Dive Brief:
- GE HealthCare’s recall of malfunctioning oxygen sensors was categorized by the U.S. Food and Drug Administration as a Class I event, the agency said in a Friday notice.
- GE HealthCare contacted customers in May to warn them that certain TruSignal devices can limit the effectiveness of external cardiac defibrillation or unintentionally expose patients to electrical currents.
- No patients have suffered injuries or died as a result of the faulty devices. However, the FDA sees potential for the fault to cause serious injuries or deaths, and GE HealthCare is advising customers to use alternative oxygen sensors.
Dive Insight:
Healthcare professionals use TruSignal devices to continuously monitor blood oxygen and pulse rate. Put on the skin, the sensors provide insights into the status of patients that inform treatment decisions.
GE HealthCare has identified three problems with multiple products in the TruSignal franchise, including its disposable AllFit sensor and reusable Sensitive Skin sensor.
In the first safety issue, affected sensors can potentially reduce the amount of electrical energy that reaches the patient during external defibrillation and, in doing so, limit the success of the procedure and the restoration of a normal rhythm. GE HealthCare told customers the problem could go unnoticed.
The second issue happens when the sensors are saturated with fluids. When that happens, patients may be exposed to unintended voltage if they come into contact with a faulty external power source. The third issue relates to the presence of material that can block parts of the devices and cause them to provide inaccurate blood oxygen readings.
In response, GE HealthCare issued a notice about 7,559 devices that it distributed in the U.S. between the start of January 2021 and May 4, 2023. The company is asking customers to use alternative sensors, such as TruSignal devices that are not affected by the recall, if possible. Affected sensors can be used if there are no alternatives and the devices are not saturated with fluids.