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Enterobacter sakazakii In Powdered Infant Formula DR. ABDULRAHMAN LOTFY Preventive Medicine – Jahra Hospital October 2011
FDA warning to health professionals powdered infant formula not to be used in neonatal intensive care settings.
Enterobacter sakazakii  Opportunistic pathogen that can cause infections such as necrotizing enterocolitis, bacteraemia, meningitis and brain abscess/lesions.  The species was defined in 1980, by Farmer et al.
The Organism  Gram-negative straight rod Enterobacteriaciae family (Coliform bacterium). the cells are motile (flagellated) and do not form spores.
Electron Microscope Photo web site (http://www.magma.ca/~scimat/E_sakaza.htm).
What is the magnitude of the problem?  The frequency in infants appears to be very low, yet the disease is devastating. Despite the low frequency of reported infections, mortality rate is relatively high  (33%).
Risk Factors
CLINICAL MANIFESTATIONS &  Clinical Manifestations         Complications: Ventriculitis (inflammation in the ventricles of the brain). Brain cysts and abscesses, Cerebral infarction,  Hydrocephalus    (abnormal increase in the amount of cerebrospinal fluid within the cranial cavity Necrotizing enterocolitis (localized death of small and large intestine tissues). Death may occur within a few hours to several days.
Mortality Rate:
Fatality From Meningitis* *Only one death has been reported  in the absence of meningitis, a neonate exhibiting bacteremia.
Antibiotic Susceptibility of E. sakazakii Susceptibility  Resistence Ampicillin,  Tetracycline, Chloramphenicol, Gentamicin, and third-generation cephalosporins.  aminoglycosides : Although E. sakazakii isolates are typically susceptible to it , such antibiotics are not recommended for primary treatment because of poor penetration into the central nervous system. Cefazolin, and extended-spectrum penicillins.
Treatment
Sporadic cases and outbreaks of Enterobacter sakazakii infection for which powdered infant formula (PIF) was implicated as the source agent. Drudy D et al. Clin Infect Dis. 2006;42:996-1002 © 2006 by the Infectious Diseases Society of America
Is the risk similar in all regions and countries? Reporting only in a few developed countries
A significant public health problem
Source of E. sakazakii Infections In early cases of E. sakazakii infections, an environmental source of the organism could not be identified Vertical transmission is not documented. Dried infant formula, has been identified epidemiologically as the source of E. sakazakii in three outbreaks of neonatal meningitis and linked to one outbreak of necrotizing enterocolitis.
Ecology of E. sakazakii
E. Sakazakii and flies household flies, were found to carry E. sakazakii. Similarly, E. sakazakii has been isolated from the gut flora of fruit flies, with no differences in distribution between males and females. Surprisingly, the organism was only isolated from a culture of fruit flies propagated in 1998 and not from a colony of flies over 30 years old.
Foods from which the organism has been isolated Meat &  minced beef,  Sausages Vegetables,(Lettuce, alfalfa sprouts) Tofu;  Bread,  Cheese;  Rice seed •Herbs & spices •Sous (licorice drink) •Dried products (infant cereal,, spices, whey, egg yolk , flour/meal)
Occurrence in food production environments and households
PIF and E. sakazakii  Powdered milk substitute infant formulas are the principal sources from which E. sakazakii has been isolated.
WHO – NO E.s. in BF.  In the current state of knowledge, no exclusively BF infants have been reported to have Enterobacter sakazakii infections.  Based on the available information, in 50-80 % of cases, PIF is both the vehicle and the source (direct or indirect) of E. sakazakii induced illness.
Survey - 1988  E . sakazakii was isolated from 20 of 141 dried infant formulas from 35 countries in a 1988 survey
latest  study ( 2008 published 2010)  In 2008 a study was done in Japan showed that E.sakazakii  isolated in 6% of PIF samples suggesting that commercially available PIF products can be contaminated with this type of bacteria
How does infant formula get contaminated with Enterobacter sakazakii?  Basically there are three routes by which Enterobacter sakazakii can enter infant formula:
1. Raw material used for producing the formula; 2. Contamination of the formula or other dry ingredients after pasteurization 3. Contamination of the formula as it is being reconstituted by the caregiver just prior to feeding.
colony-forming unit (CFU ) is a measure of viable bacterial or fungal numbers.  Unlike direct microscopic counts where all cells, dead and living, are counted, CFU measures viable cells. For convenience the results are given as CFU/mL (colony-forming units per milliliter) for liquids, and CFU/g (colony-forming units per gram) for solids.
