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– outdated germicide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