FDA meeting on fluoro rad exposure: Who's responsible--manufacturers or FDA?

GAITHERSBURG, Md.—The afternoon session of Tuesday’s FDA meeting focused on fluoroscopy devices, during which regulators, manufacturers and providers sought to answer questions regarding steps that could be taken by manufacturers that would help reduce unnecessary patient exposure to ionizing radiation. Fluoroscopic procedures are one of the three largest contributors, along with CT and nuclear medicine, to per capita exposure.

The FDA/CDRH’s Sean M. Boyd kept nearly 15 regulators, providers and manufacturers on cue, having less than 10 minutes to explain how equipment features could be improved, and precisely address the dizzying array of nuances that may challenge of effectively maintaining image quality but deliver minimum doses.

Focusing on specific procedures guided by fluoroscopy, discussion arose about the distinctness of interventional cardiology and radiology and thus necessitating a different risk/benefit analysis. In this specialty, the dynamic between device manufacturers and radiologic technologist distinguishes itself even further because it has become critical that the provider take the lead role due to the volume increase.

“The interventional era has now increased the volume of cases, so operator and volume means the physician is key for assessing risk of exposure,” said James A. Goldstein, MD, speaking on behalf of the Society for Cardiovascular Angiography and Intervention. He discouraged the temptation for “one size fits all” solutions, and emphatically noted that “fluoroscopy is not CT. CT dose is predetermined by selection of a specific protocol. With fluoroscopy the best you can do is determine the dose rate, so total dose varies considerably, showing again how key the operator is.”

While the need for more user training and education was consistently reinforced during the meeting, Stephen Balter, PhD, of Columbia University Medical Center in New York City, saw more. “One problem is that dose management components [to fluoroscopy systems] are often included as additional options. We think manufacturers should supply this and we should not have to pay extra for safety,” Balter said.

However, other presenters directed the responsibility onto the regulatory bodies. Julian J. Nicholas, MD, a gastroenterologist with Scripps Clinic in San Diego, who worked under contract with the FDA until October 2009, accused the agency of ignoring his warnings about the risk of unnecessary radiation exposure from radiology exams.

Nicholas also asked: “What will you learn here today?" And answering his own question he said, "You will learn about a history of FDA physicians and scientists warning the CDRH of the dangers [of radiation exposure]. That FDA physicians and scientists felt pressured that the CDRH was suppressing [evidence of unnecessary patient exposure].” Nicholas also revealed that after nine FDA physicians and scientists met with the CDRH’s director to report on radiation concerns, he was informed his contract would be terminated. “I was told I was no longer needed,” he said.

Nicholas did not return for his scheduled presentation later in the afternoon.

The FDA’s notice in the Federal Register that requested comments for this public meeting are due by April 15.