DIALYZER REUSE , Dialysis prescription.pptx

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1. DIALYZER REUSE Presenter : Dr Chandra Shekar C (Senior Resident) Moderator : Dr Sharon Kandari (Assistant Professor, Dept of Nephrology, AIIMS,Rishikesh )

2. DIALYZER REUSE Processing of a used dialyzer cartridge with or without connecting tubing, for repeated hemodialysis in the same patient First described in 1964 by Shaldon , who refrigerated coil dialyzers containing the patient’s heparinized blood until the next dialysis L argely limited to hollow fiber capillary dialyzers Automated reprocessing machines were introduced in 1980–1981 and contributed to the increasing trend to reuse dialyzers Miles A.M.V., Friedman E.A. (1996) Dialyzer Reuse — Techniques And Controversy. 2

3. REPROCESSING THREE PHASES 1. PRE-FIRST USE 2. THE DIALYSIS TREATMENT 3. POST DIALYSIS 3

4. PRE-FIRST USE Assigning to patient with proper labelling The dialyzer is preprocessed to measure the baseline TCV. During preprocessing, the dialyzer is rinsed, pressure-tested, and filled with a germicide. 4 Daugirdas JT, Blake PG, Ing TS. Dialyzer reuse. Handbook of dialysis. 5 th Ed. p237-251

5. PRE-FIRST USE 5

6. THE DIALYSIS TREATMENT INSPECTION OF DIALYZER :  not discoloured  leaking  showing significant clotting EXAMINE FOR GERMICIDE :  assure that a sufficient volume of disinfectant fluid was present in the dialyzer to assure direct contact. 6 Daugirdas JT, Blake PG, Ing TS. Dialyzer reuse. Handbook of dialysis. 5 th Ed. p237-251

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8. DIALYZER TREATMENT PRIMING :  priming the dialyzer with normal saline and starts a recirculating rinse, with minimal ultrafiltration , Qb 200ml/min, Qd 500ml/min , 15 to 30min  A void introducing air into the arterial circuit during this rinsing process, trapped air in the fibers or dialysate compartment may reduce the effectiveness of germicide removal. 8 Daugirdas JT, Blake PG, Ing TS. Dialyzer reuse. Handbook of dialysis. 5 th Ed. p237-251

9. DIALYZER TREATMENT PRIMING :  R otate dialyzer at intervals during flushing to release trapped air in the dialysate compartment  After the rinse, assure that the dialyzer, extracorporeal circuit, and saline bag are free of residual germicide by use of a test strip of appropriate sensitivity. REBOUND OF GERMICIDE: If the start of the treatment is delayed for some reason- caused by either the dialysate or saline flow being interrupted while the dialyzer is in standby 9 Daugirdas JT, Blake PG, Ing TS. Dialyzer reuse. Handbook of dialysis. 5 th Ed. p237-251

10. VIDEO 2 10

11. POST DIALYSIS At the end of a treatment, the blood in the dialyzer is returned to the patient is followed by 1. RINSING AND REVERSE ULTRAFILTRATION 2. CLEANING 3. DIALYZER PERFORMANCE 4. DISINFECTION 11

12. RINSING AND REVERSE ULTRAFILTRATION Process when dialyzer was still on the dialysis machine. common practice is to put the dialyzer on a manifold that flushes AAMI standard water through the blood and dialysate compartments for 20–30 minutes. a positive pressure gradient from the dialysate to the blood compartments is maintained to help flush clots and plasma detritus from the blood circuit. 12 Daugirdas JT, Blake PG, Ing TS. Dialyzer reuse. Handbook of dialysis. 5 th Ed. p237-251

13. VIDEO 4 13

14. CLEANING TWO STEPS: 1) Initial rinsing of the dialyzer and cleaning the headers with RO water. 2) to put the dialyzer on a machine (or through a manual process) that further rinses and cleans the fibers using one of a number of chemical cleaning agents. During this cleaning step, staff inspect and clean the headers to remove lipids and clots. 14 Daugirdas JT, Blake PG, Ing TS. Dialyzer reuse. Handbook of dialysis. 5 th Ed. p237-251

