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1 Department of Radiology, Magnetic Resonance Services, University of
Pittsburgh, 200 Lothrop St., Pittsburgh, PA 15213-2582.
2 Penrose-St. Francis Health System, Colorado Springs, CO 80907.
3 Department of Neuroradiology, University of California, San Francisco, 505
Parnassus Ave., Rm. L371, San Francisco, CA 94143-0628.
4 Department of Anesthesiology, New York University School of Medicine, 550
First Ave., RI-605, New York, NY 10016-4998.
5 Department of Radiology, University of California, San Diego, 200 W Arbor Dr.,
San Diego, CA 92103-8224.
6 National Electrical Manufacturers Association, Hitachi Medical Systems America
Inc., 1959 Summit Commerce Park, Twinsburg, OH 44087.
7 Department of Radiology, Mayo Clinic, 200 1st St., SW, Rochester, MN
55902-3008.
8 Department of Radiology, Hennepin County Medical Center and the University of
Minnesota, 701 Park Ave., Minneapolis, MN 55415.
9 American College of Radiology, 1891 Preston White Dr., Reston, VA 20191.
10 1266 Highland Ave., Ambridge, PA 15033.
11 Durham Radiology Associates, 4323 Ben Franklin Blvd., Ste. 500, Durham, NC
27704.
12 6040 Meadow Ln., Bakerstown, PA 15007.
13 Office of Device Evaluation, Center for Devices and Radiological Health,
United States Food and Drug Administration, 9200 Corporate Blvd., HFZ-470,
Rockville, MD 20850.
14 6072 Elston Shore Rd., Neavitt, MD 21652.
Received March 4, 2004;
accepted after revision March 4, 2004.
Address correspondence to J. Hayden.
Introduction
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The original paper was published in the AJR in June 2002 [1]. After reviewing feedback from MRI users and other interested parties, as well as changes that had transpired throughout the MR industry in the interim, the panel reconvened in late 2002 and several times in 2003 and agreed on additions and modifications to the document. The following are changes to be made to the original MR Safe Practice Guidelines document published in 2002. The panel intends to post the entire document with these changes as well as an executive summary of the document on the ACR Web site (www.acr.org) following this publication. As was indicated in the original publication, the paper is intended to be used as a template for MR facilities to follow in the development of an MR safety program. These MR Safe Practices Guidelines were developed to help guide MR practitioners regarding these issues and provide a basis for them to develop and implement their own MR policies and practices. It is intended that these MR Safe Practice Guidelines (and the policies and procedures to which they give rise) be reviewed and updated on a regular basis as the field of MR safety continues to evolve.
These White Papers do not attempt to deal with all aspects of MR safety, but rather those that apply to already installed, active sites, whether clinical or research. With the increasing advent and use of 3.0-Tesla and higher strength magnets, users need to recognize that one should never assume MR compatibility or safety information about a device if it is not clearly documented in writing. Decisions based on published MR safety and compatibility should recognize that all such claims apply only to specifically tested conditions, such as static magnetic field strengths, static gradient magnetic field strengths and spatial distributions, and the strengths and rates of change of gradient and radiofrequency magnetic fields.
Finally, there are a whole host of other issues that should be considered during the site-planning stages that are not dealt with in these articles. These include, among others, cryogen emergency vent locations and pathways, 5-gauss line siting considerations, patient access pathways, considerations regarding fringe field blooming that may result in the event there is a failure of an actively shielded MR imaging system, etc. These issues, and many others, should be reviewed with those experienced with MR site planning and familiar with the patient safety and patient-flow considerations prior to committing construction to a specific site design. In this regard, enlisting the assistance of an architectural firm experienced in this area and doing so early in the design stages of the planning process may prove most valuable.
It remains the intent of the ACR that these MR Safe Practice Guidelines will prove helpful as the field of MRI continues to evolve and mature, providing patient services that are among the most powerful, yet safest, of all diagnostic procedures to be developed in the history of modern medicine.
This paper addresses four new topics and then several additions and revisions to the original paper. Changes to the original paper are in Appendix 1.
The four new topics are:
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If the patch is removed, a specific staff member should be given responsibility for ensuring that it is replaced or repositioned.
