Table 6.
Recommendations based on everything I have learned about Cronobacter over the last 40 years.
| To microbiologists |
|---|
| • Preserve all Cronobacter isolates for future study |
| • See previous paragraphs for the many others |
| To government agencies |
| • Make a Cronobacter infection a reportable disease as it’s the case for many other serious infectious diseases. In the United States the state on Minnesota has done this, but it is apparently be the only state that has established this reporting requirement |
| To CDC – additional recommendations to add to your excellent recommendations for safely preparing infant formula |
| Powder examination steps |
| • Examine the powder and other items used in formula preparation carefully before each feeding |
| • Examine the powder for insects, insect parts, or other foreign objects. One manufacturer had a serious contamination problem with beetles, beetle larvae, beetle parts. They had to recall millions of packages of this adulterated producta (34). In my kitchen simulation experiments I sometimes saw flying and crawling insects in the areas around the sink that pose a possible contamination danger to the powdered formula or other items used in formula preparation |
| Water safety steps |
| • Always boil the water used in preparing formula, even if it is distilled or bottled water. Bacteria can contaminate water in numerous ways |
| Safety steps for the scoop used to measure the amount of powdered formula |
| • Insert a spoon or long forceps into boiling water for 1 min. This is a disinfection step to kill most germs that may be present |
| • Place the disinfected spoon or long forceps of a clean dish that has similarly been disinfected |
| • Insert the disinfected spoon or long forceps into the can of powdered infant formula to remove the measuring spoon |
| • Place the spoon in a small glass container that similarly been disinfected. Cover with aluminum foil to prevent contamination from germs in the air that can contaminate the spoon |
| • With your fingers touch only the handle of the scoop and remove it from its container |
| • Measure the correct amount of powder. Add water and mix as instructed |
| • Place the scoop back into the glass and cover it with foil |
| • By doing the above steps you greatly reduce the contamination of the powder with the scoop and your fingers |
| To CDC – an additional recommendation |
| • Do not use the word “infection” in “Cronobacter infection” unless infection has actually been documented |
| To the powdered infant formula industry |
| • Make a product that is free of contamination with Cronobacter, Salmonella, other pathogenic bacteria, other microorganisms, insects, insect parts, or other foreign objects |
| • Do much more intensive sampling and testing to detect and isolate Cronobacter and other pathogenic bacteria when you are testing for contamination of finished powdered formula, raw materials, the factory environment, and items supplied by contractors powdered formula |
| • Use sensitive and specific methods in the above testing that isolate and identify both viable and “viable but non-culturable” strains of Cronobacter, Salmonella, and other pathogenic bacteria |
| • Freeze or otherwise permanently preserved for future study all strains of Cronobacter, Salmonella, and other pathogenic bacteria isolated in the sampling and testing described above |
| • Notify FDA and when a strain of Cronobacter, Salmonella, or other pathogenic bacteria is isolated in any of the above |
| • Permanently preserve samples/cans (“library samples”) of powdered infant formula from each batch/lot made in the production facility. The reason for doing this is that additional testing is then possible to rule out or rule in the probable source when a case of infection by Cronobacter, Salmonella, or other pathogenic bacteria is reported following ingestion of the powder |
| • Implement CDC’s descriptions above (with improvements) for preparing infant formulas safety and add these to the label/instructions for each can of powdered infant formula |
| • Do not allow water to accumulate on the roof of the production facility! This was a documented problem at a Mead Johnson facility that produced powdered formula. The Structure Tech Company stated on its internet site: “Mead Johnson, a division of Bristol-Myers Squibb, was experiencing leakage conditions over their manufacturing operations, some of which were sterile environments.” The internet description above was apparently removed after this was damaging quotation was revealed in a legal case involving the Mead Johnson facility |
| To FDA |
| • Change from being an advocate of the powdered infant formula industry to being an advocate for public safety |
| • Require the powdered infant formula industry to implement the items listed above and those stated in previous paragraphs of this paper |
| • Provide documentation why you told the powdered infant formula industry it only needed to test one 333 gram sample of a lot of powdered formula when you own data from 2002 showed that this is an inadequate sample size, and that four 333 gram samples were needed to detect Cronobacter contamination |
| To the International Formula Council |
| • Do not distort facts in your role as an advocate for the powdered infant formula industry |
| • Do not make ridiculous statements such as “Enterobacter sakazakii is not a pathogen.” You lose all credibility when you act in an irresponsible manner in making a statement such as this |
| To mothers and preparers of powdered infant formula in the home and hospital |
| • Do breast feeding whenever possible |
| • When you cannot breast feed, use liquid formula rather than powdered infant formula |
| • When powdered infant formula is used, carefully read and follow CDC’s detailed description for preparing it more safely |
| • Add addtional safety steps listed above to further decrease injection risks |