If a blood center leukoreduces all of its units, should they also use enhanced visual inspection procedures following leukoreduction?
As stated above, FDA regulations require visual inspection procedures during storage and immediately before distribution (21 CFR 606.160(b)(3)(ii) and 640.5(e)). Particulates have been observed in leukoreduced red blood cell products at a greatly diminished frequency. However, the medical director of each blood center should consider whether to utilize enhanced visual inspection techniques, above and beyond those that should already have been in place to comply with FDA regulations.
