(CNSNews.com) - Compromised, tainted, or questionable blood may have entered the blood supply from 2003 to 2006, but the American National Red Cross can't or won't say for sure.
"I can't give you a yes or no answer -- all I can say is we are not aware of any adverse reactions," Red Cross spokeswoman Stephanie Millian told Cybercast News Service.
Last month, the U.S. Food and Drug Administration (FDA) levied more than $4.6 million in fines against the Red Cross for recalling more than 1,000 units of unsuitable blood and blood products during those years.
"To our knowledge, none of the units that were recalled, or that were transfused prior to the recall, have caused any adverse reaction or event in the recipient," Millian said.
The FDA cited the Red Cross for 113 instances of failure to properly handle blood or keep appropriate records.
Though some of the incidents were clearly clerical errors, the FDA also said the Red Cross had "failed to control suspect blood components," had "failed to quarantine" blood products and had "inappropriately released" tainted blood component(s):
- even after discovering clots in red blood cells (more than 10 units)
- after failing to properly test more than 125 units for syphilis
- even though 12 units clearly "should have been discarded"
The Red Cross also failed to "defer" or exclude from its inventory:
- more than 60 units of blood taken from donors who it later learned had traveled in malaria risk areas
- more than nine units that came from donors who had traveled in an area where there was known Creutzfeld Jakob Disease (CJD) - the human form of "mad cow disease"
And it failed to properly screen out donors:
- who had failed to answer questions about their health status, including whether they were HIV-positive or
- who were at "increased risk of infection with hepatitis" or
- who had tested "repeatedly reactive" for hepatitis B on "multiple occasions."
Under questioning from Cybercast News Service, the Red Cross, which couldn't say whether possibly tainted blood may have been transfused into patients, was quick to deny that any dangerous blood may have escaped.
"We haven't sent out HIV-positive units that have been transfused -- I can tell you that," said Eva Quinley, senior vice president for quality and regulatory affairs at the American National Red Cross.
"We have complete traceability of all our products, so we know the disposition of all the units," she said. "We know whether the units were transfused, or whether they were destroyed, or whether they expired."
Quinley also ruled out the possibility that any hepatitis-infected blood was actually transfused into patients.
"To my knowledge, no, that did not occur," the Red Cross executive told Cybercast News Service. "That would be a Class 1 recall, and we haven't had a Class 1 recall.
"Class 1 recalls are ones that would involve a definite risk to the blood supply, where (there's) a hepatitis-positive unit, or an HIV-positive unit. We have not had a Class 1 recall. All of ours have been Class 2 or lower," Quinley added.
Class 2 recalls involve products where the FDA has determined that any medical consequences are "reversible."
The Red Cross relies upon hospitals to report any "adverse reactions or incidents" involving potentially bad blood.
"We haven't had any adverse reactions reported," Millian said.
Concerning instances where the FDA said the Red Cross "inappropriately released" units of blood or "improperly tested for syphilis," Quinley said, "I can't say that none of those units weren't transfused, but the risk that that would pose is not as high as the Class 1's, and in fact, with the syphilis units you mentioned, the organism that causes syphilis dies within 72 hours of collection, and the organism that causes malaria, is very rare, and the travel we did the recall for was to areas where the risk was extremely low that it would be present. ...
"To our knowledge, there have been no adverse results in recipients that might have received blood that was a part of the recall. We haven't received any reports of that at all," Quinley said.
Millian explained that because blood can be stored for up to 42 days, the Red Cross was able to pull most of the recalled blood from shelves before it was ever used - or before it was sent to hospitals. Suspect blood was destroyed, she said.
But despite the assurances of "complete traceability," the Red Cross couldn't immediately and categorically tell Cybercast News Service what happened to the potentially contaminated blood and whether it had all actually been destroyed.
"We do have the information. We can provide it, but it will take a long time to get it together for you, because we have to go back to each of our regions to get that information," Quinley said. "It will take a long while, because we don't get it centrally."
In fact, during interviews that occurred over a period of nearly two weeks, the Red Cross executive said the information retrieval process could take several weeks longer.
'What is their excuse?'
Consumer watchdog groups like Ralph Nader's Public Citizen say the fact that the Red Cross can't immediately account for the disposition of its blood products is "irresponsible."
"Why can't they keep the records centrally?" asked Dr. Sidney Wolfe, director of Public Citizen's Health Research Group.
"The Red Cross is a huge organization. It has a very large budget, and in an age of electrons flying at the speed of light practically, what is their excuse? I just don't understand it."
Wolfe is far from surprised by the latest round of FDA fines. The Red Cross, he said, has developed "a 20-year reputation for the mishandling of blood."
"The American Red Cross has a history of not following a variety of rules and regulations regarding the collection of blood, the storage of blood, the labeling of blood, and the failure to stop blood that's contaminated from being shipped out and used by patients," Wolfe told Cybercast News Service.
