AAMI TIR50 2014 RA 2017
$115.49
AAMI TIR50:2014/(R)2017 – Post-market surveillance of use error management
| Published By | Publication Date | Number of Pages |
| AAMI | 2014 | 46 |
This document will address the issue of use error detection for medical devices from clinical, manufacturer, and regulatory perspective regarding human factors assessment. The goal is to provide guidance on how clinicians and manufacturers can best collect and leverage post-market use error data to improve product safety and usability.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | Blank Page |
| 3 | Title page |
| 4 | AAMI Technical Information Report Copyright information |
| 5 | Contents |
| 7 | Glossary of equivalent standards |
| 8 | Committee representation |
| 10 | Foreword |
| 11 | 1 Purpose 2 Scope 2.1 Stakeholder entities (not all inclusive) 2.2 Reporting entities (not all inclusive) |
| 12 | 3 Terms and definitions |
| 13 | 4 How to use this document 5 Background 5.1 Manufacturer’s perspective |
| 14 | 5.2 Clinical perspective |
| 15 | 5.3 Lay users perspective 6 Regulatory focus on use error post-market surveillance |
| 16 | 7 Process recommendations for manufacturers 7.1 Process flow high level introduction |
| 18 | 7.1.1 Deployment 7.1.1.1 Identifying potential use errors |
| 19 | 7.1.1.2 Identifying collector/influencer roles and tools |
| 20 | 7.1.1.3 Computer systems impact 7.1.1.4 Tying use error risk analysis to customer complaint and inquiry categorization |
| 21 | 7.1.1.5 Training 7.1.2 Valid use event reports received (inputs for “reports”) |
| 22 | 7.1.3 Triage |
| 24 | 7.1.4 Analysis |
| 25 | 7.1.5 Monitor and trend |
| 27 | 7.1.6 Action |
| 28 | 7.2 How post-market surveillance use error management drives value for your company 7.2.1 Data trending 7.2.2 Recommendations for how and when to take action |
| 29 | 8 Process recommendations for clinical users 8.1 Process flow high-level introduction |
| 30 | 8.2 Use error event 8.3 Immediate impact on user/patient |
| 32 | 8.4 Evaluate experience to determine root cause |
| 34 | 8.4.1 Monitor, trend and report to patient safety bodies 8.5 Reporting to manufacturer 8.6 Organization activities 8.6.1 General training on use error 8.6.2 Develop an understanding of the value of reporting close calls |
| 35 | 8.6.3 Address the blame game 8.6.4 How post-market surveillance use error management drives value in clinical environments 8.6.5 Develop use error and close call reporting process for clinical organizational environments |
| 36 | 8.6.6 User dissatisfaction 8.6.7 Utilize internal resources to identify use error events 8.6.8 Proactive assessment |
| 37 | 8.6.9 Scalability |
| 38 | Annex A: Example questions for collecting use error or close call data A.1 Introduction A.2 High level use error event questions A.3 Probing use error event questions A.3.1 The Story (if time is short these are the minimum questions to be asked) |
| 39 | A.3.2 Area specific questions: UPCARE inspired questions to help further understand the circumstances surrounding the event |
| 43 | Annex B: Connecting use error to customer complaints B.1 Introduction B.2 Injecting device example |
| 46 | Bibliography |
