12/24/2023 0 Comments Simon med![]() ![]() SimonMed said it adheres to strict regulatory requirements. “Lots and lots of accidents, if they don’t produce hospitalizations or worse, essentially go unreported,” said Gilk. 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. “Of course, it’s not, that’s insane,” said Sonn. ![]() 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. It doesn't rise to the minimum reporting threshold for FDA,” said Gilk. “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. The FDA only requires reporting for what it calls “a serious adverse event” if there was an “admission to the hospital.” 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.īut here’s what is key: Windust was only taken to the ER and never admitted to the hospital. The department is now reviewing SimonMed’s exemption. 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. “That magnetic field grabbed hold of the chain and the padlock and essentially pulled the prisoner up against the MRI,” said Gilk. 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. After being asked to go in and help Lacey, the guard said he was also stuck to the machine because of his gun. Records showed the SimonMed tech told the prison guard not to remove the metal shackles around Lacey’s waist. 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. In my opinion, it's pretty serious,” said Tobias Gilk, an MRI safety expert. “While it may not rise to the level of FDA classification of a serious reportable event. 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. ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |