DIALYZER REPROCESSING
Manual
Engr. Apollo M. Arquiza
Objectives
• To review the process on dialyzer “use” and
“reuse”, quality control monitoring and
documentation
Outline
• DEFINITION OF HEMODIALYZER REUSE
• SYSTEM DIAGRAM FOR REPROCESSING DIALYZER
• MANUAL REPROCESSING
• SEMI-AUTO REPROCESSING
• PREPARING DIALYZER FOR THE FIRST USE
• HANDLING DIALYZER AFTER DIALYSIS
• PREPARING DIALYZER FOR NEXT USE
• QUALITY CONTROL MONITORING
• DOCUMENTATION
• QUALITY ASSURANCE AUDIT FOR REUSE STAFF
TECHNICAL DEFINITION OF
HEMODIALYZER REUSE
• Hemodialyzer reuse is the practice of using
the same dialyzer for multiple dialyses
exclusively for the same patient.
• This is accomplished by utilizing restoration techniques
including cleaning, testing, and sterilization.
• Mutiple use of dialyzer begins with labeling of new dialyzer
REF. QUALITY ASSURANCE GUIDELINES FOR HEMODIALYSIS DEVICES
REF. CORE CURRICULUM FOR THE DIALYSIS TECHNICIAN 4TH ED.
HAZARD AND CAUSE
• Pyrogen reaction / bacteremia
– caused by inappropriate water treatment
– improperly prepared germicide
– outdated germicide
– not enough contact time
– improper storage conditions
– inadequate filling of dialyzer
• Reaction to residual germicide
– caused by inappropriate sterilant rinse
• Poor/excessive ultrafiltration rate
– caused by low total cell volume
REF. QUALITY ASSURANCE GUIDELINES FOR HEMODIALYSIS DEVICES
CORE CURRICULUM FOR THE DIALYSIS TECHNICIAN 4TH ED.
CRITICAL POINT
• The problems were due to user error
• These incidents could have been avoided through:
– Simple test
– observation
– implementation of quality control procedure
REF. QUALITY ASSURANCE GUIDELINES FOR HEMODIALYSIS DEVICES
SYSTEM DIAGRAM FOR
REPROCESSING DIALYZER
(ANSI/AAMI RD47:2008 RECOMMENDED PRACTICE)
NEW DIALYZER PREPARATION
NEW DIALYZER
STORAGE
RELABEL
PREPROCESS (optional)
FIRST USE
DIALYZER REPROCESSING
SUPPLIES
CHECK REJECT
STORAGE
TAP WATER TERMINATION OF DIALYSIS END TX
TIME LIMIT
WATER TREATMENT RINSE & CLEAN
FAIL SPECS RELABEL
PERFORMANCE TEST (TCV) REJECT
LEAK TEST REJECT
STERILANT FILL
INSPECTION REJECT
DIALYZER PREPARATION FOR TREATMENT
STORAGE
TIME LIMIT
INSPECTION REJECT
PATIENT ID CHECK
STERILANT TEST (POT)
REJECT
LEAK TEST (HEAT D.)
STERILANT RINSE
STERILANT TEST (RESID) REJECT
INITIATE DIALYSIS END TX
REF. AAMI DIALYSIS STANDARDS 2015
MANUAL REPROCESSING
MANUAL REPROCESSING
CURRENT PRACTICE / CAPABILITY;
– CLEANING IS ACHIEVED BY WATER RINSE,
REVERSE U.F. OR NSS RINSE
– STERILANT FILL IS ACHIEVED BY HD MACHINE
GRAVITY FILL OR BY USING A SYRINGE
– TCV MAY BE POSSIBLE BY USING
A GRADUATED CYLYNDER
MANUAL REUSE FLOW PROCESS
TAP WATER TERMINATION OF DIALYSIS END TX
WATER TREATMENT RINSE & CLEAN
FAIL SPECS PERFORMANCE TEST (TCV) MAYBE/NONE
LEAK TEST NONE
STERILANT FILL
INSPECTION 2/3 FULL? NO
STERILANT TEST POT ? NO
INSPECTION, RECORD, RELABEL
DISINFECT EXTERIOR
STORAGE
MANUAL REUSE FLOW PROCESS
PREPARATION PRIOR TO INITIATING DIALYSIS
STORAGE
TIME LIMIT
INSPECTION REJECT
PATIENT ID CHECK
STERILANT TEST (POT)
REJECT REPACK, RELABEL, STORE
LEAK TEST (HEAT D.)
