Tag Archives: prevention

Questions and Answers about Cronobacter sakazakii and the Use of Powdered Infant Formula

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Provided by Illinois Department of Public Health

If you are concerned about your infant’s health or the infant is experiencing symptoms of meningitis or septicemia, which include fever, fussiness, vomiting, lethargy, not eating, listlessness or spine arching, immediately contact your pediatrician or local health care provider.

  • What is Cronobacter sakazakii? What diseases can the bacteria cause?

Cronobacter sakazakii, formerly known as Enterobacter sakazakii, is a bacterium. Illness from this organism is rare, but infection can cause meningitis and septicemia in infants. The infection can be fatal or result in long-term complications.

  • Where does the bacterium come from? Where can it be found?

The bacteria are everywhere in the environment and have been found in the intestinal tract of healthy humans and animals. Ingestion of food contaminated with the bacteria or the presence of the bacterium on surfaces, such as kitchen countertops, does not always result in illness.

  • How does powdered infant formula get contaminated with Cronobacter sakazakii? Can it be found in other foods?

The way powdered infant formula becomes contaminated with these bacteria is not well understood. Contamination can occur from the raw ingredients used in the formula, during the manufacturing process or during the preparation/reconstitution process. Contamination also may occur through blenders, feeding bottles and utensils used to cleanse feeding bottles. Contamination may be more likely when reconstituted formula is kept at improper temperatures prior to use or for a longer duration than suggested by manufacturers. The organism has been found in other foods, but only powdered infant formula has been linked to disease outbreaks.

  • Who is at risk for getting this infection?

Those at elevated risk for infection are premature and low birth-weight infants, infants with immune system problems or babies born to mothers with immune system problems.

  • How can this risk be minimized or reduced?

Commercially sterile liquid formula is less frequently associated with illness and can be used in instead of powdered infant formula, where possible. If powdered infant formula is chosen, remember it is not a sterile product and the use of boiled water can reduce the risk of infection. This includes tap water, bottled water or water specifically indicated for use in infant care.

Powdered infant formula should be prepared/reconstituted immediately before feeding time, according to package instructions and cooled appropriately before giving to the infant.

Additional tips to reduce infection risk

Clean utensils

  • Wash hands, forearms and fingernails thoroughly before handling any feeding materials or preparing formula.
  • All bottles, nipples, caps and rings should be washed in hot, soapy water with thorough rinsing.

Preparing formula

  • Before use, powdered formula should be kept dry in an airtight container with a firm cap or lid and stored in a cool, dark area. Make sure the expiration date has not passed.
  • During formula preparation, bring water to a bubbling boil for two minutes and allow the water to cool before mixing.
  • Avoid reheating formula and do not use a microwave oven to warm the formula.

Storing formula

  • Formula should be prepared in small amounts immediately before feeding time to minimize the need for storing prepared/reconstituted formula.
  • Prepared/reconstituted formula should not be stored at room temperature for more than one hour or more than four hours in the refrigerator.
  • Throw out any formula left in a bottle after feeding.

 

Posted from idph.state.il.us

Update on Enfamil, Infants and Cronobacter Infections

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Posted from healthmap.org

Jan 5, 2012
By Anna Tomasulo

In mid December of 2011, four infants were diagnosed with a rare bacterial infection. Two died. The infecting agent was Cronobacter sakazakii, formerly known as Enterobacter sakazakii. The US Centers for Disease Control and Prevention typically see four to six cases a year; however, in 2011 twelve cases were recorded. These most recent cases were found in four different states: Missouri, Illinois, Oklahoma and Florida.

As a precautionary measure, retailers recalled a powdered infant formula, Mead Johnson’s Enfamil, due to supposed association with the C. sakazakii infections. Two of the infected infants consumed Enfamil brand powdered baby formula, while the other two reportedly drank several different brands.