15. CLEANING If the header caps are removable, the associated “O” rings can be removed, allowing a direct rinse of the exposed ends of the fiber bundle and potting compound. Header caps and their “O” rings must be exposed to a disinfectant (bleach or peracetic acid) before being replaced on the dialyzer. If the procedure uses assist devices, it must specify that these devices be used on only one dialyzer before they are cleaned and soaked in an appropriate germicide 15 Daugirdas JT, Blake PG, Ing TS. Dialyzer reuse. Handbook of dialysis. 5 th Ed. p237-251

16. CLEANING 16

17. VIDEO 5 17

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19. CLEANING 19

20. TESTS OF DIALYZER EFFICACY PRESSURE TEST FOR LEAKS: A blood path integrity test works by generating a pressure gradient across the membrane and observing for a pressure fall in either the blood or the dialysate compartment. Pressure gradient - instilling pressurized air or nitrogen into the blood side of the dialyzer or by producing a vacuum in the dialysate side. Only minimal amounts of air should be observed to leak through an intact wetted membrane 20 Daugirdas JT, Blake PG, Ing TS. Dialyzer reuse. Handbook of dialysis. 5 th Ed. p237-251

21. TESTS OF DIALYZER EFFICACY PRESSURE TEST FOR LEAKS: D amaged fibers usually rupture S creen for defects in the dialyzer O-rings, potting compound and end-caps. 21 Daugirdas JT, Blake PG, Ing TS. Dialyzer reuse. Handbook of dialysis. 5 th Ed. p237-251

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23. TESTS OF DIALYZER EFFICACY BLOOD COMPARTMENT VOLUME (TCV ): Indirectly measures changes in membrane clearance for small molecules such as urea. Every dialyzer destined for reprocessing should be processed before its initial use in order to measure a baseline TCV for that particular dialyzer. (??? MANUFACTURE LABELLED) The change in TCV from baseline is then tracked by remeasuring TCV after each reuse. A reduction in TCV of 20% corresponds to a 10% reduction in urea clearance, the maximum decrease acceptable for continued use 23 Daugirdas JT, Blake PG, Ing TS. Dialyzer reuse. Handbook of dialysis. 5 th Ed. p237-251

24. TESTS OF DIALYZER EFFICACY BLOOD COMPARTMENT VOLUME (TCV ): HOW TO MEASURE ? - The blood compartment volume (TCV) is measured by purging the filled blood compartment (header volume and fiber volume) with air and measuring the volume of obtained fluid. REASON FOR FAILURE TO REACH TARGET REUSE : TCV test failures suggests excessive clot formation during dialysis and should prompt a review of the heparin prescription 24 Daugirdas JT, Blake PG, Ing TS. Dialyzer reuse. Handbook of dialysis. 5 th Ed. p237-251

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26. VIDEO 6 26

27. VIDEO 7 27

28. EXAMINATION AFTER REPROCESSING EXAMINE FOR GERMICIDE :  Peracetic acid has no vapor pressure and depends on direct contact to be effective  Hold dialyzer horizontally- both headers should be at least two-thirds full.  presence of germicide is confirmed by using a test strip of appropriate sensitivity.  contact time of the dialyzer with the germicide : should exceeds the minimum number of hours required for that particular germicide (????11HRS ) Daugirdas JT, Blake PG, Ing TS. Dialyzer reuse. Handbook of dialysis. 5 th Ed. p237-251 28

29. TESTS OF DIALYZER EFFICACY WATER PERMEABILITY The dialyzer ultrafiltration coefficient - an indirect measure of membrane mass transfer properties for larger molecular weight substances measured by determining the volume of water passing through the membrane at a given pressure and temperature. decrease in KUF  reduction in β2- microglobulin clearance  does not affect fluid removal (machines with automated ultrafiltration ) 29 Daugirdas JT, Blake PG, Ing TS. Dialyzer reuse. Handbook of dialysis. 5 th Ed. p237-251

