MRI Safety Update 2008: Part 2, Screening Patients for MRI
Contents
1. No O St gal Oo Extremidad artificial 6 prost tica Si respondi afirmativamente indiqos la fecha y que tipo de crugts ONo Malla met lica stent filtro 6 anillo met lico a OS No Shunt espinal 6 intraventricular Fecha Tipo de cirug a Sa Paces Tipo de cirug a Osi ONo Cat ter y u orificio de acceso vascular 2 Anteriormente Je han hecho alg n estudio o ex men de diagn stico MRI CT Ultrasonido Rayos X etc CINoO Si O et Bolno ee a a S No Cat terde Swan Ganz 6 de termodiluci n y m Si respondi afirmativamente deserfbalos a continuaci n P ITE man oe OS ONo Parche de medicamentos Nicotina Nitroglicerina A AVISO IMPORTANTE Parte del Cuerpo Fecha Lagar lnstivaci n Osi No Cualquicr fmgmemo met lico cuerpo extra o OS ONo Implante ti TA del Os ON reat iP Sins ae nadie Antes de entrar a la zona de MR 6 a la sala del esc ner de os ep ten MR tendr que quitarse todo objeto met lico Incluyendo OS No Grapas quir rgicas clips 6 suturas met licas a MAANGA elena DAN AA MANIA Rocio Medicina Nuclear OS ONo Aniculaciones artificiales cadera rodilla etc loma Calas wien bios allas de po vi Owo FSi ONo Varilla de hweso coyuntura tomillo clavo alambre Ate boyas incluyendo body pie ainan 3 Ha tenido alg n problema relacionado con estudios procedimientos anteriores con MR ONO s chapas etc Seas Sas Jus Qiero S007 Pa Si respondi afirmativamente descr balos Si ONo D2. 23 24 25 26 27 28 29 30 3 put 33 34 Cardiac Catheterization Council on Clinical Cardiology and the Council on Cardiovascular Radiology and Intervention endorsed by the American College of Cardiology Foundation the North American Society for Cardiac Imaging and the Society for Cardiovascular Magnetic Resonance Circulation 2007 116 2878 2891 Shinbane J Colletti P Shellock FG MR in pa tients with pacemakers and ICDs defining the is sues J Cardiovasc Magn Reson 2007 9 5 13 Baker KB Tkach JA Nyenhuis JA et al Evalua tion of specific absorption rate as a dosimeter of MRI related implant heating J Magn Reson Im aging 2004 20 315 320 Shellock FG Comments on MRI heating tests of critical implants editorial J Magn Reson Imag ing 2007 26 1182 1185 Woods TO Standards for medical devices in MRI present and future J Magn Reson Imaging 2007 26 1186 1189 American Society for Testing and Materials ASTM International Standard practice for marking medical devices and other items for safe ty in the magnetic resonance environment West Conshohocken PA ASTM International 2005 designation F2503 05 The Joint Commission Website Sentinel event alert preventing accidents and injuries in the MRI suite www jointcommission org Senti nelEvents SentinelEventAlert sea_38 htm Published February 14 2008 Accessed June 25 2008 U S Food and Drug Administration Center f
3. No Bonejoles pin screw nail wire plate ete hearing aids dentures partial plates keys beeper cell If yes please describe OYe O No IUD diaphragm or pessary phone eyeglasses hair pins barrettes jewelry body jury to the eye involving a metallic object or fragment e g metallic slivers OYes GO No Dentares or partial plates piercing jewelry watch safety pins paperclips money shavings foreign body ete ONo Yes OYes O No Tattoo or permanent makeup clip credit cards bank cards magnetic strip cards If yes please describe OYes No Body piercing jewelry coins pens pocket knife nail clipper tools clothing 5 Have you ever been injured by a metallic object or foreign body e g BB bullet shrapnel etc ONo Yes OYes O No with metal fasteners amp clothing with metallic threads If yes please descnbe urrently taking or have you recently taken any medication or drug ONo Yes OYes Ono Please consult the MRI Technologist or Radiologist If ase list OYes ONo you have any question or concern BEFORE you enter ergic to any medication ONo OYes OYes ONo the MR system room If yes please list Do you have a history of asthma allergic rea respiratory disease or reaction to a contrast NOTE You may be advised or required to wear earplugs or other hearing protection during medium or dye used for an MRI CT or X ri ONo O Yes the MR procedure to prevent possible problems or hazards related to acoustic noise 9 Do you have anemia or any dis
4. October 2008 MR system room and MR environment Please consult the MRI Technologist or Radiologist if you have any questions or concerns BEFORE you enter the MR system room This reminder along with standard policies and procedures to control access to the MRI system room and to inspect the patient or individual as well as all items intended for use in the scanner room will serve to prevent accidents and injuries 1 2 7 9 11 17 Implants and Devices An important feature of MRI safety entails the identification of implants and devices and careful consideration of the associated risks 1 11 17 Currently more than 1 800 objects have been tested relative to the use of MRI with over 600 items evaluated at 3 T or higher 12 14 MRI test findings at 3 T are particularly important for Screening Patients for MRI patient management given the large increase in clinical applications and growing use of this high field strength MR system 18 19 Notably comprehensive reviews discussing MRI information for cardiovascular im plants 20 specifically for pacemakers and implantable cardioverter defibrillators 21 have been published recently in the peer reviewed literature Information for implants and devices is available as a compiled list and in its entirety in an online format at www MR Isafety com 12 14 New implants and devices are developed on an ongoing basis which necessitates con tinuous endeavors to obtain curr
