GE HealthCare is warning healthcare providers that tens of thousands of its TruSignal pulse oximeters sold in the last few years could potentially put hospitalized patients at risk of a worsened condition, further injuries or even death.
The medtech giant began the recall in mid-May, and the FDA gave the safety event its most serious Class I rating this month, according to a notice from the agency Friday.
The recall spans a broad range of TruSignal sensors, including models that are clipped to the ear or finger, marketed as single-use or reusable and used on both adults and children. The devices are used in clinical settings to continuously monitor both pulse rate and arterial oxygen saturation, or SpO2, a measure of how much oxygen is in the blood.
In total, GE HealthCare has recalled more than 81,000 devices distributed around the world between January 2021 and March of this year, according to a series of entries in the FDA’s recall database; fewer than 10% of those sensors, about 7,500, were sold to healthcare providers in the U.S. Nearly half of the recalled devices were sold under the TruSignal AllFit name; those 36,000 sensors are disposable and indicated for use by all patient populations, from neonatal to adult.
The recall began earlier this year after GE HealthCare learned that some of the sensors may be at risk of malfunctioning, which the FDA has linked to flaws in the design of the devices.
The faulty sensors may prevent a defibrillator from sending the full programmed amount of energy to a patient’s heart if the pulse oximeter is being used at the same time, potentially blocking the delivery of critical therapy to a patient who may be experiencing cardiac arrest or another life-threatening heart condition.
Defective TruSignal devices could also “unintentionally expose patients to electrical currents from other sources,” per the FDA notice. Additionally, they may provide inaccurate SpO2 readings, which could affect patients’ treatment plans.
GE HealthCare hasn’t received any reports of injuries or deaths associated with the recall.
The company is advising healthcare providers to avoid using the impacted TruSignal sensors. If no alternative is available, they can continue to be used with some precautions, including detaching the sensors when defibrillation is needed and stopping use of the sensors if they become saturated with fluids or if their built-in emitters or detectors are found to be obstructed by the device’s materials.
In a statement sent to Fierce Medtech, a GE HealthCare spokesperson said, “Patient safety is our top priority. We are informing customers of the potential issue and providing them with interim instructions until the affected products are replaced. There are no reports of patient injury as a result of this issue.”
Pulse oximeters have already been in the hot seat as of late. Following the release of study data showing that many of the devices currently on the market are less effective at collecting readings through darker skin, the FDA assembled a panel last fall to discuss solutions to the devices’ racial biases.
Both BioIntelliSense and Masimo have recently touted pulse oximeters proven to be skin tone-agnostic, and GE HealthCare, too, has confirmed that its own TruSignal SpO2 sensors work well across a range of skin tones in a small study conducted in 2021.