Implementation of Field Safety Corrective Actions

A Field Safety Corrective Action (FSCA) is an action taken by a manufacturer to report any technical or medical reason leading to a systematic recall of devices of the same type by the manufacturer to the National Competent Authority.

A FSCA is used 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 are notified via a Field Safety Notice.

In the EU, 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given by the manufacturer regarding the use of the device (e.g. where the device is no longer on the market or has been withdrawn but could still possibly be in use e.g. implants) or change in analytical sensitivity or specificity for diagnostic devices, which might lead to or might have led to the death of a patient, user or to a serious deterioration in his state of health (1,2)

Manufacturer Requirements

The manufacturer:

•      (or AR)Shall notify the relevant National Competent Authority about FSCA

•      Has the responsibility for investigating incidents and for taking any corrective action necessary

•      Should ensure that these guidelines are made known to their AR within the EEA, Switzerland and Turkey.

•      Should ensure that their AR within the EEA,Switzerland and Turkey, any other agents authorised to act        on their behalf for purposes relating to medical devices vigilance, are kept informed of incident reports as        appropriate.

•      Should submit a report to the  relevant CA whenan incident occurs. As a consequence of the combined        use of two or more separate devices (and/or accessories) made by different manufacturers, each should        submit a report to the relevant CA.

•      Must keep the NB advised of issues occurring in the post production phase affecting the certification. (3)

Competent Authority (CA) Requirements

The CA:

•       Shall evaluate the report

•       Advise as appropriate and intervene if necessary.

•       Evaluate the acceptability of the risk, taking into account criteria such as: causality, technical / other         cause, probability of occurrence of the problem, frequency of use, detectability, probability of occurrence         and severity of harm, intended purpose and benefit of the product.

•       Typically monitors the investigation being carried out and may intervene at any time.

•       May take harmonised measures applicable to all devices of that kind. Could establish a link with any         other relevant National Competent Authority or the EMEA, if required.

•       Should take coordinating action to ensure that an investigation is carried out if several manufacturers         are involved (3).

Notified Body (NB) Requirements

Notified Bodies do not play a key operational role in the Medical Device Vigilance System, but the overall performance of the Medical Device Vigilance System is supported by NB activity in the following areas:

•      Assessment of vigilance procedures.

•      Audit of the implementation of the vigilance procedures meeting the requirements of MDR Article 87        and link with other systems e.g. Corrective and Preventive Action (CAPA), FSCA.

•      Assessmentof the impact of vigilance issues on the certification granted.

•      Liaise with the CA if required, e.g. specific investigations/audits based on a request of the CA3.

•      Check manufacturer has a robust QMS in place that has been implemented appropriately that meets        the requirements of MDR Article 10, including, appropriate processes in place to collect data, risk        management meeting the requirements of ISO 14971 (4,5).

Conclusion

The issuance of a field safety corrective action is not as straight forward as writing an email to multiple jurisdictions and pressing send. There are considerations to be made by the governing regulation, competent authority and notified body. These differ even within the EU where the member states shall follow the upcoming MDR from May 2021.

About Mi3:

Mi3 are the experts in designing, developing and manufacturing end-to-end advanced medical and surgical solutions – providing specialist knowledge in high precision injection moulding, thermoplastic engineering, tubing systems, and regulatory compliance.

We take your product ideas from consultation to concept to production, and work alongside you to bring medical innovations to life. Visit www.mi-3.co.uk/regulatory to learn more about the regulatory support services we can provide or contact us directly by clicking here to discuss your requirements.

References:

1.  GHTF/SG2/N57R8:2006 - Medical DevicesPost Market Surveillance: Content of Field Safety Notices

2.  No author.Additional Guidance Regarding the Vigilance System as outlined in MEDDEV2.12-1 rev8. Published by EC Directorate-General. No date.

3.  MEDDEV2.12-1 rev 8. 2013.

4.  NBOG’s Best Practice Guide 2009-2 – Role ofNotified Bodies in the Medical Device Vigilance System.

5.  MDR (EU) 2017/745.

About the Author:

Kelly Jackson is the Senior Technical Manager at Mi3 with nearly 30 years experience across the medical device, pharmaceutical and cosmetics industries. With experience in research & development, product design, validation and specialising in regulatory affairs.