GAITHERSBURG, Md.—CT took center stage at yesterday’s morning session when the FDA began its two-day public meeting to hear responses about what manufacturers of medical imaging devices could do to help reduce unnecessary patient exposure to ionizing radiation.
More than 20 regulators, providers and manufacturers had less than 10 minutes to say how equipment features could be improved. The recommendations ranged from visual or audio displays and information transmittal paths that record, report and disseminate exam data to dose setting mechanisms; requirements on how to make information useable and available in the EMRs; or a national dose registry that could be feasible on a widespread, consistent and uniform basis.
The consensus among the presenters was that tweaking one thing seemed to undermine another.
Discussion also arose about the interplay, timing and coordination of certain changes, and questions about who would be impacted most heavily became complicated. One CT manufacturer noted that “the problem is educating the operators, not the machines.”
However, most presenters and panelists repeatedly expressed their full support for the FDA’s initiative to give patients the right exam, at the right time and with the right dose.
But what is right? FDA/CDRH’s Sean M. Boyd contended that a national consolidation of information is appropriate, but it is "not clearly decided who should maintain it. Also, getting facilities that use such data to improve internal processes is outside FDA’s regulatory scope.” As a result, figuring out who is accountable for new stipulations remains a work in progress as well.
A stark reminder that one size may not fit all—beyond even the necessity to consider pediatric and adult CT concerns uniquely—meant that the scope of relevant topics included but was not limited to the feasibility of how manufacturers could possibly retrofit old scanners, adjust current scanners or anticipate future CT platform standards. Another manufacturer pointed out the necessity to look at the rich history of medical device development to anticipate options would be limited, but said it would evaluate options even though at this point “[it] would be like trying to incorporate auto pilot into the Red Baron’s biplane.”
And if CT embraces progress as evidenced by its expanded use to a full spectrum of diagnosis, management, treatment, guidance, planning and monitoring diseases, it is precisely this bang for the buck that may invite a complicated and imperfect relationship between devices and patients. Carolyn Cidis Meltzer, MD, of Emory University School of Medicine in Atlanta, and the Coalition for Imaging and Bioengineering, noted the discordant reality between the risk/benefit ratio, noting that “risk associated with this imaging and ionizing radiation is why we are here.”
Moving forward, Donald L. Miller, MD, from the National Council on Radiation Protection and Measurements, explained: “We’re going to keep working on it as we dedicate our lives to radiation safety. We will just keep working at it.” Miller reiterated that the FDA is not necessarily the answer to this problem, and it’s up to other governmental agencies as well.
The FDA’s notice in the Federal Register that requested comments for this public meeting are due by April 15.