AXREM Statement – Performing Field Safety Corrective Action Updates on Non-manufacturer Maintained Medical Devices
16 January 2025
Background
Adverse incidents involving medical devices that occur in the UK must be reported to the
Medicines and Healthcare products Regulatory Agency (MHRA) as part of medical device
vigilance. Comprehensive information on the medical device vigilance system is given in
MEDDEV 2.12/1 rev 8 and the additional guidance under ‘Post-Market Surveillance’, which
describes what, how and when to report adverse incidents involving medical devices.
This reporting may result in a Field Safety Notice (FSN) and subsequently the manufacturer
may issue a Field Safety Corrective Action (FSCA), which may require work to be undertaken on the medical device or may only involve informing the customer of actions they are required to undertake.
Corrective Actions on Medical Devices
The physical application of any FSCA safety or performance update assumes the medical device is in the manufacture supplied conformant state and has not been:
- modified or adapted from the OEM approved certification (including hardware and software.
- adjusted outside the outside the original manufacturer’s specification and device certification.
- fitted with incompatible/incorrect revision parts, or parts not approved by the medical device manufacturer.
- serviced without following the manufacturers stipulated instructions and using the consumables specified.
- installed without following the manufacturers stipulated instructions, which is a requirement of the device certification.
Applying a corrective action (involving hardware and/or software) to a medical device that does not fulfil the above could result in unintended consequences ranging from deviations in performance (e.g., radiation under or over exposure), unexpected operation (e.g., uncontrolled movement), an adverse incident, or even total loss of operation. In some cases, problems may develop over time (e.g., if an incompatible grease was used during service and it reacted with an update part).
Manufacturer Obligations
Where a Field Safety Corrective Action (FSCA) requires work on the medical device, such as installing hardware and/or software, it is essential the product is in a conformant state to accept the update to prevent an adverse incident and subsequent harm to a patient or operator.
Where the original equipment manufacturer (OEM) or their authorised agent has a contract to maintain the equipment, they will have all records of the work carried out and can satisfy themselves that the medical device is in a state to install the update. However, where the medical device owner has decided not to use the OEM or their authorised representative to maintain the equipment the status is unknow to the manufacturer.
If the manufacturer (OEM) is tasked to perform the corrective action they must confirm the status of the medical device before proceeding. This could be achieved by either the OEM carrying out a full inspection and maintenance cycle or the healthcare organisation service provider confirming compliance with the OEM service and maintenance requirements to confirm the medical device is in the OEM certified state. Any non-conformities identified as part of this work will also need rectification prior to any corrective action (update). Although the actual FSCA will be free of charge, this pre-work will be chargeable, as it is not part of the corrective action required by the vigilance system.
NOTE: The OEM will need to make available the service and maintenance documentation as well as OEM parts so that conformant service, maintenance, and repairs are undertaken.
Issue & Solutions
Where the medical device is not maintained directly by the OEM or their authorised representative the healthcare organisation (owner), or their chosen service provider, may question the necessity of charges for verifying that the device is in a suitable state to accept the FSCA (update). However, ensuring the conformity of the device is essential to minimise risks to safety, performance, or functionality, including potential liability for the OEM or other parties if any incident occurs post-update.
The possible options for providing FSCA updates on equipment not under a contract with the manufacturer (OEM) or their authorised service partner are as follows:
- OEM Inspection & OEM Implementation: The OEM is tasked to preform the pre update inspection and associated maintenance along with any corrective actions required to bring the medical device to conformity (chargeable). The OEM will then install the update in accordance with the FSCA, confirm operational status and handover to the healthcare organisation (owner/user).
- Non-OEM Inspection & OEM Implementation: The service provider supplies the OEM with documented confirmation that service, repairs, and maintenance has been conducted in accordance with the product documentation, which will be provided by the OEM if required. The OEM will then install the update in accordance with the FSCA, unless a non-conformity prevents this. The service provider then confirms the operational status of the device before handover to the healthcare organisation (owner/user).
- Non-OEM Implementation: The service provider receives the FSCA update from the OEM, installs it, and provides confirmation of successful completion to the OEM within the mandated timelines. The service provider then confirms the operational status of the device before handover to the healthcare organisation (owner/user). Refusal of Update: The medical device owner or their agent refuses the update. This decision must be formally recorded and reported to the MHRA in accordance with regulatory requirements.
Medical device owners, maintenance providers, and manufacturers must work together to ensure medical devices are safe and conformant. Timely installation of FSCA updates plays a vital role, along with maintaining medical devices in a conformant state.
Please feel free to contact AXREM if you have any questions about this statement.
You can download a copy of this statement here: AXREM Statement – Performing Field Safety 160125 Corrective Action Updates on Non-manufacturer Maintained Medical Devices Document