Under European legislation manufacturers, or their European representatives, are obliged to inform all relevant Competent Authorities (the MHRA in the UK) of any field safety corrective actions (FSCA) that they are undertaking.
A manufacturer undertakes a FSCA for technical or medical reasons connected with the characteristics or performance of a device, where death or serious injury might result. Manufacturers use a field safety notice (FSN) to tell their customers about a FSCA that they are undertaking.
The MHRA assesses each FSCA and decides whether to issue further advice, usually a Medical Device Alert. In such cases a link will be added to the relevant FSN entry.
We place manufacturers' FSNs on our website for information and they will not normally require further action unless you have been contacted directly by the manufacturer or we have issued supplementary advice.
Neither the MHRA nor the Department of Health distribute FSNs. However, we may issue a Medical Device Alert (MDA) as a result of assessing a manufacturer’s FSCA and the MDA will then be distributed via the Central Alerting System (CAS) (external link) and require separate feedback on action taken within the health service.
The following definitions are taken from the European Commission's guidance on a medical devices vigilance system, MEDDEV 2.12-1 rev 6 (external link).
For manufacturers of medical devices: FSCA and FSN forms
Forms for manufacturers or their authorised representative to use to submit Field Safety Corrective Action reports and Field Safety Notices are provided on our devices reporting section.
We have included a flyer explaining what an FSN and an FSCA are, which manufacturers can include with an FSN, to encourage healthcare professionals to respond.
1- Field Safety Corrective Action (FSCA)
A Field Safety Corrective Action is an action taken by a manufacturer to reduce a risk of death or serious deterioration in the state of health associated with the use of a medical device that is already placed on the market. Such actions should be notified via a Field Safety Notice.
Note 1
The FSCA may include
- the return of a medical device to the supplier
- device modification
- device exchange
- device destruction
- retrofit by purchaser of manufacturer's modification or design change
- advice given by manufacturer regarding the use of the device (e.g. where the device is no longer on the market or has been withdrawn but could still possibly be in use e.g. implants or change in analytical sensitivity or specificity for diagnostic devices).
A device modification can include:
- permanent or temporary changes to the labelling or instructions for use
- software upgrades including those carried out by remote access
- modification to the clinical management of patients to address a risk of serious deterioration in state of health or death related specifically to the characteristics of the device. For example:
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- for implantable devices it is often clinically unjustifiable to explant the device. Corrective action taking the form of special patient follow-up, irrespective of whether any affected un-implanted devices remain available for return, constitutes FSCA.
- for any diagnostic device (e.g. IVD, imaging equipment or devices) the recall of patients for retesting or the retest or review of previous results constitutes FSCA.
- advice relating to a change in the way the device is used e.g. IVD manufacturer advises revised quality control procedure -use of third party controls or more frequent calibration or modification of control values for IVDs.
Note 2
This guideline uses the definition of FSCA as synonym for recall mentioned in Article 10(1), paragraph 1b) of the Medical Devices Directive and Article 11 In Vitro Diagnostic Medical Devices Directive since there is no harmonised definition of recall.
2 - Field Safety Notice (FSN)
A communication to customers and/or users sent out by a manufacturer or its representative in relation to a Field Safety Corrective Action
