MR Labeling Information for Implants and Devices: Explanation of Terminology

Shellock, Frank G.; Woods, Terry O.; Crues, John V.

doi:10.1148/radiol.2531091030

Cited by 170 publications

(124 citation statements)

References 5 publications

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“…According to this terminology, testing "MRI safety" required in vitro tests in order to assess static magnetic field interactions, MRrelated heating and, in some cases, induced electrical currents. In order to test "MR compatibility," the assessment and description of artifacts are also required, in addition to the above-mentioned tests [4,9].…”

Section: Medical Devicesmentioning

confidence: 99%

“…After a while, the CDRH's classification method proved confusing, which could potentially lead to accidents and injured patients; therefore, as of August 2005, the ASTM published the classification method currently in use, which defines three groups [4,9] Each group was represented graphically (Fig. 1).…”

Section: Medical Devicesmentioning

confidence: 99%

“…Likewise, the use of these devices does not generate significant image artifacts, except when the studied region is exactly the same or is very close to the device's position -in this case, it may compromise the quality of the MR images. To overcome this problem, it might be necessary to optimize the MRI parameters in order to suit this particular device [4].…”

Section: Essure®mentioning

confidence: 99%

“…The magnets in use today in MR are in the 0.5-3.0-T range, or 5000 to 30,000 gauss. MRI uses gigantic magnets, which are capable of creating magnetic fields with an intensity varying from 0.2 to 9.4 T [4]. Nowadays, MRI for medical diagnosis employs devices ranging from 0.5 to 3.0 T. For comparison purposes, the earth's magnetic field is approximately 0.00005 T, exhibiting slight variations around the equator and the poles.…”

Section: Introductionmentioning

confidence: 99%

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Magnetic resonance imaging and gynecological devices

Correia¹,

Ramos

Machado³

et al. 2012

Contraception

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Background: Performing magnetic resonance imaging (MRI) on women with gynecological devices is a completely accepted practice. The goal of our review is to assess how safe it is to perform MRI on women using contraceptive implants or devices. Study Design: Literature review, searching in PubMed-Medline/Ovid for the following keywords: magnetic resonance imaging, intrauterine devices, Implanon® and Essure®. Results: Though plastic devices do not represent a contraindication to the use of the technique, those including metallic components have been submitted to several tests, after which they were classified as MR Conditional (devices presenting no risks in MR-specific environments) by the Food and Drug Administration. Thus, the use of MRI can be safely advised to women with this type of device as long as the magnetic resonance equipment is ≤3.0 T. Conclusions: Presently, there is no scientific evidence that contraindicates performing MRI on women with any kind of gynecological device. Therefore, this procedure is safe as long as it is performed under previously tested conditions.

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Section: Medical Devicesmentioning

confidence: 99%

Section: Medical Devicesmentioning

confidence: 99%

Section: Essure®mentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Magnetic resonance imaging and gynecological devices

Correia¹,

Ramos

Machado³

et al. 2012

Contraception

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“…Various policies [23][24][25][26] have been implemented to safeguard healthcare workers, volunteers and patients with the ultimate goal of avoiding unforeseen disasters and injuries due to ferromagnetic objects. These measures safety initiatives and awareness campaigns spearheaded by scientific organizations and other bodies and include safety training, risk reduction strategies, occupational health instructions, safety guidelines and warning signs.…”

Section: Introductionmentioning

confidence: 99%

Development and evaluation of a small and mobile Magneto Alert Sensor (MALSE) to support safety requirements for magnetic resonance imaging

et al. 2011

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Objective: The purpose of this study is to (i) design a small and mobile Magnetic field ALert SEnsor (MALSE), (ii) to carefully evaluate its sensors to their consistency of activation/deactivation and sensitivity to magnetic fields, and (iii) to demonstrate the applicability of MALSE in 1.5 T, 3.0 T and 7.0 T MR fringe field environments.Methods: MALSE comprises a set of reed sensors, which activate in response to their exposure to a magnetic field. The activation/deactivation of reed sensors was examined by moving them in/out of the fringe field generated by 7TMR. Results:The consistency with which individual reed sensors would activate at the same field strength was found to be 100% for the setup used. All of the reed switches investigated required a substantial drop in ambient magnetic field strength before they deactivated.Conclusions: MALSE is a simple concept for alerting MRI staff to a ferromagnetic object being brought into fringe magnetic fields which exceeds MALSEs activation magnetic field. MALSE can easily be attached to ferromagnetic objects within the vicinity of a scanner, thus creating a barrier for hazardous situations induced by ferromagnetic parts which should not enter the vicinity of a MR-system to occur.

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Safety and Sensory Aspects of Main and Gradient Fields in MRI

Schenck

1996

eMagRes

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MR Labeling Information for Implants and Devices: Explanation of Terminology

Abstract: Note: This copy is for your personal non-commercial use only. To order presentation-ready copies for distribution to your colleagues or clients, contact us at www.rsna.org/rsnarights.

Cited by 170 publications

References 5 publications

Magnetic resonance imaging and gynecological devices

Magnetic resonance imaging and gynecological devices

Development and evaluation of a small and mobile Magneto Alert Sensor (MALSE) to support safety requirements for magnetic resonance imaging

Safety and Sensory Aspects of Main and Gradient Fields in MRI

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