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Medicines and Healthcare products Regulatory Agency gov.uk

Radiofrequency (RF) Safety Considerations for Wireless Cardiotocography (CTG) Monitoring Systems (DSI/2026/012)

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The MHRA has conducted a review into the use of wireless cardiotocography (CTG) systems that use radiofrequency (RF) telemetry channels. Signal crossover, erroneous CTG traces and signal dropouts have been identified as patient safety risks associated with these devices.

The MHRA has conducted a review into the use of wireless cardiotocography (CTG) systems that use radiofrequency (RF) telemetry channels. Signal crossover, erroneous CTG traces and signal dropouts have been identified as patient safety risks associated with these devices. In rare circumstances, signal crossover may result in the fetal heart rate from one CTG monitor being displayed on another CTG monitor operating on the same RF channel. These risks may result in misinterpretation of CTG traces and inappropriate clinical decisions which could lead to adverse consequences.

The risk relates to classic telemetry systems operating within the Industrial, Scientific and Medical (ISM) frequency band where a limited number of channels are available.

Actions for Healthcare Professionals including Clinical and Medical equipment management staff:

  • ensure that two or more wireless CTG devices are not operating on the same RF channel unless there is sufficient distance between them to prevent signal crossover or interference (see under Operational Controls in the Actions for NHS Organisations section for further details). For example, in the absence of any obstacles such as walls or pillars, a distance of 100 metres may be required between two devices operating on the same RF channel to avoid signal crossover. Note that the wall between adjacent rooms may not be sufficient to prevent signal crossover. There is also the potential for signal crossover between floors. The Instructions for Use and/or manufacturer guidance should be consulted for device-specific advice on this matter

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    September 17, 2026 13:30
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