CHBT Reuse and Disinfection Protocols 1 — Questions and Answers
Question 1: What is the primary justification for dialyzer reuse programs in hemodialysis?
- Cost reduction and potential improvement in biocompatibility due to protein coating of the membrane reducing first-use syndrome (Correct answer)
- Reused dialyzers provide higher clearance than new dialyzers
- Reuse is required by CMS as a cost-saving measure for ESRD programs
- Reused dialyzers have a smaller priming volume, reducing patient blood loss
Correct answer: Cost reduction and potential improvement in biocompatibility due to protein coating of the membrane reducing first-use syndrome
Dialyzer reuse reduces facility costs and may reduce first-use syndrome. Protein deposition on the membrane during first use creates a more biocompatible surface for subsequent uses. However, reuse programs require strict protocols to maintain safety and efficacy.
Dialyzer reuse reduces facility costs and may reduce first-use syndrome. Protein deposition on the membrane during first use creates a more biocompatible surface for subsequent uses. However, reuse programs require strict protocols to maintain safety and efficacy.
Question 2: Which test is performed to determine if a reused dialyzer is still suitable for patient use?
- Total cell volume (TCV) test to verify at least 80% of original fiber bundle volume is maintained (Correct answer)
- Culture of the dialyzer interior for bacterial growth
- Weighing the dialyzer to confirm it has not gained mass from protein accumulation
- Visual inspection only; no laboratory testing is required
Correct answer: Total cell volume (TCV) test to verify at least 80% of original fiber bundle volume is maintained
The total cell volume (TCV) measures the volume of the hollow fiber bundle. A minimum of 80% of the original (new) TCV must be maintained for the dialyzer to be reused. Values below 80% indicate clotting or fiber collapse reducing dialysis efficiency.
The total cell volume (TCV) measures the volume of the hollow fiber bundle. A minimum of 80% of the original (new) TCV must be maintained for the dialyzer to be reused. Values below 80% indicate clotting or fiber collapse reducing dialysis efficiency.
Question 3: What is the most commonly used disinfectant for dialyzer reprocessing in the United States?
- Peracetic acid/hydrogen peroxide mixture (e.g., Renalin) (Correct answer)
- Formaldehyde (37% solution)
- Glutaraldehyde
- Sodium hypochlorite (household bleach)
Correct answer: Peracetic acid/hydrogen peroxide mixture (e.g., Renalin)
Peracetic acid-based disinfectants (like Renalin) are now the most common, having largely replaced formaldehyde due to toxicity concerns. They provide effective germicidal action and break down into non-toxic byproducts (acetic acid, oxygen, and water).
Peracetic acid-based disinfectants (like Renalin) are now the most common, having largely replaced formaldehyde due to toxicity concerns. They provide effective germicidal action and break down into non-toxic byproducts (acetic acid, oxygen, and water).
Question 4: Before a reprocessed dialyzer is returned to a patient, what must be verified to ensure patient safety?
- Residual disinfectant must be tested and confirmed below safe threshold levels before connecting to the patient (Correct answer)
- The dialyzer should be refrigerated for at least 12 hours before reuse
- The disinfectant fill must remain in the dialyzer until connected to the blood circuit
- Visual clarity of the dialyzer housing confirms adequate disinfection without chemical testing
Correct answer: Residual disinfectant must be tested and confirmed below safe threshold levels before connecting to the patient
Residual disinfectant testing is mandatory before patient use. Disinfectant remaining in the circuit at connection can cause severe adverse reactions (hemolysis with peracetic acid, formaldehyde toxicity). The dialyzer is also flushed and primed before use.
Residual disinfectant testing is mandatory before patient use. Disinfectant remaining in the circuit at connection can cause severe adverse reactions (hemolysis with peracetic acid, formaldehyde toxicity). The dialyzer is also flushed and primed before use.
Question 5: What information must be labeled on a reprocessed dialyzer?
- Patient name/ID, number of previous uses, date of last reprocessing, and disinfectant used (Correct answer)
- Only the patient's name and room number
- The dialyzer serial number and manufacturing date only
- The technician's name and the machine it will be used on
Correct answer: Patient name/ID, number of previous uses, date of last reprocessing, and disinfectant used
AAMI and CMS standards require reprocessed dialyzer labels to include patient identification, number of prior uses, date/time of reprocessing, and the disinfectant used. This ensures the correct dialyzer is used for the correct patient and use limits are tracked.
AAMI and CMS standards require reprocessed dialyzer labels to include patient identification, number of prior uses, date/time of reprocessing, and the disinfectant used. This ensures the correct dialyzer is used for the correct patient and use limits are tracked.
Question 6: Under AAMI guidelines, what is the maximum number of times a dialyzer can be reused before mandatory discard?
- There is no universal maximum; reuse continues as long as the dialyzer passes TCV and integrity testing at each reprocessing (Correct answer)
- A maximum of 10 uses for all dialyzers regardless of performance
- A maximum of 3 uses for high-flux dialyzers and 5 for low-flux
- 25 uses for automated reprocessing systems and 10 for manual
Correct answer: There is no universal maximum; reuse continues as long as the dialyzer passes TCV and integrity testing at each reprocessing
AAMI standards specify performance criteria (TCV ≥80%, integrity test passage) rather than a fixed use limit. The dialyzer is discarded when it fails any performance criterion. However, many facilities set internal policy limits (often 12–20 uses) as an additional safety measure.
AAMI standards specify performance criteria (TCV ≥80%, integrity test passage) rather than a fixed use limit. The dialyzer is discarded when it fails any performance criterion. However, many facilities set internal policy limits (often 12–20 uses) as an additional safety measure.
CHBT Reuse and Disinfection Protocols 1
What is the primary justification for dialyzer reuse programs in hemodialysis?