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MDA/2006/001 - Reporting Adverse Incidents and Disseminating Medical Device Alerts

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Document details:

Type: Medical Device Alert
Series No: MDA/2006/001
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 5
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Issued: 04 January 2006 at 15:15
Ref: MDA/2006/001


 
IMMEDIATE ACTION
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ACTION
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UPDATE
 
INFORMATION REQUEST

 

Reporting Adverse Incidents and Disseminating Medical Device Alerts
This document encourages users to report adverse incidents involving medical devices through the Medicines and Healthcare products Regulatory Agency's adverse incident reporting system. It also summarises procedures for the dissemination of Medical Device Alerts.		  

ACTION BY:

  • Chief Executives and SABS Liaison Officers of NHS Trusts including Primary Care Trusts (England)
  • Directors and Medical Device Liaison Officers (MDLOs) of Social Services Departments (England)
  • Headquarters of Commission for Social Care Inspection (CSCI)
  • Headquarters of Healthcare Commission [Commission for Healthcare Audit and Inspection (CHAI)]
  • Directors (local and regional services) of the Health Protection Agency.
  
ACTION:
The following actions should be taken:
  • establish, review and maintain local procedures and encourage staff and users to report adverse incidents in accordance with published MHRA guidance
  • ensure a MDLO has been appointed to encourage and train staff and users to report adverse incidents (this role is often combined with the SABS Liaison Officer)
  • advise MHRA of changes to MDLO contact details
  • ensure local dissemination of Medical Device Alerts by the SABS Liaison Officer (LO)
  • facilitate and encourage use of the MHRA's online adverse incident reporting system
  • ensure that the MHRA website is regularly checked for updates and further information.
  

DISTRIBUTED to:

NHS Trusts (England) - Chief Executives*
Commission for Social Care Inspection (CSCI) - Headquarters
Healthcare Commission (CHAI) - Headquarters
Primary Care Trusts (England) - Chief Executives*
Social Services (England) - Directors*
Health Protection Agency (HPA) - Directors

* via CE Bulletin

  >Page 2
CONTACTS:
Details of MHRA contacts for reporting adverse incidents and disseminating MDAs.
Change of address or removal from address list for CHAI and CSCI.		  >Page 5




ACTION DEADLINES FOR THE SAFETY ALERT BROADCAST SYSTEM (SABS)
Deadline (Action underway): 11 January 2006
Deadline (Action complete): 01 February 2006

 

Page last modified: 07 February 2008