AAMI RD47 : 2008

Glossary of equivalent standards
Committee representation
Foreword
Introduction: Need for this AAMI recommended practice
1 Scope
   1.1 Inclusions
   1.2 Exclusions
2 Normative references
3 Definitions
4 Records
   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
        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
        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
   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
11 Reprocessing
   11.1 Transportation and handling
   11.2 Rinsing and cleaning
   11.3 Performance measurements
        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)
        11.4.2 Exterior
   11.5 Inspection
   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
   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
   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
   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
   14.7 Hemodialyzer labeling
   14.8 Reprocessing
   14.9 Preparation for dialysis
Annexes
A - Rationale for the development and provisions
    of this recommended practice
B - Systems diagram for reprocessing dialyzers
C - Self-assessment of compliance with recommendations
    for hemodialyzer reprocessing
Bibliography

Specifies the essential elements of good practices for reprocessing hemodialyzers in order to help ensure device safety and effectiveness.