This piece was originally published in the November 2016 issue of electroindustry.
Tony Roder, Global Regulatory Affairs Executive, GE Healthcare
Recapping 2016 Accomplishments
The Computed Radiography and Digital Radiography Group of the MITA X-ray Section published NEMA/MITA XR 30-2016 Quality Control Tools for Digital Projection Radiography in response to a request from the American Association of Physicists in Medicine (AAPM) Task Group (TG) 150 on Acceptance Testing and Quality Control of Digital Radiographic Imaging Systems. Before publication, MITA considered input from AAPM TG 150 and the Food and Drug Administration (FDA). XR 30 defines a set of minimum requirements to facilitate quality control of digital projection radiography.
The section’s Interventional Group developed NEMA/MITA XR 31-2016 Standard Attributes on X-ray Equipment for Interventional Procedures to offer healthcare providers a reference to identify key features that help manage patient radiation dose delivery while providing image quality. It describes eight features that should be taken into consideration when performing risk management evaluations on existing stationary interventional x-ray equipment.
In August, the FDA revised its Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices. MITA’s Solid State X-ray Imaging Devices Task Force provided input that applied concepts in a previous version to current technology. This is significant because the document went through an extensive process when it was originally released in 1999; changes that added alternatives to what previously existed did not have to go through a lengthy revision process. This is a great example of making regulatory clearance activities more predictable and applicable to modern technology.
MITA’s X-ray Section continues to work with the FDA and the Conference of Radiation Control Program Directors to allow the FDA and individual states to accept compliance with International Electrotechnical Commission (IEC) standards in lieu of outdated federal performance standards.
In August 2016, the FDA released Medical X-ray Imaging Devices Conformance with IEC Standards, a draft guidance document. The FDA performance standards, which are included in regulation, take significant time and effort to revise and are, therefore, often out of date. Relevant IEC standards referenced in the document are developed in an open, consensus-based fashion, which provides flexibility and allows them to keep up with technology.
The FDA seems committed to partnering with industry and other stakeholders to consider conformance to voluntary standards as a pathway for regulatory compliance. This is important in eliminating antiquated requirements and unnecessary duplication across regulatory schemes.
MITA’s X-ray Section’s Mammography Group is working with the FDA on its Virtual Imaging Clinical Trial for Regulatory Evaluation project. Its goal is to perform a complete in silico (i.e., performed on computer) clinical study and compare the results to those in a previously approved product submission. The FDA wants to demonstrate that computational modeling may be used to refine, reduce, and ultimately replace the burden of expensive and lengthy imaging clinical trials.
The MITA Computed Tomography Image Quality Task Force designed a reference phantom for objective quantification of head and body low-contrast detectability (LCD). It offers the potential to quantitatively assess LCD for clinical protocols in the body and the head in relation to dose. During development, researchers found that many approaches are valid and different approaches may be appropriate, depending on the situation. The task force is drafting a white paper to provide details and rationale for decisions that were made during the development of the original project.
The group will engage the FDA and the Association of the Heads of the European Radiological Protection Competent Authorities to drive transparency and consistency in how these agencies evaluate industries efforts in documenting dose reduction that result from technological advances.
Having established a successful track record, the MITA X-ray Section continues to achieve the board’s strategic priorities.Read the November 2016 issue of electroindustry.