This recommended practice is addressed to the physician responsible for reprocessing hemodialyzers. It covers personnel and patient considerations, records, equipment, physical plant and environmental safety, reprocessing material, patient identification and hemodialyzer labeling, reprocessing and storage procedures, disposition of rejected dialyzers, preparation for subsequent use, patient monitoring, and quality assurance and quality control. This document does not endorse either single use or reuse of dialyzers.

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PDF Pages	PDF Title
1	ANSI/AAMI RD47:2020; Reprocessing of hemodialyzers
3	Title page
4	AAMI Recommended Practice Copyright information
5	Contents
6	Committee representation
8	Foreword
9	Introduction: Need for this AAMI recommended practice
11	1 Scope 1.1 Inclusions 1.2 Exclusions 2 Normative references
12	3 Definitions
14	4 Records
15	4.1 Dialyzer reprocessing manual 4.2 Reprocessing record 4.3 Equipment maintenance record 4.4 Personnel health monitoring records 4.5 Complaint investigation record 4.6 Quality assurance and quality control record 5 Personnel qualifications and training 5.1 Qualifications 5.2 Training 5.2.1 Curriculum
16	5.2.2 Documentation 6 Patient considerations 6.1 Medical issues 6.2 Patient education 7 Equipment 7.1 Water systems
17	7.2 Reprocessing systems 7.2.1 Utility requirements 7.2.2 Process control testing 7.2.3 Maintenance 7.2.4 Repairs 8 Physical plant and environmental safety considerations 8.1 Reprocessing area and ventilation Table 1—OSHA environmental exposure limits (29 CFR 1910, 2018), except as indicated
18	8.2 Storage area 8.3 Laboratory area 8.4 Personnel protection 8.5 Environmental safety 8.2 Storage area 8.3 Laboratory area 8.4 Personnel protection 9 Reprocessing supplies 9.1 Specifications and testing
19	8.5 Environmental safety 9.2 Inventory control 10 Hemodialyzer labeling 10.1 Time of labeling 10.2 Label composition 10.3 Information recorded 11 Reprocessing 11.1 Transportation and handling
20	11.2 Rinsing and cleaning 11.2.1 Dialyzer precleaning 11.2.2 Initiation of cleaning 11.2.3 Water quality for cleaning 11.2.4 Cleaning agents 11.3 Performance measurements 11.3.1 Performance test after each use 11.3.2 Ultrafiltration 11.3.3 Blood path integrity test
21	11.4 Germicide 11.4.1 Interior (blood/dialysate compartment) 11.4.1.1 Germicidal process 11.4.1.2 Dialyzer header cleaning and disinfection 11.4.1.3 Chemical germicide diluent
22	11.4.1.4 Chemical germicidal procedure 11.4.1.5 Water quality monitoring 11.4.1.6 Chemical germicide concentration 11.4.2 Exterior 11.5 Inspection 11.6 Disposition of rejected dialyzers 11.7 Storage
23	12 Preparation for dialysis and testing for chemical germicides and potentially toxic residues 12.1 Visual inspection 12.2 Verification of patient identification 12.3 Verification of germicidal contact 12.3.1 Presence test of each hemodialyzer 12.3.2 Process control and sampling 12.3.2.1 Process control
24	12.3.2.2 Sampling for process validation 12.4 Priming the dialyzer and rinsing the germicide 12.4.1 Testing for residual germicide 12.5 Written procedure for tests for germicide or other residues 13 Monitoring 13.1 Dialysis
25	13.2 Symptoms 13.2.1 Fever and chills 13.2.2 Other symptoms 13.2.3 Recording 13.3 Dialyzer failures 13.4 Clinical results 14 Quality assurance
26	Table 2—Quality assurance audit schedule 14.1 Records 14.2 Schedule of quality assurance activities 14.3 Patient considerations 14.4 Equipment 14.5 Physical plant and environmental safety considerations
27	14.6 Reprocessing supplies 14.7 Hemodialyzer labeling 14.8 Reprocessing 14.9 Preparation for dialysis
28	Annex A (informative) Rationale for the development and provisions of this recommended practice A.1 Scope
29	A.2 Normative references A.3 Definitions A.4 Records A.4.1 Dialyzer reprocessing manual A.5 Personnel qualifications and training A.6 Patient considerations A.6.1 Medical issues
30	A.6.2 Patient education A.7 Equipment A.8 Physical plant and environmental safety considerations A.9 Reprocessing supplies A.9.1 Specifications and testing
31	A.9.2 Inventory control A.10 Hemodialyzer labeling A.10.1 Time of labeling A.10.2 Label composition A.10.3 Information recorded A.11 Reprocessing A.11.1 Transportation and handling
32	A.11.2 Rinsing and cleaning A.11.3 Performance measurements A.11.3.1 Performance test after each use
34	A.11.3.2 Ultrafiltration
35	A.11.3.3 Blood path integrity test A.11.4 Germicide A.11.4.1 Interior (blood/dialysate compartment) A.11.4.1.1 Germicidal process
38	A.11.4.1.2 Dialyzer header cleaning and disinfection A.11.4.2 Exterior A.11.5 Inspection A.11.6 Disposition of rejected dialyzers A.11.7 Storage A.12 Preparation for dialysis and testing for chemical germicides and potentially toxic residues
39	A.12.1 Visual inspection A.12.2 Verification of patient identification A.12.3 Verification of germicidal contact A.12.4 Priming the dialyzer and rinsing the germicide A.12.4.1 Testing for residual germicide
40	A.13 Monitoring A.13.1 Dialysis A.13.2 Symptoms A.13.3 Dialyzer failures A.13.4 Clinical results
41	A.14 Quality assurance
42	Annex B (normative) Systems diagram for reprocessing dialyzers
43	Annex C (informative) Self-assessment of compliance with recommendations for hemodialyzer reprocessing C.1 General C.2 Audit flow chart
45	C.3 Systematic audit for compliance with the main recommendations of ANSI/AAMI RD47
66	Bibliography

Published By	Publication Date	Number of Pages
AAMI	2020	68


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Standard Title	ANSI/AAMI RD47:2020, Reprocessing of hemodialyzers
Published Code	AAMI
Publication Date	2020
Pages Count	68

AAMI RD47 2020

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