Article1999

Blood component recalls in the United States

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Blood donation and transfusion practices Clinical Laboratory Practices and Quality Control Blood transfusion and management

Abstract

BACKGROUND: United States blood suppliers are required to recall marketed blood components later found to be in violation of Food and Drug Administration (FDA) regulations for safety, purity, and potency. Many recalled units have already been transfused. Analysis of the frequency and nature of blood component recalls would be useful for blood suppliers, transfusion services, and physicians. STUDY DESIGN AND METHODS: Each blood component recall in the weekly FDA Enforcement Report from 1990 through 1997 was examined for the number of units, recall reason, and hazard class. Units for manufacturing were excluded. RESULTS: In 8 years, an estimated 241,800 blood components were recalled, or approximately 1 in 700 units available to US hospitals. Eighty-eight percent of recalled units were in 22 large recalls of over 1000 units each. The most common reasons were incorrect testing for syphilis (57% of units) or viral markers (19%), reactive or previously reactive donor viral markers (6-11%), and inadequate donor-history screening (4%). Twelve units were in the FDA's highest hazard Class I, 24 percent were in Class II, and 76 percent were in Class III. Over 43,900 units had HIV-related problems, but only 3 units involved HIV transmission. Large recalls have declined since peaking in 1995, but units in small recalls increased 116 percent in 1997 over the previous 7-year average. CONCLUSIONS: Although high-risk recalls are rare, many blood component recalls pose medical concerns for physicians and patients. The recent decline in large recalls may be due to increased FDA oversight, stricter accreditation standards for quality improvement, and more centralized donor testing in large specialized laboratories. However, smaller recalls, which involve nearly all blood suppliers, were sharply higher in 1997.

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References

1977Standards for blood banks and transfusion services.1995Estimated Risk of Transmission of the Human Immunodeficiency Virus by Screened Blood in the United States 1998Collection and transfusion of blood and blood components in the United States, 1994 1997Safety of the Blood Supply in the United States: Opportunities and Controversies

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2013Blood Component Recalls and Market Withdrawals: Frequency, Reasons, and Management in the United States 2008A policy informing qualitative study to improve the process of blood product recalls and withdrawals

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