AVONDALE, AZ — An Arizona imaging center wasn’t required to tell federal regulators about an incident where an inmate and guard were stuck to an MRI machine, causing serious injuries, based on existing federal mandatory reporting requirements.
“While it may not rise to the level of FDA classification of a serious reportable event. In my opinion, it's pretty serious,” said Tobias Gilk, an MRI safety expert.
Inmate Lacey Windust and a prison guard were both stuck to an MRI machine at a SimonMed Imaging Center in Avondale in May 2022 after a SimonMed tech allowed them to go inside the imaging room with metal on, according to an Arizona Department of Corrections incident report.
Records showed the SimonMed tech told the prison guard not to remove the metal shackles around Lacey’s waist. After being asked to go in and help Lacey, the guard said he was also stuck to the machine because of his gun.
MRI stands for Magnetic Resonance Imaging – the machine is essentially a giant magnet so it’s no secret MRI's and metal don’t mix.
“That magnetic field grabbed hold of the chain and the padlock and essentially pulled the prisoner up against the MRI,” said Gilk.
The ABC15 Investigators learned state regulators were unable to investigate or take enforcement action because the SimonMed in Avondale and others are not currently licensed or regulated by the Arizona Department of Health Services due to an exemption provided in state law. The department is now reviewing SimonMed’s exemption.
Prison records showed the 37-year-old Windust was taken to the emergency room with a deep cut on her hand that required stitches, bruises, and imprints from where the metal shackles pulled on her body.
But here’s what is key: Windust was only taken to the ER and never admitted to the hospital.
The FDA only requires reporting for what it calls “a serious adverse event” if there was an “admission to the hospital.”
“Going to the emergency room and getting a dozen stitches or a cast, even though you or I would probably, rightly, consider that to be a pretty significant injury and accident. It doesn't rise to the minimum reporting threshold for FDA,” said Gilk.
Windust’s sister Tawny Sonn told ABC15 she wants SimonMed to be held accountable for what happened to her sister and was concerned to hear the incident also didn’t have to be reported to federal regulators.
“Of course, it’s not, that’s insane,” said Sonn.
The ABC15 Investigators searched the federal database of adverse events for medical devices and found no report matching the date or description of what happened at the SimonMed in Avondale.
“Lots and lots of accidents, if they don’t produce hospitalizations or worse, essentially go unreported,” said Gilk.
SimonMed said it adheres to strict regulatory requirements.
“Any incidents that occur are fully investigated and all such incidents are reported to the appropriate regulatory agencies and accrediting bodies, consistent with the obligations imposed under HIPAA and other state and federal laws and regulations,” the company said in a statement.
But when ABC15 asked if SimonMed reported this incident, the company didn’t answer that question.
After ABC15 originally published this article, SimonMed reached back out and shared this public report indicating the company did voluntarily report this incident to the FDA, but the report was filed more than 10-months after the incident happened in March 2023. The inmate and guard were stuck to the MRI machine on May 11, 2022, which is why the report didn’t come up in previous searches.
SimonMed was unable to share any information about why the company voluntarily reported the incident nearly a year after it happened.
The FDA said it does have other mandatory reporting requirements specific to medical devices. But the requirements only apply to the companies who make the devices or in this case the MRI machine and only if the manufacturer becomes aware of a death or serious injury.
“I think efforts to try and be transparent about how accidents occurred … and how other providers can learn from these mistakes so as not to repeat them,” said Gilk.
