E.sakazakii to become a Notifiable Disease

Media release

5 April 2005

E.sakazakii Meningitis to become a Notifiable Disease

A potentially fatal form of meningitis in premature babies linked to contaminated milk powder should be made a notifiable
disease according to a report released today.

The internationally peer reviewed report into Government agencies' response to infant formula contamination follows the death in July last year of a premature Waikato infant who died of meningitis. The death was caused by Enterobacter sakazakii sourced to powdered infant formula used in providing care for the baby.

Along with any notification of any instances of the disease, the report also recommends each notification be investigated and efforts made to trace and isolate the source of infection.

In 2004 the Ministry and the New Zealand Food Safety Authority advised all neonatal intensive care units against using powdered formula for pre-term babies where an alternative was available and reinforcing good hygiene practices when preparing formula.

The latest report puts under the spotlight the actions of the Ministry of Health, and later the New Zealand Food Safety Authority, following warnings in 2002 by United States based agencies the Centres of Disease Control (CDC) and the Food and Drug Administration (FDA).

The CDC and FDA warned US health care providers of a fatal case of E.sakazakiiwhich had occurred in the US the previous year and recommended against using powdered infant formulas in neonatal intensive care settings unless there was no alternative available. They also made handling recommendations to minimise infection risk when powdered formula had to be used.

However, in New Zealand there had been no reported cases of meningitis from E.sakazakii, the risks of infection were regarded as very small and the product implicated in the death in the US was not available here, and so the US alerts in 2002 were not passed on.

The alerts were emphasised in January 2004 by the World Health Organisation (WHO) following an international workshop on the issue. The WHO advice was considered by the Ministry and the New Zealand Food Safety Authority and a local response to the WHO recommendations was being developed.

Unfortunately within a few months of this work being commenced a case of E.sakazakii meningitis occurred in a neonatal intensive care unit in New Zealand.

As soon as the Ministry was notified, the Ministry and the Food Safety Authority issued advice recommending against powdered formula for pre-term babies where an alternative was available and reinforcing good handling practices when the formula was being prepared.

Director of Public Health Dr Mark Jacobs, one of the authors of the report, said the key findings of the report are that the Ministry and Food Safety Authority acted appropriately in August last year and overall the Ministry acted reasonably in 2002 given what was known at the time. However, the report found that the Ministry could have passed on the FDA recommendations in 2002 to hospitals with neonatal intensive care units.

The main recommendations of the report include the Ministry and Authority agreeing clearer roles and accountabilities for food borne illness; formalising communications between the two agencies; identifying a clear risk management pathway within the Ministry for international alerts on food safety and reviewing relevant public health advice and promotional material.

The final recommendation, to make meningitis infection from E.sakazakii a notifiable disease will help provide good information to help assess the effectiveness of these steps.

Dr Jacobs said there is still much we don't know about this disease and both the Ministry and the Food Safety Authority will ensure future international recommendations to further limit risk of infection are considered and implemented here as quickly as possible.

He said it was particularly unfortunate that the process of providing appropriate advice within New Zealand was overtaken before it was completed by the tragic death of a premature baby.

Dr Jacobs said it's hoped that the recommendations from this report, along with steps already taken, should help reduce the risk of similar tragedies in the future.

He said the review also provides a reminder to both health professionals and the public that powdered infant formula is a food and like most foods is not sterile. He says it reinforces the importance of good hygiene when anyone is preparing infant formula to minimise the risk of infection from possible contaminants.

Dr Jacobs said as a good rule of thumb any infant formula should be prepared immediately before use and any prepared formula that is not used should be discarded.

What sparked this report?
The report followed the death of a premature baby at a Waikato neonatal intensive care unit in July 2004. The baby died of meningitis caused by Enterobacter sakazakii which was believed to have come from powdered infant formula.

What is Enterobacter sakazakii?
Enterobacter sakazakii is a bacteria that was first associated with the deaths of premature babies in 1958. Over the last 40 years infections linked to this organism have been reported in neonatal units worldwide. The bacteria can lead to meningitis, sepsis or necrotizing enterocolitis. It is found in the environment and can sometimes contaminate food, particularly powdered infant formula. The bacteria may be present in the powder when it is bought or it can be introduced when the formula is being prepared.

Why didn't the Ministry pass on the warning it received in 2002 from the United States Centres of Disease Control and the Food and Drug Administration?
The Ministry of Health based its risk assessment on two factors:
1. The Centres of Disease Control warning - on which the FDA warning was based - related to a specific brand of infant formula not used in New Zealand.
2. No cases of meningitis from Enterobacter sakazakii have ever been reported here.
The risks were therefore regarded as very small.

Did the Ministry take any subsequent action?
Yes, in January 2004, when the advice was revised by the World Health Organization following an international workshop on the issue. A local response was being developed by the Ministry of Health and the New Zealand Food Safety Authority at the time the Waikato death occurred.

What action did the Ministry take in response to the Waikato death?
The Ministry of Health and the NZFSA issued advice to hospital neonatal units recommending against the use of powdered formula for premature babies where an alternative was available. They reinforced the advice given to parents and health professionals about the safest ways to prepare and store infant formulas.

Specifically, hospital neonatal units were advised to feed a ready-made liquid formula to neonatal babies who were not being breastfed. Ready-made formula is sterilised in the bottle, with far less risk of infection than powdered milk which is pasteurised - not sterilised - and requires greater care with preparation. Where powdered milk is used, the Ministry recommended the formula be prepared immediately before feeding and that caregivers only prepare the amount they need for one feed.

