The Medicines and Healthcare products Regulatory Agency (MHRA), UK’s authority responsible for the regulation of medical devices, issued guidance on field safety notices (FSNs). The document is intended to assist medical device manufacturers in preparing the appropriate notices and improvement of communications related thereto.
Field Safety Notices Concept in Brief
According to the regulation, manufacturers of medical devices approved by the MHRA and placed on the UK market shall properly inform the authority about any and all corrective actions taken with regard to such devices by submitting a Field Safety Notice (FSN). The basics of drafting FSNs are already described in the EC guidance on Medical Devices Vigilance System. Present MHRA guidance highlights certain specific aspects and provides medical device manufacturers with additional information and recommendations to assist them in maintaining compliance with post-market surveillance requirements.
The MHRA emphasizes the importance of the measures necessary to improve the traceability of the medical devices after making them available to patients and healthcare professionals.
These measures should include, inter alia, the following ones:
- Maintaining records, including the manufacturing date and batch/serial number;
- Unique device identifiers (UDI);
- Recording the information about the devices directly supplied to end-users and distributors.
The text of the notice should be clear and understandable even for those who have no special qualification and knowledge. Everything related to the risk, associated with the use of the device, should be especially clear so that the users of the device could understand the issue and the particular actions to be performed.
When it comes to safety issues, timing is of the essence. Thus, according to the MHRA guidance, it is important to submit the notice as soon, as possible, to ensure that the information about the risks associated with the device is available for healthcare professionals and users without the undue delay. In the case that the medical device manufacturer reasonably needs additional time to perform a rigorous investigation, the initial notice should be provided immediately after the manufacturer becomes aware of the issue associated with the device, while the additional information collected in the course of an investigation should be provided as a follow-up notice.
The MHRA also advises to supplement the information provided in the FSN with the unique device identifiers to make it easier to outline the scope of medical devices covered by the notice. This information should be also provided together with the notices related to the safety corrective actions (FSCA) – special measures taken by the medical device manufacturer to mitigate the risk associated with the use of the device. It is also recommended to use the templates suggested by the authority to ensure that the notice contains all the information necessary to assess the issue and risks.
It is also important to mention that medical device manufacturers may submit draft notices to the authority. However, in case of urgent issues, the appropriate notices should be made available immediately without the undue delay.
Common Mistakes When Publishing Notices
In order to assist medical device manufacturers in preparing the notices that fit the intended purpose, the authority supplemented the guidance with the list widely spread mistakes to emphasize the importance of the aspects associated thereto.
According to the MHRA, while publishing the notices, medical device manufacturers often:
- Fail to indicate lot numbers:
- Use a lot of special terms making the notice difficult to understand for anyone without special qualification or knowledge:
- Fail to provide the information about the issue, the potential impact it could have on the patients` health or recommendations regarding the particular actions to be taken:
- Do not include correct contact details of their authorized representatives:
- Fail to add the appropriate date when the notice has been published, or the signature of the authorized person responsible for safety issues:
- Provide the information in poor translations, that could create grounds for additional mistakes in understanding the document.
Key Points the Notice Shall Include
Besides describing the mistakes medical device manufacturers often make when submitting the notices, the MHRA guidance also includes a list of key points to be covered by the FSN. These points include, inter alia, the following ones:
- The contact information included in the notice should be correct and up-to-date;
- The information about the recipients should be generic;
- The notice should contain a cover letter;
- It is strongly recommended to include all important information into the single notice submitted in a PDF form, and do not create different versions of the documents for users and distributors separately. The document should be intended for all categories of recipients the notice is addressed to. At the same time, the document should not be provided as a scanned copy in order to make it possible to use searching features;
- The notice should contain the information about the UDI of the devices covered by the scope of the FSN, as well as the NHS Supply Chain codes.
Publishing the Field Safety Notices
After being submitted by the medical device manufacturer, the FSN will be published on a special page of the regulating authority.
The authority does not limit the medical device manufacturer in choosing the particular methods to make the notice available to the users and healthcare professionals. The manufacturer may choose ones providing the widest coverage. According to the MHRA guidance, the core idea is that those the FSN is being addressed should be informed about safety issues associated with the medical device they use as soon as it is reasonably possible.
When distributing the notice, the medical device manufacturer shall ensure it has been duly received by its recipient. For this purpose, various proofs of acknowledgment could be used. The recipients shall explicitly confirm that the notice has been successfully received and acknowledged. The authority states that the particular method used should not only confirm that the notice itself has been received, but also that the information it contains has been duly processed. Sometimes the authority could also assist medical device manufacturers by issuing Medical Device Alerts to warn attention to the notice. It is also advised to make the information about the FSN available using the network of Medical Safety Officers (MDSO) to accelerate and improve the distribution of important information about the safety issues the notice contains.
Field Safety Corrective Actions (FSCA)
The present MHRA guidance on Field Safety Notices also covers some aspects related to the Field Safety Corrective Actions to be performed by the manufacturer of the device in order to address safety issues associated thereto. Depending on the importance of the issue and the potential impact it could cause on public health, certain specific measures could be necessary to attract attention. For example, in certain cases, a public warning could be needed. The manufacturer shall inform the MHRA about the grounds for concerns and any actions to be taken.
Summarizing the information provided hereabove, the MHRA guidance provides medical device manufacturers with the particular recommendations regarding the way the Field Safety Notice and the notice on Field Safety Corrective Actions should be drafted, published, and distributed.
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