5. Roentgen Ray Society AJR 191 October 2008 OBJECTIVE This article is the second part of a two part series on MRI safety In this article part 2 the topic of screening patients for MRI procedures is addressed CONCLUSION To prevent incidents and accidents associated with MRI it is necessary to regularly revisit the safety topics that directly impact patient management especially with respect to the subjects that are new those that should be reassessed because of recent changes topics that deserve emphasis because of controversy or confusion and information that should be considered in light of new findings n consideration of the constant evolution of issues related to MRI safety and the need to up date and revise existing guide lines and policies and procedures there is an ongoing challenge to be aware of the latest developments associated with this topic No tably comprehensive reviews and textbooks have been written on the subject of MRI safety and there are Websites with content that is updated on a regular basis 1 15 Therefore the reader is referred to those im portant resources The goal of this article is to provide an MRI safety update that covers selected topics including those that are new e g MRI contrast agents and nephrogenic systemic fibrosis NSF subjects that should be reassessed because of recent changes e g screening patients and individuals topics that deserve emphasis because
6. ated with MR procedures a review J Magn Reson Imaging 2000 12 37 45 Shellock FG Kanal E Policies guidelines and recommendations for MR imaging safety and pa ion m tient management SMRI Safety Committee J Magn Reson Imaging 1991 1 97 101 Kanal E Shellock FG Policies guidelines and recommendations for MR imaging safety and pa oo tient management SMRI Safety Committee J AJR 191 October 2008 10 1 13 14 15 16 18 19 20 Screening Patients for MRI Magn Reson Imaging 1992 2 247 248 Shellock FG Kanal E Guidelines and recom mendations for MR imaging safety and patient management III Questionnaire for screening pa tients before MR procedures The SMRI Safety Committee J Magn Reson Imaging 1994 4 749 751 Wood TO MRI safety In Akay M ed Wiley en cyclopedia of biomedical engineering Hoboken NJ Wiley 2006 2360 2371 Shellock FG Chapter 24 Magnetic resonance bioeffects safety and patient management In Edelman R Hesselink J Zlatkin M Crues JV 3rd eds Clinical magnetic resonance imaging 3rd ed Philadelphia PA Saunders 2005 680 733 Shellock FG Reference manual for magnetic resonance safety implants and devices 2008 edition Los Angeles CA Biomedical Research Publishing Group 2008 Shellock FG Magnetic resonance procedure health effects and safety Boca Raton FL CRC Press 2001 Shellock FG MRIsafety com MRI safet
7. con te dispositivo u obje de MRI ANTES de entrar a la sala del esc ner Recuerde que el im n del sistema MR est SIEMPRE encendido Fecha N mero de paciente Nombre Bid Altura en Por favor indique si tiene alguno de los siguientes Apel Primer Nombre Segundo Nombre OSi ONo Pinza s de aneurisma OS ONo Mareapasos card aco Fecha de nacimiento Var n Hembra Parte del cuerpo a ser examinada Os ONo Implante con desfibrilador para conversi n cand sca ICD y ae E Oe p n OS No Implante clectr nico 6 dispositivo electr nico ii Tel fono iaid OS ONo Implante 6 dispositivo activado magn ticamente Clotad Tet A Oasi ONo Sistema de pcuroestimulaci n Ciudad el fono abajo C OS ONo Estimulador de la m dula espinal OS No Hectrodos alambres internos i a OS ONo Estimulador de crecimiemto fusi n del hueso oo Sn Sf No Implante coclear otol gico u otro implante del o do OS ONo Bomba de infusi n de insulina 6 similar Motivo M j d MR s nto oe RACA ean Ae PA alii OS ONo Dispositivo implantado para infusi n de medicamento Sf No Cualquier tipo de pr tesis ojo penal etc dico que le refiri el fono M dico que le refiri Tel fono OS ONo Pr tesis de v lvula cardiaca A A ___ _ _ _______ _ __ _ ___ _ _ _ _ Osi No Muelle alambre del p rpado 1 Anteriormente Je han hecho alguna cirug a u operaci n e g artroscop a endoscop a etc de cualquier tipo
8. for the patient and the one for other individuals have the following statement to emphasize the need to prevent the introduction of unwanted items into the MR system room Remove all metallic objects before entering the MR environment or MR system room including hearing aids beeper cell telephone keys eyeglasses hair pins barrettes jewelry including body piercing jewelry watch safety pins paperclips money clip credit cards bank cards magnetic strip cards coins pens pocket knife nail clipper steel toed boots shoes and tools Loose metallic objects are especially prohibited in the MAGNETIC RESONANCE MR PROCEDURE SCREENING FORM FOR PATIENTS objects may be hazardous to you and or may interfere with the al MRI MR o not enter the MR system object Consult the MRI Date Patient Number R system magnet is ALWAYS on Name E _ Age Height Weight La aame Fint same Nottie Tesal Please indicate if you have any of the following Date of Birth Malet Female Body Part to be Examined OYes ONo Aneurysm ctipts Wienss mark on the figures Debo OYes O No Cardiac pacemaker the location of any implant or metal man dy yen OYes O No Implanted cardioverter defibrillator ICD inside of or on your body Address Telephone home OYes O No Hectronic implant or device Oye O Magnetically activated implant or device ay Telephone work OYe O Neurostimulation system OYes O No Spinal cord stimulator State Zp Co