Is the report critical of the lack of action taken by the Ministry of Health and NZFSA in relation to the 2002 warning?
The Ministry was found overall to have acted reasonably in 2002 given the information that was available at that time. The report found both agencies had acted appropriately following the death of the Waikato infant. However, it said the Ministry could have passed on the FDA recommendations to hospitals with neonatal intensive care units in 2002.

In brief, what changes does the report recommend?
The report recommended that:
- Enterobacter sakazakii be made a notifiable disease with any notification of the disease investigated and efforts made to trace and isolate the source.
- the Ministry of Health and NZFSA agree to more clearly define their roles and lines of accountability for food-borne illness; improve communication between the two agencies; and identify a clear risk management pathway within the Ministry for international alerts on food safety and reviewing public health advice and promotional material.

Are there any timeframes for instituting these changes?
All relevant current Ministry information and health promotion material related to infant feeding is to be reviewed by the end of May 2005 to ensure it is consistent with the current recommendations.

The current recommendations made by the Ministry and NZFSA regarding Enterobacter sakazakii be reviewed in light of emerging information, by October 2005 at the latest.

What are the Ministry of Health and New Zealand Food Safety Authority recommendations for use of powdered infant formula?
Our Recommendations for all newborn babies:

• Breast is best!! Breast-milk contains all the nutrition newborn babies need and breastfeeding benefits both the mother and the baby.

• But if infant formula is the only option then…
for Full-term (37-42 weeks) and Healthy Newborns:

• Powdered infant formula is not sterile which means it may contain bacteria, however these bacteria almost never cause illness as long as the milk is prepared and stored properly.

• Healthy term babies have an extremely low risk of infection by Enterobacter sakazakii from powdered infant formula.

• If you are not breast-feeding the next best alternative is dairy-based powdered infant formula.

• It is now recommended that when preparing dairy-based powdered infant formula you only prepare the amount you need for baby’s next feed, and that you prepare it as close as possible to feeding time.
(A more detailed Guideline for preparing Infant Formula safely is attached below.)

for Premature, Low Birth Weight and Sick Babies (admitted to Neonatal Units):

• Breast milk is best for these babies too, but some may need formula or additional milk powder added to their expressed breast milk.

• If not breastfed, these babies should be fed ready-made liquid formula instead of powdered milk formula. Ready-made liquid formula is sterilised in the bottle, which means there is no risk of infection for babies given this formula.

• If no alternative to powdered formula is available then strict preparation and administration guidelines should be followed to minimise infection risk. Parents of premature babies should check with their neonatal unit staff.

Guidance for Preparing Infant Formula Safely

Before making up the formula:

• Make sure the powdered formula is stored in a clean dry place. Keep the formula covered, and check the use-by date. Use the powder within 4 weeks of opening the tin. Uncovered formula can become contaminated by bacteria or viruses carried on dust particles in the air or present in the environment.

• Sterilise bottles and teats (ask your Lead Maternity carer, Well child nurse or chemist for more information on how to do this if you’re not sure).

• For at least the first 3 months, all water (including bought water) used to make up formula should be boiled and cooled on the day it is used. Boil for 3 minutes on the stove top or until an automatic kettle switches off. Keep boiled water covered while it cools and until you need to use it.

• Water from tanks or bore holes should still be boiled and cooled for babies and toddlers until they are about 18 months old.
Unboiled water and unsterilised bottles can carry bacteria and viruses that can make baby ill.

Mixing the Formula:

• Always wash your hands thoroughly before preparing bottle feeds. Keep everything you use to make up baby’s feeds clean. Be especially careful in the first 3 months.

• Make up the formula carefully using the boiled, cooled water you have already prepared and following the instructions on the packaging exactly. Infant formula is balanced for baby’s nutritional needs, a stronger or weaker formula can harm baby.

• If baby is hungry and demands more, give more formula at each feed or give them an extra feed. Do not alter the formula strength.

• We recommend that you only prepare the amount you need for baby’s next feed, and that you prepare it as close as possible to feeding time.
Warming the Formula

• Formula can be heated by placing the bottle in a container of hot water.

• Microwaves can heat unevenly. If using a microwave, prepare the milk in a clean jug and pour it into the bottle before use, or at least shake the milk thoroughly after heating and leave to stand for 2 - 3 minutes. Shake again before using.

• Test the temperature of the milk on your skin – it should feel just warm (about body temperature).

• Use warmed formula within 20 minutes.

• Some babies may be quite happy fed with milk at room or fridge temperature.
Handling Prepared Formula:

• Throw out any formula that is left in the bottle after a feed, and wash and resterilise the bottle. Never reheat formula that has already been warmed or offered for feeding.
If you have to prepare a bottle in advance:

• If you have to prepare a bottle in advance (for a baby-sitter, or to take out with you), keep the prepared bottle at 4°C in the back of the fridge (check your fridge temperature).

• If carrying a bottle with you, keep the bottle cold in a chilly bin or insulated carrier.

• Throw out any prepared formula that’s been out of the fridge for more than 4 hours.

• Prepared formula should not be kept in the fridge any longer than 12 hours and ideally shorter times are better.
The temperature that babies like their formula is also a perfect temperature for harmful bugs to grow. Following the above guidelines means you will generally not be giving the bacteria a chance to grow to levels that can make baby sick. Please keep in mind that although infant formula powder is pasteurised it is not sterile (it can contain very low levels of bacteria) and in addition, there are lots of ways powder can accidentally be contaminated in the home. By taking care with handling and storage of prepared formula you can still protect baby from foodborne illness.

ENDS

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