CMS SOM App. H, Tag V311

(b)(1)

6 Patient considerations

6.1 Medical issues

An order to reprocess hemodialyzers shall be made by a physician knowledgeable about

reprocessing and its medical and economic implications. Because the current human

immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C status of a patient cannot be

known with certainty, all staff potentially exposed to the patient’s blood shall observe

Standard Precautions. Precautions for all infectious hazards should be emphasized and

included in the reprocessing procedures. Written procedures should stipulate whether and

how reprocessing will be done for patients who have shown sensitivity to materials used in

the reprocessing of hemodialyzers.

Interpretive Guidance § 494.50(b)(1)

ANSI/AAMI RD47:2002/A1:2003

6 Patient considerations

6.1 Medical issues

Dialyzers should not be reprocessed from patients who have tested positive with Hepatitis B

surface antigens.

AAMI Rationale for the Development and Provisions of this Recommended Practice

A.6 Patient considerations

A.6.1 Medical issues

The AAMI Renal Disease and Detoxification (RDD) Committee’s primary objective was not to

recommend medical indications for reprocessing or evaluate the medical or economic

implications of reprocessing but to provide recommendations for safe reuse practice.

At the time of this writing, the Centers for Disease Control and Prevention (CDC) does not

object to reprocessing and reusing dialyzers from patients with Hepatitis C or patients with

known HIV infection because of the low viral burden and transmission efficiencies. The AAMI

RDD Committee recommends, however, that standard precautions be used in the reprocessing of

all dialyzers.

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These precautions include the use of gowns, masks, and gloves. Each facility should be aware of

the hazards of infection and set policies accordingly.

Additional Guidance:

Dialyzers of patients who are positive for Hepatitis B must not be reprocessed. Refer to V301.

Facilities may also opt to exclude patients with other conditions from their reuse program.

Facility reuse policies must specify which patients would be excluded.

There should be evidence in policy or in the minutes of the governing body that the medical

director has made the decision to reprocess dialyzers. Additionally, physician orders for dialysis

therapy must include whether the patient is participating in the reuse program. If a patient has

shown sensitivity to the materials used in reprocessing, this problem must be addressed in the

patient assessment and plan of care.

Standard precautions must be followed in all reprocessing/reuse activities: PPE appropriate to

the task must be worn; and, all blood spills must be immediately cleaned. While it is not expected

that reprocessing staff would change gloves between handling separate dialyzers during routine

tasks, gloves that are visibly soiled with blood, as would occur during header cleaning, must be

changed between dialyzers, as well as when reprocessing staff switch from performing a “dirty”

task to a “clean” task, with appropriate hand hygiene performed prior to donning fresh gloves.