STERILANT RINSE
STERILANT TEST (RESID) REJECT
INITIATE DIALYSIS END TX
SEMI-AUTO REPROCESSING
SEMI-AUTO REPROCESSING
• CAPABILITIES;
– RINSING AND CLEANING (AUTOMATIC)
– PERFORMANCE TEST (Manual via graduated cylinder)
– LEAK TEST (automatic via pressure sensor)
– STERILANT FILL ( automatic pump)
– STERILANT MIXING (manual via graduated cyl.)
– COMMON STERILANT CAN BE USED
(i.e. Formaldehyde, Citric acid, Peracetic acid)
SEMI AUTOMATED REUSE FLOW PROCESS
TAP WATER TERMINATION OF DIALYSIS END TX
WATER TREATMENT RINSE & CLEAN
FAIL SPECS PERFORMANCE TEST (TCV) REJECT
LEAK TEST REJECT
STERILANT FILL
INSPECTION 2/3 FULL? NO
STERILANT TEST POT ? NO
INSPECTION, RECORD, RELABEL
DISINFECT EXTERIOR
STORAGE
SEMI AUTOMATED REUSE FLOW PROCESS
PREPARATION PRIOR TO INITIATING DIALYSIS
STORAGE
MIN TIME
INSPECTION REJECT
PATIENT ID CHECK
STERILANT TEST (POT)
REJECT REPACK, RELABEL, STORE
LEAK TEST (HEAT D.)
STERILANT RINSE
STERILANT TEST (RESID) REJECT
INITIATE DIALYSIS END TX
PREPARING DIALYZER
FOR THE FIRST USE
PREPARING DIALYZER FOR THE
FIRST USE
• Dialyzer Labeling
– Patient name
– Number of uses
– Date & time of last reuse
– Reuse staff initials / identifier
– Result of test done (TCV, Leak Test, Potency)
REF. CORE CURRICULUM FOR THE DIALYSIS TECHNICIAN 4TH ED.
PREPARING DIALYZER FOR THE
FIRST USE
• Pre-process
– Removes residual germicides
– Removes particles, bisphenols, & other noxious
substances
– Allows an accurate measures of TCV
REF. CORE CURRICULUM FOR THE DIALYSIS TECHNICIAN 4TH ED.
PREPARING DIALYZER FOR THE
FIRST USE
• Total Cell Volume
– Test for baseline TCV
– Set Minimum allowed TCV (80% of baseline)
REF. CORE CURRICULUM FOR THE DIALYSIS TECHNICIAN 4TH ED.
HANDLING DIALYZER
AFTER DIALYSIS
HANDLING DIALYZER AFTER
DIALYSIS
• Good rinse back
– Return as much blood as possible
back to the patient.
REF. CORE CURRICULUM FOR THE DIALYSIS TECHNICIAN 4TH ED.
HANDLING DIALYZER AFTER
DIALYSIS
• Rinsing and cleaning
– Header clot removal
– Rinsing with R.O. water
– Reverse ultrafiltration
– Cleaning agents
REF. CORE CURRICULUM FOR THE DIALYSIS TECHNICIAN 4TH ED.
HANDLING DIALYZER AFTER
DIALYSIS
• Performance Test
– Measuring TCV after each reuse
– Perform a leak test
– Inspect for crack, chips, or defects in
plastic housing
REF. CORE CURRICULUM FOR THE DIALYSIS TECHNICIAN 4TH ED.
HANDLING DIALYZER AFTER
DIALYSIS
• Disinfection
– 2/3 full
– Pass potency test (for Peracetic acid)
– Ensure minimum contact time
REF. CORE CURRICULUM FOR THE DIALYSIS TECHNICIAN 4TH ED.
