E. sakazakii Fact Sheet
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Several species within the genus enterobacter have been recognized as causative agents of hospital- acquired infections. Enterobacter sakazakii is a rod-shaped bacterium that has been implicated in several outbreaks of neonatal meningitis. It has been isolated from clinical materials including cerebrospinal fluid, blood, skin, wounds, respiratory tract (sputum, throat, and nose), the digestive tract and urine. Researchers have also isolated E. sakazakii from reconstituted milk-based infant formula. The presence of the microorganism in the finished product, therefore, probably originated in the factory, likely from heat-sensitive micronutrients added post-pasteurization.
E. sakazakii is a rare cause of invasive disease in neonates. Infection has been known to cause meningitis, which can result in severe neurological complications. Illnesses associated with E. sakazakii, including sepsis, meningitis, or necrotizing enterocolitis, have prompted the recall of certain powdered infant formulas in the United States.
Infant infections in the healthcare setting can be avoided by the proper handling and use of infant formula products. Clinicians should be aware that not all powdered formulas are sterile, and could potentially contain opportunistic pathogens such as E. sakazakii. A recent survey indicated that of 16 responding facilities, nine used powdered formulas in the NICU setting; four (25%) reported powdered formula as a principal source of patient feeding, and five (31%) reported use of powdered formula along with other formula types for principal feeding.
Risk for infection depends upon several factors, including the quantity of bacteria present in the product, handling after preparation, and underlying patient characteristics (e.g., immunosuppression, premature birth, or low birth weight). Because powdered formula is not always sterile, and may provide a good medium for growth, prolonged periods of storage or administration of powdered formula at room temperature might amplify the amount of bacteria already present. Health-care providers can reduce the risk to hospitalized neonates by choosing alternatives to powdered forms when possible. Individuals preparing formula should in all cases ensure they are following the manufacturer's written instructions.
A study of the thermal resistance of E. sakazakii in reconstituted dried infant formula demonstrated that the organism is highly thermo-tolerant. Thus, process controls during manufacture, along with the use of aseptic procedures during the storage and preparation of dried infant formula, can significantly reduce the potential for illness.
The FDA has already proposed recommendations concerning the preparation of powdered infant formula in the NICU, and advises that formula products be selected on the basis of nutritional need. They also recommend that written guidelines be available in the event of a product recall. These guidelines should include notification of health care providers, a system for reporting and following up on specific formula products used, and retention of recall records.
References:
Centers for Disease Control and Prevention. Enterobacter sakazakii infections associated with the use of powdered infant formula -- Tennessee, 2001. MMWR Morb Mortal Wkly Rep 2002; 51 (14): 298-300.
Weir, Erica. “Powdered infant formula and fatal infection with Enterobacter sakazakii”. Canadian Medical Association Journal, Vol. 166, 2002.
Kanhai et al. “Occurrence of Enterobacter sakazakii in food production environments and households”. Lancet, Vol. 363, 2004.
