GovWire

Field safety corrective actions (FSCA) are taken by the manufacturer to prevent or reduce the risk of a serious incident in relation to a device which has already been placed on the market or put into service.

You should communicate details of FSCA to customers and users using a field safety notice (FSN). The UK medical devices regulations state that following submitting the initial report and proposed notice the manufacturer must implement the FSCA as soon as possible and monitor its progress.

There are existing guidelines for writing and distributing FSNs in the?guidance on GB post-market surveillance.

In this guidance for manufacturers, we provide supplementary information and give advice on how to produce and distribute effective FSNs.

Good traceability

You should keep records to help trace your distributed product. This should include:

• records of medical devices by manufacturing date and batch, version or serial number

• unique device identifiers (UDI)

• keeping traceability of medical devices directly supplied to users and distributors

Contracts with distributors should include keeping onward traceability records to end users and agreements on information sharing as far as is practicable. If distributors are not willing to share customer lists with you, your contract should require them to do so directly with the MHRA on request. Responsibility for ensuring the communication reaches end users remains with the manufacturer.

For connected devices, software and apps, consider:

• how you can use the technology to aid traceability

• how to distribute the message of FSNs

• how to enable updates to be delivered to the field

When supplying to large organisations such as NHS trusts, recording the address and name of the responsible department is important for traceability. Where possible, record the name of the user or person responsible for the device as well as anybody responsible for the purchase.

In addition, when supplying NHS organisations, recording the name of the NHS trust will enable you to identify the medical device safety officer (MDSO) to contact. This will help you target your communication to get maximum replies to your FSNs.

FSN?content

Manufacturers can use this template to write your FSNs.Where a section of the template is not applicable, it can be removed for ease of reading.

First, read the?FSN?template Q&A.

There is also an?FSN?customer reply? template and?an FSN?distributor/importer reply? template.

The FSN should be on a company letterhead, be written in English and include the following:

• A clear title, with Urgent FIELD SAFETY NOTICE followed by the commercial name of the affected product, an FSCA identifier (for example, date or FSCA reference number) and the type of action.
• Specific details to enable the affected product to be easily identified, for example, type of device, model name and number, batch/lot or serial numbers of affected devices, part or order number and UDIs where available. We recommend that the manufacture dates are also included for ease of identification.
• A factual statement explaining the reasons for the FSCA. This should include a description of the device deficiency or malfunction, clarification of the potential hazard associated with the continued use of the device and the associated risk to the patient, user or other person and any possible risks to patients associated with previous use of affected devices.
• Advice on actions to be taken by the user. Include as appropriate:
  • how to identify an affected device
  • method of recovery, quarantine, disposal or modification of device
  • review and implementation of additional risk mitigation measures
  • recommended review of patients previous results or patient follow up, for example, implants, IVD
  • timelines for completion of these actions
• A request to pass the field safety notice to all those who need to be aware of it in the organisation and to maintain awareness over an appropriate defined period.
• If relevant, a request for a copy of the field safety notice to be passed on to all organisations to which any affected devices have been transferred, and for the details of onward distribution of these devices to be given to the manufacturer.
• If relevant, a request that the recipient of the field safety notice alerts other organisations to which incorrect test results from the use of the devices have been sent, For example, failure of diagnostic tests.
• Confirmation that the MHRA has been advised of the FSCA.
• Contact point for customers how and when to reach the designated person. This person should be either the manufacturer if UK based, the UK responsible person or Northern Ireland authorised representative.
• An acknowledgment form for the receiver.

Omit any comments and descriptions that attempt to:

• play down the level of risk in an inappropriate manner
• advertise products or services

Maximising efficacy of FSN communication

Write the?FSN?in a clear style and at an appropriate level for the intended audience. Remember that in some cases patients will read the notice, so its best to avoid jargon or unnecessary technical language.

The risk to the user is the key element of the notice. Make it clear what the problem is and what the recipient must do.

Do not delay sending an?FSN?because you are waiting to include information on the cause of the problem. In such circumstances, there is the option to send a follow-up?FSN.

The FSN must be sent in a format that enables customers to search for UDI information (wherever available), catalogue numbers, model numbers and LOT numbers. We consider it best practice to include unique device identifiers (UDIs) in your field safety corrective action (FSCA) communications.

We have worked with?GS1?and?HIBCC?to produce the following templates for the incorporation of detailed device information in field safety notices (FSNs) and we encourage you to use these.

If you use GS1 UDIs, use the?GS1 UDI device and header spreadsheet?. The?GS1 recommendations on FSCA and recalls using unique device identifiers and GS1 standards?provides background information and details on how to fill in the spreadsheet.

If you use HIBCC UDIs, use the ?HIBCC UDI device and header spreadsheet?.

Manufacturers must submit their initial FSCA report and draft?FSN?to us before sharing with customers (except for urgent FSNs). This is so we can provide advice on the FSCA implementation strategy or comments on the proposed FSN. If you receive no response within 5 days of submitting the draft, you should circulate the 