REF. CORE CURRICULUM FOR THE DIALYSIS TECHNICIAN 4TH ED.
HANDLING DIALYZER AFTER
DIALYSIS
• Storage
– Wipe or soak to clean external part
with a disinfectant
– Segreggate new and reprocessed dialyzer
– Storage condition should prevent deterioration,
contamination, breakage
REF. CORE CURRICULUM FOR THE DIALYSIS TECHNICIAN 4TH ED.
HANDLING DIALYZER AFTER
DIALYSIS
• Dialyzer Rejection
– < 80% of the original/baseline TCV
– Failed leak test
– Failed Aesthetic appearance
– Maximum Use
– None reuse
REF. CORE CURRICULUM FOR THE DIALYSIS TECHNICIAN 4TH ED.
PREPARING DIALYZER
FOR NEXT USE
PREPARING FOR NEXT USE
• Dialyzer inspection
- Ensure minimum dwell time
- Test for presence of germicides reprocessed dialyser
REF. CORE CURRICULUM FOR THE DIALYSIS TECHNICIAN 4TH ED.
PREPARING FOR NEXT USE
• Removal of Germicide
– Rinse out the germicide thoroughly
– Test for germicide safe residual level
– Keep fluid flowing in the extracorporeal circuit
REF. CORE CURRICULUM FOR THE DIALYSIS TECHNICIAN 4TH ED.
PREPARING FOR NEXT USE
• Prior to treatment
– Double check label & patient information
– Verify with two persons
(staff & staff or staff & patient)
– Record & Sign
REF. CORE CURRICULUM FOR THE DIALYSIS TECHNICIAN 4TH ED.
DIALYZER REUSE CONTROL POINT
DIALYZER REUSE CONTROL POINT
• Transporting and Handling
– shall be clean and sanitary manner
– dialyzer that cannot be reprocessed within 2 hours
should be refrigerated
• Rinsing & Cleaning
– Intended to removed gross deposits of blood
– Rinsing with R.O. water that meet AAMI/DOH std.
– Cleaning with chemical or by reverse ultrafiltration
REF. AAMI DIALYSIS STANDARDS 2015
DIALYZER REUSE CONTROL POINT
• Performance Test
– Measurement of TCV (Total Cell Volume)
– At least 80% of the orig. TCV is acceptable
– Should be preprocessed to established orig. TCV
• Blood Path Integrity Test (Leak Test)
– Shall be done between uses
– 10-15% drop of the test pressure
within a period of time
– use negative or postive air pressure
REF. AAMI DIALYSIS STANDARDS 2015
DIALYZER REUSE CONTROL POINT
• GERMICIDE PROCESS
– Shall accomplished high level disinfection
– Header cleaning and disinfection shall be done
before dialyzer is reprocessed
– Minimum dwell time limit shall be established
– Dialyzer exterior should be clean & disinfected
– Ensure that germicide is not outdated
REF. AAMI DIALYSIS STANDARDS 2015
DIALYZER REUSE CONTROL POINT
• INSPECTION CRITERIA
– Dialyzer jacket should be free from visible
blood and other foreign materials.
– Should have no leaks or cracks in
the jacket blood and dialysate ports
– No more than few dark, clotted fibers
should be evident on inspection
REF. AAMI DIALYSIS STANDARDS 2015
DIALYZER REUSE CONTROL POINT
• INSPECTION CRITERIA
– Headers should be free of all but
small peripheral clots and other deposits
– Blood and dialysate ports shall be capped without
evidence of leakage
– Label shall be properly filled out and legible
REF. AAMI DIALYSIS STANDARDS 2015
DIALYZER REUSE CONTROL POINT
• DISPOSITION OF REJECTED DIALYZER
– Failure to meet performance test
– Failure to meet inspection
– other release criteria (max. use, no reuse, etc.)
– Shall be immediately discarded or further reprocessed
– Furhter reprocessed should be quarantine
REF. AAMI DIALYSIS STANDARDS 2015
DIALYZER REUSE CONTROL POINT
• VERIFICATION
– Verification of patient I.D.
