The initiative “is meant to address cases of excess radiation exposure like in the case of the CT perfusion scans,” said Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health. FDA officials said the three-pronged initiative will require manufacturers to incorporate dosage safeguards into their machines, establish quality assurance practices to be incorporated into mandatory accreditation requirements for hospital and free-standing imaging facilities, and set up a registry to capture dose information on a variety of imaging studies.
But while manufacturers, accrediting organizations and radiology providers largely welcomed the effort, some questioned whether the FDA's plan can be fully successful given a culture of rapid technology adoption and the limits of current regulation.
“We're looking, I think, at some very serious cases that we need to pay attention to,” said Paul Schyve, senior vice president of the Joint Commission, which accredits free-standing imaging facilities as well as hospital imaging facilities as a part of a hospital's overall accreditation process. “But, they are symptomatic of a larger problem and that's that the creation of new technology is outpacing our ability to understand the risks.”
The FDA has said it intends to issue requirements for manufacturers to incorporate machinery safeguards and provide radiology practitioners with more training and support as one means of lowering the risk of errors when providers are using new technology.
Imaging devicemakers are apprehensive, however, about the FDA's suggestion that built-in equipment safeguards, which would warn users when a set radiation dose level is out of line with what is expected for a patient undergoing a particular procedure, could be a useful tool in preventing excessive radiation exposure.
“I think we're open to working with the FDA and other stakeholders on ways to provide additional safety information to operators, but it's complicated,” said Dave Fisher, managing director of the Medical Imaging & Technology Alliance, a group representing radiology equipment manufacturers. “There are a lot of studies and a lot of information to go through and collect” in order to identify dose-warning levels for specific procedures, Fisher said. “And, we need to be careful about how that information is delivered so it can be effective. If a pop-up occurs too frequently then it could just be ignored” by the technician.
Schyve agreed that there is legitimate reason for manufacturers and other stakeholders to be concerned over an equipment-use warning system. “We do know through our experience with computerized physician order entry that if you have too many alerts people will ignore them,” he said. “But the answer is not to not build alerts into machines. What we need is to understand the interaction between the user and the machine. The answer is to have wise alerts.”
For their part, accreditation organizations said it remains to be seen whether the FDA's plan to incorporate quality assurance practices such as equipment-testing, dose-monitoring and practitioner-training requirements into mandatory accreditation requirements for free-standing and hospital-based imaging facilities will necessitate significant changes to their current accreditation processes.
Under the 2008 Medicare Improvements for Patients and Providers Act, or MIPPA, all outpatient facilities that bill Medicare will be required to be accredited beginning Jan. 1, 2012. But current law does not require CMS-designated accrediting organizations—the American College of Radiology, Intersocietal Accreditation Commission and Joint Commission—to have shared, standardized requirements and processes for determining imaging facilities' accreditation. As a result, accreditation organizations may have varying requirements for facilities to incorporate quality assurance practices into their mandatory routines.
Sandy Katanick, CEO of the Intersocietal Accreditation Commission, said she doesn't expect the FDA's efforts to substantially affect her organization's accreditation requirements. “It may tighten what we now have in place, but shortly after the Cedar-Sinai (CT perfusion radiation) events, which were all about CT technology, our board convened very quickly and decided it was time to make quality assurance a requirement” of accreditation, she said.
Pam Wilcox, the American College of Radiology's assistant executive director of quality and safety, said her organization already has significant quality assurance practices built into their accreditation requirements, but that it was “too early to know if there will be additional requirements” under the FDA initiative.
But Schyve, of the Joint Commission, said he believes the FDA's initiative could require accreditation organizations to develop more specific quality assurance practices for CT, nuclear medicine and fluoroscopy equipment maintenance, user training and dose monitoring. “I think what will be different is the surveyors will say, ‘What is happening with these specific technologies that have been identified,' ” and that may mean additional training of accreditation surveyors, Schyve said.
The current leeway that accrediting organizations have to establish their own requirement for radiation providers could prompt an influence battle between the groups, with each vying for the FDA to shape quality-assurance requirements similar to its own existing requirements. The agency may also have its hands full trying to sort out how and whether to require hospital imaging facilities to meet more specific accreditation requirements for the three identified modalities.
Currently, hospital imaging facility accreditation is voluntary. Most of those imaging centers are accredited as a part of the hospital's overall accreditation process. It's a loophole that vexes Katanick, particularly since recently reported cases of excess radiation have occurred at well-established hospital facilities.
“Probably our biggest pet peeve is that when the MIPPA law was passed it only applied to outpatient facilities, but these problems are not limited to those facilities,” Katanick said.
Nancy Foster, vice president for quality and patient-safety policy for the American Hospital Association, said she believes a separate accreditation requirement for hospital imaging facilities would be redundant given that these facilities are already reviewed as a part of a hospital's overall accreditation. “If it does move into the direction of having a separate accreditation requirement for hospital radiation facilities, we'd want to have a conversation with the FDA about the wisdom of that,” Foster said. “It certainly could be burdensome, but the primary concern is that radiology would be separate from the overall accreditation process. You need all departments working in harmony so things are done in the best interest of the patient.”
The AHA and other stakeholders will have an opportunity to weigh in on the FDA's plans for preventing excess radiation exposure on March 30 and 31 when the agency holds a public workshop.
While FDA officials hope to come away from the meeting with some substantive tactics for preventing unnecessary radiation exposure during certain types of imaging studies, the initiative won't address another area of concern: preventing excessive radiation exposure during disease treatment.
Human and machine errors that caused patients to be exposed to excessively high radiation doses during cancer treatment were the subject of news reports earlier this year. The incidents, which occurred on patients being treated with linear accelerator technology, are currently under investigation by the FDA, Shuren said. He acknowledged, however, that a similar prevention initiative, if it develops at all, is a ways off.
“With radiation therapy, there is less information about dose parameters because they are tailored to individuals,” Shuren said. “There are also more safeguards already built into that equipment.”
The FDA's ability to substantially reduce radiation risk is likely to be limited by its scope of power and its capacity for getting stakeholders to work together. For example, a number of safety experts believe that broader licensing requirements are needed to ensure that the professionals operating imaging and radiation-treatment machinery are properly trained. Currently, however, only four states require that medical physicists be licensed, 33 require radiology therapists be licensed and 37 require radiology technicians be licensed. The FDA has no jurisdiction on licensing requirements.
“Licensing is a state issue,” said Donald Frush, the Radiological Society of North America's current chair of pediatric case-based courses and a professor of radiology and pediatrics at 788-bed Duke University Hospital, Durham, N.C.
Frush said FDA officials will need to work closely with accreditation organizations to effect any improvements in professional credentialing that it wants to see take place. Likewise, the agency will have to be persistent in its efforts to rally stakeholders around the creation of a radiology dose registry for the three diagnostic procedures if the registry is to be useful in setting usable guidelines for practitioners.
“A registry could conceivably trigger an alarm when a series of exams exceed a standard, like in the case of the Cedars-Sinai incidents with CT perfusion scans,” Frush said. “But calling for a registry and doing it are two different things. I applaud the effort and everyone needs to play their role in making it happen, but it's extremely difficult. There are lots of technical issues that need to be considered.”
Pointing to the difficulties that the ACR had establishing its CT dose registry, Frush said the FDA's efforts to make radiology procedures safer are likely a long-haul, multiyear proposition. “You have manufacturers who register their doses in different ways,” Frush said. “Machines don't measure in millisieverts, and it's not clear even in the scientific community if that's the most effective way to do it. This is not going to take a year.”
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