MHRA: Wireless CTG RF Safety Alert DSI/2026/012 Issued

• The MHRA's DSI/2026/012 alert highlights patient safety risks associated with wireless cardiotocography (CTG) systems using radiofrequency (RF) telemetry.
• Identified risks include signal crossover, erroneous CTG traces, and signal dropouts, particularly in systems operating within the ISM frequency band with limited channels.
• These issues can lead to misinterpretation of fetal heart rate data, potentially resulting in inappropriate clinical decisions and adverse patient outcomes.
• The Medicines Healthcare products Regulatory Agency recommends clinical verification of CTG traces, correlation with other clinical features, and the maintenance of a device register by EBME/Clinical Engineering staff.
• Healthcare professionals are urged to report incidents related to wireless CTG systems to enhance patient safety and ensure compliance with medical device regulations.

The potential for misinterpretation of these vital physiological measurements can lead directly to inappropriate clinical decisions, with serious adverse consequences for patient well-being.

The Medicines Healthcare products Regulatory Agency (MHRA) has issued a significant alert, DSI/2026/012, following a comprehensive review into the safety of wireless cardiotocography (CTG) systems. These devices, which utilize radiofrequency (RF) telemetry channels, have been identified as posing several critical patient safety risks. The MHRA's findings underscore the potential for serious adverse outcomes if these risks are not adequately managed by healthcare providers and medical device manufacturers in the UK.

Key concerns highlighted by the MHRA's investigation include signal crossover, the generation of erroneous CTG traces, and instances of signal dropouts. These issues are directly linked to the operational characteristics of wireless CTG systems and their reliance on shared RF telemetry. The agency's proactive stance aims to mitigate the risks associated with these widely used medical devices, ensuring the continued safety of maternal and fetal monitoring during pregnancy and labor.

Cardiotocography (CTG) serves as a standard method for monitoring fetal well-being, meticulously recording fetal heart rate (FHR) and uterine contractions. Historically, this monitoring relied on wired ultrasound and pressure sensors affixed to the maternal abdomen. The advent of wireless CTG systems marked an evolution in this technology, offering the significant advantage of enabling physiological measurements without physically tethering the pregnant woman to bedside equipment, thereby affording greater freedom of movement during labor.

However, this technological advancement introduces specific vulnerabilities. Wireless CTG systems frequently operate using shared RF telemetry channels, particularly within the Industrial, Scientific and Medical (ISM) frequency band, which is characterized by a limited number of available channels. This shared spectrum creates a susceptibility to signal crossover or interference, especially when multiple devices operate within close proximity. Such interference can manifest between rooms on the same floor, across different floors, during patient transfers, or when devices are relocated between clinical areas. In rare but critical circumstances, this signal crossover can lead to the fetal heart rate from one CTG monitor being erroneously displayed on another monitor operating on the same RF channel, directly impacting MHRA wireless CTG RF safety DSI/2026/012.

The identified risks—signal crossover, erroneous CTG traces, and signal dropouts—carry profound implications for patient safety. The primary concern is the potential for misinterpretation of the vital CTG traces, which are crucial for assessing fetal health. When healthcare professionals receive inaccurate or misleading data, it can lead to inappropriate clinical decisions. These decisions, in turn, could result in adverse consequences or harm to both mother and baby.

Evidence supporting these concerns stems from a combination of incident reports and direct feedback from stakeholders within the healthcare sector. The cumulative effect of these factors underscores the critical need for robust measures to address Wireless Cardiotocography monitoring risks. The MHRA's alert emphasizes that the integrity of CTG signal crossover patient safety is paramount, and any compromise in data accuracy poses a direct threat to effective obstetric care.

To mitigate the identified RF telemetry medical device risks, the MHRA has issued clear recommendations for healthcare providers. These directives are crucial for ensuring compliance with Medical device regulation UK and safeguarding patient well-being. Firstly, healthcare professionals must clinically verify CTG traces at the commencement of monitoring and continuously throughout the entire period. This verification should include ensuring that CTG traces correlate accurately with other clinical features observed in the patient.

Secondly, facilities are mandated to introduce and maintain a comprehensive register. This register, to be managed by EBME (Electro-Biomedical Engineering) or Clinical Engineering staff, is essential for tracking device usage and potential issues. Furthermore, the MHRA stresses the importance of incident reporting; healthcare professionals are urged to report any adverse events or concerns related to wireless CTG systems. Adherence to these guidelines is vital for preventing misinterpretation of data, avoiding inappropriate clinical decisions, and ultimately enhancing MHRA wireless CTG RF safety DSI/2026/012.

Healthcare providers and medical device manufacturers in the UK must review their use and production of wireless CTG systems to ensure compliance with MHRA safety recommendations, mitigate patient safety risks from signal crossover, and update incident reporting protocols to avoid potential regulatory penalties or product liability claims.

Source: Original reporting via the Medicines Healthcare products Regulatory Agency