With 2 infants dead in Ohio the CDC Investigates additional Cronobacter cases in US

Why is not Cronobacter sakazakii reportable in more that one state in the US?

Why was the first illness on September 16, 2021, but the first recall not until February 20, 2022?

According to the CDC, on February 10, 2022, CDC was notified of FDA’s investigation of consumer complaints of infant illness related to products from Abbott Nutrition in Sturgis, Michigan. These complaints include three reports of Cronobacter sakazakii infections and one report of Salmonella Newport infection in infants. CDC and FDA are conducting additional laboratory testing and investigation to better understand these cases as well as any additional cases.

In September 2021, and FDA inspection uncovered several issues:

• Personnel working directly with infant formula, its raw materials, packaging, or equipment or utensil contact surfaces did not wash hands thoroughly in a handwashing facility at a suitable temperature after the hands may have become soiled or contaminated.
• You did not maintain a building used in the manufacture, processing, packing or holding of infant formula in a clean and sanitary condition
• An instrument you used to measure, regulate, or control a processing parameter was not properly maintained.
• You did not monitor the temperature in a thermal processing equipment at a frequency as is necessary to maintain temperature control.
• You did not install a filter capable of retaining particles 0.5 micrometer or smaller when compressed gas is used at a product filling machine.

No recall was initiated.

From September 16, 2021, to January 5, 2022, CDC received reports of three Cronobacter cases in infants that were later found to be linked to FDA’s ongoing investigation. On February 16, 2022, CDC asked clinicians and state and local health departments to provide information on other cases of Cronobacter infection associated with infant formula from November 2020 through the present. Since then, CDC has identified one additional reported case of Cronobacter infection in an infant who consumed formula produced at this facility.

As of February 28, 2022:

• Four infants in Minnesota (1), Ohio (2), and Texas (1) consumed formula produced at the Sturgis, Michigan, facility before they got sick.
• These infants consumed formula that included Similac Sensitive, Similac Pro-total Comfort, Similac Advance, and Similac PM 60/40.
• Cronobacter infections may have contributed to the death of two infants in Ohio.

CDC has received reports of more possible cases of Cronobacter illnesses in infants and is investigating to determine if these cases are linked to formula products produced at the Abbott Nutrition facility in Sturgis, Michigan. CDC is performing whole genome sequencing on Cronobacter bacteria isolated from available patient samples to compare them with the environmental samples taken at the facility to determine if there is any relation.

FDA reports one complaint of a Salmonella infection in an infant who was fed recalled formula. CDC’s routine outbreak surveillance has not detected an outbreak of Salmonella illnesses linked to this case reported to FDA or any other cases of Salmonella linked to recalled formula.

The FDA has noted that Cronobacter infection surveillance is not handled the same way as infection with more common foodborne pathogens, such as Salmonella or E. coli O157:H7. Cronobacter is not nationally notifiable and not reportable except in one state, which means doctors and labs are not required to report cases to their health department. Because Cronobacter is not a nationally notifiable pathogen, FDA relies on consumer complaints of illness sent to the Agency and on health care providers informing FDA directly about infants with Cronobacter infections. In addition, because Cronobacter is not nationally notifiable, whole genome sequencing (WGS) is rarely performed on these isolates.

Republished with permission from Bill Marler and Marler Clark. Copyright (c) Marler Clark LLP, PS. All rights reserved.