AXREM, the association of healthcare technology providers for imaging, radiotherapy and care, has released a statement on safety updates on non-contract medical devices. Medical device regulations require manufacturers to provide updates for devices in response to identified issues. These may be related to product safety or performance and are reported to the MHRA as well as affected customers.
Performing an update on a medical device requires certain conditions are met to ensure the update operates as expected. All previously required updates must have been installed, including to parts that have been exchanged. The product must be unmodified from the conformity assessed state (CE or UKCA marked) and operating within the manufacturer’s documented specification. All required service and maintenance actions should have been performed and only manufacturer approved spares used.
AXREM states: “Installing any update without ensuring the preconditions are met can lead to erroneous medical device operation and hazards both to operators and patients.” Where the medical device owner/operator does not have a contract with the manufacturer or approved agent, it is difficult to verify prerequisite conditions are met. In this case it would be necessary to undertake an inspection of the device.
AXREM says its members have reported that during inspections prior to returning medical devices to contract, or where inspections have been carried out prior to performing an update, these preconditions have not always been met. For example, fitted parts have not had the required updates applied, as they have been harvested from scrapped equipment, incorrect versions of parts for the device have been used, non-OEM parts have been fitted, safety components have not been replaced at the required interval, software has been modified to bypass service keys, etc. This can impact the safety of the device and is not in line with the MHRA published guidance on managing medical devices. MHRA guidance on managing medical devices states: “If a device fails in use following replacement of a part with one not corresponding to the device manufacturer’s specifications and this leads to the death or serious injury of a patient/user, there is a greater likelihood of the organisation responsible for medical device repair/maintenance being held liable for the injuries caused.”
Published on page 17 of the April 2023 issue of RAD Magazine.