9. have had clips placed within their gas trointestinal tract as this could be harmful to patients Long Clip HX 600 090L The Long Clip HX 600 090L Olympus Medical Systems is indicated for placement within the gastro intestinal tract for endoscopic marking hemo stasis or closure of gastrointestinal tract luminal perforations within 20 mm as a supplementary method Currently the Long Clip HX 600 090L is labeled as follows Do not perform MRI procedures on patients who have clips placed within their gastrointestinal tracts This could be harmful to the patient Additional information Olympus endo scopic clips have been shown to remain in the patient an average of 9 4 days but retention is based on a variety of factors and may result in a longer retention period Before MRI the physician should confirm that there are no residual clips in the gastrointestinal tract The following techniques may be used for confirmation 1 View the lesion under radiologic imag ing Olympus clip fixing devices are radiopaque Using radiography the phy sician can determine if any residual clips are in the gastrointestinal tract If no clips are evident under radiologic imaging MRI may be performed 2 Endoscopically examine the lesion If no clips remain at the lesion MRI may be performed QuickClip2 HX 201LR 135 and HX 201 UR 135 The QuickClip2 HX 201LR 135 and HX 201UR 135 Olympus Medical Sys tems are indicated for
10. reservoir formation in Long term effect on IOP of a stainless steel glau 39 Boston Scientific Website Resolution Clip infor the orbit an unusual complication of Ahmed coma drainage implant Ex PRESS in com mation www bostonscientific com templatedata glaucoma valve implantation Am J Neuroradiol bined surgery with phacoemulsification Br J imports collateral Endoscopy prospec_resolu 2007 28 1565 1566 Ophthalmol 2005 89 425 429 Erratum in Br J tion_01_us pdf Accessed June 25 2008 FOR YOUR INFORMATION The reader s attention is directed to the commentary on this article which appears on the following pages FOR YOUR INFORMATION The reader s attention is directed to part accompanying this article titled MRI Safety Update 2008 Part MRI Contrast Agents and Nephrogenic Systemic Fibrosis which begins on page xxx AJR 191 October 2008
11. trabeculec tomy buphthalmos and juvenile glaucoma neovascular glaucoma and glaucoma sec ondary to uveitis traumatic glaucoma catar act with glaucoma and high risk cases of primary glaucoma Importantly for certain glaucoma drainage implants radiographic findings may suggest the diagnosis of an orbital foreign body if the ophthalmic history is unknown as reported by Ceballos and Parrish 32 In that case report a patient was denied an MRI examination for fear of dislodging an apparent metallic foreign body In fact the patient had a Baerveldt glaucoma drainage implant that was mistakenly identified as an orbital metallic object based on its radiographic characteristics i e due to the presence of barium impregnated silicone At least one glaucoma drainage implant the ExPRESS miniature glaucoma shunt Op tonol Ltd is made from 316L stainless steel However many other glaucoma drainage im plants are made from nonmetallic materials and are safe for patients undergoing MRI pro cedures Commonly used devices that do not contain metal include the following e Baerveldt glaucoma drainage Pharmacia Co Krupin Denver eye valve to disk implant E Benson Hood Laboratories e Ahmed glaucoma valve New World Medical e Molteno drainage device Molteno Oph thalmic Ltd and e Joseph valve Valve Implants Limited implant Hemostatic Ligating Vascular Clips In general it was previously believed th
12. 12 14 The terminology applied to implants and devices relative to the MRI environment has evolved over the years In 1997 the Center for Devices and Radiological Health pro posed definitions for the terms MR safe and MR compatible as follows 27 MR safe The device when used in the MRI environment has been demon strated to present no additional risk to the patient or other individual but may affect the quality of the diagnostic information The MRI conditions in which the device was tested should be specified in conjunction with the term MR safe since a device which is safe under one set of conditions may not be found to be so under more extreme MRI conditions MR compatible A device shall be considered MR compatible if it is MR safe and the device when used in the MRI environment has been demon strated to neither significantly affect the quality of the diagnostic information nor have its operations affected by the MR system The MRI conditions in which the device was tested should be specifi ed in conjunction with the term MR safe since a device which is safe under one set of conditions may not be found to be so under more extreme MR conditions To implement this terminology MR safe ty testing of an implant or object involved assessments of magnetic field interactions heating and in some cases induced elec trical currents whereas MR compatibility testing required all of t
