Patient's Death Linked to IV Drug
Mary Washington fatality causes recall of tainted heart solutionSep 23, 2005 | Richmond Times Dispatch
Mary Washington Hospital reopened its heart-surgery unit yesterday after one patient recently died and two became seriously ill after operations using a drug later found to be contaminated.
The Fredericksburg hospital and the Virginia Department of Health are also reviewing the deaths of two additional heart patients this year. But hospital and state health officials said they might not be able to conclude whether the intravenous-drug solution contributed to those deaths.
The cardiac unit had been closed since Sept. 9. The drug manufacturer, Central Admixture Pharmacy Services Inc., issued a voluntary "urgent drug recall" notice through the Food and Drug Administration on Sept. 16, instructing hospitals in Virginia, Maryland, Delaware and Washington to stop using and to quarantine the drug, called cardioplegia solution.
Dr. Donald Stern, director of the state health department's Fredericksburg-area district, said yesterday that he is not aware of any deaths or severe illnesses at other Virginia hospitals but that hospitals are not required to report the complications that arose in the Fredericksburg cases.
Stern noted that Mary Washington Hospital performs a relatively smaller number of such surgeries about 320 open-heart surgeries annually and is therefore "very sensitive" when it comes to noticing "clusters" of patient complications.
"In larger programs, we wonder that they may not be so sensitive," he told reporters at a news conference at Mary Washington Hospital yesterday afternoon. "Is there more going on out there? It's hard to tell."
In the Richmond area, VCU Medical Center is the only hospital to use cardioplegia solution from Central Admixture Pharmacy Services, also known as CAPS. Dr. Michael Edmond, Virginia Commonwealth University hospital epidemiologist, said state health officials contacted the Richmond hospital Sept. 12 about a possible problem with the solution, and they immediately took it out of service.
Edmond said they started making their own replacement cardioplegia solution, which is used to help stop the heart during open-heart surgeries. He said VCU does not have any evidence of adverse patient outcomes that could be linked to the solution.
"If you have a contaminated product, if it is delivered into the bloodstream, the effect is seen relatively quickly," Edmond said.
The FDA said yesterday that it had received a preliminary report of infection in a patient who received cardioplegia solution while at a Maryland hospital.
The drug manufacturer also recalled several other drugs manufactured at its Lanham, Md., facility and instructed hospitals to quarantine the products.
Mary Washington Hospital reopened its elective cardiac-surgery unit, after two weeks, on the recommendation of the national Centers for Disease Control and Prevention and the state health department. Hospital officials said they will mix their own cardioplegia solution for the short term and hope to find another manufacturer for the longer term.
Stern said the CAPS drug solution came to the hospital in sealed bags and that the liquid itself was the "most likely source" of the contamination.
"We have not found any other likely source of contamination," he said.
CAPS President Eric Steen said yesterday that the company has not heard of problems from its approximately 1,000 clients nationwide, including 45 other hospitals served by its Lanham facility.
Central Admixture Pharmacy Services Inc. is based in Irvine, Calif.
Steen said the company is performing its own tests and working with federal officials to determine the source of the contamination.
"If we're the cause of it, we'll learn from that and take responsibility," he said.
Mary Washington Hospital suspended elective heart surgeries after Dr. John M. Armitage's team identified an "unusual cluster" of patients who had developed a severe reaction termed systemic inflammatory response syndrome. Those three patients underwent surgery between Aug. 31 and Sept. 7.
Armitage said the cluster was identified Sept. 8 and that the hospital tested the cardioplegia solution in its own laboratory and found bacterial contamination. The cardiac unit was then closed.
Stern said at least five of 39 bags of CAPS solution picked up from Mary Washington Hospital tested positive for contamination. The FDA says it determined two "lots," from which the bags are drawn, were contaminated.
After further review, Armitage, along with hospital and state health officials, determined that the deaths of two other heart patients, one in January and one in June, were "suspect."
But Armitage said health officials may never know what role, if any, the solution played in those deaths because they occurred months ago and the intravenous bags have been disposed of, unlike the more recent cases that resulted in the hospital's testing of the solution.