30. TESTS OF DIALYZER EFFICACY CLINICAL CONFIRMATION : Correlate with laboratory measure Kt/V or Urea Reduction Ratio (URR) 30 Daugirdas JT, Blake PG, Ing TS. Dialyzer reuse. Handbook of dialysis. 5 th Ed. p237-251

31. DISINFECTION/STERLIZATION GERMICIDES : After a dialyzer has been cleaned and tested, germicides are instilled in both blood and dialysate compartments For an appropriate contact duration Formaldehyde or glutaraldehyde is not used nowadays Peracetic acid is the most common germicide used The presence of germicide must be ensured through procedural controls and should be verified both at the completion of reprocessing and prior to use 31 Daugirdas JT, Blake PG, Ing TS. Dialyzer reuse. Handbook of dialysis. 5 th Ed. p237-251

32. DISINFECTION/STERLIZATION GERMICIDES : The presence of peracetic acid is confirmed using test strips. In manual reprocessing systems –each dialyzer must be checked for the presence of germicide. In automated systems- only a sample needs to be tested each day. 32 Daugirdas JT, Blake PG, Ing TS. Dialyzer reuse. Handbook of dialysis. 5 th Ed. p237-251

33. HEAT STERLIZATION Heated 1.5% citric acid at 95°C (Levin,1995) or using heated water at 105°C (Kaufman, 1992) are nonnoxious chemical alternatives to disinfection ADVANTAGE : Spores are destroyed. DISADVANTAGE :  They are somewhat cumbersome, as they are not available in automated form.  affects the durability of many types of dialyzers being reprocessed 33 Daugirdas JT, Blake PG, Ing TS. Dialyzer reuse. Handbook of dialysis. 5 th Ed. p237-251

34. FINAL INSPECTION Visual examination after reprocessing procedure If the dialyzer does not meet the visual inspection standards  it should be sent for another cycle of reprocessing.  dialyzer should be discarded if it is damaged or unaesthetic in appearance 34 Daugirdas JT, Blake PG, Ing TS. Dialyzer reuse. Handbook of dialysis. 5 th Ed. p237-251

35. LABELLING Affix a label after the dialyzer has passed performance testing and inspection . At a minimum, the label should indicate  the patient’s name, a warning regarding the existence of a similar name in the unit, ( atleast )  the number of reuses, the baseline and current TCV, the time and date the dialyzer was reprocessed The same information – record in the reuse master file. Dialyzer failed any tests and was discarded - record 35 Daugirdas JT, Blake PG, Ing TS. Dialyzer reuse. Handbook of dialysis. 5 th Ed. p237-251

36. STORAGE The temperature of the storage room- the recommended germicide contact time depends on storage temperature. Peracetic acid  shelf life of 14–21 days  shorter in dialyzers with significant residual blood  sterilized dialyzers should be re-disinfected every 14 days. It is not certain how long a dialyzer (even with periodic re-disinfection) can safely be stored before it should be discarded. 36

37. ADVANTAGES 37

38. CLINICAL BENEFITS COST: While the initial cost of the multiple use dialyzer is more than the equivalent dialyzer labeled for single use, the average cost of the multiple-use dialyzer falls with each reuse. the cost of reprocessing 38 Daugirdas JT, Blake PG, Ing TS. Dialyzer reuse. Handbook of dialysis. 5 th Ed. p237-251

39. CLINICAL BENEFITS TYPE B REACTION : Occur later in the dialysis session Chest and back discomfort, dyspnea , hypoxemia, and hypotension Membrane–blood interaction (bio- incompatability ) Complement-mediated (alternative pathway) sequestration of leucocytes in the pulmonary circulation. Polyacrylonitrile and polysulfone - less complement activation and are better tolerated than older cellulose membranes. Brenner & Rector’s The Kidney. 11th edition 39

40. CLINICAL BENEFITS TYPE B REACTION : (ON MULTIPLE USE ) The dialyzer membrane becomes coated with proteinaceous material Peracetic acid-do not remove this protein coat during the cleaning phase, rendering the membrane more biocompatible during subsequent use. Bleach has the effect of stripping off this proteinaceous coat, potentially resulting in a less biocompatible dialyzer Brenner & Rector’s The Kidney. 11th edition 40

