The NEMA Smart Dose Standard is the next step in a longstanding effort by Siemens Healthcare and the industry to reduce and optimize dose to improve patient safety. As such, Siemens Healthcare fully supports the NEMA Smart Dose Standard and the CT Dose Differential Payment Policy, which establishes a dose optimization standard and provides an incentive for providers to meet that standard.
It has come to the attention of Siemens Medical Solutions USA, Inc. that some third-party organizations that are engaged in the sale or servicing of medical devices claim that they can “upgrade” Siemens scanners to comply with the NEMA XR-29 Smart Dose Standard. In some cases, these organizations make claims that their XR-29 solutions are “tested” or “validated” on Siemens CT technology.
While Siemens embraces the XR-29 standard and recognizes that it can help provide safer CT imaging for the patients and improved radiation dose monitoring practices, to date, no third-party organization has validated this type of hardware/software approach in coordination with Siemens. It is not technically possible for a third-party organization to independently alter Siemens medical devices to comply with XR-29. Utilizing a third-party solution in an attempt to comply with XR-29 may negatively affect the effectiveness of the medical device and void the device’s warranty or service agreement protection. This type of modification is not covered by FDA’s 510(k) clearance process for Siemens medical devices.
The alteration of Siemens devices by such untested solutions can negatively affect the operation of the scanner and can potentially be harmful to patients.
Siemens cannot evaluate whether scanners modified by third-party providers comply with XR-29. Siemens cannot issue compliance certificates for any such Siemens scanners that use these solutions.