Sharing Data Safely
The role of technology in productivity and patient safety explored at new ACR meeting.
The relationship between radiologists and technology is complicated. Strides in digital imaging technology enable radiologists to do more work in less time and provide more data that needs to be evaluated.
The increasing number of opportunities to share and access data — through such registries as the ACR Dose Index Registry® (DIR®) — has paved the way for detailed dose resources and guidelines like the ACR Appropriateness Criteria®. But technology has also created such questions as "Which mobile devices and software can safely and effectively be used for a proper read?"
To clarify and discuss the physician-technology relationship in its many forms, the College brought together experts in informatics and dose at the First Annual ACR Imaging Informatics Summit and Dose Monitoring Forum, held Nov. 3-4, 2011, in Washington, D.C. The summit addressed everything from the integration of electronic health-care software that meets meaningful use criteria to the FDA's role in approving mobile imaging devices and software for diagnostic or medical use.
Defining the FDA's Role
Several forum speakers questioned the FDA's level of involvement in the development of mobile medical devices by discussing the approval of Mobile MIM software, developed by MIM Software Inc., of Cleveland in 2008. According to Baku Patel, policy advisor for the FDA Center for Devices and Radiological Health, when the Mobile MIM app was submitted to Apple's app store, "[the software] was mostly just a curiosity," as far as the FDA was concerned. In other words, the administration wasn't certain how many consumers would be interested in such an app.
However, it is expected that 500 million smartphone users will be using health apps like Mobile MIM by 2015, according to Patel. With such a large number of individuals predicted to use these apps, he says that there should be a designed and proven application process for getting mobile medical apps approved. Nevertheless, he admits, the FDA is focused only on reviewing apps that meet its definition of "mobile medical devices" that are either used as accessories to an already regulated medical apparatus or apps that "transform a mobile communication device into a regulated medical device." Other apps, such as those patients use to look up medical definitions or record their own health information, do not meet the aforementioned requirements established by the FDA and therefore are not under the administration's auspices. (For more information about Mobile MIM, read "iPad + Rad = ? on page 17 of the July/August ACR Bulletin.) In an effort to distinguish mobile medical apps that require approval from other apps, the FDA released its 2011 Medical Device Data System Rule (http://1.usa.gov/2011MDDSR) and its 2011 Medical Device Mobile App Draft Guidance (http://1.usa.gov/2011MDMADG).
Despite the progress made by the FDA to address new technologies, many individuals, including the Mobile MIM developers, other mobile app developers, radiologists, and physicists, wonder why it took approximately three years to get FDA approval for Mobile MIM. Donna-Bea Tillman, Ph.D., director of regulations and policy for Microsoft's Health Solutions Group, stated that the FDA should understand that apps that are new today are old tomorrow. Therefore, the "regulatory paradigm," as she described the lengthy FDA review process, should be able to adapt in the same way it adapted to digital imaging from plain film. Otherwise, it's possible by the time apps are approved by the administration, they'll be obsolete or eclipsed by an updated version.
“The patient wants to know that someone is looking out for them. Having a [dose] index to compare to will assuage them more than anything else.” — Richard L. Morin, Ph.D., FACR
Using Data to Ensure Safety
In addition to the mobile apps vying for approval from the FDA, other important technologies and resources are being developed within the radiology field. Among the most revolutionary of these is data-gathering software to be used to compile the DIR, which is designed to collect and compare dose information, or the ACR Appropriateness Criteria, which provide clinical-decision support to help ensure the appropriateness of specific treatment decisions.
Before the DIR's national debut in May 2011, the College completed several pilot projects in which a version of the DIR data-gathering software was installed and tested at the Medical University of South Carolina, the University of North Florida, the Mayo Clinic at Jacksonville, and other facilities, explained DIR Chair Richard L. Morin, Ph.D., FACR, from the Mayo Clinic in Florida. During these projects, information was transmitted from the facilities to the ACR and the entered into the DIR.
Among the many discoveries during the projects was the fact that names of specific procedures were not standardized across the various organizations or even within a single facility. For example, one group identified a single pelvis imaging procedure by 13 different names.
To help facilities standardize terms to ensure valid registry data, the DIR committee is currently utilizing the "Radlex Playbook," a document containing lists of different names for the same procedures together with preferred DIR terms.
The bottom line, stated Morin, is that the data contained within the DIR can help physicians identify the median dose for a specific procedure. Using such data can help calm a patient's fears of a CT scan, for example. "The patient wants to know that someone is looking out for them," Morin says. "Having a [dose] index to compare to will assuage them more than anything else." In other words, patients can take comfort in knowing that they are being exposed to radiation in an amount consistent with others receiving the same examination.
The DIR and ACR Appropriateness Criteria — as well as the new mobile medical apps that are surging into the market — are changing the face of radiology. With guidance from such entities as the ACR, along with other experts within the specialty, these resources will be seamlessly integrated into mainstream use.
By Brett Hansen