How Safe Is It To Receive A Blood Transfusion?

How safe is the blood supply today?

As steward of more than half of the nation's blood supply, the American Red Cross painstakingly and continually updates and refines procedures to ensure that today's supply is safer than it ever has been. In the face of recent threats to the blood supply, including hepatitis and HIV, medical advances in screening donors and testing blood have dramatically improved blood safety. The Red Cross continues to assure the safety of the blood supply through its state-of-the-art blood services operations which have been developed to meet the blood banking challenges of the next century. 

What is a recall?

As defined by the Food and Drug Administration (FDA), a recall is "an action taken by a firm to either remove a product from the market or to conduct a field correction." A field correction is a recall that does not result in the destruction of a blood product. It is a labeling error that must be corrected before the product is used.

There are three types of recalls: Class I recalls are for dangerous or defective blood products that could cause serious health problems or death. It is important to note that the Red Cross has only had a handful of Class I recalls, all due to bacterial contamination, an exceedingly rare and largely unavoidable occurrence. Class II recalls are for products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Class III recalls are for products that are unlikely to cause any adverse health reaction but are in violation of FDA regulations.

If the blood supply is safe, why are there errors and blood recalls?

The vast majority of errors that occur do not pose a safety risk to blood recipients. Currently, more than 90% of errors are discovered before the blood is distributed. Because our error detection systems are continually improving, we are discovering more errors and accidents, including many that occurred long ago. Errors that are discovered from long ago are reported and recalls are conducted based on the new information. Because of the age and type of these errors, in most cases the blood has already been safely transfused.

Some recalls have been prompted by clarification in FDA policy with no prior indication that earlier procedures were inappropriate. Many recalls are a result of accidents, which are both unpredictable and unpreventable, rather than errors on the part of the Red Cross.

Because the operations of the Red Cross Blood Services involve tens of millions of transactions, errors are inevitable. These errors range from equipment malfunction, such as fluctuating storage temperatures in blood refrigerators to improper or missing documentation. Not every error or accident affects the quality of the blood, and in most cases, the errors are discovered prior to release of the product. However, if a unit associated with an error is released, it must be recalled.

What types of transmissible diseases does the Red Cross test for?

Every unit of blood is tested for evidence of exposure to viruses which might cause diseases. Blood is tested for HIV-1 and HIV-2 (the viruses that cause AIDS), hepatitis B, hepatitis C, human T-cell lymphotropic viruses (HTLV-I and HTLV-II), ALT (the level of a liver enzyme), and syphilis.

What measures has the Red Cross implemented to screen donors for hepatitis?

new tests are being developed and implemented all the time. The introduction of hepatitis C testing in May 1990 reduced the rate of infection with hepatitis C by more than 90%, from approximately 1 in 200 to less than 1 in 3,000, and the introduction of an improved test in March 1992 has reduced that risk again. The current estimate is 1 in 103,000.

What measures has the Red Cross implemented to screen donors for HIV?

In spring of 1985, the Red Cross began testing all newly donated blood to detect the antibody to HIV-1 (AIDS). In April 1987, the Red Cross adopted the use of an improved FDA-licensed HIV-1 test that effectively detected at least 80% of blood that was infected with HIV-2 - a second AIDS-like virus. In February 1992, the Red Cross implemented the FDA licensed HIV-1/2 combination test that tests for a new strain of the AIDS virus still very rare in this country. In March 1996, the Red Cross began additional testing of all donated blood for the HIV antigen.

Currently, the estimated risk that an HIV infection donation would be available for transfusion is 1 in 676,000. In addition to the implementation of tests to screen the blood supply for HIV, factors which have contributed significantly to the reduction in risk are donor education, the introduction of donor screening which includes direct questions regarding risk factors, and screening each donor against a national Red Cross file of donors who may transmit an infectious disease.

Will I be informed by the Red Cross if I receive a tainted transfusion?

If a unit of blood is released and later discovered to be tainted or determined to be at risk of contamination, the Red Cross will conduct a "look back," a process that tracks and identifies recipients who may be at risk for infection. The Red Cross then notifies the hospital where the patient was treated. The hospital is then responsible for notifying the recipient as soon as possible.