Jim Shannon – 2014 Parliamentary Question to the Department of Health
The below Parliamentary question was asked by Jim Shannon on 2014-06-17.
To ask the Secretary of State for Health, when he plans to publish the results of the investigation of the recent death of babies due to bacillus cereus.
Jane Ellison
Bacillus cereus is a spore forming bacterium found widely in the environment in dust, soil and vegetation. There is limited prevention as it is a naturally occurring bacterium. However, the Food Standards Agency has published advice on their website which details information on potential food poisoning caused by Bacillus cereus.
The Medicines and Healthcare products Regulatory Agency (MHRA) undertake inspections of manufacturing facilities with reference to the standards of Good Manufacturing Practice to verify that companies are producing medicines that are of the correct quality and safety. The manufacture of sterile products, such as Total Parental Nutrition, is subject to special requirements in order to minimise risks of bacterial contamination.
In the case of medicines, the MHRA and Public Health England (PHE) are currently investigating what has caused the recent incident where Total Parenteral Nutrition became contaminated with Bacillus cereus . Based on the information we currently have, we believe this is an isolated incident and the appropriate immediate action has been taken to avoid a recurrence.
The devolved administrations have been informed of the current incident involving Bacillus cereus. The investigations into the cause of this incident are still ongoing. The Department will continue to discuss matters with the devolved administrations for minimising Bacillus cereus infection.
The investigations being undertaken by MHRA and PHE are in their advanced stages and preliminary findings will be published as soon as possible. While the MHRA and PHE are undertaking their own investigations, it would be normal practice for the Coroner to report on the individual case he is currently considering.
