Cardiology: Guidance and publications

Guidance and publications relating to cardiology

• 21 Mar 2012 | External defibrillators used for cardiac arrest - top tips
  

  We receive reports of adverse incidents relating to all types of defibrillators. We have produced a leaflet and a poster for healthcare professionals, giving tips on how to prevent many of the common incidents.

• 10 Mar 2011 | Reporting Adverse Incidents and Disseminating Medical Device Alerts - DB 2011(01)
  

  This publication provides guidance on the MHRA's system for reporting adverse incidents for medical devices, and information on the dissemination of Medical Device Alerts.

• 21 Jan 2011 | New information on possible risk of liver injury with dronedarone (Multaq)
  

  Dronedarone (Multaq) is used in adults with past or current occurrence of a heart condition called atrial fibrillation (AF). Following cases of rare but serious liver injury in patients using dronedarone, a Direct Healthcare Professional Communication is being circulated which outlines the need for liver function testing and for patients to be vigilant for symptoms of liver injury.

• 18 Oct 2010 | One Liners issue P1 – October 2010
  

  The annual cost of medical devices in the health service is now almost as great as that for pharmaceutical products. It is therefore vital that within each trust or healthcare organisation there are systems in place for the purchasing and management of medical devices. This special poster edition of One Liners aims to set out some of the main issues that need to be taken into account.

• 24 May 2010 | Report on Devices Adverse Incidents in 2009
  

  This annual report provides an overview of medical device-related adverse incident reports received by the MHRA in 2009.

• 29 Mar 2010 | Vascular closure devices poster
  

  A new poster for healthcare professionals with reminders on safe practices when using VCDs.

• 09 Dec 2009 | Electrocardiogram top tips poster
  

  A poster aimed at healthcare professionals, with best practice advice on electrocardiogram (ECG) tests.

• 18 Mar 2009 | Coronary stents - guidance on the vigilance system (VG04)
  

  Advice for manufacturers on the notification of adverse incidents involving CE marked devices under the medical device vigilance system.

• 11 Nov 2008 | Artificial heart valves - guidance on the vigilance system (VG02)
  

  This document gives advice to manufacturers on the notification of adverse incidents involving CE marked devices under the medical devices vigilance system.

• 12 May 2008 | Implantable defibrillators, pacemakers and leads
  

  This poster gives guidance on reporting adverse incidents involving these devices.