CLSI HS11 P : 1ED 2005
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A MODEL FOR MANAGING MEDICAL DEVICE HAZARDS AND RECALLS
06-01-2006
12-01-2013
Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Definitions
4 Responsibilities
4.1 The Recall Officer
4.2 The Recall Coordinator(s)
5 Risk Assessment
5.1 Inventory Management
5.2 Contingency Planning
6 Obtaining Alert Information
6.1 Receiving Alert Information
6.2 Alert Information Sources
7 Planning and Implementing a Strategy for Responding to
Alerts
7.1 Segmentation of the Alert Response Strategy
7.2 Checklist for the Alert Response Strategy
7.3 Organization Preparedness
7.4 Monitoring for and Responding to Alerts
7.5 Reviewing the Effectiveness of the Alert Response
Strategy
8 Internal Communication
8.1 Internal Communications of Alerts
8.2 Communication Responsibilities of the Recall Officer
(RO)
9 Communication to Patients and Family
10 Testing and Training
11 Recordkeeping
12 Reporting
12.1 Interim Report
12.2 Final Report
12.3 Annual Evaluation
12.4 Final Summary
References
Appendix A. Other Types of Hazard and Recall Information
Appendix B. Sample Action Plan Checklist
Appendix C. Sample Policy Development Checklist
Appendix D. Sample Database Fields
Appendix E. Sample Alerts
Appendix E. (Continued)
The Quality System Approach
Related CLSI/NCCLS Publications
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