41. DD FOR DIALYZER REACTION Reactions to dialyzers, dialyzer sterilants , disinfectants or administered medications . Exposure to contaminated water , pyrogenic reaction, hemolysis and air embolism should be ruled out TREATMENT : -saline for hypotension -epinephrine for anaphylaxis or severe hypotension, -urgent cessation of HD - without blood return -possibly corticosteroid use 41 Brenner & Rector’s The Kidney. 11th edition

42. CLINICAL BENEFITS BIOHAZARDOUS WASTE : Dialyzer reprocessing reduces the number of dialyzers and packaging included in that waste. Reduces the waste burden to the environment Price for the disposal of waste Other hand, there are environmental issues with reprocessing as well 42 Daugirdas JT, Blake PG, Ing TS. Dialyzer reuse. Handbook of dialysis. 5 th Ed. p237-251

43. DISADVANTAGES 43

44. MORTALITY AND MORBIDITY 44

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46. MORTALITY AND MORBIDITY Study by Lacson et al followed patients in 23 Fresenius units who were converted from peracetic acid reprocessing to single use It showed a decreased relative risk of mortality and a reduction in inflammatory markers after conversion to single use Clin J Am Soc Nephrol 6: 297–302, 2011. 46

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48. FORMLADEHYDE VS PERACETIC ACID Patients developed anti-N antibodies acute “formaldehyde reactions”  burning at the needle site  itching during dialysis in the access arm. 48 Daugirdas JT, Blake PG, Ing TS. Dialyzer reuse. Handbook of dialysis. 5 th Ed. p237-251

49. POTENTIAL BACTERIAL/ PYROGEN CONTAMINATION Improperly processed dialyzers. More often in centers that reuse dialyzers. SOURCE :  the water used to rinse and clean the dialyzers water to prepare the germicides  Bacteria sequestered in clotted fibers (may not be exposed to the sterilant but can be dislodged during the dialysis treatment)  Peracetic acid is less effective in dialyzers with substantial residual blood and protein Any step in the reprocessing procedure that introduces a foreign object and/or unsterile water 49 Daugirdas JT, Blake PG, Ing TS. Dialyzer reuse. Handbook of dialysis. 5 th Ed. p237-251

50. POTENTIAL BACTERIAL/ PYROGEN CONTAMINATION Gram-negative water-borne bacteria - Stenotrophomonas maltophilia (Pseudomonas), - Burkholderia cepacia , - Ralstonia pickettii ( biofilm ) Scrupulous attention to water treatment is required 50 Daugirdas JT, Blake PG, Ing TS. Dialyzer reuse. Handbook of dialysis. 5 th Ed. p237-251

51. ANAPHYLACTOID WITH DISINFECTANTS 51

52. ANAPHYLACTOID WITH DISINFECTANTS O ccurred in patients dialyzed with cuprammonium cellulose, cellulose acetate and polysulfone dialyzers reprocessed with peracetic acid. Peracetic acid –produce a strong negative charge on the protein-coated membrane and thereby activate factor XII, kininogen , kallikrein and subsequently, bradykinin ACE inhibitor–induced inhibition of bradykinin degradation may potentiate the reaction. 52 Daugirdas JT, Blake PG, Ing TS. Dialyzer reuse. Handbook of dialysis. 5 th Ed. p237-251

53. ANAPHYLACTOID WITH DISINFECTANTS A small case series by Schmitter and Sweet in 1998, reactions in patients taking ACE inhibitors began when bleach was added to the reuse procedure. Polyacrylonitrile membrane- ACEi 53 Daugirdas JT, Blake PG, Ing TS. Dialyzer reuse. Handbook of dialysis. 5 th Ed. p237-251

54. BLEACH AND DIALYZER RECATION Dialyzer membrane becomes coated with a proteinaceous material- making membrane biocompatible Bleach has the effect of stripping off this proteinaceous coat- making membrane biocompatible TYPE B REACTION 54 Daugirdas JT, Blake PG, Ing TS. Dialyzer reuse. Handbook of dialysis. 5 th Ed. p237-251