Tests conducted by the CDC revealed that the C. sakazakii found in Missouri and Illinois are genetically different, suggesting that the cases are not related. While tests from Missouri show presence of the bacteria in an open container of Enfamil as well as in an open container of nursery water (a distilled water used to prepare infant formula), no traces of the bacteria were found in other sealed containers of the powdered formula tested from the same lot. How the water and powder were contaminated remains unclear and the investigation continues.

In a joint statement released Dec. 30, the FDA and the CDC stated that there is no need for a recall of Enfamil formula.

Currently, the CDC is asking that public health officials nationwide be vigilant for other cases of Cronobacter infection among infants.

Symptoms of C. sakazakii infection include fever, poor feeding, and listlessness. Infection can lead to meningitis and septicemia. Infants with low birth weight or immune system problems have an increased risk of infection. Despite the rare occurrence of this illness, its severity should not be misjudged as it can result in long-term complications or death. The CDC recommends that any infant with C. sakazakii infection be brought to a physician for treatment.

Further, the CDC recommends breastfeeding over formula use. However, when breastfeeding is not feasible, the CDC and FDA provide the following recommendations for infant formula use:

  • Wash hands and all feeding utensils with soap and water before beginning preparations.
  • Water used in infant formula should be boiled first and then cooled quickly to serve to the infant.
  • Only prepare enough formula for one feeding and discard any leftovers.
  • Read “use by” date, storage information and preparation methods very carefully.

Resources:
Reporting a problem to the FDA:
fda.gov/Safety/ReportaProblem/ucm2005658.htm

FAQs and helpful hints from FDA on infant formula:
fda.gov/Food/FoodSafety/Product-SpecificInformation/InfantFormula/ConsumerInformationAboutInfantFormula/ucm108079.htm
fda.gov/ForConsumers/ConsumerUpdates/ucm048694.htm


Photo credit: Preston Smalley

The Problems With (Convenient, Cheap) Powdered Baby Formula

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Posted from TheAtlantic.com

Dec 28 2011, 6:10 PM ET

It might make feeding your infant easier than the alternatives, but there are at least three different ways it can become contaminated.

Mead Johnson Nutrition says it has tested additional samples of its Enfamil baby formula and still does not find the bacteria responsible for the death of one newborn infant and the illness of another.

The bacteria at fault are Cronobacter sakazakii, formerly known as Enterobacter sakazakii (bacterial taxonomists proposed this reclassification in 2007).

Last week, several retailers pulled Enfamil infant formula from their shelves because of fears that Enfamil was contaminated with this organism.

Walmart was the first to issue a recall.

The retailers actions were unusually cautious. Neither Mead Johnson nor federal investigators had evidence that the formula caused the illnesses. Federal agencies had not asked for a recall. But the retailers must have connected the dots:

The most likely source of C. sakazakii is powdered infant formula.
The two infants ill with C. sakazakii were fed Enfamil powdered formula (although the second ill infant drank several kinds of formulas).
In the chapter on infant feeding in my book, What to Eat, I noted that the main difference between one kind of infant formula and another is its cost. Powdered formula is much cheaper than the already reconstituted kinds. I asked:

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Beyond the difference in cost, does it matter which level of convenience you choose?

It might. Powdered formulas are not sterile. In this, they differ from concentrate and ready-to-serve formulas, which have been heated to sterilize them.

In 2002, the FDA warned pediatricians that powdered milk formulas could be contaminated with Enterobacter sakazakii, a type of bacteria that causes rare but terrible and sometimes fatal infections in infants, especially those who are premature, weak, or in hospitals.

The FDA says it is not aware of any E. sakazakii infections in healthy full-term infants in home settings.

Reports from other countries, however, suggest that even healthy babies may sometimes acquire such infections [see Kwan Kew Lai, "Enterobacter sakazakii infections among neonates, infants, children, and adults: case reports and a review of the literatur," (Medicine, March 2001.]
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In 2001, the CDC published a case report on this type of infection. It pointed out that “…in 50-80 percent of cases, powdered infant formula is both the vehicle and the source (direct or indirect) of E. sakazakii-induced illness.”

