How Providers First Did More Harm This Week
It also wants facilities to take seven actions:
- Assess if any patients received excess radiation doses from CT perfusion scans.
- Review radiation dosing protocols for all CT perfusion scans to ensure correct dose.
- If more than one scan is performed on a patient, make sure any subsequent dose is adjusted.
- Make sure dosing protocols are followed every time.
- Check the display panel before each scan to make sure the dosage is appropriate.
- Make sure technologists are trained for the specific scanner and imaging protocol.
- Make sure technologists are trained on dose-saving features such as automatic exposure control. If the user activates AEC without carefully reviewing and adjusting the associated parameters, a default setting may occur that may not be appropriate for that scan, leading to an overexposure.
The FDA also made note that the scanners themselves can be improved to make sure the incidents don't reoccur. In a letter Monday to the Medical Imaging and Technology Alliance, Jeffrey Shuren, MD, Director for the FDA Center for Devices and Radiologic Health made five suggestions that he hopes the alliance will convey to manufacturers.
For instance, the manufacturers might install "Pop-up Notification at Threshold for Deterministic Injury" alerts to redesign certain aspects of the machines and fortify the education that goes along with their sale or lease.
Shuren also suggested "reorganizing or developing additional equipment operation information that users could readily access, understand, and apply to reduce the possibility of inadvertent application of unnecessary amounts of radiation."
The remedies "surfaced during our investigation and reflect issues that appeared to contribute to the possibility of unintended high exposure," Shuren wrote.
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