– Verification of proper germicide contact
– Verification of presence test of each dialyzer
– Verification of germicide residual of each dialyzer
REF. AAMI DIALYSIS STANDARDS 2015
DIALYZER REUSE CONTROL POINT
• MANUAL AND SEMI AUTOMATED SYSTEM
– R.O. water pressure shall be 25 - 35 psi
– R.O. water quality meet AAMI/DOH std.
– Leak test functional check
– Repair and Maintenance Record
QUALITY CONTROL MONITORING
QUALITY CONTROL MONITORING
• DAILY MONITORING
– PPE, MSDS & SPILL CONTROL supplies
– Test recommend by the reprocessing
manufacturer/developer
– Dialyser Performance
– Test for Membrane Integrity
REF. QUALITY ASSURANCE GUIDELINES FOR HEMODIALYSIS DEVICES
QUALITY CONTROL MONITORING
• DAILY MONITORING
– Aesthetics appearance of reprocessed dialyzer
– Checked for effective concentration of germicide
(potency)
– Verify time and date the dialyzer was filled with
germicide
– Confirmed Patient Name or ID
– Test for absence of residual germicide
REF. QUALITY ASSURANCE GUIDELINES FOR HEMODIALYSIS DEVICES
QUALITY CONTROL MONITORING
• MONTHLY MONITORING
– Water meet AAMI microbiological requirements (AAMI 13959:2014
REF. AAMI DIALYSIS STANDARDS 2015
QUALITY CONTROL MONITORING
• PATIENT MONITORING
– Routine Blood Chemistry
– Routine intradialytic monitoring
• EQUIPMENT MONITORING
– Pessure
– Flow
– Maintenance
– Repair
• PERSONNEL MONITORING
– TRAINING AND CONCERN
REF. QUALITY ASSURANCE GUIDELINES FOR HEMODIALYSIS DEVICES
QUALITY CONTROL PROCEDURE
• Reprocessing Equipment (Manual, Semi-Auto, Fully Auto)
• Mixing & Storage of Cleaning agents & Germicides
• Labelling
• Dialyzer Performance Testing
• Testing of Presence and Absence of Germicides
• Storage of Reprocessed dialyzer
• Preparation of reprocessed dialyzer for use
• Patient Monitoring
• Recordkeeping
REF. QUALITY ASSURANCE GUIDELINES FOR HEMODIALYSIS DEVICES
Documentation
REF. QUALITY ASSURANCE GUIDELINES FOR HEMODIALYSIS DEVICES
QUALITY ASSURANCE AUDIT FOR
REUSE STAFF
QUALITY ASSURANCE AUDIT FOR
REUSE STAFF
• TOUR OF REPROCESSING
– TECHNICIANS LEADS AND PROVIDE RESPONSE
– OBSERVE CLEANLINESS OF THE REUSE ROOM
– FOLLOW METHOD SPECIFIC POLICY & REPROCESSING
MANUAL
– DOES SYSTEM METHOD AGREE WITH DOCUMENTATION?
QUALITY ASSURANCE AUDIT FOR
REUSE STAFF
– ASK FOR SYSTEM COMPONENTS TO BE IDENTIFIED
– ASK HOW COMPONENTS FUNCTIONS
– ASK HOW PROPER FUNCTION IS VERIFIED
– ASK REPROCESSING STEPS AND ITS RATIONALE
QUALITY ASSURANCE AUDIT FOR
REUSE STAFF
– ASK WHAT GERMICIDE IS USE
(NAME, MIN TIME, DILUTION, MSDS)
– OBSERVE TESTING (Potency, Residual)
– ASK WHAT TO DO IF COMPONENT FAILS
– REVIEW IF DOCUMENTATION ARE FILL UP
APPROPRIATELY
• CONCLUSION :
Dialyzer reprocessing, when done correctly
is safe and effective for patient.
If done incorrectly, it can pose hazard to
patient and staff.
A. Arquiza/3/14/16
