Whitney Palmer

MRI Safety Concerns Prompt FDA Meeting

Published on the Oct. 13, 2011 DiagnosticImaging.com website

By Whitney L.J. Howell

In recent years, speculations about imaging safety have swirled around the long-term effects of CT scans. But, industry leaders are hoping to now turn the water cooler conversation toward making MRI safer for both you and your patients.

Even though MRI scans themselves are widely considered to be extremely safe, data from the FDA Manufacturer and User Facility Device Experience database reveal patients and providers are sustaining injuries during the MRI process. In fact, from 2004 to 2009, the number of injuries spiked four-fold to 193 accidents.

Whether more accidents are really occurring or injury reporting is on the rise is up for debate among radiologists. But the trend is concerning enough to prompt the FDA to hold a conference later this month to examine the biggest MRI safety concerns and discuss best practices to truncate the number of incidents.

“There are increasing numbers of MR scans and an increasing demand to scan patients with implants or accessory medical devices and other equipment. With the increased use, we are also seeing a number of preventable incidents,” said Sunder Rajan, PhD, of the FDA’s Center for Devices and Radiological Health Division of Physics Biophysics Laboratory. “Given the new experience base, this is a good time for FDA to learn what MR practices are being used and what changes practitioners feel would improve safety to the MR environment.”

The Main Concerns

MRI accidents and injuries fall into three main categories: thermal burns, projectiles, and hearing loss in poorly protected patients.

According to Tobias Gilk, president and MRI safety director at Mednovus and senior vice president at the design and architecture firm Rad-Planning, thermal burns pose the greatest risk to patients because they are associated with a relatively recent technology advancement – gradient improvements that allow for better image quality and scan efficiency.

“Burns are a newer safety issue that have grown out of the advancement of stronger, faster gradients,” Gilk said. “Moving to a stronger magnetic field from 1.5T to 3T makes it necessary to use more radiofrequency, increasing the chance that a patient will be burned.”

In addition, ferromagnetic objects in the MRI suite also pose a real danger to patients and providers. The 2001 Colombini case in which a 6-year-old boy died when an oxygen tank flew across the room and struck him during his imaging procedure brought this risk possibility industry-wide attention.

Although these incidents are rare, they are expensive. A U.S. Department of Veterans Affairs’ Center for Patient Safety study found that each occurrence costs more than $43,000, accounting for MRI machine repair, injury treatment, and legal costs. It doesn’t, however, take into account lost revenue due to an inoperable MRI machine.

Regardless of the reason, Emanuel Kanal, MD, director of magnetic resonance services at the University of Pittsburgh Medical Center and chair of the American College of Radiology (ACR) MR Safety Committee, said you must still take precautions to prevent projectile accidents.

“The most serious incidents, albeit quite rare, involve projectile effects,” he said. “These need to be addressed if we are to significantly lower the incidence of MR-safety relative adverse events.”

Unfortunately, there are no regulations that require proper identification of materials unsuitable for being in a MRI suite, Gilk said. And, sometimes it’s the MRI suite itself that creates the risk. When it comes designing a new suite, he said, many office architects look at a prototype design and implement it without taking the unique factors of the hospital or physician office into account.

To read the remainder of the article: http://www.diagnosticimaging.com/mri/content/article/113619/1970950

October 19, 2011 - Posted by wjpalmer | Healthcare, Politics | American College of Radiology MR Safety Committee, American College of Radiology MR Safety Guidelines, Bill Faulkner, Colombini case, cost of MRI accidents, death in MRI suite, Emanuel Kanal, FDA Center for Devices and Radiological Health Division of Physics Biophysics Lab, FDA Manufacturer and User Facility Device Experience Database, FDA meeting about MRI safety, federal regulation of MRI safety, hearing loss from MRI, implantable devices and MRI, increase in Telsa strength resulting in thermal burns, lack of regulation on ferromagnetic substances in MRI suite, lack of regulations around MRI conditional devices, main concerns about MRI safety, Mednous, MRI conditional devices, MRI safety, Ph.D., projectiles in MRI suite, Rad-Planning, safety of implantable devices with MRI, spike in MRI-related accidents, Sunder Rajan, Terry O. Woods, thermal burns, Tobias Gilk, U.S. Department of Veterans Affairs' Center for Patient Safety, University of Pittsburgh Medical Center