February 28, 2017 — The American College of Radiology (ACR) published updated guidelines regarding the NEMA XR-29 (MITA Smart Dose) Standard, finally setting a clear and specific set of guidelines for an acceptable Certificate of NEMA XR-29 Compliance. The publication specifically declares, "certificates of NEMA XR-29 Compliance from third-party vendors are acceptable if: (1) The third-party vendor has obtained the required FDA [U.S. Food and Drug Administration] 510(K) pre-market clearance for their upgrade product; and (2) The third-party vendor upgrade product has been approved by CMS [Centers for Medicare and Medicaid Services]."
Furthermore, the document states, "Currently, the only FDA- and CMS-approved third-party vendor NEMA XR-29 upgrade product is the Medic Vision SafeCT-29."
The SafeCT-29 system is an add-on system that helps achieve compliance with the XR-29 Standard for computed tomography (CT) and positron emission tomography (PET)/CT systems equipped with automatic exposure control (AEC) and Reference protocols. SafeCT-29 provides the XR-29 Dose Check and RDSR functions. It is the first and only FDA 510k-cleared third-party solution on the market, according to Medic vision.
The timing of this guideline announcement is critical, according to Medic Vision, as CMS penalties for non-compliance triple this year. Health institutes that did not receive OEM support for XR-29 compliance and did not purchase SafeCT-29 as a third-party FDA-cleared solution for CT and PET/CT scanners, may now have to start over and potentially be subject to the 15 percent CMS penalty, which went into effect on Jan. 1, 2017.
For more information: www.medicvision.com