This piece was originally published in the November 2016 issue of electroindustry.
Megan A. Hayes, Director, Regulatory and Standards Strategy, MITA
Standards facilitate efficient and timely market access for medical imaging products. That’s why MITA develops standards—to improve products for patients.
In 2013, MITA successfully lobbied Congress to enact payment differential that provides higher payment for procedures performed with devices that comply with XR 29-2013 Standard Attributes on Computed Tomography Equipment Related to Dose Optimization and Management.
MITA renewed its focus on standards development in 2015 and launched the Standards Committee, whose activities include implementing of MITA standards that better ensure the safety and efficacy of imaging devices and elevating the MITA brand so that the alliance is recognized as a thought leader in national and international medical device standardization.
Since its launch in 2015, the Standards Committee has
- developed and maintains a comprehensive list of relevant SDOs in which it may participate as a means to efficiently and effectively find common industry positions on critical standards and provide input into standards under development that may have impact on members;
- reviewed and prioritized MITA standards under development with the goals of opening new market opportunities and adding value to members’ medical imaging devices;
- implemented a process to review standards and potential standards to prioritize their development;
- implemented a project initiation template that facilitates the coordination of standards and technical efforts within MITA and oversees their development; and
- begun developing a process for providing input into outside organizations’ standards development efforts.