Device Safety Information – DSI/2026/012

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.