13. The Practice of Radiology Review MRI Safety Update 2008 Part 2 Screening Patients for MRI Frank G Shellock Alberto Spinazzi Keywords electromagnetic fields implants MRI environment MR conditional MR safe MR unsafe radiology department policies DOI 10 2214 AJR 08 1038 2 Received April 2 2008 accepted after revision May 10 2008 F G Shellock has received unrestricted educational and research support from Bayer Healthcare Bracco Diagnostics Siemens Medical Solutions Philips Healthcare GE Healthcare Toshiba Medical Systems Hitachi Medical Systems C R Bard Boston Scientific Corporation Abbott Laboratories Medtronic Inc Johnson amp Johnson St Jude Medical Biomet Lumasense Advanced Neuromodulation Systems Arrow International Smiths Medical Stryker Instruments Cordis DePuy Integra Neuroscience Edwards Laboratories Newmatic Medical Resonance Technology Codman Cyberonics Smith and Nephew Inrad eV3 Cook Inc Stryker Conor Medical and Advanced Bionics A Spinazzi is an employee of Bracco Diagnostics Inc Keck School of Medicine University of Southern California and Institute for Magnetic Resonance Safety Education and Research 7511 McConnell Ave Los Angeles CA 90045 Address correspondence to F G Shellock frank shellock gte net 2Group Medical and Regulatory Affairs Bracco Diagnostics Inc Princeton NJ AJR 2008 191 1 10 0361 803X 08 1914 1 American
14. ameters may be nec essary The following chart provides a com parison between the signal void and imaging pulse sequence at 3 Tesla Signal Void Pulse Scan Orientation Size Sequence Relative to Implant 1590 mm T1 SE long axis view 1022 mm T1 SE short axis view 2439 mm GRE long axis view 2404 mm GRE short axis view Summary To prevent incidents and accidents itis vital to be cognizant of basic information as well as the latest findings that impact the use of MRI to ensure safety for patients staff members and others Having this knowledge is particularly important because of the evolutionary advancements in MRI technology and the increased potential for hazardous situations to occur in this environment References Shellock FG Crues JV 3rd MR procedures bio logic effects safety and patient care Radiology 2004 232 635 652 Shellock FG Biomedical implants and devices jas to assessment of magnetic field interactions with a 3 0 Tesla MR system J Magn Reson Imaging 2002 16 721 732 Schenck JF Safety of strong static magnetic fields J Magn Reson Imaging 2000 12 2 19 Schaefer DJ Bourland JD Nyenhuis JA Review of patient safety in time varying gradient fields J Magn Reson Imaging 2000 12 20 29 Shellock FG Radiofrequency energy induced Ww S uu heating during MR procedures a review J Magn Reson Imaging 2000 12 30 36 McJury M Shellock FG Auditory noise associ
15. at because virtually all hemostatic also called ligating vascular clips and similar devic es including endoclips deployed through endoscopes are made from nonferromag netic materials such as tantalum titanium and certain forms of stainless steel patients with these implants are not at risk for injury in association with MRI procedures 11 12 14 38 Furthermore patients with nonferro magnetic versions of these implants may un dergo MRI examinations procedures imme diately after they are placed To date for the hemostatic clips that have undergone MRI testing there has been no patient injury or other problem related to MRI However several new hemostatic clips in use today present potential problems for patients referred for MRI procedures Patients with these clips require special attention to ensure the safe use of MRI In some cases MRI is deemed unsafe In others a waiting period is necessary and radiographs must be obtained and inspected to determine whether the clips are present before performing MRI Specific MRI related labeling statements for the hemostatic clips that require further attention during the MRI screening procedure are as follows Resolution Clip The Resolution Clip Boston Scientific is indicated for place ment in the gastrointestinal tract for endo scopic marking or hemostasis Currently the Resolution Clip is labeled as follows 39 Do not perform MRI procedures on patients who
16. at contains an electronic circuit that is activated externally by a low power electromagnetic field emitted by a battery powered scanner The microtransponder is implanted subcu taneously With regard to MRI procedures the labeling for this device states Patients with the VeriChip Microtransponder may safely undergo MRI diagnostics in up to 7 T cylindric systems 12 14 Instructions for patients undergoing MRI e The patient should be monitored continu ously throughout the MRI procedure using visual and audio means e g intercom system e Instruct the patient to alert the MR system operator of any unusual sensations or problems so that if necessary the MR system operator can immediately terminate the procedure e Provide the patient with a means to alert the MR system operator of any unusual sensations or problems e Do not perform MRI if the patient is sedated anesthetized confused or other wise unable to communicate with the MR system operator Insulin Pumps The MRI information pertains to the fol lowing insulin pumps from Animas Cor poration a Johnson amp Johnson Company e Animas 2020 Insulin Pump IR Animas 1200 e IR 1000 Insulin Pump e IR 1100 Insulin Pump and e IR 1200 Insulin Pump Each insulin pump indicated should not be exposed to very strong electromagnetic fields such as those from MRI units RF welders or magnets used to pick up automobiles Very strong magnetic fields su
