In April 2002, an outbreak of Enterobacter sakazakii infection, including a fatal case of meningitis in a preterm neonate, was reported in association with a batch of contaminated Portagen powder.  This event, added to several other similar previous occurrences worldwide, led the CDC to advise clinicians to be aware of the potential risk for infection from use of non-sterile powdered formula in premature and immuno-incompetent neonates.

Whereas liquid infant formulas can be heated to high enough temperatures to ensure sterility, powdered formulas cannot.  Clinician should be aware that milk-based powdered infant formulas are not commercially sterile products.

Subsequently both the FDA and the ADA have issued a statement that “powdered infant formulas should not be used in neonatal intensive care settings unless there is no alternative available.”  The appropriate infant formula should be chosen for each patient based on assessment of individual nutrition needs, and if powdered formula must be used:

1.)    Trained personnel should prepare powdered formula under aseptic technique in a designated preparation room.

2.)    The manufacturer’s instructions should be followed.

3.)   The prepared product should be refriegerated immediately and discard if not used within 24 hours.

4.)   The “hang” time for continuous enteral feeding should not exceed 4 hours.

Vanderbilt’s formula storage and preparation guidelines were already in compliance with these recommendations; still, several modifications were made to ensure patient safety.

•Presterilized liquid formulas should be fed whenever possible. 

•Rather than Nutrition Services using concentrated powders to fortify formulas, liquid Osmolite will be added instead.

•Only milk-based powdered formulas have been implicated, therefore polycose powder is still considered a safe carbohydrate additive to increase caloric density.

•Human milk fortifiers have not been associated thus far with E. sakazakii contamination, and the known benefits of nutritional supplementation for the preterm infant currently outweigh any theoretical risks.

Since the original report and Mead Johnson’s recall of the implicated batch of Portagen, E. sakazakii contamination of several batches of Wyeth formulas was reported in November 2002; and most recently Mead Johnson recalled a batch of Enfacare Lipil due to E. sakazakii contamination.  Therefore,

•Infants being fed fortified breast milk should continue to have their fortification provided by HMF or SNC during nearly their entire hospitalization or until they weigh > 3- 3.5 kg.  Not until an infant is deemed healthy enough for discharge and Rooming In is planned should breast milk fortification be changed to a transitional formula powder.

Discussed and resolved at Clinical Division Meeting 4/15/02. Revisited 4/10/03.

References:

CDC. Enterobacter sakazakii infections associated with the use of powdered infant formula-Tennessee, 2001. MMWR 2002; 51(14): 298-300.

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5114a1.htm

FDA. Health Professionals Letter on Enterobacter sakazakii Infections Associated with Use of Powdered (Dry) Infant Formulas in Neonatal Intensive Care Units.

http://www.cfsan.fda.gov/~dms/inf-ltr3.html

The American Dietetic Association. Preparation of formula for infants: guidelines for healthcare facilities, 1991.  Revised 11/27/02 and available at:

http://www.eatright.org/formulaguide.html

Mead Johnson. EnfaCare Lipil Infant Formula Powder Recall, 1/9/2003.

http://www.meadjohnson.com/about/pressreleas/enfacarelipilpdrrecall.html