1. Reuse-Reprocessing Unit
Dr.Vikranth Reddy
Consultant Nephrologist
Care Hospitals, Banjara Hills, Hyderabad

2. 22 2

3. Reuse Overview More than 80% facilities currently reprocess
and reuse dialyzers
Economics - Need of the hour

4. Reuse Overview
Clarification of terms: “Reprocessing” the processes of cleaning and germicide instillation into the dialyzer “Reuse” the clinical use of the reprocessed dialyzer “Manual” vs. “Automated” reprocessing

5. What is dialyzer reprocessing?
The act of restoring a previously used dialyzer so that it is suitable for use again.
After a dialyzer is used, it can be rinsed free of blood, chemically cleaned, disinfected and reused.

6. Centralized Reprocessing
Dialyzers are transported to an off-site location for reprocessing
Surveyors must observe dialyzer reprocessing at the centralized location

7. Reprocessing techniques
Rinsing
Cleaning
Performance testing
Disinfection & sterilization

8. Rinsing
At the termination of dialysis, the dialyzer is rinsed and filled with saline while still at the dialysis machine.
At the time of processing the dialyzer is flushed with the pressurized dialysis quality water.

9. Cleaning Agents include Peracetic acid based products.
Hemoclean RP ( 4.5% Peracetic acid and 19 % Hydrogen Peroxide, Acetic acid 14%) is the commonly used.

10. Changing Practice Pattern
Centres Using Formaldehyde : 94% ---> 20%
Centres using Paracetic Acid : 5% ----> 72%
Number of times a dialyser is reused varies from centre to centre.
Cost of dialysis has come down . It might be the time to consider abolition of reuse practices.

11. Performance testing Performance testing includes tests of
Membrane integrity
Clearance
Ultrafiltration capability

12. This test checks for the leak in the
Membrane integrity
This test checks for the leak in the
dialyzer casing
membrane
and supporting material

13. Ultrafiltration capability
Of the dialyzer is determined by the measuring the volume of water that passes through the membrane at a given temperature and pressure.

14. Disinfection and sterilization
Methods of disinfection may be chemical or heat based.
Germicides must be completely removed by flushing of the both blood and dialysate compartments.

15. Reuse : “Process” No reuse dialyzers for HBV+ patients
Dialyzers for reuse must be labeled for multiple use
Program set up and design = 3 sections:
Records: meet MR standards, centralized in reprocessing manual
Personnel: qualifications, training, health monitoring
Patients: must be informed, individual medical conditions considered, have an order for reuse

16. Manual
Automated

17. Single Slot

18. Dual Slot

19. Multiple Slots

20. Equipment for reprocessing
Water system
the system providing water for reprocessing must meet all requirements for pressure, flow rate, bacteriological and pyrogenic contamination.

21. Reprocessing System Reprocessing equipment
Multivalve reprocessing machine (manual)
Note: No TCV or pressure leak test perform
- Automated dialyzer reprocessing system
(Renatron, Echo, Core Med)
In India we have only Renatron – hence preferred

22. Utility requirement
The quality, pressure, flow rate, and temperature of the water used for reprocessing should be specified in the dialyzer reprocessing manual.
There is sufficient drain capacity and that the reuse room is properly ventilated

23. Reprocessing System Maintenance
Written maintenance procedures and a schedule of preventive maintenance shall be established. In the case of purchased reprocessing equipment or safety equipment, the recommendations of the vendor should be followed.

24. Reuse room and environmental safety consideration
Storage area
Reprocessing materials, dialyzers awaiting reprocessing, and reprocessed dialyzers should be stored in a manner to prevent deterioration, contamination, or breakage.

25. Reuse room and environmental safety consideration
Personnel Protection
Durable gloves and protective clothing should be worn when handling the dialyzer during initiation and termination of dialysis and during the reprocessing procedure.
Eye protection should be worn when performing steps that may result in spills or splashes of substances of known or suspected toxicity or contamination.

26. Dialyzer Labeling
Each reprocessed dialyzer should be labeled with a unique identification of the patient who is using the dialyzer. Markings should be resistant to removal by normal reprocessing and dialysis procedures. The dialyzer labeling should not obscure the manufacturer's model number, lot number, or indicators of the direction of blood and/or dialysate flow or other pertinent information.

27. Patient Considerations
Medical Issues
An order to reprocess dialyzers should be made by a nephrologist / physician / dialysis manager knowledgeable about reprocessing and its medical and economic implications.

28. Reprocessing Technique
Rinsing and reverse ultrafiltraion
Cleansing
Measurement of dialyzer performance
Disinfection / Sterilization
Germicidal removal.

29. Rinsing / Cleaning
For effective cleaning it is recommended that the blood compartment of the dialyzers be flushed with R/O water to remove remaining blood before connecting to a reprocessing unit.

30. Cleaning Chemicals
Diluted solutions of peracetic acid, hydrogen peroxide, or other chemicals
Cleaning agent can be shown to be reduced to safe levels by subsequent flushing and that the structural integrity and performance of the dialyzers are not significantly affected.
Recommend – 2% - Hemoclean RP / Renalin – Prefer to use a single sterilant for multiple functions avoiding errors & reduce storing space.

31. Dialyzer header cleaning and disinfection
The cleaning and disinfection of the header space should be done, only when necessary and before the dialyzer is reprocessed.
If the header space is cleaned it should be done in a manner to prevent infection and damage to the dialyzer.
Once cleaned and before reassembling the end of the dialyzer, the o-ring and the header cap should be disinfected. This procedure is done prior to reprocessing the dialyzer.

