Reuse and Disinfection Protocols Flashcards

What is the 'pressure test' (integrity test) performed during dialyzer reprocessing?

Answer: A test that pressurizes the blood compartment with air to detect ruptured fibers that would allow blood-dialysate mixing

The pressure integrity test applies compressed air to the blood compartment and monitors for pressure drop. A drop indicates ruptured fibers that could allow blood to mix with dialysate (blood leak). Dialyzers failing this test must be discarded.

A dialyzer being reprocessed shows a TCV of 74% compared to its original volume. What action should be taken?

Answer: Discard the dialyzer; TCV below 80% is below the acceptable reuse threshold

A TCV of 74% is below the 80% minimum required for safe reuse. The fiber bundle has lost too much volume (due to clotting or fiber damage), reducing effective surface area and dialysis efficiency. The dialyzer must be discarded.

What is the purpose of the 'water rinse' step during dialyzer reprocessing?

Answer: To flush out blood, clots, and debris from the fiber bundle before disinfectant is applied

The rinse step removes blood, proteins, and cellular debris from the blood and dialysate compartments. Thorough rinsing before disinfectant application is essential — organic material (blood) neutralizes disinfectants and prevents effective sterilization.

Why must a reprocessed dialyzer not be used within a minimum contact time after disinfectant filling?

Answer: The disinfectant requires a minimum contact time (typically several hours) to achieve sufficient germicidal efficacy against all target organisms

Disinfectant minimum contact time is critical to achieve the required log reduction of microorganisms. Peracetic acid-based disinfectants typically require 11 hours of contact. Reusing dialyzers before this time may result in inadequate disinfection.

Which body of standards primarily governs dialyzer reuse practices in the United States?

Answer: ANSI/AAMI RD47 (Reuse of Hemodialyzers) in conjunction with CMS ESRD Conditions for Coverage

ANSI/AAMI RD47 is the primary standard for dialyzer reuse, covering reprocessing procedures, disinfectant efficacy, TCV testing, labeling, and staff training. CMS enforces compliance through its ESRD Conditions for Coverage (42 CFR 494).

If a patient requests that their dialyzer not be reused, what is the appropriate response?

Answer: Honor the patient's request; patients have the right to refuse dialyzer reuse and must be informed of their rights

Patient autonomy requires that all patients be informed about reuse practices and given the right to refuse. CMS ESRD regulations mandate that facilities inform patients of their reuse policy and respect refusals. Coercion or ignoring opt-out requests is prohibited.