as they can be fatal.
“It seems that the recently reported infections, and a tragic death, have been associated with an intravenous feeding product. The immediate response has been for the affected hospitals to stop using the product, and it is generally easy for them to switch to alternative suppliers so that babies who need intravenous feeding do not go without it for a prolonged period.
“Naturally, parents whose babies are in intensive care anywhere in the country may be concerned, and if so I would urge them to talk to the doctors and nurses looking after their baby.”
Dr Alastair Sutcliffe, Paediatric Epidemiologist, UCL, said:
“Premature babies are by definition immunoparetic and thus more likely to handle bacterial infections such as this one poorly.
“Bacillus cereus is a rare human pathogen and thus any sepsis attributed to it would raise concerns.
“It is to the great credit of Public Health England that they have done such a fine piece of detective work to close in on the probable cause – namely that a fluid which is used as an intravenous feed (when a baby is so ill they can’t be fed) is contaminated.
“This occurrence is rare in UK manufactured products although there have been previous incidents involving both medicinal products and indeed food products given to children, for example the baby formula tragedy in China.
“I am glad the outbreak is under control and that most of the affected infants are responding to antibiotics.”
Prof Stephen Forsythe, Professor of Microbiology, Nottingham Trent University, said:
“All babies involved in this case were born prematurely – in such babies, even if mothers want or try to breast feed, mothers’ milk alone is not nutritious enough to support the babies so it is either fortified (topped up with formula) or a substitute is used, which is usually a rehydrated powder or total parenteral nutrition. The latter are sterile ready to use liquid feeds that are gently pumped into the neonate. They are used when the baby is unable to digest mother’s milk. They are prepared aseptically and should be free of bacteria.
“On this occasion is appears that the liquid feed was contaminated by the bacterium Bacillus cereus and the babies would have virtually no immune system to protect them. The bacterium is a spore-former and is therefore harder to control than many other types of bacteria as it will be better able to survive high processing temperatures. Nevertheless the bacterium is well known and is normally controlled.
“This seems like a totally exceptional and unusual incident, however unfortunately it has already had a tragic ending.”
Dr David Elliman, Consultant in Community Child Health, Whittington Health NHS Trust, said:
“Those babies who were needing intravenous nutrition would likely be those most susceptible to infection.”
Statement from CUH Addenbrooke’s Hospital:
“Public Health England has been investigating a small number of cases of infections on neonatal units within six UK hospitals, including CUH Addenbrooke’s. The infections were traced back to a feeding substance which has now been withdrawn. All the babies concerned are being treated and have responded well. Public Health England believes the outbreak is now controlled but will be following up to make sure there is no further risk. If parents have any concerns they should speak to their clinician.”
Prof Adam Finn, Professor of Paediatrics, University of Bristol, said:
“When a medicine makes patients sick, it is everyone’s worst nightmare. This contamination incident seems to have been detected quickly but, tragically, not quickly enough to save a life lost. Having stopped the outbreak, the next priority will be to understand how it came to happen and ensure it cannot recur.”
Prof Ron Cutler, Director of Biomedical Science Degree Programmes, Queen Mary University of London (QMUL), said:
“Bacillus cereus is widespread in the environment. It is commonly found in the soil. Poorly cooked food such as rice, which can be contaminated with these spores, are a common cause of food poisoning.
“Because they form spores it makes it more difficult to disinfect surfaces and materials contaminated with these spores without using high temperatures and/or powerful disinfectants. In addition when untreated, spores can survive in environments for long time periods.
“B. cereus is possibly the most common aerobic spore bearer in soil, dust, and plants. B. cereus is also often present in food production environments due to the adhesive nature of its endospores. This characteristic enables the bacterium to spread to all kinds of food.
“Because of the ubiquitous distribution of B. cereus in food products, the bacterium is ingested in small numbers and becomes part of the transitory human intestinal flora.”
https://www.gov.uk/government/news/investigation-into-bacillus-cereus-infections
Declared interests
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