CLSI QMS10 A : 1ED 2006

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 Record keeping
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
Summary of Delegate Comments and Subcommittee Responses
The Quality System Approach
Related CLSI/NCCLS Publications

Describes a framework for healthcare delivery organizations to respond to externally generated notifications of medical device Alerts while focusing on the quality constructs of process control, occurrence management, and process improvement.