Field safety corrective actions is one of the pillar process associated to post-market surveillance and its key importance is related to the impact of this specific process to the safety of the devices on the market. We have already been extensively discussing about post-market surveillance, including vigilance reporting, EU MDR requirements related to post-market surveillance, or discussion on specific documents like post-market surveillance plan or periodic safety update report.
In this article we will go through the main requirements associated with the FSCA Process according to EU MDR 2017/745.
What is a Field Safety Corrective Action (FSCA)?
According to the definition reported on the European Commission Guidelines on a Medical Devices Vigilance System MEDDEV 2.12-1, a Field Safety Corrective Action (FSCA) is defined as follows:
“FSCA 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.”
The definition provided is quite broad, but a field action it may include the following:
- the return of a medical device to the supplier;
- device modification;
- device exchange;
- device destruction;
- retrofit by purchaser of the manufacturer’s modification or design change;
- suggestions provided by the manufacturer regarding the use of the device.
Classic examples of field actions are modification of the devices or of the labelling of the device, software upgrade to fix safety-related issues. Advices to change the way in which the device it used in the clinical practice it is also considered a field action.
Typically, any field action is accompanied by a so-called field safety notice. The definition of field safety notice is also provide on the Guidelines on a Medical Devices Vigilance System MEDDEV 2.12-1:
A communication to customers and/or USERs sent out by a MANUFACTURER or its representative in relation to a Field Safety Corrective Action.
In other words, the FSN (Field Safety Notice) is the explanation or communication to the customer in relation to a FSCA.
It is important to mention that an FSCA does not arise when a manufacturer is exchanging or upgrading devices in the absence of a safety risk or when actions on the market (for example, removal of the device from the market) are for purely commercial reasons.
EU MDR Requirements for FSCA
The requirements for the FSCA in relation to the EU MDR 2017/745 are reported the Article 87(b). In this article, it is explained that manufacturers shall report to the relevant competent authorities
“any field safety corrective action in respect of devices made available on the Union market, including any field safety corrective action undertaken in a third country in relation to a device which is also legally made available on the Union market, if the reason for the field safety corrective action is not limited to the device made available in the third country”.
This set the obligation of the manufacturer to inform the relevant competent authorities in case of FSCA. Moreover, always in Article 87 it is clearly mentioned:
Except in cases of urgency in which the manufacturer needs to undertake field safety corrective action immediately, the manufacturer shall, without undue delay, report the field safety corrective action referred to in point (b) of paragraph 1 in advance of the field safety corrective action being undertaken.
Basically, it means that the field safety notice shall always precede the field safety corrective action, unless the safety of the patients is at risk and the field action needs to be taken immediately.
Analysis of Field Safety Corrective Actions
In the Article 89 of the EU MDR 2017/745 there are additional requirements related to the Field Actions. Specifically, it is mentioned:
- the field safety corrective action taken shall be brought without delay to the attention of users of the device in question by means of a field safety notice.
- The field safety notice shall be edited in an official Union language or languages determined by the Member State in which the FSCA is taken.
- The content of the draft field safety notice shall be submitted to the evaluating competent authority (unless in case of urgency).
- Unless duly justified by the situation of the individual Member State, the content of the field safety notice shall be consistent in all Member States.
Moreover, some requirements related to traceability in the Field Action process are also mentioned in the Article 89. Specifically, the FSCA shall allow the identification of the device(s) involved, including the UDIs, and identification of the manufacturers (for example, the SRN of the manufacturer that has undertaken the field safety corrective action).
Field Actions and Risk Management Process
Risk management process has been the subject of many posts and discussion through the QualityMedDev blog post. We have been discussing of different topics ranging from the risk analysis to risk-benefit analysis, until to arrive to the risk management plan.
The process of field action is strictly linked with risk management. In fact the manufacturer shall take a decision when an FSCA is needed and this decision is typically based on the following:
- The hazard arising from the device shortcoming
- The probability of the hazard occurring
- Whether the risk outweighs any possible hazard caused by the FSCA due to itstemporary/permanent removal from use, modification, exchange, retrofit or due to new advice being provided by the manufacturer.
As you can see, the decision is always based on risk-related considerations. This is why it is essential to have a solid risk management process to ensure adequate decisions are taken when safety of the patient is under discussion.
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Source: https://www.qualitymeddev.com/2021/06/21/field-safety-corrective-actions-eu-mdr-requirements/