The CDC’s conclusion:

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Clinicians should be aware of the potential risk for infection from use of nonsterile enteral formula in the neonatal health-care setting.
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The World Health Organization has a Q&A:

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How does infant formula get contaminated with Enterobacter sakazakii? Can other foods also be contaminated?

Basically there are three routes by which Enterobacter sakazakii can enter infant formula:

a) through the raw material used for producing the formula;

b) through contamination of the formula or other dry ingredients after pasteurization; and

c) through contamination of the formula as it is being reconstituted by the caregiver just prior to feeding.

Enterobacter sakazakii has been detected in other types of food, but only powdered infant formula has been linked to outbreaks of disease.
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So the recalls were precautionary. It’s hard to argue with that — unless you are a stockholder; Mead Johnson stocks declined by five percent as a result.

At the moment, the source of these particular C. sakazakii infections is unknown. Let’s give the retailers credit for taking precautions to protect the public.

As for infant feeding in general: Breastfeeding is best, of course. If you are using formulas to feed your infant, the liquid ones are safer — but much more expensive.

Image: Mark Lennihan/Associated Press.

Bacteria Tied to Baby’s Death Linked to Formula Since 1980s

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Posted from BusinessWeek.com

January 05, 2012, 8:42 AM EST

By Robert Langreth and Alex Nussbaum
(Updates with company comments in the 16th paragraph.)

Dec. 28 (Bloomberg) — The rod-shaped bacteria that killed a Missouri infant this month have infected at least 120 infants worldwide since 1958 and have been linked to the use of baby formula in the past, public-health researchers say.

The potential for the bacteria, called Cronobacter, to infect infants through powdered baby formula has only been known since the 1980s, said Kieran Jordan, a microbiologist at the Moorepark Food Research Centre of Ireland’s Agriculture and Food Development Authority, in a telephone interview. Cronobacter ends up in powdered formula because it is well adapted at surviving in very dry environments, he said.

The bacteria may grow rapidly if the powdered product, with even small amounts of Cronobacter, is reconstituted in water that’s not hot enough to kill it, Jordan said. Once in a child, the infection can target the brain and spinal cord, causing swelling of the brain lining, health officials said.

“Once the baby powder is rehydrated it is a very rich environment for the bacteria to grow,” said Jordan, who has published multiple studies on Cronobacter.

The U.S. Food and Drug Administration advises boiling water for one minute and then letting it cool before mixing formula. Studies suggest powder needs to be mixed with water heated to at least 158 degrees Fahrenheit (70 degrees Celsius) to kill off bacteria, the agency says on its website.

‘Not Sterile’

Powdered infant formula is “not a sterile product,” said Chris Braden, who heads the Division of Foodborne, Waterborne and Environmental Diseases at the U.S. Centers for Disease Control and Prevention in Atlanta.

While formula sold as a liquid typically is pasteurized and “a very low risk,” it’s also more expensive, he said. Powdered formula should be used within a couple of hours of being mixed, and parents should remember to wash hands and equipment like bottles and nipples before preparation.

Not taking safety precautions can lead to permanent damage, Braden said. Even when children survive the infection, they may have neurological deficits, including developmental delays and seizures, he said.

Proving infant formula caused a given case of Cronobacter can be difficult because the bacterium is found “in the kitchen, in soil, even around the house,” Braden said in a telephone interview. It takes a “quite intensive investigation” to prove a cause, he said.

Mead Johnston Results

Mead Johnson Nutrition Co.’s Enfamil Newborn was pulled from store shelves by retailers last week after it was learned that a baby from Lebanon, Missouri, had taken it before becoming sick and dying. The company’s tests after the death showed no evidence of the bacteria in the same batch of product as that being evaluated by U.S. regulators, Mead Johnson said in a Dec. 25 statement.

State and federal regulators also are analyzing the case of an Illinois newborn given formula who fell sick with the infection during a trip in Missouri, and CDC officials yesterday confirmed a third Cronobacter infection in an Oklahoma baby who was hospitalized. While the Oklahoma child used powdered formula, it wasn’t the same brand and there’s too little evidence yet to say what caused the illness, Braden said.

