CMS SOM App. H, Tag V301

hemodialyzers and bloodlines–

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

patients;

Interpretive Guidance § 494.50(a)(1)

Note that, in the Interpretive Guidance, the term “reprocessing” refers to the processes of

cleaning and the installation of germicide into a dialyzer, and the term “reuse” refers to the

clinical use of a reprocessed dialyzer for hemodialysis.

.

Hepatitis B positive (HBV+) patients must be excluded from any reprocessing/reuse program.

Facilities must provide single-use dialyzers and bloodlines for patients who are HBV+.

If the facility reuses dialyzers and/or bloodlines for Hepatitis B positive patients, this

requirement is not met. This practice may impact the health and safety of the other patients

whose dialyzers are reprocessed and should be considered as Condition level non- compliance.

No Tag

(Rev. )

§ 494.50(a)(2) – Must be reused only for the same patient; and

Interpretive Guidance § 494.50(a)(2)

Page 118 of 420

This tag is informational. This requirement is addressed in the ANSI/AAMI RD:47 guideline at

V327 and should be cited there.