CHBT Reuse and Disinfection Protocols 2 — Questions and Answers
Question 1: What is the 'pressure test' (integrity test) performed during dialyzer reprocessing?
- A test that pressurizes the blood compartment with air to detect ruptured fibers that would allow blood-dialysate mixing (Correct answer)
- A test of the dialyzer housing strength to ensure it can withstand treatment pressures
- A check of the dialysate compartment pressure against the machine specifications
- A flow test to verify the dialyzer can achieve target blood flow rates
Correct 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.
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.
Question 2: A dialyzer being reprocessed shows a TCV of 74% compared to its original volume. What action should be taken?
- Discard the dialyzer; TCV below 80% is below the acceptable reuse threshold (Correct answer)
- Reprocess a second time; the TCV may improve after additional cleaning
- Use the dialyzer but extend treatment time to compensate for reduced clearance
- Send the dialyzer to the manufacturer for fiber bundle replacement
Correct 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.
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.
Question 3: What is the purpose of the 'water rinse' step during dialyzer reprocessing?
- To flush out blood, clots, and debris from the fiber bundle before disinfectant is applied (Correct answer)
- To apply the disinfectant solution evenly through the fibers
- To rehydrate the dry membrane after the pressure test
- To test water quality before it contacts the dialyzer
Correct 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.
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.
Question 4: Why must a reprocessed dialyzer not be used within a minimum contact time after disinfectant filling?
- The disinfectant requires a minimum contact time (typically several hours) to achieve sufficient germicidal efficacy against all target organisms (Correct answer)
- The dialyzer membrane needs time to rehydrate after the reprocessing rinse
- CMS regulations require a minimum 12-hour quarantine for all reprocessed equipment
- The disinfectant must evaporate partially before the dialyzer is safe to use
Correct 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.
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.
Question 5: Which body of standards primarily governs dialyzer reuse practices in the United States?
- ANSI/AAMI RD47 (Reuse of Hemodialyzers) in conjunction with CMS ESRD Conditions for Coverage (Correct answer)
- FDA 21 CFR Part 820 (Quality System Regulation for medical devices)
- OSHA 29 CFR 1910.1030 (Bloodborne Pathogen Standard)
- Joint Commission Environment of Care standards
Correct 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).
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).
Question 6: If a patient requests that their dialyzer not be reused, what is the appropriate response?
- Honor the patient's request; patients have the right to refuse dialyzer reuse and must be informed of their rights (Correct answer)
- Explain that reuse is a standard practice and the patient does not have a choice
- Allow the patient to opt out only if they pay the higher cost of single-use dialyzers themselves
- Document the request but continue reuse since it is medically equivalent
Correct 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.
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.
CHBT Reuse and Disinfection Protocols 2
What is the 'pressure test' (integrity test) performed during dialyzer reprocessing?