AXREM Remote Service Handover Statement

25 March 2024

AXREM have been approached requesting a version of the current AXREM Ionising Radiation Controlled Area and Equipment Handover Form that is suitable for use when remote service is performed.

However, this current form was only intended to be used when the controlled area was to be transferred to the direct control of another party, who would then be working under their own local rules. Also, as someone working remotely is not subject to the ionising radiation regulations, since there is no exposure risk, and since they can’t control access to the ionizing radiation equipment, the use of the handover form is not applicable. So, to be clear:

• The person conducting remote service is not affected by ionising radiation.
• Someone remote from the equipment is unable to supervise the “Controlled Area”.

In general, most remote service activities do not involve making any changes that could impact radiation safety. Even a software update (e.g., patch for cybersecurity) would have been tested to ensure it did not impact safety, including anything that could affect radiation quality.

Remote service and remote updates do not happen without user knowledge. Typically, remote service must be enabled by the user before the session can begin. Remote software updates are notified to the user (e.g., message on screen at switch on) and any actions needed are clearly displayed.

If remote service has been carried out by an engineer, then just as with a site visit, a service report will be generated and delivered by the normal mechanisms (e.g., via email to a monitored mailbox). As with any service intervention the user must read the report to satisfy themselves the equipment is ready to be returned to service. If the report indicates changes may have affected radiation quality, then this will be made clear, so appropriate action can be taken.

Therefore, in the case of remote service a cycle of transfer is present, just as with a normal site visit. This typically has the following steps:

• Remote service access is requested by the remote engineer.
• User either grants or denies remote access.
• Remote engineer conducts work once access is granted.
• Remote engineer closes remote session and completes a service report.
• User reads the service report and takes any actions required, which could include not using the equipment until further actions are completed.
• Once any required actions are completed the equipment is returned to service.

It is important that the healthcare organisation and remote service company have appropriate standard operating procedures (SOP) in place that align with the above steps.

Please also note that the manufacturer of a medical device, following risk assessment (e.g., ISO 14971) and quality management (e.g., ISO 13485) appropriate for such a device, will only release remote service activities that can be completed safely.