17. atop a rotating spiral cam that contains a stepper motor Applying a specific magnetic field to the stepper motor will cause the cam to turn slightly increasing or decreasing the tension on the spring and ball thus changing the opening pressure of the valve With regard to MRI the product insert for the Codman Hakim Programmable Valve states MRI information The Codman Hakim Programmable Valve is considered MR Conditional according to ASTM F 2503 The valve demonstrates no known hazards when an MRI is performed under the follow ing conditions e MRI can be performed at any time after implantation e Use an MR system with a static magnetic field of 3 T or less e Use an MR system with a spatial gradient of 720 gauss cm or less e Limit the exposure to RF energy to a whole body averaged specific absorption rate SAR of 3 W kg for 15 minutes e Verify the valve setting after the MRI procedure see Programming the Valve product insert information provided with the valve In non clinical testing the valve produced a temperature rise of 0 4 degrees C at a max AJR 191 October 2008 imum whole body averaged specific absorp tion rate SAR of 3 0 W kg for 15 minutes of MR scanning in a 3 T Excite General Elec tric MR scanner MR image quality may be compromised if the area of interest is relatively close to the device Distortion may be seen at the bound aries of the artifact Therefore optimization of the MR imaging par
18. ch as that associat ed with MRI can magnetize the portion of the insulin pump s motor that regulates in sulin delivery and thus damage this device For the patient If you plan to undergo an MRI remove the insulin pump beforehand and keep it outside of the MR system room during the procedure If the pump is accidentally allowed into the MR system room disconnect the pump immediately and contact Animas Pump Support for important instructions For the health care professional Do not bring the insulin pump into the MR system at any time If the pump is accidentally allowed into the MR system room disconnect the pump immediately and contact Animas Pump Support for important instructions Cozmo Pump an infusion pump Ac cording to the User Manual for the Cozmo Pump Deltec which is a device used to administer insulin the following is stated regarding MRI Caution Avoid strong electromagnetic fields like those present with Magnetic Resonance Imaging MRI and direct x ray as they can affect how the pump works If you cannot avoid them you must take the pump off MiniMed 2007 Implantable Insulin Pump System The MiniMed 2007 Implant able Insulin Pump System Medtronic is designed to withstand common electrostatic and electromagnetic interference but must be removed before an MR procedure Any magnetic field exceeding 600 G will interfere with the proper functioning of the pump for as long as the pump remai
19. de OYes O No Internal clectrodes or wires OYes O No Bone growth bone fusion stimulator Reason for MRI and or Symptoms OYes O No Cochlear otologic or other ear implant OYes O No Insulin or other infusion pump Referring Physician Telephone OYe ONo Implanted drug infusion device OYes O No Any type of prosthesis eye penile etc OYes O No Heart valve prosthesis 1 Have you had prior surgery or an operation e g arthroscopy endoscopy ete of any kind ONo Yes OYes O No Eyelid spring or wire If yes please indicate the date and type of surgery OYe ONo Antificial or prosthetic limb Date Type of surgery OYes O No Metallic stent filter or coil Date Type of surgery OYes O No Shunt spinal or intraventricular a had a prior diagnostic imaging study or examination MRI CT Ultrasound X ray ete ONo OYes OYes O No Vascular access port and or catheter s please list Body part Dow Faahty OYes ONo Radiation seeds or implants Yes O No Swan Ganz or thermodilutic CTICAT Sas OI zz Oe OYe O No Medication patch Nicotine OYes No Any metallic fra a Ye ONo Wie mesh imi IMPORTANT INSTRUCTIONS clear Medicine OYe ONo Tissue expander e g breast Other OYes O No Surgical staples clips or metallic sutures Before entering the MR environment or MR system OYes O No Joint replacement hip knee ete room you must remove al metallic objects including 3 Have you experienced any problem related to a previous MRI examination or MR procedure ONo Yes OYes O
20. de static magnetic field strength spatial gradient time varying magnetic field dB dt radiofrequency RF fields and specific absorption rate SAR Additional conditions including specific configurations of the item e g the routing of leads used for a neurostimulation system may be required For MR conditional items the item labeling includes results of testing sufficient to characterize the behavior of the item in the MRI environment In particular testing for items that may be placed in the MRI environment should address magnetically induced displacement force and torque and RF heating Other possible safety issues in clude but are not limited to thermal injury in duced currents and voltages electromagnetic AJR 191 October 2008 compatibility neurostimulation acoustic noise interaction among devices and the safe functioning of the item and the safe opera tion of the MR system Any parameter that affects the safety of the item should be listed and any condition that is known to produce an unsafe condition must be described MR unsafe An MR unsafe item is one that is known to pose hazards in all MRI environments MR unsafe items include magnetic items such as a pair of ferromag netic scissors In addition to the new terms ASTM In ternational introduced corresponding icons consistent with international standards for colors and shapes of safety signs 24 25 The icons are intended for use on items that ma
