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Result : Searchterm 'Safety Guidance' found in 0 term [] and 27 definitions []
| previous 11 - 15 (of 27) nextResult Pages : [1 2 3 4 5 6] | | | | Searchterm 'Safety Guidance' was also found in the following service: | | | | |
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Implants that involve magnets such as magnetic sphincters, stoma plugs, dental implants, etc., can be demagnetized by the MRI device. They should be removed prior to the examination.
A particular danger is presented by small metallic surgical implants. Haemostatic or other clips in the CNS can move in their position. Dislocation by magnetic attraction or torque presents a risk in MRI examinations. There is a minimal risk in other parts of the body, because after the healing phase of six to eight weeks, fibrosis and encasement of the clip help to keep it in a stable position.
The label stainless steel is not a guarantee for non-ferromagnetic steel.
See also Cardiac Pacemaker and MRI Safety. | | | | • For this and other aspects of MRI safety see our InfoSheet about MRI Safety. | | | • Patient-related information is collected in our MRI Patient Information.
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Not necessarily a contraindication, but the examination may damage or impair it. An insulin pump can be disconnected easily for a period of time. Remove the pump while outside the 5 Gauss line, because the pump batteries and motor are magnetic. | | | | • View the DATABASE results for 'Insulin Pump' (3).
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Most of the commonly used intrauterine contraceptive devices (IUD) do not move under the influence of the magnetic field, do not heat up during sequences usually applied for pelvic imaging, and do not produce major artifacts in vitro or in vivo.
Thus, patients with either all plastic or copper IUDs can be safely imaged with magnetic resonance imaging ( MRI) machines. | | | | | |
| | | Searchterm 'Safety Guidance' was also found in the following service: | | | | |
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The owner of MRI equipment has to ensure that the equipment does fulfill the local requirements.
In some countries, the requirements are more stringent than in others; in other countries, they are nonexistent.
The user in general is unable to check power output, gradient strength, or even field strength.
The manufacturer has to cover authorized hardware and software updates after the initial installation and has to give guarantee for the requirements.
Specially designed computer programs usually supervise the power output of MRI devices and will not allow or will interrupt any imaging or spectroscopy procedure exceeding those limits considered safe.
See also European Medicines Agency, FDA information:
www.fda.gov/cdrh/safety/mrisafety.html | | | | • View the DATABASE results for 'Legal Requirements' (3).
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If a device is to be labeled MR Safe, the following information should be provided:
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Data demonstrating that when the device is introduced or used in the MRI environment (i.e. the MRI scan room) it does not pose an increased safety risk to the patient or other personnel,
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a scientifically-based rationale for why data are not necessary to prove the safety of the device in the MR environment (for example, a passive device made entirely of a polymer known to be nonreactive in strong magnetic fields).
If a device is to be labeled MR Compatible, the following information should be provided:
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Data demonstrating that when the device is introduced or used in the MRI environment, it is MR safe that it performs its intended function without performance degradation, and that it does not adversely affect the function of the MRI scanner (e.g. no significant image artifacts or noise). Any image artifact or noise due to the medical device should be quantified (e.g., % volume affected, signal to noise ratio),
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a scientifically-based rationale for why data are not necessary to prove the compatibility of the device in the MRI environment.
Test Conditions:
The static magnetic field strength ( Gauss (G) or Tesla (T)) to which the device was tested and demonstrated to be MRI 'safe', 'compatible', or 'intended for use in' should be related to typical machine ratings (e.g. 0.5 T, 1.5 T, 2.0 T, and shielded or unshielded magnet, etc).
The same conditions should be used for the spatial gradient ( field strength per unit distance (i.e., G/cm)) in which the device was tested and demonstrated to be 'safe', 'compatible', or 'intended for use in'.
Also the RF transmitter power used during testing of the device, should be related to this typical machine ratings. | | | | • View the DATABASE results for 'MR Compatibility' (4).
| | | • View the NEWS results for 'MR Compatibility' (2).
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