Wal-Mart Stores Inc., one of the retailers who pulled the Mead Johnson product from store shelves, said it would await the result of government tests before taking further action.

The CDC in 2009 estimated the number of infants infected with the bacteria and reviewed a 2008 Cronobacter outbreak in which two babies in New Mexico were confirmed with the illness. One of the infants died and the other survived with severe brain damage, according to the CDC’s Oct. 30, 2009, issue of Morbidity and Mortality Weekly Report, an agency publication.

‘Only Risk Factor’

While investigators couldn’t pinpoint the source of the bacteria, infant formula “was the only known risk factor in the two cases,” according to the 2009 paper from the Atlanta-based health agency.

In 2001, a Tennessee baby died following progressive brain damage from Cronobacter infection. The baby was given powdered formula from a batch that was found to contain the bacteria, according to a study in the April 12, 2002, Morbidity and Mortality Weekly Report.

The incident prompted Mead Johnson to voluntarily recall the batch in March 2002, according to the CDC’s report. It also heightened awareness among formula makers, said Susan Ricker, Mead Johnson’s director of global quality services.

New Standards

“The industry started working with the regulators and the health officials worldwide to make sure that new and effective standards for Cronobacter testing were in place,” Ricker said in a telephone interview.

Mead Johnson now performs 2,300 “quality-control checks” on formula, including tests for nutritional quality and microbiological contamination mandated by U.S. and international standards, according to Ricker. The company samples 300 grams of each batch for Cronobacter contamination, equipment is washed regularly and there’s a system in place to identify “critical control points” where bacteria could enter.

“Once we have released a batch, we are stating it is safe for our consumers,” Ricker said.

The Glenview, Illinois-based company also takes steps to educate consumers about safety, said Chris Perille, company spokesman, in an e-mail.

All labels indicate that powdered formulas aren’t sterile and shouldn’t be fed to premature infants or those with immune problems unless under medical supervision, he said. The labels also cover proper hygiene, use and storage.

‘Very Young Infants’

The bacteria, when found, usually will have infected babies that are premature or have weak immune systems, said Mary Alice Smith, a toxicologist at the University of Georgia.

“It does seem to be the very young infants that are most susceptible to it,” said Smith, who has studied the bacterial infection and has received research funding from Mead Johnson.

The blood brain barrier in newborn babies, as well as parts of the gastrointestinal tract, may not be fully developed, making them more susceptible to the bacteria than older children and adults, Smith said.

–With assistance from Stephanie Armour in Washington. Editors: Andrew Pollack, Reg Gale

COMMONWEALTH of VIRGINIA: Department of Health Letter

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Posted from vdh.state.va.us

January 3, 2012

RE: FDA and CDC Update Regarding an Investigation of Cronobacter Illness in Infants

Dear Clinicians:

I am writing to share with you an important update issued by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) regarding Cronobacter illness in infants. Many of you may have heard about this situation through the press and media. I wanted to be sure you have accurate and timely information to address questions that may arise from your patients. It is important to note that Cronobacter can cause a severe infection in young infants that may lead to bacterial sepsis or meningitis. While no cases have been reported to the Virginia Department of Health, four recent cases of Cronobacter infection have occurred in infants in other states that resulted in two deaths.

If you diagnose a Cronobacter case in an infant by laboratory culture, please notify your local health department. As always, your local health department staff will work with you to collect additional information about the case and potential exposures. If you have any questions about Cronobacter, please contact Dr. Laurie Forlano, Acting State Epidemiologist, at 804-864-7554.

Thank you for your continued efforts and support in keeping our most vulnerable Virginians healthy.

Sincerely,

Karen Remley, MD, MBA, FAAP
State Health Commissioner
================================================================
FDA and CDC Update Regarding an Investigation of Cronobacter Illness in Infants
RELEASED: December 30, 2011

The Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and state health departments continue to investigate four recent cases of Cronobacter infection in infants in four states: Florida, Illinois, Missouri, and Oklahoma. There is currently no evidence that indicates the Cronobacter infections in these infants are related.

