AAMI RD47 : 2008
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Hardcopy , PDF
01-27-2020
English
01-01-2008
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
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