Medical Device Alert: All medical devices (MDA/2014/037)

Delays in acting on Field Safety Notices (FSNs) can compromise patient safety.



CAS deadlines
Action underway: 27 October 2014, action complete: 26 November 2014

Note: These deadlines are for systems to be in place for cascading FSNs and for a MDSO to be in post (in England).

MHRA is aware that FSNs sent by manufacturers are not always cascaded in an effective and timely manner to the relevant people that need to be aware of the reported problem and for the required actions to be carried out.

MHRA often has to issue Medical Device Alerts (MDAs) reminding users about manufacturers' FSNs where there is insufficient feedback that it has reached the appropriate people and been acted upon.

A Field Safety Notice (FSN) is a communication sent by medical device manufacturers, or their representatives, in connection with a Field Safety Corrective Action (FSCA). FSNs outline actions to be taken to reduce the risk of death or serious injury associated with the use of a medical device.

A manufacturer undertakes a FSCA for technical or clinical reasons connected with the characteristics or performance of a device, where death or serious injury might result. Manufacturers use a FSN to tell their customers about a FSCA that they are undertaking.

The MHRA assesses each FSCA and decides whether further advice is required e.g. a Medical Device Alert (MDA). If a MDA is issued it will then be distributed via the Central Alerting System (CAS recipients of MDAs are required to submit separate feedback on action taken). MDAs are not issued for every FSN.

We currently place manufacturers' FSNs on our website for information only and they will not normally require further action by you unless you have been contacted directly by the manufacturer or we have issued supplementary advice such as a Medical Device Alert.

It is very important that your organisation takes the actions detailed in the FSN and replies to the manufacturer, acknowledging receipt of the FSN. Your organisation's reply is the evidence that the manufacturer, and subsequently the MHRA, needs to monitor the progress of the FSCA. Without this reply the manufacturer cannot properly verify if the FSCA is complete and so the MHRA may need to issue advice.  Your organisation could be liable if it does not act on safety information provided by the manufacturer and something goes wrong as a result.

For England only - Patient Safety Alert NHS/PSA/D/2014/006 (external link) issued 20 March 2014 highlights recommended changes to strengthen local clinical governance arrangements including the need to identify Medical Devices Safety Officers (MDSO) who will replace Medical Devices Liaison Officers (MDLO).

In the future, manufacturers will have access to the MDSO/MDLO contact list and will be requested to include MDSO contact when issuing FSNs. Therefore, it is important for MDSOs in England to be registered with the CAS team as requested in NHS/PSA/D/2014/006.

For Northern Ireland - MDLOs should be registered with the Northern Ireland Adverse Incident Centre and keep their contact details current with their appropriate body in accordance with their administration guidance.





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