CLSI QMS10 A : 1ED 2006
Withdrawn
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A MODEL FOR MANAGING MEDICAL DEVICE ALERTS (HAZARDS AND RECALLS) FOR HEALTHCARE ORGANIZATIONS
01-09-2015
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 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
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