Red Cross Problems Halt Tissue Dispersal
The American Red Cross has voluntarily halted the distribution of human skin and heart valves to hospitals nationwide after the Food and Drug Administration raised safety questions about the handling of tissue at the organization’s donor bank in Costa Mesa.
In a warning letter issued this week, the FDA faulted the Red Cross for not following procedures to prevent damage, infectious diseases or cross-contamination in the tissues.
The FDA said that workers at the Costa Mesa facility -- which processes about 20% of the nation’s skin for burn units and a similar quantity of heart valves for transplantation -- didn’t properly test disinfectants and failed to ensure that tissue was safely packed and shipped, among other issues. The FDA also found that employees in “critical management and production positions” hadn’t been properly trained.
The shortcomings came to light during a routine inspection last fall and “may be symptomatic of serious underlying problems,” the FDA warned. The Red Cross was ordered to correct the problems, but its response in late February was “inadequate,” regulators said.
The FDA’s mid-March letter gave the Red Cross 15 days to take “specific steps” to ensure that its tissue bank is following safety procedures.
“Obviously we want to make the proper corrections as soon as we can, and that is what we will do,” said Ryland Dodge, a Red Cross spokesman in Washington, D.C.
Dodge said the Red Cross wasn’t aware of anyone harmed by its tissue and that its February plan to the FDA was “more of an overall response instead of the detailed response they wanted, which we are preparing now.”
He said the organization would work with other tissue suppliers to ensure that hospitals aren’t affected.
At UCI Medical Center in Orange, which has Orange County’s largest burn unit, the Red Cross’ action wasn’t expected to cause a problem, said spokeswoman Kim Pine.
In the last 10 years, hospitals such as L.A. County-USC Medical Center have turned to bioengineered skin substitutes as an alternative to human skin, said burn center director Dr. Warren Garner.
“The engineered alternatives work as well or better and are safer. And there’s no risk of disease transmission,” Garner said.
He added that for hospitals that still use skin from donors, “there is some capacity at other burn banks” to temporarily cover a pullout by the Red Cross.
A message left with the FDA district director who wrote the warning letter to the Red Cross was returned by an agency spokeswoman who said she hadn’t read the letter and couldn’t comment.
Last year, the Red Cross agreed to tighten safety procedures in its handling of blood following years of complaints by the FDA. The agreement came after government regulators sought to hold the Red Cross in civil contempt.
