Provides guidance on the application of human factors engineering principles to instructions provided by manufacturers for cleaning medical devices.<\/p>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 1<\/td>\n | AAMI TIR55:2014\/(R)2017, Human factors engineering for processing medical devices <\/td>\n<\/tr>\n | ||||||
| 3<\/td>\n | Title page <\/td>\n<\/tr>\n | ||||||
| 4<\/td>\n | AAMI Technical Information Report Copyright information <\/td>\n<\/tr>\n | ||||||
| 5<\/td>\n | Contents <\/td>\n<\/tr>\n | ||||||
| 7<\/td>\n | Glossary of equivalent standards <\/td>\n<\/tr>\n | ||||||
| 8<\/td>\n | Committee representation <\/td>\n<\/tr>\n | ||||||
| 11<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
| 13<\/td>\n | Introduction 1 Scope 1.1 Inclusions 1.2 Exclusions 2 Definitions and abbreviations <\/td>\n<\/tr>\n | ||||||
| 15<\/td>\n | 3 A human factors engineering and design controls approach to device processing 3.1 General <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | 3.2 Design and development planning 3.3 Design inputs 3.4 Design outputs <\/td>\n<\/tr>\n | ||||||
| 17<\/td>\n | 3.5 Design verification 3.6 Design validation <\/td>\n<\/tr>\n | ||||||
| 18<\/td>\n | 4 Design of devices for processing 4.1 General 4.2 Physical characteristics of reusable devices 4.2.1 Weight 4.2.2 Number and size of components and configuration of set <\/td>\n<\/tr>\n | ||||||
| 19<\/td>\n | 4.2.3 Color 4.2.4 Sharp internal corners and angles 4.2.5 Dead-end channels and zones 4.2.6 Lumens and channels 4.2.7 O-rings 4.2.8 Springs, coils, and twisted or braided wires 4.2.9 Disassembly and reassembly <\/td>\n<\/tr>\n | ||||||
| 20<\/td>\n | 4.2.10 Instrument identification 4.3 Material characteristics of processed devices 4.3.1 Material type 4.3.2 Visual evaluation of cleanliness 4.3.3 Visual evaluation of device degradation 4.3.4 Visual evaluation of rinsing effectiveness 4.3.5 Biofilm 5 Design of processing procedures 5.1 General considerations <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | 5.1.1 Decontamination area 5.1.2 Prep and packaging area 5.1.3 Sterile storage area 5.2 Processing personnel 5.2.1 General considerations 5.2.2 Use error 5.2.3 Human capabilities <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | 5.2.4 Human capacity for learning <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | 5.3 The processing procedure 6 Design of processing instructions 6.1 General considerations for content of IFU 6.1.1 Searching <\/td>\n<\/tr>\n | ||||||
| 24<\/td>\n | 6.1.2 Comprehending 6.1.3 Applying 6.2 Language and readability <\/td>\n<\/tr>\n | ||||||
| 25<\/td>\n | 6.3 Content 6.4 Images <\/td>\n<\/tr>\n | ||||||
| 26<\/td>\n | 6.5 Considerations for printed IFU 6.6 Considerations for electronic IFU <\/td>\n<\/tr>\n | ||||||
| 27<\/td>\n | 7 Education, training, and competency assessment tools 7.1 Structure of education and training 7.2 Preparing the trainer 7.3 Key considerations in design and execution of training <\/td>\n<\/tr>\n | ||||||
| 28<\/td>\n | 7.4 Competency assessment <\/td>\n<\/tr>\n | ||||||
| 29<\/td>\n | 8 Validation 8.1 Human factors validation <\/td>\n<\/tr>\n | ||||||
| 30<\/td>\n | 8.2 Personal protective equipment <\/td>\n<\/tr>\n | ||||||
| 31<\/td>\n | 8.3 Cleaning, disinfection, packaging, and sterilization validation 8.3.1 General 8.3.2 Cleaning instructions (real-life setting considerations) 8.3.3 Disinfection procedure 8.3.4 Packaging method 8.3.5 Sterilization procedure 8.3.6 Accessories <\/td>\n<\/tr>\n | ||||||
| 32<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" AAMI TIR55:2014\/(R)2017 – Human factors engineering for processing medical devices<\/b><\/p>\n |