State medical officer: Faulty pharmacy sterilization linked to patient deaths
By NEAL WAGNER / City Editor
A faulty sterilization process at a Birmingham medical company likely led to nine fatal bacterial infections at Alabama hospitals, including two at Shelby Baptist Medical Center in Alabaster, said state Health Officer Dr. Donald Williamson.
Williamson’s announcement came eight days after the Alabama Department of Public Health announced patients had died at Shelby Baptist and five other hospitals after receiving total parenteral nutrition supplements from the Birmingham-based Meds IV company.
All nine patients who died had developed serratia marcescens bacterial infections after receiving TPN, which is an intravenous nutritional supplement given to patients who, for medical or surgical reasons, are otherwise unable to receive their required nutrition through their gastric systems.
Williamson said ADPH and Center for Disease Control investigators discovered serratia marcescens bacteria in a tap water faucet, in an amino acid mixing container, on an impellor used to mix amino acids used in TPN manufacture and in the amino acids themselves at the Meds IV pharmacy.
The “DNA fingerprint” of the bacteria found at the Meds IV pharmacy matched the bacteria found in the deceased patients, Williamson said.
Williamson said it is not uncommon to find serratia marcescens bacteria in tap water, and it is not uncommon for pharmacies to use tap water to wash mixing containers.
Meds IV used tap water and soap to wash the container used to mix the amino acids. After the amino acids were mixed in the container, they were passed through a 0.2-micron filter to sterilize them before they were used to mix TPN.
“Had everything worked correctly, we would have had a sterile compound,” Williamson said. “What clearly happened was that there was a failure in the sterilizing step.
“Had the (sterilization) process worked, it should have kept the (serratia marcescens) organisms out of the amino acid solution,” Williamson added.
Williamson said the 0.2 micron filter was the right size to filter out bacteria and viruses, and ADPH and CDC investigators are still unsure why the filter at Meds IV failed to filter out serratia marcescens.
“There are several things we still have to investigate,” he said. “We will be working with other involved entities to discover exactly what went wrong in the sterilization process.”
ADPH and CDC began investigating Meds IV after an infection control manager at Shelby Baptist discovered a link between five serratia marcescens infections at the hospital and TPN in mid-March. The infection control manager then contacted the two entities, along with Meds IV, and reported the link.
Williamson said he did not believe the amino acids used at Meds IV were used to mix any other substances than TPN. He said it likely will be a “several week process” before ADPH and CDC are able to determine what part of the pharmacy’s sterilization process failed.
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