Field safety notice (FSN) is one of the main tool that can be implemented by a manufacturer to inform customers of any safety-related issue related to their medical devices. It is one of the key elements of post-market surveillance systems for medical devices.
We have already been talking about post-market surveillance topics, dealing with the requirements for vigilance reporting, post-market surveillance plan, periodic-safety updated report etc. We have also been discussing about field safety corrective actions as method for the maintenance of the safety of the device sold on the market.
In this article, we will be going through the main requirements related to field safety notice which actually are highly related to the ones for field safety corrective actions, mainly in relation to the new European Medical Device Regulation.
What are Field Safety Notice?
Field safety notices (FSNs) are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market.
The official definition has been provided within the MEDDEV 2.12 rev 8:
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 filed safety notice is typically sent to the customers in combination with a field corrective action, that may include a recall or other type of actions on the device ( for example, a software update).
Field Safety Notice Requirements according to EU MDR / IVDR
The requirements associated to the field safety notice process are established within article 89 of the EU MDR 2017/745 and Article 84 of the EU IVDR 2017/746. The requirements mentioned in the two articles are basically the same.
In article 89 of the MDR, there is a specific requirement focused on the language of the field safety notice; in fact it is reported:
The field safety notice shall be edited in an official Union language or languages determined by the Member State in which the field safety corrective action is taken.
Typically, the draft of the field safety notice shall be submitted to the competent authority for evaluation; this standard procedure can be avoided if the safety notice is urgent. Moreover, it is important to mention that the content of the field safety notice shall be the same in any member state, unless it is duly justified by a specific situation of the individual member state.
The following elements are considered mandatory within a field safety notice:
- UDIs of the device involved;
- Identification of the manufacturer (Single Registration Number);
- reasons for the field safety corrective action with reference to the device malfunction and associated risks for patients, users or any other person;
- A clear indication of all the actions to be taken by users
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Information on EUDAMED System
When the electronic system EUDAMED will become available, all the field safety notice shall be handled through EUDAMED, where they will end up in the section accessible to the public. This will allow to have the field actions readily available to the general public through the electronic system mentioned within Article 92 of the European Medical Device Regulation.
What are the exact contents of a Field Safety Notice
As we have seen, the text of the EU MDR / IVDR is rather general on the specific contents that need to be mentioned. In this section, we will go more in details on the specific contents that need to be mentioned in a Field Safety Notice, in order to provide an appropriate level of information to the end users.
This is not an exhaustive list, but it will surely help to have an in depth overview of the specific contents of a field safety notice.
- Information to properly identify the devices involved:
- Device Type(s): Brief description of the device(s); if a photo would help the identification of the device, it would be helpful to include it;
- Commercial name(s); Unique Device Identifier (UDI); Device Model/Catalogue/part number(s)
- Software version and affected serial or lot number range, only if relevant
2. Information to properly describe the reason for the field action / field safety notice:
- Description of the product problem;
- Hazard giving rise to the FSCA: in this section, the greatest threat to the patient/end user as a consequence of not following the advice shall be properly described. Ideally, it would be important to mention the residual risk;
- Probability of problem arising and predicted risk to patient/users: the expected likelihood/severity of patient/end user harm shall be indicated, based on consideration from the risk management process;
3. Type of actions to be performed to mitigate the risks shall be included. Specifically:
- Actions to be taken by the user, along with relevant deadline
- Specify if a confirmation that specific actions have been taken by the user shall be provided.
Conclusions
In conclusion, we have been discussing the main requirements associated to the FSN and field safety corrective actions process, with a specific focus on the requirements associated to EU MDR and IVDR. It is important to mention that EU may publish some specific implementing act on the management of FSN according to the EU MDR since the information mentioned within the regulation are pretty limited.
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