21. ease s that affects your bl story of renal kidney disease renal kidney failure renal kidney transplant high blood pressure hypertension 1 attest that the above information is correct to the best of my knowledge I read and understand the contents of this form and had the liver hepatic disease or seizures No OYes opportunity to ask questions regarding the information on this form and regarding the MR procedure that 1 am about to undergo If yes please describe Signature of Person Completing Form Date For female patients Signanore 10 Date of last menstrual period Post menopausal ONo Yes one amic ae gt Form Completed By O Patent Relative O Nurse Ht or experiencing a late menstrual period ONo Yes ame Talaicaship w pini y ONo OYes ONo GYes Form Information Reviewed By Prat same Signature 14 Are you currently breastfeeding ONo Yes O MRI Technologist O Nurse O Radiologist O Other A Fig 1 Forms with latest information used for screening patients before undergoing MRI procedures and for screening nonpatient individuals before entering MRI environment e g MRI technologist physician relative visitor allied health professional maintenance worker custodial worker fire fighter security officer Forms may be downloaded for use atwww MRlsafety com A D Forms given to patients for screening before MRI A and B in English C and D in Spanish Fig 1 continues on next page AJR 191
22. een the conductive material and the patient 5 Position the Foley catheter with tem perature sensor in a straight configuration down the center of the patient table to prevent cross points and conductive coils or loops 6 The wire and connector of the Foley catheter with temperature sensor should not be in contact with the patient during the MRI procedure position the device accordingly 7 MRI should be performed using an MR system with static magnetic strength of 1 5 or 3 T only 8 At 1 5 T the MR system whole body averaged SAR should not exceed 3 5 W kg for 15 minutes of scanning 9 At 3 T the MR system reported whole body averaged SAR should not exceed 3 W kg for 15 minutes of scanning Glaucoma Drainage Implants Shunt Tubes A glaucoma drainage implant or device also known as a shunt tube is implanted to maintain an artificial drainage pathway to control intraocular pressure for patients with glaucoma 12 14 32 37 Intraocular pressure is lowered when aqueous humor flows from inside the eye through the tube into the space between the plate that rests on the scleral surface and surrounding fibrous capsule The implantation of a glaucoma drainage device is used to treat glaucoma Shellock and Spinazzi that is refractory to medical and standard surgical therapy These cases are usually in patients in whom standard drainage pro cedures have failed or in patients who have a poor prognosis including failed
23. ent docu mentation for these items before subjecting a patient or individual to the MRI environ ment In addition the nuances of MRI test ing especially with respect to evaluating MRI related heating and identifying func tional alterations which have been described previously 1 2 12 14 22 24 and the ter minology applied to label implants and de vices must be understood to facilitate patient management 12 24 25 Importantly for electronically activated implants the label ing that ensures the safe use of MRI is high ly specific to the conditions that were used to assess the device and any deviation from the defined procedures can lead to deleteri ous effects severe patient injuries or fatali ties 1 13 17 20 23 Terminology A recent Sentinel Alert from the Joint Commission 26 states the following In general do not bring any device or equipment into the MRI environment unless it is proven to be MR Safe or MR Conditional MR Safe items pose no known hazard in all MRI environments and MR Conditional items have been demonstrated to pose no known hazards in a specified MRI environment with CUESTIONARIO PREVIO A ESTUDIO CON RESONANCIA MAGNETICA MR ADVERTENCIA Ciertos implantes dispositivos u objetos pueden ser peligrosos y o pueden interferir con el PARA PACIENTES gt pis No si tiene alguna pregunta c lacionadas
24. foreign body ONoO Yes If yes please describe _ 7 3 Have you ever been injured by a metallic object or foreign body eg BB bullet shrapnel ctc ON0oO Yes If yes please describe 4 Are you pregnant or suspect that you are pregnant ONoO Yes implants devices of objects may not enter the MR environment or M regarding an implant device or object Please indicate if you have any of the following O Yes O No Aneurysm clip s O Yes O No Cardiac pacemaker ais S ke eee e ACD Remove all metallic objects before entering the MR 0 Yes O No Magnetically activated implant or device environment or MR system room including hearing O Yes lo Neurostimulation system alds beeper cell phone keys eyeglasses hair pins O Yes O No Spinal cord stimulator barrettes Jewelry Including body plercing Jewelry O Yes Cochlear implant or implanted hearing aid watch safety pins paperclips money dip credit OY es Insulin or infusion pump cards bank cards magnetic strip cards coins pens OYe C Implanted drug infusion device pocket knife nail dipper steel toed boots shoes and O Yes Any type of prosthesis or implant tools Loose metallic objects are especially prohibited OYa Artificial or prosthetic limb in the MR system room and MR environment O Yes Any metallic fragment or foreign body x O Yes Any external or internal metallic object Yes Please consult the MRI Technologist or Radiologist if awe you have any question
