AAMI RD47 2008 RA 2013
$140.32
ANSI/AAMI RD47:2008/(R)2013 – Reprocessing of hemodialyzers
| Published By | Publication Date | Number of Pages |
| AAMI | 2008 | 67 |
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.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI RD47:2008/(R)2013, Reprocessing of hemodialyzers |
| 2 | Objectives and uses of AAMI standards and recommended practices |
| 3 | Title page |
| 4 | AAMI Recommended Practice Copyright information |
| 5 | Contents |
| 7 | Glossary of equivalent standards |
| 9 | Committee representation |
| 10 | Foreword |
| 11 | Introduction: Need for this AAMI recommended practice |
| 13 | 1 Scope 1.1 Inclusions 1.2 Exclusions 2 Normative references |
| 14 | 3 Definitions |
| 16 | 4 Records 4.1 Dialyzer reprocessing manual |
| 17 | 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 |
| 18 | 5.2.2 Documentation 6 Patient considerations 6.1 Medical issues 6.2 Patient education 7 Equipment 7.1 Water systems 7.2 Reprocessing systems 7.2.1 Utility requirements 7.2.2 Process control testing |
| 19 | 7.2.3 Maintenance 7.2.4 Repairs 8 Physical plant and environmental safety considerations 8.1 Reprocessing area and ventilation 8.2 Storage area |
| 20 | 8.3 Laboratory area 8.4 Personnel protection 8.5 Environmental safety 9 Reprocessing supplies 9.1 Specifications and testing 9.2 Inventory control 10 Hemodialyzer labeling 10.1 Time of labeling 10.2 Label composition 10.3 Information recorded |
| 21 | 11 Reprocessing 11.1 Transportation and handling 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 |
| 22 | 11.3.1 Performance test after each use 11.3.2 Ultrafiltration 11.3.3 Blood path integrity test 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 |
| 23 | 11.4.1.3 Chemical germicide diluent 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 |
| 24 | 11.6 Disposition of rejected dialyzers 11.7 Storage 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 |
| 25 | 12.3.2.1 Process control 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 |
| 26 | 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 |
| 27 | 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 14.6 Reprocessing supplies |
| 28 | 14.7 Hemodialyzer labeling 14.8 Reprocessing 14.9 Preparation for dialysis |
| 29 | Annex A Rationale for the development and provisions of this recommended practice A.1 Scope A.2 Normative references A.3 Definitions |
| 30 | A.4 Records A.4.1 Dialyzer reprocessing manual A.5 Personnel qualifications and training A.6 Patient considerations A.6.1 Medical issues A.6.2 Patient education |
| 31 | A.7 Equipment A.8 Physical plant and environmental safety considerations A.9 Reprocessing supplies A.9.1 Specifications and testing A.9.2 Inventory control A.10 Hemodialyzer labeling A.10.1 Time of labeling |
| 32 | A.10.2 Label composition A.10.3 Information recorded A.11 Reprocessing A.11.1 Transportation and handling A.11.2 Rinsing and cleaning |
| 33 | A.11.3 Performance measurements A.11.3.1 Performance test after each use |
| 35 | A.11.3.2 Ultrafiltration A.11.3.3 Blood path integrity test A.11.4 Germicide |
| 36 | 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 |
| 39 | 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 |
| 40 | 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 A.13 Monitoring A.13.1 Dialysis A.13.2 Symptoms |
| 41 | A.13.3 Dialyzer failures A.13.4 Clinical results A.14 Quality assurance |
| 42 | Annex B Systems diagram for reprocessing dialyzers |
| 43 | Annex C 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 |
| 65 | Bibliography |
