MHRA Information and Alerts

The Medicines and Healthcare products regulation agency is a Department of Health agency that enhances and safeguards the health of the public by ensuring that medicines and medical devices work and are acceptably safe. No product is risk free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. Below are important links and documents that relate to the use and monitoring of CRM devices.

 

The following are provided by the:  
Medicines and Healthcare Products Regulatory Agency:

Reporting Pacemaker ICD problems

Pacemaker and ICD Safety Information

Latest Medical Device Alerts (general)

Latest Field Safety Notices from industry (general)

Guidelines for perioperative management of ICD's and PMs

 

Following the recent announcements by MHRA and St Jude Medical regarding Riata and Riata ST ICD leads, see attached   recommended management plan for patients with these leads. HRUK are still working closely with St Jude Medical and MHRA to monitor the situation and will update you whenever possible. Please contact HRUK   with any clinical queries relating to management or St Jude Medical for details of serial numbers/leads that may relate to your patients. We shall also be most grateful for any information that you may have regarding your experience with these leads.