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Main article: Magnetic resonance imaging (MRI)
2023: Instead of poisonous gadolinium. Fresenius unveils MRI contrast agent substitute
On August 8, 2023, Fresenius Kabi announced the release of Gadobutrol, a universal contrast agent substitute for Gadavist, which is used in magnetic resonance imaging (MRI) procedures. Read more here.
2017
Europe saw danger in gadolinium-based contrast agents
In March 2017, the European regulator proposed to remove several gadolinium-based contrast agents (GBCAs) from the market due to concerns that the substance remains in the human body after magnetic resonance imaging (MRI). We are talking about the most common drugs in medical imaging. Read more here.
Study of the negative effects of MRI on human DNA
On February 14, 2017, AuntMinnie.com published an article on the effect of magnetic resonance imaging (MRI) on human DNA. Scientists have been studying this issue for several years, but they managed to find little evidence of the negative impact of MRI machines on the human genetic apparatus.
About 10 studies were studied, six of which were published from 2013 to 2016. Two of them provide data on DNA damage (genotoxicity) from MRI, in other works opposite conclusions were made.
 | In our opinion, the danger has not been proven, "says John Mulder, Ph.D., professor emeritus of radiation oncology at the Medical College of Wisconsin. - Of course, we are not advocates for patients to forgo useful medical imaging because of this as-yet hypothetical problem. |  |
The widespread use of X-ray computed tomography in clinical practice raises concerns related to the effects of small doses of radiation on the body. In 2015, scientists at the Stanford Cardiovascular Institute reported that diagnostic procedures can lead to damage to the DNA of cells, to mutations that entail the development of tumors.
The magnetic resonance imaging procedure, which is used to visualize and diagnose the state of the entire body, exposes patients to radiation at least 150 times more powerful than occurs with chest X-rays, the researchers noted.
At the same time, according to John Mulder, studies conducted from 2007 to 2016 showed mixed results of genotoxicity in MRI, and the work itself was small enough, they lacked measurements and comparisons. As for the potential side effects from MRI, the studies mainly focused on radio frequencies, static and gradient fields, he noted.[1]
MRI risks for patients with implantable pumps
On January 11, 2017, the Food and Drug Administration (FDA) issued an official warning for patients using implantable infusion pumps. They are advised to carefully undergo magnetic resonance imaging (MRI). Read more here.
2016
Draft International Safety Rules for MRI
In July 2016, a group of leading international organizations specializing in radiological diagnostics presented a draft safety requirements for medical institutions when using magnetic resonance imaging (MRI).
The document, published on the website of the Journal of Magnetic Resonance Imaging, lists the responsibilities and requirements for the heads of the MRI research laboratory, directors and safety experts for MRI examinations. These individuals will be required to have a high level of training in all aspects related to MRI, advanced knowledge of the technology, and the ability to monitor the coordination of the patient scanning process.
The head of the MRI laboratory will have to monitor the safe conduct of examinations of each patient at any time of the day and night, be responsible for the operation of more than one MRI apparatus and be always in touch for MRI operators, medical technologists and radiologists.
The role of MRI Safety Lead may be delegated to a Radiology Laboratory Assistant, MRI Technologist, or other qualified professional who will be able to be in touch 24 hours per day 7 days per week, providing proper medical directions and procedures. In addition, the MRI safety officer will have to ensure that facility staff working with magnetic resonance imaging are fully aware of safety measures and behavior in emergency situations.
Finally, an MRI safety expert may be a physicist or other person with technical expertise in the art. It will require highly qualified advice on engineering, scientific and administrative issues of the safe use of MRI equipment. He or she must necessarily have a medical education or experience in the part of dispensing prescription drugs or in other non-MRI aspects.
| | This long and necessary document finally presents a set of recommendations on how to create the right organizational structure for managing safety in MRI, as well as clear distribution of roles and responsibilities, says one of the authors of the project, Fernando Calamante, Ph.D., working at the Institute of Neurology and Mental Health (Victoria, Australia). - It is important to note that this document is agreed by leading MRI organizations around the world, so it has strong relevance and practical effectiveness for the recommended structure. | |
Tobias Gilk, senior vice president of radiological planning and founder of Gilk Radiology Consultants, notes that the rules developed in the MRI community have a wide coverage both in terms of geography and markets for which the new standards are designed.
| | The industry is guarding itself. We understand that we need to define roles and responsibilities in order to protect patients and protect institutions from the risks associated with MRI safety, Gilk notes. | |
These guidelines, created several years, have become a necessity due to the increase in the number of side effects that occur after magnetic resonance imaging. In 2004, 40 such incidents were recorded in the United States, and in 2012 this number increased to 164, according to data from the U.S. Food and Drug Administration (FDA) and the special database MAUDE (User Facility Device Experience), which contains information about complications in operations and medical examinations.
Meanwhile, the European Union (EU) has issued a directive on the limit values of electric and magnetic fields affecting health professionals. Europe has instructed the MRI community to develop its own rules and effective professional training programs for specialists in this area.
The AuntMinne.com portal notes that by mid-July 2016, it is unclear how well X-ray departments and medical imaging centers are familiar with MRI safety issues and are able to follow new safety instructions.
Fernando Calamante says it is difficult to judge the experience of an institution, as they differ greatly from each other in their knowledge of MRI safety, organizational structure, procedures used to ensure security and resources.[2]
Accumulation of gadolinium in the brain in MRI
In early 2016, Europe began to actively discuss the negative impact of gadolinium when used in magnetic resonance imaging (MRI). It is assumed that this rare earth metal can accumulate in brain tissues and cause serious diseases. Read more about the problem here.
Notes
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