Image reconstruction software developer Medic Vision Imaging Solutions is directing attention to recently updated frequently asked questions (FAQ) from the American College of Radiology (ACR) on complying with the National Electrical Manufacturers Association (NEMA) XR-29 standard, also known as MITA Smart Dose.
The ACR said in the March 4 update of its FAQ that certificates of XR-29 compliance from third-party vendors are acceptable if the third-party vendor has obtained the required U.S. Food and Drug Administration (FDA) clearance for the NEMA XR-29-2013 upgrade or modifications provided. The certificate of compliance must also contain the following information and attestations:
- A list of the NEMA XR-29-2013 attributes already present on the CT system prior to installation of the third-party vendor upgrade product
- A list of the NEMA XR-29-2013 attributes installed on the CT system during the installation of the third-party vendor upgrade product
- Attestations to the following facts:
- Upon completion of the upgrade installation, the CT system is fully compliant with the NEMA XR-29-2013 safety standards (i.e., contains the following four required attributes of NEMA XR-29-2013 compliance: DICOM Structured Report, Dose Check, Automatic Exposure Control, and Reference Protocols)
- Each of the attributes of NEMA XR-29-2013 installed during the upgrade are fully functional
- Upon completion of the upgrade, the CT system is fully operational as a whole
The full FAQ can be found on the ACR's website. Medic Vision said its SafeCT-29 offering is the only third-party software to be approved by the FDA and the U.S. Centers for Medicare and Medicaid Services (CMS) for providing XR-29 compliance.
The company noted that CMS penalties for noncompliance with the standard tripled in 2017. Institutions that did not receive support for XR-29 compliance from their OEM vendor and did not purchase a third-party, FDA-cleared software are potentially subject to a 15% CMS penalty as of January 1, 2017, Medic Vision said.
