§ 494.50 Condition: Reuse of hemodialyzers and bloodlines.

(a) Standard: General requirements for the reuse of hemodialyzers and bloodlines. Certain hemodialyzers and bloodlines—

(1) May be reused for certain patients with the exception of Hepatitis B positive patients;

(2) Must be reused only for the same patient; and

(3) Must be labeled for multiple reuse in accordance with the premarket notification provisions of section 510(k) of the Food, Drug, and Cosmetics Act and 21 CFR 876.5860.

(b) Standard: Reprocessing requirements for the reuse of hemodialyzers and bloodlines. A dialysis facility that reuses hemodialyzers and bloodlines must adhere to the following reprocessing guidelines: