A full explanation of the massive FDA recall of GE MRI systems.
Last week, the FDA issued a Class I recall, the most serious category of recalls, for all GE Healthcare MRIs with superconducting magnets.
The approximately 13,000 MRI scanners were deemed to have a “reasonable probability that the use of or exposure to [the device] will cause serious adverse health consequences or death,” according to the criteria for an FDA Class I recall.
GE posted a press release on February 4 announcing they had initiated a voluntary field corrective action for all GE MR systems with superconducting magnets that were manufactured from 1985 through today.
The release states that some MR systems were modified by service personnel or equipment users to disable the magnet rundown unit, which is a method of shutting off the magnetic field in an emergency situation. A disconnected magnet rundown unit might delay removal of a heavy object, which could result in life-threatening injuries, GE’s release said.
More than 30 MRI models are included in the recall, as listed on the FDA web site:
This recall is different from the kind of recalls consumers typically see, in the sense that the MRI does not have to be shipped back or stopped from operating, Ben Fox, director of external affairs for the Americas at GE Healthcare told Diagnostic Imaging in an e-mail. “[The] recall instructs users to perform the 5-minute check, then back to business as usual.”
In a letter to facilities that use these systems, GE instructed personnel to confirm that the MRU is connected to the magnet:
1. Verify the green Charger Power LED is lit.
2. Depress and hold the test battery switch for 15 seconds. The green battery test LED should light and remain lit while the test battery switch is depressed.
3. Place the test heater toggle switch in the A position. The green heater test LED should light.
4. Place the test heater toggle switch in the B position. Green heater test LED should light.
“If the MRU test does not perform as described in each of the 4 steps above, with the specified LED lighting in each step, GE Healthcare strongly recommends that you stop using the system, and immediately call your GE Healthcare representative,” the letter states.
The recall can be traced back to a November incident in India in which two employees of Tata Memorial Hospital in Parel, Mumbai were injured when an MRI’s magnetic field pulled in an oxygen cylinder and pinned the two employees against the machine for 4 hours while hospital employees attempted to quench the magnet.
GE wants to emphasize that the FDA notice was not related to any manufacturing defect or product-related error, and is solely in response to this single safety incident caused by human error in India, Fox said.
What’s unclear is whether it was a hospital human or a GE human that made the error. In a November article in the Mumbai Mirror, a Tata Memorial Hospital committee alleged that it was GE engineers that disabled the magnet rundown unit without the facility’s knowledge. In fact, the Mirror article reports that GE engineers removed the switch from all GE’s MRIs in India “after a patient fiddled with [the switch] at one of the centers, leading to a release of a large amount of helium gas.”
More recently, the Mirror reported that the panel set up to investigate the accident submitted an incomplete report to the state, noting that the hospital was not cooperating. The panel did cite the hospital’s “alleged irregularities of negligence in operation of the MRI machine at the hospital,” according to the article.
Fox said the investigation at the Tata Memorial Hospital is still ongoing, but that GE did not remove the MRU from all of its MRIs in India. GE learned that an MRI system in India had been modified to disable the MRU in late November 2014. Soon after, GE initiated a field corrective action for MR systems in India. A global review followed since this involved a key safety component. As a result of the review, GE issued a voluntary field corrective action for all GE MR systems with superconducting magnets and instructed customers to confirm that their MRU is functioning properly. After discussions with the FDA, GE issued a press release on February 4, and the FDA announced their recall on February 18.
While a situation in which individuals are pinned to an MRI isn’t common, there are sites in the U.S. that have discovered that their quench buttons had been disabled, according to Tobias Gilk, secretary and treasurer of the Board of Directors of the American Board of Magnetic Resonance Safety and vice president of RADIOLOGY-Planning.
“There are still pretty regular incidences of patients or technologists getting pinned against the MRI scanner by a ferromagnetic object, and the quench function is the one and only option to save the person if their life is in immediate danger,” Gilk said. “The fact that these could be disabled should be of concern to anyone with these systems.”
GE might also have downplayed the risk, Gilk said. “If GE’s ‘urgent medical device correction letter’ had effectively addressed this risk, I can’t imagine that the FDA would have stepped in with the recall notice two weeks later,” he said.
Gilk has heard from staff at GE sites that the staff usually receives verbal assurances that the quench buttons are checked as part of the regular preventive maintenance (PM) service. He noted that the sites’ employees indicated that they usually don’t get a summary at all of what items were included in the PMs, or what corrective actions needed to be taken, if any.
“For quench buttons, which are the only means of quickly freeing someone trapped against a superconducting MRI scanner, I think it’s perfectly reasonable for sites to expect documentation that this essential safety tool is operational,” he said.
“Maintaining a high level of safety and quality is a priority for GE Healthcare,” GE’s Fox said. “GE Healthcare is currently following up with all customers as well to inspect and test their Magnet Rundown Unit and will correct affected systems at no cost.”