The safety profile of automated collections: an analysis of more than 1 million collections.

BACKGROUND

Recent technology allows for the collection of 2-unit red cells (RBCs) and single-unit RBCs plus plasma or platelets (PLTs).

STUDY DESIGN AND METHODS

With a common definition of adverse events, 1,023,682 whole-blood collections were evaluated and compared with 249,154 two-unit apheresis RBC collections, 40,870 single-apheresis RBC collections, and 90,082 apheresis PLT collections.

RESULTS

The data show that manual whole-blood collections have a low incidence of moderate and severe reactions (47.1 per 10,000 collections, 0.47%). Single-unit RBCs collected by apheresis have the same safety profile (37.44 per 10,000 collections, p > 0.20). Double-RBC collections by apheresis and plateletpheresis have a significantly lower reaction rate (15.65 per 10,000 collections, p < 0.00005; and 14.84 per 10,000 collections, p < 0.00005, respectively).

CONCLUSION

It is concluded that automated collections are safe or safer than manual whole-blood collections. There should be few concerns when procedures are performed according to manufacturer's instructions.