55. TRANSMISSION OF INFECTIOUS AGENTS Of the concern are hepatitisB (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) Require exclusion of patients with HBV from reuse and instruct that they be dialyzed in a separate isolation room HIV may continue on a reuse program- exclude from reuse to limit staff exposure to HIV-infected blood No reuse in patients with HCV 55 Daugirdas JT, Blake PG, Ing TS. Dialyzer reuse. Handbook of dialysis. 5 th Ed. p237-251

56. DECREASED DIALYZER PERFORMANCE UREA CLEARANCE : A reused hollow-fiber dialyzer - becomes less efficient as a portion of its capillaries become plugged with protein or clot As long as the fiber bundle volume is at least 80% of the baseline value, urea clearance remains clinically acceptable. THE HEMO STUDY by Cheung et al independent of the reuse method, urea clearance decreased 1.4%–2.9% over 20 uses. 56 Daugirdas JT, Blake PG, Ing TS. Dialyzer reuse. Handbook of dialysis. 5 th Ed. p237-251

57. DECREASED DIALYZER PERFORMANCE HEPARIN DOSING : The reusability of dialyzers will deteriorate quickly unless adequate heparin anticoagulation is given. Increased numbers of reuses with individually targeted heparin dosing Whole blood activated clotting time (ACT) to 150% of the baseline. Dialyzer reuse rates increased significantly over time in the treatment group ( 11 ±9 to 18 ±12 reuses ) but remained unchanged in the control group American Journal of Kidney Diseases, Vol 35, No 1 (January), 2000: pp 89-94 57

58. DECREASED DIALYZER PERFORMANCE UREA CLEARANCE : 1. BICARBONATE DIALYSIS CONTAINING CITRIC ACID : Bicarbonate dialysate containing a small amount of citrate in place of acetate -results in increased urea clearance in a reuse setting calcium chelation by citrate coming in from the dialysate at the membrane boundary layer - reduced activation of clotting factors and platelets Hemodialysis International 2005; 9: 264–267 58

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60. DECREASED DIALYZER PERFORMANCE β 2 MICROGLOBULIN CLEARANCE : Protein deposits adsorbed on the membrane or convectively transported to the membrane surface and not removed by the reuse process  reduce the ultrafiltration rate  larger molecule clearance. Of most concern is the rapid fall off in β2-microglobulin clearance when highflux cellulose dialyzers are reused with peracetic acid/hydrogen peroxide/acetic acid without a bleach cycle. 60 Daugirdas JT, Blake PG, Ing TS. Dialyzer reuse. Handbook of dialysis. 5 th Ed. p237-251

61. DECREASED DIALYZER PERFORMANCE ALBUMIN LOSS: Bleach during reuse procedures- an increase in permeability to albumin that correlates with the number of reuses. for dialyzers with very high water permeability. 61 Daugirdas JT, Blake PG, Ing TS. Dialyzer reuse. Handbook of dialysis. 5 th Ed. p237-251

62. MANUFACTURER SINGLE USE RECOMMENDATION FDA developed guidelines that allow manufactures to label their dialyzers for multiple use. Maximum number of reuse 62 Daugirdas JT, Blake PG, Ing TS. Dialyzer reuse. Handbook of dialysis. 5 th Ed. p237-251

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64. REUSE OF OTHER DISPOSABLES Does not allow reuse of blood tubings or transducer protectors. 64 Daugirdas JT, Blake PG, Ing TS. Dialyzer reuse. Handbook of dialysis. 5 th Ed. p237-251

65. CONSENT There is no rule requiring informed consent as a condition for reprocessing dialyzers. Patients and their family (caregivers) be fully informed about all aspects of their care For reuse, the facility should provide written information about the risks and benefits of reprocessing in language appropriate for the patient 65 Daugirdas JT, Blake PG, Ing TS. Dialyzer reuse. Handbook of dialysis. 5 th Ed. p237-251

66. THANK YOU 66