Red Cross Halts Blood Use
Officials Point To Baxter International's Collection BagsJan 2, 2003 | Baxter Bulletin
Hospitals in Georgia and northern Florida were warned Friday to halt use of some blood from the American Red Cross because it was contaminated with unidentified white particles.
The Red Cross reported the particles are not infectious agents and that no harmful effects in patients have been reported.
While acknowledging he didn't know the nature or source of the particles, Chris Hrouda, Red Cross chief executive officer for blood services in the southern region, said the problem was "likely with the bags." Hrouda said only blood in bags manufactured by Baxter International Inc., a leading manufacturer of blood-collection containers, had been found to be contaminated.
Vick Crawley, Mountain Home plant manager for Baxter Healthcare, a division of Baxter International, said the bags were not manufactured locally.
"The Mountain Home plant manufactures needles for blood packs and PVC sheeting that the bags are made out of," Crawley said. "The bags themselves are manufactured at other locations.
"We (also) manufacture kits that include containers for platelet collection. Those kits are not currently used by the American Red Cross," he said.
The Red Cross said it has identified the location of all the possibly contaminated blood and was working with Baxter International and the Food and Drug Administration to find out how the contamination happened.
Officials said it is probably not related to sabotage.
"We haven't ruled anything out, but it's hard to fathom that it could be that," Hrouda said. "We still don't exactly know what these particles are."
The contaminant, which is not organic, can be seen with the naked eye and is practically translucent, said Dr. Christopher D. Hillyer, an Emory University professor who works with the Red Cross. It is not uniform, with some bags containing more than others.
Hillyer said the blood may turn out to be usable, after it is tested for potential problems.
A spokeswoman for Baxter International said the company's investigation showed the substance was "biologic in nature and most likely blood related."
"You're talking about living cellular material it needs to be handled under pretty precise circumstances," Deborah Spak said.
Mary Malarkey, director of case management for the Food and Drug Administration's Center for Biologics Evaluation and Research, said the Red Cross plans to ask the Centers for Disease Control and Prevention to test the material.
The Red Cross said so far 110 of the approximately 4,000 units at its regional center were contaminated. The agency provides blood to 140 hospitals in Georgia and northern Florida, but it didn't know how much, if any, of this blood was affected.
Dr. Leslie Holness of the FDA said all the bags affected were an older type of product being phased out by the Red Cross, and added the Southern Region is the only one still using the bags.
Members of the Georgia Hospital Association were advised not to use the blood, forcing them to postpone elective surgeries and use backup blood for emergencies. There are 185 hospitals in this association, but not all of them get blood from the Red Cross.
"We're taking more of a cautious approach and putting the blood on hold," said Kevin Bloye, a spokesman with the Georgia Hospital Association. "For some of our hospitals without a large supply of blood in reserve, that's a big problem."
"Blood is available for emergency surgeries," said Marcy Blount, spokeswoman for the Red Cross. "We are asking hospitals not to use some of the blood in their inventories while we are having a quality assurance review."
Emory University Hospital expected to receive blood from outside the region by the afternoon, spokesman Brad Minor said. Because the hospital often faces blood shortages for other reasons, plans were in place to change surgery schedules.
"It hasn't affected any patient care," Minor said. "We've basically rescheduled our surgeries so the ones that don't require blood are in the morning and the ones that do are in the afternoon.
"We deal with blood shortages all the time, so it's nothing new to us."
All surgeries at Northside Hospital with a major risk for blood loss were canceled Friday, said spokeswoman Katherine Watson.
Patients undergoing minor surgeries were asked to sign a consent form to make sure they were aware of the problem.