Whitney Palmer

Healthcare. Politics. Family.

MRI Safety Still a Concern, But National Guidance Lacking

Published on the July 27, 2012, DiagnosticImaging.com website

By Whitney L.J. Howell

Last October, the U.S. Food and Drug Administration (FDA) held a meeting to examine the biggest MRI safety concerns and outline best practices to reduce injuries associated with the scans. So far, however, the industry has received no national guidance on how to accomplish this goal.

But the lack of official instruction at the federal level doesn’t mean the push toward greater MRI safety — being recognized this week during MRI Safety Week — has stalled. Advancements are underway at the state level and in the accreditation process to prevent another tragedy, such as the 2001 Colombini case when a 6-year-old boy died when an oxygen tank flew across the room and struck him during the imaging process.

“Any protection that is implemented will benefit the 30 million Americans who get MRIs on an annual basis,” said Tobias Gilk, president and MRI safety director at Mednovus and senior vice president at the design and architecture firm Rad-Planning. “People are beginning to look harder at MRI risk factors as the power of our magnets continue to increase.”

State Regulations

Many states and the Joint Commission have implemented new regulations that strictly govern the design and construction of new MRI suites. These requirements do not mandate retrofitting existing installations.

“There are a growing number of states that are adopting this building code,” Gilk said. “Anyone who does MRI suite work — renovation, upgrade, equipment replacements, anything with a building permit — in virtually every jurisdiction must follow these state standards.”

To conform to the building regulations, health care engineers must meet eight standards, Gilk said. They must follow the American College of Radiology’s (ACR) 4-Zone Principles that addresse integrated access controls and screening practices. There must also be a clear line-of-sight between the operator’s console and patient inside the MRI machine, and designers must include demarcation lines to keep individuals with implantable medical devices far enough away. The presence of ferromagnetic-only detectors is required, and new MRI suites must also have exhaust fans and other protective measures to eliminate any cryogen that escapes into the imaging area.They must include an always-illuminated sign to remind staff that the MRI magnetic field is always active even without a patient.

These new design codes also require a clearly marked safe zone in which staff can use MR conditional equipment. Most importantly, Gilk said, designers and engineers must remember there is no cookie-cutter model for MRI suites. Each site is different and requires individual planning.

Accreditation

In a switch from years past, Gilk said, the Joint Commission is requiring far more documentation to prove you are making your MRI suite as safe as possible for patients. As part of the ACR’s 4-Zone Principles, the Commission now requires proof that you have established access control and provide proper staff supervision. You must also produce documentation that you have adequately trained your MRI personnel in safety procedures and protocols, he said.

“The Joint Commission wants to see evidence of screening protocols for implants and devices, clinical contraindications, and physical screenings,” Gilk said. “They want to see what you’re doing to make sure visitors aren’t carrying objects that will become dangers in the magnet room and what processes or tools are in place that accidents don’t occur.”

Requiring these measures — from an accreditation standpoint — is a giant step forward, he said.

To read the remainder of the story at its original location: http://www.diagnosticimaging.com/mri/content/article/113619/2092918

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July 27, 2012 Posted by | Healthcare | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , | Leave a comment

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 | Healthcare, Politics | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , | Leave a comment

   

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