Federal and state health officials were trying to figure out how intravenous feeding bags became contaminated with bacteria after nine critically ill patients died and 10 others were sickened at Alabama hospitals after being treated with the commonly used solutions.
Health officials on Tuesday would not directly link the deaths to the outbreak of serratia marcescens bacteria at six hospitals, but the bags were pulled off the market.
"There is nothing to suggest the deaths were directly related to the bacterial infection," said State Health Officer Donald Williamson who declined to give details on the patients including their ages and illnesses.
On March 16, two hospitals reported increased cases of serratia marcescens to the Alabama Department of Public Health. Officials linked the infection to TPN, a common nutritional supplement delivered directly from the plastic bags into the bloodstream through IV tubes.
A single pharmacy, Birmingham-based Meds IV, made the bags. Williamson said the company has notified its customers of the contamination, has discontinued production and was being very cooperative.
"We wouldn't be nearly as far along as we are without them," said Williamson.
Calls to Meds IV and its owner seeking comment were not returned.
Meds IV is registered to Edward Cingoranelli, who appears to have been involved in at least three other medical supply companies, according to the Alabama Secretary of State's office. Meds IV was incorporated two weeks after one of the other firms.
When Select Specialty Hospital in Birmingham learned one of its suppliers may have distributed bags containing the bacteria, it started investigating and stopped using Meds IV products, said the hospital's chief executive officer. Other hospitals also immediately stopped using the products.
"We are committed to high-quality patient care and are fully cooperating with government officials in their ongoing investigation of the supplier," Jeffrey Denney said.
Hospitals have very strict infection control for TPN. The supplement compound of several different nutrients, including electrolytes, is delivered daily in bags that are pre-mixed, not done in the hospital. The supplement is administered into a central line intravenously, going directly into the patients' blood stream. Patients are monitored carefully for symptoms of septic shock.
Serratia marcescens bacteria grow in moist areas and can settle in hospital patients' respiratory and urinary tracts. The bacteria is common and easily treatable if detected early. Patients with serratia sepsis may have fever, chills, shock, and respiratory distress.
Besides Select Specialty, other hospitals hit with the outbreak were Baptist Princeton, Baptist Shelby, Medical West and Cooper Green in the Birmingham area and Baptist Prattville, north of Montgomery.
The state health department, Centers for Disease Control and Prevention in Atlanta, and the Food and Drug Administration are investigating.
Williamson said the risk of more patients being exposed to the bacteria has ended.
"There are no outstanding cases of this infection. It is contained and closed," Williamson said.
The CDC in 2005 identified the bacteria as causing blood stream infections in about a dozen patients in New Jersey and California that were treated with contaminated salt solutions administered through IVs from similar bags.