ACR says CMS and FDA approval is required for third-party XR-29 compliance
DOTmed Healthcare new update to the ACR’s guidelines for achieving NEMA XR-29 compliance from third-party solutions could spell good news for Medic Vision, one of a handful of companies offering CT add-on software to meet the standards.
While the requirement has been somewhat ambiguous for third-party solutions, the new update specifies that these CT upgrades must be FDA-cleared and approved by CMS to be valid.
That leaves Medic Vision’s SafeCT-29 as the only third-party XR-29 solution on the market — at least for now.
“The DOTmed Healthcare Medical Imaging community has been waiting for clear guidance since the XR-29 standard became effective in 2016,” said Eyal Aharon, CEO of Medic Vision, in a statement. “We’ve advocated for clarity surrounding the XR-29 compliance guidelines that were too vague and raised concerns among CT operators and vendors. These updated guidelines not only provide clarity but ensure adherence to the highest standard for patient safety,” he added.
Scanner OEMs like Philips, Siemens, and GE have established upgrade pathways for many of their CT scanners to ensure compliance — but older models are being left behind, as well as the majority of PET/CT systems.
Last September, Philips decided to recommend Medic Vision’s SafeCT-29 to its noncompliant CT and PET/CT customers who cannot become compliant through the OEM’s own upgrades.
The XR-29 requirements are:
- Automatic exposure control (AEC) to access radiation dose in real time
- Built-in adult and pediatric protocols for the operator to choose from
- Dose Check for automatic notification of when scan settings are likely to exceed dose thresholds
- DICOM SR to incorporate dose history into the patient record
SafeCT-29 provides full compliance with some of those functions, namely: XR-29 Dose Check and Dose Report (“RDSR”), according to Medic Vision.
CMS penalties for non-compliance tripled at the beginning of 2017, so providers may now be subject to a 15 percent CMS penalty if they are not compliant with the standard.