Neoventa manufactures and markets fetal monitoring equipment and training for improved obstetric care. A central product used in fetal monitoring is a fetal scalp electrode that is attached to the fetus’s scalp to pick up the heartbeat. Neoventa’s fetal scalp electrode is called Goldtrace Fetal Spiral Electrode (FSE) and has a unique gold-plated spiral to ensure the best possible signal quality.
In recent months, there has been a global shortage of fetal scalp electrodes on the market, partially caused by a product recall by Philips. At Neoventa, we are aware that fetal scalp electrodes are an important product which is necessary to perform internal fetal monitoring during labour. Therefore, we have taken immediate measures to increase the production of Goldtrace FSE so that healthcare staff can have access to the necessary tools needed for mothers and babies to have a safe delivery.
Goldtrace FSE has been developed specifically for Neoventa’s fetal monitoring devices and is, according to its intended use, compatible with Stan S31 and Stan S41. Due to the general shortage in the market, the question has arisen as to whether Goldtrace FSE can be used together with Philips’ CTG devices. Neoventa has performed various electrical tests on the Goldtrace FSE and the Philips’ fetal scalp electrode. Both devices have also been tested together with the Philips Avalon fetal monitor. Neoventa has determined that there are no technical obstacles to using Goldtrace FSE in combination with Philips Avalon fetal monitor.
For local guidance regarding regulatory implications of usage of Goldtrace FSE in combination with CTG systems from other manufacturers, please consult your local regulatory specialists or local authorities.
If you have any further questions, please contact Neoventa or your local Neoventa representative.