Current Regulations Affecting Occurrence of E. sakazakii in Powdered Infant Formulas Regulations governing the prevalence of E. sakazakii in powdered infant formulas falls under the hygienic  requirements for allowable levels of coliforms.  For the Codex Alimentarius, these requirements include: minimum of four of five control samples with < 3 coliforms/g and  a maximum of one of five control samples with >3 but ≤ 20 coliforms/g.  Based upon these test parameters, dry milk-based infant formula that contains E.sakazakii at levels of < 1 organism per 100 g of formula would not be reliably detected.
What  do we  do now??
Recommendations & Preventative Strategies  The promotion of breast milk feeding, The World Health Organization recommends that infants should be exclusively breast-fed for the first 6 months of life.  Infants who are not breast-fed should be provided with a suitable breast milk substitute, formulated in accordance with Codex Alimentarius Commission standards.  To reduce the risk of infection in infants fed PIF, recommendations have been made for the preparation and storage of PIF
[object Object],Take care , E.sakazakii  inside
Education: The ideal  practice of re-warming of reconstituted formula.  Better understanding of the progression and pathogenesis ES related diseases
Why education?  Many individuals unaware that PIF is not a sterile product Lack information on how handling, storage and preparation practices can influence the risk Effective risk communication practices needed for the public and health professionals
Summary & Conclusion E. sakazakiiis a pathogenic microorganism The precise pathogenesis of ES remains a mystery.  Natural habitat is not known yet Found in infant formula Thermo-tolerant  FDA recommend method need some improvement  There are much more work to be done……. Appropriate measures by parents, infant formula manufacturers, and health care providers, as well as understanding of the pathogenesis, are important in the prevention.
THANK YOU  Breastfeeding Is A Tender From The First Moment

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E.sakasaki

  • 1. Enterobacter sakazakii In Powdered Infant Formula DR. ABDULRAHMAN LOTFY Preventive Medicine – Jahra Hospital October 2011
  • 2. FDA warning to health professionals powdered infant formula not to be used in neonatal intensive care settings.
  • 3. Enterobacter sakazakii  Opportunistic pathogen that can cause infections such as necrotizing enterocolitis, bacteraemia, meningitis and brain abscess/lesions. The species was defined in 1980, by Farmer et al.
  • 4. The Organism Gram-negative straight rod Enterobacteriaciae family (Coliform bacterium). the cells are motile (flagellated) and do not form spores.
  • 5. Electron Microscope Photo web site (http://www.magma.ca/~scimat/E_sakaza.htm).
  • 6. What is the magnitude of the problem? The frequency in infants appears to be very low, yet the disease is devastating. Despite the low frequency of reported infections, mortality rate is relatively high (33%).
  • 8. CLINICAL MANIFESTATIONS & Clinical Manifestations Complications: Ventriculitis (inflammation in the ventricles of the brain). Brain cysts and abscesses, Cerebral infarction, Hydrocephalus (abnormal increase in the amount of cerebrospinal fluid within the cranial cavity Necrotizing enterocolitis (localized death of small and large intestine tissues). Death may occur within a few hours to several days.
  • 10. Fatality From Meningitis* *Only one death has been reported in the absence of meningitis, a neonate exhibiting bacteremia.
  • 11. Antibiotic Susceptibility of E. sakazakii Susceptibility Resistence Ampicillin, Tetracycline, Chloramphenicol, Gentamicin, and third-generation cephalosporins. aminoglycosides : Although E. sakazakii isolates are typically susceptible to it , such antibiotics are not recommended for primary treatment because of poor penetration into the central nervous system. Cefazolin, and extended-spectrum penicillins.
  • 13. Sporadic cases and outbreaks of Enterobacter sakazakii infection for which powdered infant formula (PIF) was implicated as the source agent. Drudy D et al. Clin Infect Dis. 2006;42:996-1002 © 2006 by the Infectious Diseases Society of America
  • 14. Is the risk similar in all regions and countries? Reporting only in a few developed countries
  • 15. A significant public health problem
  • 16. Source of E. sakazakii Infections In early cases of E. sakazakii infections, an environmental source of the organism could not be identified Vertical transmission is not documented. Dried infant formula, has been identified epidemiologically as the source of E. sakazakii in three outbreaks of neonatal meningitis and linked to one outbreak of necrotizing enterocolitis.
