Across state lines, the requirements for quality control measures governing medical radiation devices range from comprehensive to virtually non-existent.
In some places, they exist but are not strictly enforced. This variability could mean that a patient faces a much higher risk of harm depending on where she or he seeks care. In this article, we identify the consequences of variable regulation of medical radiation devices, especially insofar as under-regulation affects the safety of patients in healthcare.
Yet while under-regulation leads to measurable harms from too much radiation, it may also fail to catch a device outputting too little radiation—a problem that can impede diagnosis and may even, if the patient has to undergo a second scan, end up in more exposure overall.
Forms of variation
1. Equipment-based
Today, a state like California regulates its highest tech modalities such as Computed Tomography (CT) scanners quite closely—but it does not demand frequent monitoring of modalities like intraoral dental units or even radiographic units. What accounts for this equipment-based variation?
One reason is historical: in 2009, several widely publicized incidents of CT overexposure were reported in the state. Since then, according to Melissa Martin, MS, DABR, a prominent California Medical Physicist and Past President of the American Association of Physicists in Medicine, “California has specific requirements for CT and fluoroscopic monitoring, yet the requirements for evaluating radiographic units are not consistent.”
2. Site-based
Another type of inconsistency obtains across the state’s sites: while California hospitals are required by the Joint Commission (JC) to evaluate radiographic units, explains Martin, they often go untested in private offices. “We consistently find older c-arm units in surgical centers that exceed the ‘typical patient dose rate,’” she says. “Their service guys crank up the outputs to help with the image quality on these older units, which is not surprising. This is one of our most common violations.”
In New York, too, the quality assurance requirements for dental units in hospitals are supposed to be performed annually under the direction of a medical physicist. Dental x-ray units in private offices, however, are only evaluated every five years—and by a Certified Radiation Equipment Safety Officer (CRESO) rather than a physicist. (CRESO individuals can be physicists, but do not have to be; other individuals are certified under the less rigorous CRESO requirements.) The consequences of this variation become clear every time an annual evaluation of a dental unit identifies an issue like inappropriate dosage, generator miscalibration, or other mechanical problem.
3. Frequency
Other states have regulations that are less stringent than California’s for all of their medical radiation equipment. For instance, while Florida has strict licensure requirements for its medical physicists, it does not require that a medical physicist evaluate radiographic or fluoroscopic modalities with any regular frequency.
Infrequent monitoring of fluoroscopic machines poses harm to a greater number of patients as the uses of this equipment have proliferated. Fluoroscopic machines have been used for pain management for some time, and are increasingly being used to perform complex interventional procedures in lieu of surgery. This burgeoning application of fluoroscopy has already caused significant injury due to inappropriate monitoring of the machines.
Effects of variation
Excessive doses of medical radiation can lead to skin injuries, tissue damage, and, statistically, forms of cancer in patients. Medical assistants and physicians can also sustain damage from excessive doses, including to their eyes.
These are perhaps the more dramatic effects of insufficient monitoring of radiation-based equipment. But insufficient monitoring can also lead to poor diagnostic performance, for instance when radiation-based machines put forth too little radiation. In this scenario, the scanner may return “noisy” images that contain inadequate diagnostic information. This malfunction can in turn necessitate additional imaging that could have been avoided had the machine been monitored appropriately. Worse, an important medical finding could be missed because of the poor quality image. In this case the ramifications are obvious.
Specifications vs. frequency: what’s most important?
Ultimately, our data suggest that frequency of monitoring is as important as the parameters themselves—especially because this is where the most variation occurs.
There are a number of reasons why greater-frequency quality control makes sense.
• First, variability in machine performance increases over time. Financial strain (common outside of the major medical centers) often prompts institutions to continue using machines well past their intended lifetime; coupled with less-than-adequate service contracts and overworked or understaffed in-house personnel, these machines’ performance can decline substantially over time. This effect is heightened by factors like excessive workload, poor-quality repairs, and unavailability of replacement parts.
• Second, regular QC visits improve system performance because the follow-up ensures that previously uncovered items have been addressed adequately. We’ve observed that a quality assurance visit at six months can uncover incomplete corrective action related to issues found on the annual evaluation. For a single CT unit, this follow-up can spare hundreds of patients sub-optimal radiation exposure.
A simple solution?
Because states like New York, New Jersey, and Ohio already have regulations in place to protect patient safety and maintain the dosage for optimal diagnoses, one way to tackle the disparities between states is simply to demand regulatory consistency across state lines. In fact, the Conference of Radiation Control Program Directors (CRCPD) has developed Suggested State Regulations (SSRs) that are not quite as stringent as New York’s program, but would still be a great improvement for many states.
The Joint Commission and American College of Radiology (ACR) have also made strides in this area, having established some uniformity in the monitoring of higher tech modalities for institutions that fall under their accreditation umbrella.
A stubbornly complex landscape
Unfortunately, expecting all states to adopt the JC’s regulations is unlikely given the many medical facilities that choose alternate accreditation organizations with fewer standards—not to mention those that function without accreditation at all. Also, because these standards do not pertain to radiographic and fluoroscopic procedures, they do not adequately address the hundreds of millions of those procedures performed each year.
The SSRs described above are another elegant and effective answer to the problem at hand, and their adoption as a national baseline could potentially improve the imaging outcome for millions of patients. Coupling them with the JC and ACR standards would provide a nationally uniform approach to medical radiation utilization.
The goal of harmonizing regulations across state lines is, like many aims of health care, difficult to achieve. But this does not mean we should not pursue it. From the ACR to the JC to the CRCPD, leading organizations in the field are working to optimize diagnostic and therapeutic performance while ensuring patient and employee safety. The pieces already exist. It is now up to the states to put the puzzle together.