32. Dialyzer Performance
The performance characteristics of dialyzers may change following reprocessing.
The ultrafiltration coefficient may increase or decrease.
Clearances of small or large molecular weight solutes may also increase or decrease depending on the chemicals, methods and dialyzer membrane used.

33. Performance measurement after each use
Baseline measurement of total cell volume:
No direct measures to measures solute clearance
TCV have been accepted as an adequate index of changes in solute transportation hollow fibre dialysis
TCV is equal to volume or saline necessary to fill the blood compartment of dialyzer
TCV can vary 8-10% from that stated by manufacturer.

34. Monitoring of Total Cell Volume
During each reprocessing, total cell volume of reused dialyzers should be checked.

35. Minimum required Total Cell Volume
Dialyzers having a total cell volume < 80% or original measured value should not be reused.
When TCV <80%, it is estimated that the relative decrease in urea clearance will be approximately 10%

36. Germicidal process
Chemical germicides used for disinfection of dialyzers must have been shown to accomplish at least high level disinfection when tested in dialyzers artificially contaminated with appropriate micro-organisms.

37. Germicides Formaldehyde Glutaraldehyde (8.8%)
As you very well know that it is highly recommended to avoid the usage of Formalin (Carcinogenic risks to Humans)
3.Peracetic acid / hydrogen peroxide / acetic acid mixtures –Environment-friendly : 100% decomposable into carbon dioxide and water
Hemoclean RP / Renalin
** These are CE certified products . 

38. Germicide
Peracetic Acid, Hydrogen Peroxide, Acetic acid – Base -Peracetic acid (renalin/ Hemoclean - RP)
The undiluted solution should be diluted to prepare two solutions of 2% (200 ml in 10 liters of water) as a cleaning agent and 3.5% (350 ml in 10 liters of water) as a disinfectant – Indian Society of Nephrology Guidelines for Hemodialysis Units, Vol 22, Supplement, December 2012,
Centers for disease control recommends that both the blood and dialysate compartments within a minimum contact time of 11 hours at a temperature of at least 20oC

39. Chemical germicide diluent and filling of dialyzer
The dialyzer should be filled with the germicide solution until the concentration in the dialyzer is at least 90 percent of the prescribed concentration. This normally takes a minimum of 3 volumes of the germicide rinsed through the dialyzer.

40. Capping the Dialyzer ports
The ports of chemically disinfected dialyzers should be disinfected and then capped with new or cleaned and disinfected caps. The caps may be disinfected with dilute bleach or with the chemical used for disinfecting the dialyzer.
(Preferred – 1 % , Hemoclean RP/ Renalin)
The manufacturer’s instructions for use of the germicide should be followed.

41. Dialyzer exterior
The outside of the dialyzer should be soaked or wiped clean of visible blood and other foreign material.
A low‑level germicide that is compatible with the dialyzer materials of construction should be used for this purpose.
1% Peracetic acid based solution preferrred

42. Dialyzer visual inspection
1. The dialyzer exterior should be free of visible blood or other foreign material.
2. There should be no leaks or cracks in the dialyzer case, the blood ports or dialysate ports.
3. There should be no dark, clotted fibers evident on the inspection of the exterior of hollow fibers.
4. The headers of hollow‑fiber dialyzers should be free of all small peripheral clots or other deposits.
5. Blood and dialysate ports should be capped without evidence of leakage.
6. The label should be properly filled out and legible.

43. Disposal of rejected dialyzers
Reprocessed dialyzers that have been rejected for failure to meet performance criteria, leakage test, visual inspection, or other release criteria should be immediately discarded

44. Storage
Reprocessed dialyzers that meet the performance and inspection criteria for multiple use should be stored to prevent damage or contamination.

45. Preparation for use Visual inspection
Verification of patient identification
Written procedure for tests ( Potency - PAA presence of > 500 ppm even at the end of 6th day. If it < 500 PPM – Dialyser should not be reused.
In Japan these standards have been enhanced up to 1000 ppm preferred, acceptable around 800 ppm for germicide) or other residues
Verification of germicidal contact

46. Potency & Residual Test Strips

47. Potency – 2,000 PPM in a Dialyser -within 24 hrs after filling - acceptable

48. Potency PAA – 1,000 PPM @3rd day accepted– At the end of 6th day still > 500 PPM is must

49. Potency < 500 PPM – Dialyser should not be reused

50. A Solution 3.5 % Dilution Before filling < 500 PPM Not to be used for Sterlising Dialyser

51. After PrimingHemocheck – 25 Mg / dl – Not Acceptable

52. Residues 5 mg /dl- To use more NS & flush till Residues are NIL

53. Hemocheck 0.5 mg – Please rinse once again till residues are ?

54. Pump Speed @ 150 -180 ml, NS -2000 ml - Residues Nil - PERFECT,

55. Advantage of dialyzer reuse
Saves cost
Reduced incidence or intradialytic symptoms – first use syndrome
Reduced exposure to residual industrial chemicals used in manufacture of new dialyzers
Enhanced dialyzer biocompatibility / reduced immune system activation

56. Reuse on mortality

57. Concerns For Dialyser Reuse
Risk to Life – mortality
Risk of Infection
Pyrogenic Reaction
Toxicity from Disinfection
Reduced Dialyser Performance
Impaired Removal of Large Molecules
Validity of dialyser blood volume measurement as a criteria for assessing dialyser function

60. Take Home Message Dialyser Reprocessing Area – Achilles heel
Avoid Formalin usage in Reprocessing units
Automated Reprocessing Unit with peracetic acid based (Hemoclean RP/Renalin) should be practiced
Reprocess & reuse for Viral Negatives
Discard Hepatitis B & Retro positives
Discourage Reuse for Hepatitis C positives (at least discard Blood Tubings – Reuse Dialyser)

64. Thank u