  • 17. Ecology of E. sakazakii
  • 18. E. Sakazakii and flies household flies, were found to carry E. sakazakii. Similarly, E. sakazakii has been isolated from the gut flora of fruit flies, with no differences in distribution between males and females. Surprisingly, the organism was only isolated from a culture of fruit flies propagated in 1998 and not from a colony of flies over 30 years old.
  • 19. Foods from which the organism has been isolated Meat & minced beef, Sausages Vegetables,(Lettuce, alfalfa sprouts) Tofu; Bread, Cheese; Rice seed •Herbs & spices •Sous (licorice drink) •Dried products (infant cereal,, spices, whey, egg yolk , flour/meal)
  • 20. Occurrence in food production environments and households
  • 21. PIF and E. sakazakii Powdered milk substitute infant formulas are the principal sources from which E. sakazakii has been isolated.
  • 22. WHO – NO E.s. in BF. In the current state of knowledge, no exclusively BF infants have been reported to have Enterobacter sakazakii infections. Based on the available information, in 50-80 % of cases, PIF is both the vehicle and the source (direct or indirect) of E. sakazakii induced illness.
  • 23. Survey - 1988 E . sakazakii was isolated from 20 of 141 dried infant formulas from 35 countries in a 1988 survey
  • 24. latest study ( 2008 published 2010) In 2008 a study was done in Japan showed that E.sakazakii isolated in 6% of PIF samples suggesting that commercially available PIF products can be contaminated with this type of bacteria
  • 25.
  • 26. How does infant formula get contaminated with Enterobacter sakazakii? Basically there are three routes by which Enterobacter sakazakii can enter infant formula:
  • 27. 1. Raw material used for producing the formula; 2. Contamination of the formula or other dry ingredients after pasteurization 3. Contamination of the formula as it is being reconstituted by the caregiver just prior to feeding.
  • 28. colony-forming unit (CFU ) is a measure of viable bacterial or fungal numbers. Unlike direct microscopic counts where all cells, dead and living, are counted, CFU measures viable cells. For convenience the results are given as CFU/mL (colony-forming units per milliliter) for liquids, and CFU/g (colony-forming units per gram) for solids.
  • 29.
  • 30.
  • 31. Current Regulations Affecting Occurrence of E. sakazakii in Powdered Infant Formulas Regulations governing the prevalence of E. sakazakii in powdered infant formulas falls under the hygienic requirements for allowable levels of coliforms. For the Codex Alimentarius, these requirements include: minimum of four of five control samples with < 3 coliforms/g and a maximum of one of five control samples with >3 but ≤ 20 coliforms/g. Based upon these test parameters, dry milk-based infant formula that contains E.sakazakii at levels of < 1 organism per 100 g of formula would not be reliably detected.
  • 32. What do we do now??
  • 33. Recommendations & Preventative Strategies The promotion of breast milk feeding, The World Health Organization recommends that infants should be exclusively breast-fed for the first 6 months of life. Infants who are not breast-fed should be provided with a suitable breast milk substitute, formulated in accordance with Codex Alimentarius Commission standards. To reduce the risk of infection in infants fed PIF, recommendations have been made for the preparation and storage of PIF
  • 34.
  • 35. Education: The ideal practice of re-warming of reconstituted formula. Better understanding of the progression and pathogenesis ES related diseases
  • 36. Why education? Many individuals unaware that PIF is not a sterile product Lack information on how handling, storage and preparation practices can influence the risk Effective risk communication practices needed for the public and health professionals
  • 37. Summary & Conclusion E. sakazakiiis a pathogenic microorganism The precise pathogenesis of ES remains a mystery. Natural habitat is not known yet Found in infant formula Thermo-tolerant FDA recommend method need some improvement There are much more work to be done……. Appropriate measures by parents, infant formula manufacturers, and health care providers, as well as understanding of the pathogenesis, are important in the prevention.
  • 38. THANK YOU Breastfeeding Is A Tender From The First Moment