25. hese as well as char acterization of artifacts In addition it may have been necessary to evaluate the impact of various MRI conditions on the functional or operational aspects of an implant or de vice 12 14 Thus over the years manufacturers gener ally used the terms MR safe and MR com patible when labeling medical implants and devices However in time it became apparent that these terms were confusing and were of ten used interchangeably or incorrectly 28 Therefore in an effort to clarify the terminol ogy and more importantly because the mis use of these terms could result in serious ac cidents for patients and other individuals the MR Task Group of the American Society for Testing and Materials ASTM International developed a new set of terms with associated icons 24 25 The new terms MR safe MR conditional and MR unsafe are de fined in an ASTM International document 25 as discussed below MR safe An item that poses no known hazards in all MRI environments Using the new terminology MR safe items include nonconducting nonmetallic nonmagnetic items such as a plastic Petri dish An item may be determined to be MR safe by pro viding a scientifically based rationale rather than test data MR conditional An item that has been demonstrated to pose no known hazards in a specified MRI environment with specified conditions of use Field conditions that define the MRI environment inclu
26. iculares u otra protecci n de sus o dos durante el procedimiento de MR para 9 Tiene anemia u otra enfermedad que afecto su sangre alg n episodio de enfermedad de ri n fracaso de ri n un transplante de preval problemas 6 risagos anecindos al nivel de rakda on la sula Gel estan de MR ri n hipertensi n rela de ataques epil pticos Si respondi afirmativamente descr balo ONo Osi Atestiguo que la informaci n anterior es correcta seg n mi mejor entender Leo y entiendo el contenido de este cuestionario y be tenido la oportunidad de hacer preguntas en relaci n a la informaci n en el cuestionario y en relaci n al estudio de MR al que me voy a Para los pacientes femeninos g someter a continuaci n 10 Fecha de su ltimo periodo menstrual En la menopausia Tirana de lo person Henao este cosstionaros Fecha 11 Est embarazada 6 tiene retraso con su periodo menstrual hr 12 Est tomando contraceptivos orales 6 recibiendo tratamiento hormonal Cuestionario lleno por Paciente OParieme OEnfermera E 13 Est tomando alg n tipo de medicamento para la fertilidad 6 recibiendo tratamientos de fertilidad ON0 O s Nombre en tetra de dex Relaci n com el paciente Si responde afirmativamente deserftalos a continuaci n Informaci n revisada por A A Fold emanation m bebe GNoG sf O T cnico de MRI O Enfermera ORadi logo Oto igs Perander Hyper MS Beta C D Fig 1 continued Forms with latest information used for screeni
27. ispositivo intrauterino UD diafragma 6 pesario Mlleres sujetapapeles clip de billetes tarjetas de cr dito 6 4 Se ha golpeado el ojo con un objeto fragmento met lico e g astillas met licas virutas objeto extra o etc O No O S OS ONo Dentaduras placas parciales de banco toda tarjeta con banda magn tica monedas Si respondi afirmativamente describa el incidente plumas cuchillos corta u as herramientas ropa con P Sf ONo Tatuaje 6 maquillaje permanente 5 Ha sido alcanzado alguna vez por un objeto met lico u objeto extra o e g penigones bala metralla etc ONoO s Jsi ONo Perforaci n piercing del cuerpo enganches de metal y ropa con hilos met licos Si respondi afirmativamente describa el incidente OSi ONo Aulifono Quireselo antes de entrar a la sala del 6 E al mente tomando ha reciertemer nado alg n medicamento o droga ONo O s esc ner de MR Por favor consulte con el T cnico de MRI 6 Radi logo si 6 afirmativamente indique el nombre del medicamento OS ONo Otro implante tiene alguna pregunta o duda ANTES de entrar a la sala 7 alg n maticam NOM s OS No Problema respiratorio 6 desonden del movimiento del esc ner de MR Si resp rmativamente indique el nombre del medicamento OS ONo Claustrofobia 8 Tiene historia de asma reacci n al rgica enfermedad respiratoria 6 reacci n a contrastes 6 tinturas usados en MRI CT 6 Rayos X ONoO s NOTA Es posible se le pida usar aur
28. ng patients before undergoing MRI procedures and for screening nonpatient individuals before entering MRI environment e g MRI technologist physician relative visitor allied health professional maintenance worker custodial worker fire fighter security officer Forms may be downloaded for use atwww MRlsafety com A D Forms given to patients for screening before MRI A and B in English C and D in Spanish AJR 191 October 2008 Fig 1 continues on next page Shellock and Spinazzi MAGNETIC RESONANCE MR ENVIRONMENT SCREENING FORM FOR INDIVIDUALS The MR system has a very strong magnetic field that may be hazardous to individuals entering the MR environment or MR system room if they have certain metallic electronic magnetic or mechanical implants devices or objects Therefore all individuals are required to fill out thi the MR environment or MR system room Be advised the MR system magnet is ALWAYS on NOTE If you are a patient preparing to undergo an MR examination you are required to fill out a different form Dae Name Age moth dy year Tad Name a Name Tide Fatal Address Telephone home __ City Telephone work State Zip Code 1 Have you had prior surgery or an operation e g arthroscopy endoscopy etc of any kind ON0O Yes If yes please indicate date and type of surgery Date Type of surgery 2 Have you had an injury to the eye involving a metallic object e g metallic slivers
