Look Backs, Recalls, and Withdrawals of Blood Products: Research and Analysis ofCases in a Five-Year Period at Our Institution

Abstract

Despite FDA-mandated regulations safeguarding the blood supply, on occasion, safety issues arise retrospectively. To address postdonation safety issues, there is a complex process involving look backs, recalls, and market withdrawals.We performed an audit of recalled and withdrawn blood products at our institution from outside blood suppliers. We conducted a search of institutional blood bank records from 2002 to 2007, seeking withdrawn and recalled blood products. We were able to identify 474 such incidents arising from a cadre of 6 blood supply sources. Based on our database analysis, the most common reason for recall or withdrawal during the stipulated period had been infectious disease risk associated with the donor unit, accounting for 30% of all causes followed by travel-related reasons (19%) and presence of clots in the blood product (13%). The other reasons included ABO incompatibility (2%), quality control issues (11%), misrepresentation on the donation form (5%), cancer (4%), medical disease (3%), drugs (8%), and miscellaneous reasons (5%). The infectious causes ranged from viral, CJD, West Nile virus, gastroenteritis, Giardia, Lyme disease, mononucleosis, and strep throat. The look-back process refers to tracking of blood products that have already been issued based on post hoc information questioning the safety of specified blood product(s). Most look-back processes are targeted toward a particular donor pathway, although in a larger blood collection enterprise, a generalized look-back process may be undertaken covering a period inferred to have global blood product safety concerns. Postdonation blood product variances may ultimately be subject to market withdrawal in instances of minor product safety issues. On the basis of postdonation scrutiny, retrospective safety monitoring alerts affected parties so that compensatory monitoring, testing, or therapy may be warranted. It adds additional security to improve the safety of the blood supply.