Trying to improve their image
But FDA scanning hearing reveals regulatory void
Atwo-day Food and Drug Administration public hearing to begin sorting out where providers, manufacturers and regulators can take steps to improve medical-imaging safety highlighted the need for standards creation in a host of areas.
But the gathering, held March 30 and 31, also brought to light the FDA’s limited power to mandate such steps.
“If we want to focus on quality assurance, focus on standardization,” Cynthia McCollough, a professor of radiology physics at the Mayo Clinic, Rochester, Minn., said during day two of the meeting.
McCollough was among radiology professionals attending the meeting who said common standards in a variety of areas are needed to improve patient safety in the medical imaging field. Those efforts should include establishing uniform equipment terminology among manufacturers, creating a common set of accreditation requirements among the three organizations recently authorized to accredit freestanding imaging facilities, and developing national certification requirements for medical-imaging technologists and other equipment users.
The FDA meeting was part of a radiationexposure reduction initiative launched by the agency in February. The three-pronged effort seeks to achieve many of the recommendations made by radiology experts during the meeting, including having manufacturers incorporate dosage safeguards into their machines, establishing mandatory qualityassurance practices to be included in accreditation requirements for imaging providers, and setting up a registry to capture dose information on a variety of imaging studies.
But while the FDA has authority to regulate manufacturers, the agency’s sway over providers and other key players that would need to take actions to improve patient safety is less substantial, agency officials acknowledged. Charles Finder, associate director of policy and clinical affairs for mammography quality and radiation programs with the FDA’s Center for Devices and Radiological Health, noted during the meeting, for exam- ple, that the FDA has no authority over the three organizations authorized to accredit free-standing imaging facilities.
“One point is that that authority has been appointed to the CMS, not the FDA, although we are working with them to develop accredita- tion requirements,” Finder said.
The lack of any central authority over the medical-imaging industry makes creating uniform standards, which would be aimed at preventing patient overdose incidents such as the ones recently reported with CT perfusion brain scans, a challenge for patient-safety advocates.
What’s more, the FDA’s efforts to take the lead on radiation safety comes on the heels of significant public scrutiny over how the agency has previously handled approval of risky medical-imaging devices.
During the first day of the meeting, a former FDA scientist said his job was eliminated after he raised concerns about the risks of radiation exposure from high-grade medical scanning, according to the Associated Press. Julian Nicholas said that he and other FDA staffers “were pressured to change their scientific opinion” after they opposed the approval of a CT scanner for routine colon cancer screening, the AP story said. Nicholas said he objected to exposing otherwise healthy patients to the cancer risks of radiation. After FDA officials pushed ahead with plans to clear the device, Nicholas, now a physician at the Scripps Clinic in San Diego, said he and eight other staffers raised their concerns with the division’s top director last September.
FDA officials said, however, the recent meeting was an encouraging sign that the entire medical imaging industry is willing to take action to prevent overdosing and improve imaging quality. “What the meeting points out is that all parties involved recognize standardization as an important issue and have expressed their willingness to work towards a solution,” said Alberto Gutierrez, director of the FDA’s in vitro diagnostic device evaluation and safety office, in an e-mail.
While manufacturers, imaging providers and regulators all expressed support of patient-safety standards, negotiating those standards will be a delicate balancing act between organizational interests and responsibility to the greater good, acknowledged medical-imaging professionals. For example, manufacturers have said they will begin building radiation dose-check features into their CT machines and that they will consider standardizing equipment terminology used during their user-training sessions. But they expressed concern over calls for industry to share proprietary codes that would allow technologists and radiologists to track and decipher the processing history of an image. “What I want is for the image to come with a history of things that have been done to it, so I can tell if what I’m seeing is something that is disease, or something that is the result of a filter” that’s been applied to the image, said Jenifer Siegelman, section chief of CT scan at 184-bed William W. Backus Hospital, Norwich, Conn. “These are major corporations that do a great job in collecting data, so we’re looking for them to provide us that same type of information.”
Bettye Wilson, a radiology technologist and trustee of the American Registry of Radiologic Technologists, said, however, that while much of the meeting focused on what manufacturers could do to improve medical imaging safety, providers and professional associations also need to support more stringent standards around what level of training should be required for imaging-equipment users. She called for the creation of a national training requirement for radiology technicians.
“My take is you can train anyone on a piece of equipment, but if they don’t have the proper educational background, that’s where the problems occur. I don’t believe it’s the job of vendors to train operators. It’s their job to train qualified operators on how to use their specific machines.”
Siegelman, above, wants images to come with a history. Wilson, left, seeks national training requirements.