Dialyzer Reprocessing
Reprocessing
• Dialyzers are reprocessed after a treatment, then used again by the same patients
• Regulated by CMS and some states
• Safe and effective if done correctly
History of Reprocessing
• 1960’s: most patients used Kiil dialyzers
• Membrane replaced after each treatment
• Took ~2 hours to “rebuild” a Kiil each time
Evolution Of Dialyzers
• 1960s-’70s: new, better dialyzers:
• Coil
• “Disposable” flat plate
• Hollow fiber
• Each new model cost more and required new
reuse methods
Reprocessing Over Time
% of treatments
using reprocessed
dialyzers
Why Reuse Dialyzers?
• Medical Reasons:
• Reduces “First Use Syndrome”; a reaction
to the membrane or ETO used to sterilize it
• Non Medical:
• Cost savings
• Enabled use of high flux dialyzers
• Landfill/environmental concerns
Discussion Questions
• If you were on dialysis, would you want a reprocessed dialyzer?
• Why or why not?
Reprocessing Guidelines
• The Association for the Advancement of Medical Instrumentation (AAMI) developed guidelines
for dialyzer reprocessing
• 1996: FDA required dialyzer manufacturers to label them for “Single” or Multiple” use
Automated vs. Manual
• Better quality control with automated systems
Preparing a Dialyzer for First Use
1. Label with the patient's name and ID number
• Include an alert to watch for similar names
• Include first & last name, middle initial, medical record #
• Leave space for # uses, reuses, ID of reprocessor, test results done on the
dialyzer
• Labels must stay readable and not cover up key data
• Labels must not obscure the blood path
Preparing a Dialyzer For Reuse
2. Measure Total Cell Volume (TCV)
• Also called fiber bundle volume or baseline clearance
• Ability of dialyzer to remove wastes
• Check each dialyzer against its own TCV
Rinse back After Treatment
• Returning the patient’s blood:
• Helps reduce red blood cell and iron loss
• Facilitates reprocessing
Preparing a Dialyzer For Reuse
3. Preprocess the dialyzer
➢ Removes residual manufacturing chemicals
➢ Allows for more accurate TCV measurement
Reprocessing Steps
1. Clean dialyzer to remove residual blood cells
2. Test performance; discard rejects
Reprocessing Steps
3. Disinfect the dialyzer
4. Store the dialyzer until next use
Used with permission from RLM Enterprises, Inc.
Dialyzer Disinfection Options
Disinfectant Pros Cons Time in
Contact
Peracetic acid Biodegradable ↑$$$ 11 hrs.
Formaldehyde ↓$$$ • Hazardous 24 hrs.
• Shower needed
• Carcinogenic
• Disposal $$
Glutaraldehyde ↓$$$ • Breathing/skin 10 hrs.
problems
• Disposal $$
Heat + Citric Acid Safe & clean • Not an option for all 20 hrs.
dialyzers
Discussion Questions
• Which disinfectant would you choose?
• Why?
Disinfectant Pros Cons Time in
Contact
Paracetic acid Biodegradable ↑$$$ 11 hrs.
Formaldehyde ↓$$$ • Hazardous 24 hrs.
• Shower needed
• Carcinogenic
• Disposal $$
Glutaraldehyde ↓$$$ • Breathing/skin problems 10 hrs.
• Disposal $$
Heat + Citric Acid Safe & clean • Not an option for all 20 hrs.
dialyzers
Hazardous Materials
• Disinfectants kill microorganisms
• By definition, they are hazardous
• Read and follow product safety information
Used with permission from Minntech Renal Systems.
Dialyzer Storage
• Wipe down outside of dialyzers
• Keep new and reprocessed dialyzers apart
• Store on wall racks or cart
• Clean storage unit per clinic protocol
Preparing for Next Use
• Inspect the dialyzer
• Is it labeled properly?
• Damaged?
• Filled with disinfectant?
• Remove disinfectant:
• Rinse dialyzer with saline and dialysate
• Test to make sure all disinfectant is out
• Verify that dialyzer is used for the right patient
Discussion Question
• How will you explain dialyzer reprocessing to patients?
Potential Hazards of Reprocessing Dialyzers
• Bacteria and endotoxin can cause pyrogenic reactions or septicemia in patients
• Patients can be exposed to hazardous reprocessing chemicals
• Reprocessing can reduce dialyzer efficiency, reducing adequacy
Documentation
• Document every step in reprocessing, from removing a new dialyzer from its package
to discarding it after a last use
Quality Assurance
• To safely reprocess dialyzers, follow good quality assurance techniques
• Monitor every aspect of the process to make sure it is done correctly
• Evaluate procedures to ensure that they are effective
Conclusion
• Dialyzer reprocessing can be safe and effective if done correctly
• If there is not adequate attention to the quality of the reuse program, it
can be dangerous for both patients and staff
