Enterobacter sakazakii Infection and Powdered Infant Formulas

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Health Professional Advisory

Enterobacter sakazakii Infection and Powdered Infant Formulas

Background:

 

On April 9, 2002, the United States Food and Drug Administration (USFDA) issued

an alert to US Health Care Professionals regarding the risk associated with

Enterobacter sakazakii infections among neonates fed milk-based, powdered infant

formulas. Historically, there have been several small E. sakazakii outbreaks

reported among infants fed milk-based, powdered formula products from various

manufacturers. In addition to powdered milk-based formulas, powdered human milk

fortifiers may also pose a hazard.

E. sakazakii is a motile peritrichous, gram-negative rod from the family

Enterobacteriaceae. This organism used to be known as a " yellow pigmented

Enterobacter cloacae " until 1980, when it was introduced as a new species based

on differences in DNA-DNA hybridization, biochemical reactions, and antibiotic

susceptibility. E. sakazakii is a rare, but life-threatening cause of neonatal

meningitis, sepsis, and necrotizing enterocolitis. In general, the reported

case-fatality rate varies from 40-80 % among newborns diagnosed with this type

of severe infection. The type of meningitis caused by E. sakazakii may lead to

cerebral abscess or infarction with cyst formation and severe neurologic

impairment.

 

There is still a paucity of information on the ecology of this bacterium.

However, studies have shown that this organism can be isolated from hospital and

processing plant environments. Reports have also suggested a correlation between

E. sakazakii infection and powdered infant formulas. Similarly, it has been

reported that premature infants and those with underlying medical conditions may

be at highest risk for developing an E. sakazakii infection.

 

Several outbreaks of E. sakazakii, in Neonatal Intensive Care Units (NICUs),

have been reported worldwide including countries such as England, Netherlands,

Greece, US and Canada. In Canada, two incidents of neonatal meningitis caused by

E. sakazakii were reported in two Canadian hospitals (1990, 1991). It should be

noted that healthy infants may not always be immune to E. sakazakii infections.

It has been reported that in Iceland, a healthy, full-term, newborn infant

became ill prior to hospital discharge and suffered permanent neurological

sequelae as a result of an E. sakazakii infection.

 

Health Canada is drawing attention to the fact that powdered infant formulas are

not commercially sterile products. Unlike liquid formulas, which are subjected

to sufficient heat to render them commercially sterile, powdered infant formulas

are not processed at high enough temperatures for sufficient time to achieve

commercial sterility. Ready-to-use liquid infant formulas are available only in

a commercially sterile form and indicated for premature or low-birth weight

infants. However, " transition " infant formulas which are used for premature or

low-birth weight infants after hospital discharge, may be either powdered or

liquid. Human milk fortifiers which are added to pre-term breast milk are also

available in powdered or liquid forms. A number of formulas, including formulas

for infants with metabolic conditions are only available in powdered form.

Powdered soy-based infant formulas may also become contaminated with E.

sakazakii through improper cleaning of production lines and may, therefore, pose

a safety hazard.

 

Recommendations:

 

Based on the above, Health Canada recommends that formula products be selected

based on nutritional and medical needs. Whenever possible, an alternative to

powdered formulas, such as ready-to-feed and concentrated liquid formulas,

should be chosen in the NICU setting and for immunocompromised infants. If there

is no alternative, the following steps will help control or minimize the risk:

 

Preparation of powdered infant formulas in a laminar flow hood by trained

personnel and using sterilized water, which should minimize contamination from

the environment. Refer to the following document for detailed procedures.

Preparation of Formula for Infants: Guidelines for Health-Care Facilities,

American Dietetic Association (updated April, 2002). Website:

www.eatright.org/formulaguide.html (official document in English; a French

translation is available on Health Canada's Website.

 

GMPs and proper sanitation should be adhered to at all times when manufacturing

and preparing any type of infant formula, liquid or powder. Since E. sakazakii

has been isolated from hospital and processing plant environments, there is a

potential for contamination with this pathogen during processing, preparation

and reconstitution of infant formulas.

 

For better assessment of the risk associated with E. sakazakii infections

related to infant formulas, Health Canada urges Health Care professionals to

promptly report adverse symptoms associated with the consumption of infant

formulas to the nearest Canadian Food Inspection Agency (CFIA) office (For more

information, please visit CFIA's website at www.inspection.gc.ca or the blue

pages).

 

At present, Health Canada is determining whether additional precautionary steps

are required to ensure the safe manufacturing and handling of infant formulas.

Health Canada is fully committed to communicating pertinent information to

Health Care Professionals and consumers, if, and as soon as it becomes

available.

 

 

 

 

karl theis jr

video field reporter

www.RealityExpander.com Ch.10 TimeWarner

Austin,Texas cell 512 297-9875

e-mail: theis888 www.exposureofthetruth.isfamous.com

 

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