Latest field safety notice guidance to manufacturers of mobility and medical devices
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued new advice to manufacturers of medical devices to help ensure field safety notices (FSNs) are clear and achieve maximum replies.
Manufacturers of equipment classed as medical devices, including mobility equipment, are required under the medical devices regulations to inform distributors and users about corrective actions involving their products as soon as possible using FSNs.
FSNs tell customers what they need to do to reduce specified risks of using a medical device identified by a manufacturer – these actions are referred to as ‘field safety corrective actions’ (FSCAs).
Each week, the MHRA publishes lists of FSNs to over 10,000 subscribers across the UK, including NHS Trusts, media outlets, trade bodies and more.
This latest guidance on effectively writing and distributing FSNs from the MHRA comes as additional advice to the European Commission’s existing guidelines FSN guidelines. (MEDDEV 2.12/1 rev.8 section 188.8.131.52)
Emphasising the importance of traceability, the MHRA’s guidance says that manufacturers should keep records to trace distributed products, including records of medical devices by manufacturing date and batch or serial number, unique device identifiers (UDI).
Contracts with distributors should include keeping onward traceability records to end-users, suggests the guidance, whilst manufacturers should record the name of the specific Trusts it supplies when distributing to NHS organisations.
Stressing that FSNs should be clear and concise, the MHRA instructs manufacturers to write in a clear style and “at an appropriate level for the intended audience,” reinforcing that end-users may read the notice so jargon and “unnecessary technical language” should be avoided.
Noting that the risk to the user is the key element of the notice, manufacturers should make it clear in their communications what the problem is and what the recipient must do.
“Don’t delay sending an FSN because you’re waiting to include information on the cause of the problem,” states the MHRA, reminding manufacturers that they can send a follow-up FSN if necessary.
Additionally, the MHRA points out that UDIs should be including in FSCA communications and in non-urgent cases, manufacturers can send there draft FSN to the regulatory agency for comment.
Common FSN mistakes
According to the MHRA, there are common mistakes that the agency has found in draft and published FSNs that manufacturers should avoid:
- missing lot numbers
- too much jargon
- badly explained or missing instructions on what to do next
- missing detailed descriptions of the problem
- missing explanations of how the problem affects the patient
- incorrect or missing contact details for the UK or EU
- missing acknowledgment form
- final FSN hasn’t been signed or dated
- poor translations – the MHRA suggests asking authorised representatives or distributors in the UK to check the English
What should be included in final FSNs
Following the above guidance, the MHRA provides a list of key elements that manufacturers should ensure are met before submitting a final version FSN:
- the correct contact details for the UK or the EU
- only generic information about the recipients – do not use a sample with an individual’s name or address on it
- include covering letters in the FSN
- send it to the MHRA as a single PDF file with all the relevant information rather than separate files with versions of FSNs (such as one aimed at distributors and another at customers)
- the PDF must not be a scanned version of a paper document because it can’t be searched for serial numbers etc.
- the UDIs of the affected devices, preferably on the UDI Device and Header Excel spreadsheet
- if possible, include NHS Supply Chain codes to help your customers decide if they have your product in stock
- if the FSCA covers all lots, state this as well as listing all the numbers
Maximising FSN distribution and response
The regulatory agency does not specify which specific methods of distributing FSNs that manufacturers should use, instead, stating that “the key element in maximising response rates is to make sure the right people know that the FSN is urgent and needs a response.”
Importantly, the MHRA confirms that a ‘read receipt’ of an email is not acceptable proof of acknowledgement of an FSN because it fails to prove that the communication has been read and acted on. The same applies to registered post, which only proves that an FSN has arrived at a destination but not that it has been read and acted upon.
“Some companies are now using an e-signature portal as confirmation that FSNs have been received, and acted on, by the organisation and we would encourage this route of distributing FSNs,” advises the regulatory agency.
To increase the number of replies to FSNs, the guidance recommends that manufacturers should coordinate with Medical Device Safety Officers (MDSO) in healthcare establishments throughout England. The list of MDSO contacts can be accessed via the MHRA’s Manufacturer’s On-line Reporting Environment (MORE) system.
Field corrective actions
Unlike FSCAs which alert and address issues posing the risk of serious injury or death, field corrective notices relate to more minor device-related safety issues. Despite field corrective actions being outside the scope of medical devices directives, the MHRA recommends that manufacturers deal with field corrective actions in a similar way to FCSAs as outlined in its guidance.
Providing examples of the difference between an FSCA and a field corrective notice, the MHRA highlights an instance of an FSCA relating to a powerchair:
“Following reports of users falling from powered wheelchairs due to failures of castor assemblies it was found that the instructions for use did not include adequate user checks and regular maintenance requirements to ensure that the castors could continue to operate correctly. The manufacturer revised the instructions for use and incorporated new requirements for user functional checks and regular maintenance.”
In comparison, the guidance points to a labelling mistake as an example of a non-FSCA instance:
“A manufacturer places an incorrect expiry date of 18 months on the labelling of a batch of product. The supported shelf life is 2 years. The manufacturer chooses to send new labels with the correct expiry date to customers.”
Where there is doubt, the MHRA says it will provide its interpretation of whether the action proposed by the manufacturer falls within the definition of an FSCA and will give advice on FSNs and associated FSCA strategies – including potential advertising campaigns and media engagement.https://thiis.co.uk/latest-field-safety-notice-guidance-to-manufacturers-of-mobility-and-medical-devices/https://i0.wp.com/thiis.co.uk/wp-content/uploads/2020/05/MHRA-advise-FSN.jpg?fit=900%2C600&ssl=1https://i0.wp.com/thiis.co.uk/wp-content/uploads/2020/05/MHRA-advise-FSN.jpg?resize=150%2C150&ssl=1Government & LegislationKnowledge HubNewsroomSector NewsSupplier NewsTrade NewsEuropean Commission,field safety corrective actions,field safety notice,FSCA,FSN,guidance,manufacturers,medical devices,Medicines and Healthcare products Regulatory Agency,MHRA,Mobility,NHS Trusts,suppliers,UDIThe Medicines and Healthcare products Regulatory Agency (MHRA) has issued new advice to manufacturers of medical devices to help ensure field safety notices (FSNs) are clear and achieve maximum replies. Manufacturers of equipment classed as medical devices, including mobility equipment, are required under the medical devices regulations to inform distributors...Calvin BarnettCalvin Barnettcalvin@thiis.co.ukAdministratorTHIIS Magazine