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Adherence to standards of care mandates following sedation guidelines developed by the American Academy of Pediatrics [3, 4], the American Society of Anesthesiologists [5], and the Joint Commission on Accreditation of Healthcare Organizations [6]. In addition, sedation providers must also comply with protocols established by the individual state and the practicing institution. These guidelines include providing:
For the neonatal and young pediatric population, special attention is needed in monitoring body temperature in addition to other vital signs. Temperature monitoring equipment that is approved for use in the MR suite is becoming more readily available. Commercially available MR-approved neonatal isolation transport units and other warming devices are also available for use during MR scans.
Pediatric screening issues:
Children may not be reliable historians, and especially for older children
and teenagers, the child should be questioned both in the presence of parents
or guardian and separately to maximize the possibility that all potential
dangers are disclosed. Therefore, it is recommended that they be gowned before
entering Zone IV to help ensure that no metallic objects, toys, etc.
inadvertently find their way into Zone IV with the patient. Pillows, stuffed
animals, or other comfort items brought from home represent real safety risks
and should be discouraged from entering Zone IV. If unavoidable, each should
be carefully checked with the powerful handheld magnet and perhaps again in
the MR scanner itself prior to permitting the patient to enter Zone IV in
order to ensure that they do not contain any objectionable metallic
components.
MR safety of accompanying family/personnel:
Although any age patient might request that others accompany them for their
MR examination, this is far more common in the pediatric patient population.
Those accompanying/remaining with the patient should be screened using the
same criteria as anyone else entering Zone IV. In general, it would be prudent
to limit accompanying persons to a single individual. Only a qualified,
responsible MR physician should make screening criteria exceptions.
Hearing protection and an MR compatible chair or stool are recommended for accompanying family members within the MR scan room.
FETAL MR CONTRAST AGENT SAFETY CONCERNS:
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As indicated before, but repeated for added emphasis, a documented, in-depth analysis of the potential risks and benefits to that patient and her fetus is necessary in order to arrive at a reasonable conclusion as to the clinical advisability of administering a gadolinium-based MR contrast agent to any pregnant patient.
MR SCANNING OF PATIENTS IN WHOM THERE ARE/MAY BE CARDIAC PACEMAKERS and/or IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDs)
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There have been numerous reports of patients with pacemakers who have undergone MR examinations, both intentionally as well as inadvertently, without difficulty or apparent injury. There have also been several patients who were inadvertently exposed to MR imaging studies who have died during the examination and/or very shortly thereafter. There is an increasing body of evidence documenting the ability of the MR imaging process to produce, in specific cases and under certain circumstances, direct cardiac stimulation and arrhythmias. It is theorized that such arrhythmogenesis and its severe hypotensive sequelae were the cause of death in at least several of these patients, some of whom were not pacemaker-dependent prior to the MR examination. It is also becoming more apparent that the primary cause of such arrhythmias seems to result from interactions between the implanted pulse generator (a.k.a., cardiac pacemaker)-lead circuitry and the RF power transmitted during the MR imaging process.
It should also be noted that there have not been to date any reports of clinically significant adverse outcomes for any pacemaker patient scanned in an MR imaging unit while appropriately monitored with cardiac supervision.
Some have suggested that it might well be possible to perform MR imaging examinations on patients with implanted cardiac pacemakers as long as rigid guidelines were carefully defined and rigidly adhered to throughout the imaging process. These include recommendations, among others, that ensure that no pacemaker-dependent patient be scanned, that the RF power transmitted during the MR imaging process not be deposited over the volume that contains the pacemaker and/or its leads, etc. This guideline makes no attempt to judge the scientific veracity of these observations or claims. However, it clearly recognizes that even if it is possible to safely perform MR imaging examinations on cardiac pacemaker patients, the expertise necessary to safely do so is exceedingly rare throughout the MR industry today.
The entire field of MR scanning of pacemaker patients is one that is exhibiting tremendous activity, research, and growth of late. Fiber-optic pacemaker devices, coated and/or shielded leads and pacing devices, and various other designs and configurations of MR pacing devices and leads are being actively investigated to attempt to devise MR safe cardiac pacemakers. It is therefore another area within MR safety that bears close observation and frequent updates over the next few months and years as progress continues to be made toward developing avenues that will enable pacemaker, and eventually, perhaps even ICD patients, to have access to the powerful diagnostic modality that is magnetic resonance imaging.
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