In the 1990s, he said, the Red Cross blood collection system was in such disarray, and inspections took so much time and money to accomplish, that the FDA took the Red Cross to court.
As part of the original 1993 consent decree, the Red Cross agreed to establish "clear lines of managerial control" over blood and to provide better training, tracking, record-keeping and investigation of problems - including better tracking of adverse reactions.
In 2002, the Red Cross was responsible for 134 cases of suspected post-transfusion hepatitis - cases the Red Cross had not investigated because they had resulted from what Wolfe later told a Senate committee were "essentially illegal" policies.
In 2003, the government sought and won permission from the federal court to assess penalties against the Red Cross - the basis for the FDA fines levied in February.
"It is beyond belief, and it seems to keep going on," he added. "There was some optimism that it was getting better, but it doesn't look like it is getting any better."
The Red Cross, meanwhile, is quick to defend itself.
"The Red Cross and the FDA both agree that the blood supply is safer today than it has ever been," Millian said.
The Red Cross, she points out, "safely supplies millions of units of blood each year," and the 1,000 recalled units represent a tiny fraction of that output.
Moreover, the organization has put in place a variety of safeguards in recent years to protect the blood supply. These include:
- Potential donors are asked to provide a photo ID and are asked specific questions about their health and medical history. Donors whose blood may pose a health hazard are asked to defer themselves.
- Blood organizations must keep an updated list of individuals who have been deferred as blood or plasma donors and check all potential donors against that list to prevent use of units from deferred donors.
- Donors also are excluded based on risk of malaria, CJD and acute illness.
- All blood products are "quarantined" until the products have been tested and donation records have been verified.
- Indeed, all blood is now tested for a variety of blood-borne viruses or infections agents, including HIV-1, HIV-2, hepatitis B virus and other forms of hepatitis, syphilis and CMV (cytomegalovirus - a form of herpes that can be fatal for infants). In all, more than a dozen tests are typically performed.
"We don't send out a unit of blood the same day that it is given because we want to wait for test results before it is sent out," Millian said.
"There's no test for malaria, but that is one of our deferral criteria, so it's not just testing that we recall blood products for, it's paperwork - it's somebody that gets the flu that night that calls us and says, 'You know what, I ended up with the flu and you might not want to use my unit.' So we recall that unit as well."
Dr. Neil Blumberg, an expert on the blood supply on the faculty of the University of Rochester Medical School, defends the Red Cross against what he called "FDA nit-picking."
"I have not heard of informally, or seen in the media, or seen reported in the medical literature, cases of units that actually are infected being infused to patients," Blumberg told Cybercast News Service.
But critics say the fact that there have been no adverse reactions reported doesn't mean that possibly contaminated blood may not have escaped - or that the Red Cross is beyond concern.
"Certainly, the whole basis for many of the violations found by the FDA over the last few years was that a whole variety of viral and bacterially contaminated blood had been released," Wolfe said.
"Now I don't know if the recent ones include that or not, but certainly it was exactly those kinds of serious things that led the FDA to get this consent decree."
In fact, the FDA's top watchdog for the blood supply, Dr. Jay Epstein, has been critical of relying upon adverse reaction reports as a guarantee of safety for the blood supply.
In documents filed against the Red Cross in federal court in 2001, Epstein - director of the Office of Blood Research and Review at the FDA's Center for Biologic Evaluation and Research of the FDA - specifically warned that it is "a dangerous assumption" to assert that the blood supply is safe "because there has been no documentation of transfusion-associated infections" from unsuitable Red Cross blood products.
"Transfusion-transmitted infections may fail to be recognized and attributed to unsuitable blood for several reasons," he wrote.
"Many infectious organisms are dormant for long periods of time before they cause infection," Epstein wrote. "Since blood-borne infections can typically be acquired from [sources other than blood], physicians may not accurately attribute blood as the source of contagion."
Even if a doctor or a patient was able to link the disease to a blood transfusion, Epstein noted, transfusion-acquired infections must be reported by physicians, and "such reporting is not required of physicians."
Even Blumberg, meanwhile, is critical of how the Red Cross handles blood.
"There are many other large blood programs nationwide that don't have as many problems as the Red Cross does with the FDA, so I think the Red Cross has to take some responsibility for that," Blumberg said.
"I honestly think the national Red Cross should get out of the business of collecting blood and delegate that to the various Red Cross regions," he added, "because I think that all health care is local, and all blood collection and donor recruitment and distribution is largely local - or regional - anyway."
Attempts by Cybercast News Service to interview Epstein and others at the FDA were not successful.
The Red Cross is responsible for 40 percent of the nation's blood supply. It was fined $793,000 for violations in 2003, $698,000 for 2004, $3,090,000 in 2005 and $68,000 in 2006.
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