The knowledge base for safety in the MRI suite suffers from a number of profound disparities. The types of risks and potential accidents for persons in the MR suite are well known to clinical and technical MR personnel, but the rates at which these accidents occur on a national basis are obscured by profound under-reporting. And though many experienced MR staffers understand the risks, it is likely that the incidental personnel—such as housekeeping, engineering, transport—who may regularly serve the area know little of the breadth of risks to which they may be exposed (or to which they may be exposing others). 2007, however, has already seen the introduction of new tools and standards, which will help improve safety in the MR suite and also may work to narrow the dangerous gaps in our knowledge and promote enhanced standards of care.
Chief among these resources is the new American College of Radiology (ACR) Guidance Document for Safe MR Practices: 2007, which supersedes the two previous ACR safety documents published in 2002 and 2004 under the title of the White Paper on MR Safety. The new document was recently published in the American Journal of Roentgenology (AJR), though, through a special arrangement, the text has been circulating in electronic format since early this spring. Because of the importance of this document and the pressing safety issues it addressed, the ACR and AJRagreed to provide the document on both organizations’ web sites for free download as soon as the final manuscript was accepted for publication.
The arrival of this new document came not a moment too soon as the FDA’s Manufacturer and User Facility Device Experience (MAUDE) Database recorded a 140% increase in reported MRI accidents for the 12-month period ending in mid 2006. Though Emanuel Kanal, MD, chair of the ACR’s MR Safety Committee, and other MR safety experts believe that accidents reported to the FDA represent less than 10% of the actual number of incidents that occur (some, including John Gosbee, MD, formerly of the VA’s National Center for Patient Safety, have speculated that reporting of MRI accidents is near 1%), this recent dramatic increase is suspected to be the result of compounding increases in risk more than a significant shift in reporting.
Factors such as increasing magnet strength, greater utilization for emergent/trauma cases, wider patient dependence on medical devices or implants that may be contraindicated for MR exams, larger numbers of sedation/general anesthesia patients, and interventional applications from image-guided biopsies to intraoperative imaging are all perceived to ratchet up the opportunities for mishaps.
These increasing risk factors, perhaps statistically insignificant individually, compound in many facilities, and, when multiplied by the estimated 20,000,000 MRI exams performed annually in the United States alone, can be the source for dramatic increases in rates of accidents. If all of these factors combined to create only 1/100th of 1% likelihood of an MR accident resulting in a serious injury, statistics would suggest that we would see an increase of 2,000 serious MR injuries, some potentially even fatalities, in any given year. For a modality with an unparalleled safety record, this sort of accident frequency would be abhorrent, particularly given the fact that the vast majority of MR accidents are completely avoidable.
At the present time, there are no specific MR safety standards at the site level that are a part of payor credentialing, national provider accreditation programs, or even state or federal regulations. The absence of professional regulations, however, is on the brink of changing.
MR safety issues are currently under scrutiny by groups as varied as the American Society of Anesthesiologists, the committee that writes the building code for hospitals and health care facilities, the VA health care system, The Joint Commission, and the ACR’s Committee on MR Accreditation. These examples highlight the disconnects that have plagued concerted efforts to standardize MR safety issues, namely, the absence of unified professional standards. The ACR’s MR accreditation program, however, has worked to bridge this gap and references ACR’s MR safety guidance as a recommendation for those seeking accreditation. But soon sites seeking MR accreditation from the ACR may face new questions and scrutiny about safety provisions as a part of that process. Source
A six year old boy undergoing an MRI (Magnetic Resonance Imaging) scan was killed by a ferromagnetic oxygen tank that was pulled into the MR scanner. Although MRI can provide important diagnostic information, medical practitioners and patients should be aware that there are several hazards associated with MRI.
The references below give more information on safety in MR environments.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm135362.htm
The ACR created a multidisciplinary blue ribbon panel to address critical issues in MR safety. Initially published in in theAmerican Journal of Roentgenology in June 2002, updated in May 2004, and then markedly expanded and updated in March of 2007 (for June, 2007 publication in the AJR), the ACR Guidance Document for Safe MR Practices: 2007″ addresses numerous MR safety related topics, such as:
“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.”
Is It Time For Regulation?
Industry leaders agree that you should have regular standards that provide for MRI safety. However, feelings around federal or state intervention are mixed.
“I’d love to see national guidelines, but I don’t know whether it needs to be federal regulation. Unequivocally, I’d like to see a set of objective standards applied to all MRI providers to ensure they offer a basic level of expertise and safety precautions in the MRI environment,” Gilk said. “Whether it’s federal regulation or an agreement between state licensing or accrediting agencies could help us take the needed steps toward preventing accidents.”
Kanal agreed that regulation is needed, but he said it needs to come from within the radiology community.
“We can either accept standards that we create and define, or we can wait for another terrible safety even to occur and be widely publicized throughout the world before pressure mounts on organized radiology to impose externally defined standards, guidelines, and practices upon us.”
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm270720.htm
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