MHRA Call For Quick Action On Field Safety Notices

Medical Device Alert Raises Concerns Regarding Delays


The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a medical device alert to raise awareness of concerns regarding delays in action being taken on field safety notices (FSNs) which could be affecting patient safety.

The organisation has stated in its latest notice that it is concerned by reports that FSNs from device manufacturers are not cascaded both effectively and in a timely manner to those who should be aware of the problems which are reported, with this impacting on the action carried out.

In the alert is aimed at chief executives and clinical governance leads, as well as others responsible for medical device safety, it has called for a system to be in place to ensure FSNs are shared effectively and action is taken.

The MHRA also stated that in England steps should be taken to ensure any relevant trusts and organisations as identified in a patient safety alert have medical devices safety officer registered with the Central Alerting System.

A deadline has been set for the latter to be in place by November 26th this year.

Expert Opinion
This is an interesting recall by the MHRA which has raised concerns as to whether the key messages issued by medical device manufacturers are always reaching their intended targets, in turn raising concerns regarding whether they are leading to the expected action.

"It is absolutely vital that steps are taken following the issue of this medical device alert, with efforts being made to ensure that health authorities have measures in place to ensure vital information is always shared effectively.

"We have seen the very real impact that problems with medical devices can have on patients, helping them to gain answers and justice regarding such issues. These people often want reassurances that steps are being taken to prevent others being affect by the same problems.

"A notice of this nature does raise concerns as to whether the current systems are effective enough at protecting further patients from harm when problems do arise – and it is vital that these issues are urgently addressed."
Kevin Timms, Solicitor