Biomedical telemetry equipment

Safety advisory - impact of changes to radio frequency spectrums

4 October 2013

Medical device sponsors, hospitals and health professionals are advised that changes to radio frequency (RF) spectrums in Australia could affect a small number of biomedical telemetry devices used in hospitals.

The changes are being managed by the Australian Communication and Media Authority (ACMA) and relate to the transition from analogue to digital television services. The transition is scheduled to start in November 2013.

For many years, the ACMA has had in place arrangements that authorised low-power biomedical telemetry equipment to utilise unused television channels.

Most modern biomedical telemetry equipment operates in the 2.4 GHz or higher frequency band. However, some telemetry equipment supplied in Australia and potentially still in use may operate in the 520-820 MHz band.

The ACMA has advised that new television services will soon fall across the 608-614 MHz band, which could disrupt some biomedical telemetry equipment, particularly older devices. These disruptions could cause the devices to stop working and/or become unstable.

The TGA is contacting sponsors of potentially affected devices to provide further information about this issue.

The TGA continues to liaise with the ACMA and, together, they are working with the Australian Institute of Biomedical Engineers to provide its members further information about this issue.

Information for sponsors

The TGA has written to medical device sponsors that may be affected by this issue, requesting information.

Those sponsors were asked the following questions:

  • Do you supply or provide after-sales support for any medical devices that use the 520-820 MHz frequency band?
  • li>Have you previously supplied any medical devices that use the 520-820 MHz frequency band?
  • Are you aware of any biomedical telemetry devices operating the in the 520-820 MHz frequency band supplied by you that are still in use, including devices that are supported by either a hospital-based clinical engineering department or a third-party service provider?

If you were not contacted but, based on the above questions, believe that you may have supplied a potentially affected device to the Australian market please email postmarketdevices@tga.gov.au, providing the model names of the affected devices, details of what frequencies within the 520-820 MHz band they use, and details of which facilities they have been supplied to. Additionally, advise the TGA if the affected devices can be re-tuned to avoid potential interference.

Information for hospitals and health professionals

Hospitals are advised to check their biomedical telemetry equipment to see if any devices utilise the 520 - 820 MHz frequency band before November 2013. If any such equipment is identified, arrange for the hospital's biomedical engineers to contact the device sponsor and/or manufacturer to obtain technical support and to check if re-tuning to avoid potential interference is possible.

Health professionals who are treating hospitalised patients who are being monitored by telemetry equipment and are concerned about this issue should reassure them that remote monitoring is just one potential method of monitoring patients. Reassure them those patients that they will be physically checked on a regular basis, as required by the nature of their condition.

If you have any questions or concerns about this issue, contact the sponsor of your biomedical telemetry equipment or phone Steven Forst at the ACMA on 02 6219 5236

Information for consumers

Patients are unlikely to notice or experience any problems associated with the above changes, and should not be unduly concerned about this issue.

Implantable cardiac devices, such as pacemakers, are not affected, as they do not use the frequencies affected by this change.

Biomedical telemetry equipment is used in hospitals for the remote monitoring of patients. Typical applications are in heart, blood pressure and respiration monitors.

Remote monitoring is just one potential method of monitoring patients. Health professionals in hospitals also physically check patients on a regular basis, as required by the nature of their condition.

The TGA is working with the ACMA, the Australian Institute of Biomedical Engineers and sponsors of potentially affected devices to address this issue.

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.