Nine people died and 10 others were sickened this month after receiving nourishment from the kits. But because all the patients were already seriously ill, investigators may never be able to determine whether the IV feeding liquid contaminated with bacteria was to blame for the deaths and illnesses, said Dr. Donald Williamson, director of the Alabama Department of Public Health.
There was a single incident in January, but officials didn't notice a pattern until this month. Officials have not released the names or illnesses of the patients who were sickened. However, patients who typically use the IV feeding liquid have severe illnesses, including gastrointestinal diseases or are chemotherapy patients, Williamson said.
Officials believe the outbreak was linked to one batch of feeding liquid produced at a Birmingham-area laboratory of Meds IV, and all the contaminated material has been recalled. "From what we know right now it is a closed circle," Williamson said.
The contamination came from products that had not been sterilized thoroughly, health officials say.
"These infections usually have a very rapid onset, within a matter of hours or days, so we think we have captured all the cases of contamination that have been related to this particular pharmacy," said Dr. Alex Kallen, health officer with the Centers for Disease Control and Prevention.
Officials with Meds IV, which was formed last year and is based in a Birmingham office park, did not respond to telephone calls and messages. The company website says it provides sterile products to hospital pharmacies, surgery centers and doctor offices.
"Our staff of pharmacists has over 50 years of sterile product admixing experience," the website says.
The product was exposed to contamination while in the compounding process in the pharmacy itself. The final usable product was not distributed outside of Alabama, Kallen said. "They come from lots of different places. They are sterilized products that are subject to very rigorous controls. The usual problem that we see is compounding of those products in the actual pharmacy rather than contamination of the precursor products," Kallen said.
Meds IV compounds the mixture according to a physician's orders. Problems were first detected at Shelby Baptist Medical Center in the Birmingham suburb of Alabaster, where two patients died and three others were infected after receiving TPN, a common nutritional supplement delivered directly from the plastic bags into the bloodstream through IV tubes. Seven patients were infected at Baptist Princeton, and four of them died. One also died at Prattville Baptist Hospital.
"We have terminated our relationship with the supplier and, as a precaution we have removed all other products from the supplier from the pharmacy stock in our hospitals," said a statement by Dr. Elizabeth D. Ennis, chief medical officer for Baptist hospitals. Williamson said two hospitals reported increased cases of bacteria called serratia marcescens to the state March 16. Officials linked the infection to TPN produced by Meds IV.
Meds IV has notified its customers of the contamination, has discontinued production and has been very cooperative, he said. 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.
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 Jeffrey Denney 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," Denney said.
Hospitals have 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 are common and easily treatable if detected early. Patients with serratia sepsis may have fever, chills, shock, and respiratory distress.
Also hit with the outbreak were UAB Medical West and Cooper Green in the Birmingham area.
The state health department, Alabama Board of Pharmacy, the CDC and the Food and Drug Administration are investigating.
The CDC in 2005 identified the bacteria as causing blood stream infections in about a dozen patients in New Jersey and California who were treated with contaminated salt solutions administered through IVs from similar bags.