Inquiry into Actions of Sector Agencies in Relation to contamination of Infant Formula with Enterobacter Sakazakii

Inquiry into Actions of Sector Agencies in Relation to Contamination of Infant Formula with Enterobacter Sakazakii
Date of publication: March 2005

In July 2004, a premature Waikato infant contracted Enterobacter sakazakii meningitis, and died. This tragic event led to an investigation which found that four other babies in the NICU were colonised with this organism, but did not become unwell. The investigation attributed the source of the organism to powdered infant formula used in the nursery.

E.sakazakii is a gram-negative rod-shaped bacterium which was first associated with neonatal deaths in 1958. Over the last 40 years about 50 cases of infection with this organism have been reported worldwide.

In April 2002 the Centre for Disease Control (CDC) and the U.S. Food and Drug Administration (USFDA) reported on a fatal case of E.sakazakii that had occurred the previous year. The USFDA made a number of recommendations to American health care providers.

They recommended that powdered infant formulas not be used in neonatal intensive care settings unless there is no alternative available. They also recommended that if a powdered formula had to be used, that risks of infection could be reduced by preparing only a small amount of reconstituted formula for each feeding, minimizing the holding time before a reconstituted formula is fed, and minimizing the time over which the formula is administered by feeding tube (hang-time) to less than 4 hours.

The New Zealand Ministry of Health (MoH) became aware of this information in mid 2002. The USFDA notification seemed to be related to a rare organism contaminating a brand of infant formula that was unavailable in New Zealand. We could not find any record that this information was passed on to hospitals or the public at that stage.

Over the next year and a half there was little public discussion about E.sakazakii but research continued, and in January 2004 WHO and FAO convened an international workshop in Geneva on the risk posed by this organism.

The Ministry of Health, and the newly formed New Zealand Food Safety Authority became aware of the report from this workshop the following month and began to consider a New Zealand response to the recommendations. On the basis that this was a rare infection, and no known cases had occurred in New Zealand, it was not considered that this process was urgent. Unfortunately within a few months of this work being commenced a cluster of cases occurred in New Zealand with one fatality.

This report considers the recent emergence of information about E.sakazakii and the recommendations regarding prevention of infection with this organism.

Addendum

Following the publication of this report the Ministry of Health has been informed of three earlier cases of Enterobacter sakazakii infection in New Zealand neonates. In 1986 a premature infant contracted E.sakazakii septicemia, but survived, apparently without serious sequelae. In 1991 premature twins contracted E.sakazakii meningitis. One twin suffered serious permanent neurological effects, and the other recovered fully.

The subsequent reports of these cases do not affect the findings or recommendations made in the report, but serve to highlight the importance of the recommendation that infection with this organism be made a notifiable disease.

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Related information

Communicable Disease

Notifiable Diseases

E. sakazakii invasive disease became notifiable on 21 July 2005
Notification enables both identification of instances of Enterobacter sakazakii (E. sakazakii) invasive disease and consideration of the need for public health action. Notification of E. sakazakii was a recommendation of a report into the investigation of the death of a premature infant who had contracted the disease in 2004.

E.Sakazakii Meningitis to become a Notifiable Disease (5 April 2005)

Recommendation to make E. sakazakii meningitis notifiable reinforced by historical cases (7 April 2005)

Infant Formula Advice Strengthened (26 August 2004)

Questions and answers about E.Sakazakii Meningitis

Guidance for Preparing Infant Formula Safely

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