Based on test results to date, there is no need for a recall of infant formula, and parents may continue to use powdered infant formula following the manufacturer’s directions on the printed label.

The ongoing investigation includes laboratory testing of various types and brands of powdered infant formula, nursery water, and, when available, clinical samples from the infants. The investigation also includes the inspection of manufacturing facilities for infant formula and nursery water.

The following results have been confirmed from completed laboratory tests, although additional lab results are pending release:

  • CDC’s laboratory conducted DNA fingerprinting of the bacteria from two recent cases of Cronobacter infection in infants (Missouri and Illinois). The results show that the Cronobacter bacteria differ genetically suggesting they are not related. (Bacteria from cases in Oklahoma and Florida are not available for analysis.)
  • CDC laboratory tests of samples provided by the Missouri Department of Health and Senior Services found Cronobacter bacteria in an opened container of infant formula, an opened bottle of nursery water, and prepared infant formula. It is unclear how the contamination occurred.
  • The FDA tested factory-sealed containers of powdered infant formula and nursery water with the same lot numbers as the opened containers collected from Missouri, and no Cronobacter bacteria were found.

The FDA has inspected the facilities that manufactured the infant formula and the nursery water that tested positive for Cronobacter bacteria. Those manufacturers have programs that test their products before they are distributed. The lots in question were tested and found negative for Cronobacter. There is currently no evidence to conclude that the infant formula or nursery water was contaminated during manufacturing or shipping.

The FDA, CDC, and state agencies continue to investigate the cause of the infections using epidemiological and laboratory methods. Currently, CDC and FDA laboratories are testing infant formula, water, and other environmental samples related to the ill infants from Illinois and Oklahoma; the results are pending. Additional steps include: completion of inspections of manufacturers, additional laboratory testing of samples, and additional DNA fingerprinting investigation.

Last week following single reports of Cronobacter illness in infants in Missouri and Illinois, CDC asked public health officials around the country to look for other cases of Cronobacter infection among infants. This generated reports to CDC of two additional cases, one in Oklahoma and the fourth recent case in Florida. The illnesses in these infants occurred in late November and early December. The infants in Missouri and Florida, tragically, died as a result of their infection while the infants in Illinois and Oklahoma have survived.

Cronobacter is a very rare cause of a severe infection in young infants, and usually occurs in the first days or weeks of life. Typically CDC is informed of about 4-6 cases of Cronobacter a year. With recent increased awareness, CDC has been informed of a total of 12 cases in 2011.

Cronobacter causes severe bacterial sepsis or meningitis in infants, which often starts with fever, and usually includes poor feeding, crying, or listlessness. Cronobacter illness is diagnosed by a laboratory culture.

Any young infant with these symptoms should be in the care of a physician. There is no need to test a child that is not sick. If a Cronobacter infection is diagnosed by a laboratory culture, CDC encourages clinicians and laboratories to inform their local or state health departments.

Cronobacter bacteria is found in the environment and in hospitals and homes. It also can multiply in powdered infant formula after the powder is mixed with water.

CDC recommends breastfeeding whenever possible. When using powdered infant formula, CDC and FDA advises that caregivers make up fresh formula each time they feed the baby and discard any leftovers. In addition, recommendations for how to prepare and use powdered infant formula more safely include:

  • Wash your hands with soap and water before preparing the formula.
  • Clean all feeding equipment in hot soapy water.
  • Prepare only enough formula for one feeding at a time and give it to the baby right away.
  • Follow the manufacturer’s directions on the printed label.For more information from FDA on infant formula safety, please see:
  • Once Baby Arrives (fda.gov/Food/ResourcesForYou/HealthEducators/ucm089629.htm)
  • DA 101: Infant Formula (fda.gov/ForConsumers/ConsumerUpdates/ucm048694.htm)