The Korea Centers for Disease Control and Prevention (KCDC) said the agency’s epidemiologic study concluded that sharing contaminated injections of lipid nutrients caused four newborns to die at Ewha Womans University Medical Center late last year.
The KCDC said Wednesday that the tainted smoflipid (injection for supplementing nutrition to patients who cannot digest orally) was epidemiologically associated with the neonatal deaths.
“The mortality risk in babies who received the lipid nutrient injection was 18 times higher than that of those who didn’t,” the KCDC said.
Regarding the pathogen test, the agency said that it found Citrobacter freundii in the lipid nutrient injections and the bacteria had identical genetic characteristics with the bacteria found in the bodies of the four babies. “We also detected the bacteria in some environmental specimens and presumed they were contaminated during the process of disposal or collection,” the KCDC said.
The health authorities added that Citrobacter freundii grew faster in the lipid nutrient injection than in normal microbial growth medium in a bacterial culture experiment. “If a lipid nutrient injection is polluted, the bacteria may multiply rapidly inside the injection,” the agency said.
Among the possible contamination scenarios of the contamination of the original product, pollution during the injection, and contamination during the preparation for the injection, the KCDC ruled out the possibility of original product contamination.
“Accepting tests on the same lipid nutrient injections and IV solutions that have been sold for the past year showed negative. There was no report of suspected pollution in the smoflipid,” the Ministry of Food and Drug Safety said.
The KCDC said that the possibility of contamination during the injection was also low.
“Three nurses administered each injection to four deaths. It was unlikely that the three nurses infected the babies with bacteria with the same genotype and form of antibiotics in each different injection simultaneously,” the KCDC said.
Instead, it was more likely that the contamination occurred in preparation for injections, the agency said.
To prevent a similar medical mishap, the KCDC said it would expand the nationwide monitoring of hospital-acquired infections, make infection management guidelines exclusively designed for neonatal intensive care units, and enhance education for infection prevention and control.