29. ns in that field Fields higher than that such as those emitted by an MR system may cause irreparable damage to the pump By comparison infusion sets MMT 11X MMT 31X MMT 32X MMT 37X MMT 39X Medtronic used with this device contain no metallic components and are safe to be used and can remain attached to the patient during an MR procedure The only exceptions are Polyfin infusion sets Polyfin infusion sets MMT 106 and MMT 107 MMT 16X MMT 30X MMT 36X Med tronic have a surgical steel needle that remains in the subcutaneous tissue These infusion sets should be removed before any MR procedure Codman Hakim Programmable Valve The Codman Hakim Programmable Valve Codman a Johnson amp Johnson Company offers the ability to optimize the opening pressure of a CSF shunt system before and after implantation This feature is considered to be an important one because the condition of the patient with the shunt will often change over the course of treatment The use of a programmable CSF shunt valve allows the surgeon to noninvasively change the open ing pressure negating the need for revision surgery to alter the valve pressure Fur thermore the programmability of the valve may allow the development of specialized treatment regimes The opening pressure of the Codman Hakim Programmable Valve is changed through the use of an externally applied magnetic field The spring in the ball and spring mechanism of the valve sits
30. ns to identify potential problems relative to an MRI procedure or the MRI environment have been developed 1 12 14 17 Screening forms with the latest information are shown in Figure 1 including screening forms for patients in English Figs 1A and 1B and Spanish Figs 1C and 1D anda screening form for nonpatient individuals Fig 1E The form intended for patients includes questions to address NSF risks 12 14 All forms may be downloaded for use at www MRIsafety com Typically screening forms were created with patients in mind and therefore ask cer tain questions that are inappropriate for in dividuals who may simply need to enter and work in the MRI environment Therefore a separate screening form was created specifi cally for individuals who need to enter the MRI environment or MR system room All nonpatient individuals e g MRI technolo gist physician relative visitor allied health professional maintenance worker custodial worker fire fighter security officer are re quired to undergo screening before being permitted in the MRI environment Once the form has been completed the MRI safety trained health care worker must review the information and perform a verbal interview to verify the form s content and to allow discussion of any questions or concerns 1 12 14 15 17 If the individual undergoing screening needs to enter the bore of the MR system and thus becomes exposed to the MRI related elec
31. of controver sy or confusion e g certain policies and procedures and information that should be considered in light of new findings e g MRI test results for implants and devices includ ing items evaluated at 3 T Screening Patients for MRI Procedures and Individuals for the MRI Environment The implementation of appropriate policies and procedures to screen a patient for an MRI examination or an individual before permitting entry into the MRI environment i e the MR system room is a vital aspect of a facility s MRI safety program that when conducted properly prevents problems accidents and injuries Therefore although this topic has been covered in great detail 1 2 7 9 11 17 it needs to be revisited because of the previously described concerns related to the use of MRI contrast agents and NSF as well as other matters that must be considered A health care worker specially trained in MRI safety must perform the MRI screening activities whether it involves a patient or another individual This worker is someone who has undergone training and education to fully understand the potential hazards and issues associated with the MRI environment and MRI procedures and who is aware of the latest information on the screening forms for patients and individuals Screening requires the use of written forms 1 2 7 9 11 17 Two different screening forms one for patients and one for other individuals that provide questio
32. of the ECG signal Therefore ECG data acquired during MRI may be inaccurate or unusable The Sleuth IMD model 2010 was deter mined to be MR conditional based on information provided in the following docu ment published by the American Society for Testing and Materials ASTM International Designation F2503 05 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment ASTM International 100 Barr Harbor Drive PO Box C700 West Consho hocken Pennsylvania 2005 25 Nonclinical testing has shown that the Sleuth IMD is MR conditional It can be scanned safely under the following con ditions e static magnetic field of 1 5 T e spatial gradient magnetic field of 250 G cm and e maximum MR system reported whole body averaged specific absorption rate SAR of 3 5 W kg for 15 minutes of scanning In nonclinical testing in a phantom the device produced a temperature rise of 1 3 C or less at a maximum whole body averaged SAR of 3 5 W kg for 15 minutes of MR scanning in a 1 5 T MR system Magnetom Siemens Medical Solutions software Num aris 4 Version Syngo MR 2002B DHHS active shielded horizontal field scanner Siemens Instructions for use The maximum whole body averaged SAR reported was measured by the MR system MR image quality may be compromised if the area of interest is in the same area or is relatively close to the position of the Sleuth IMD Table 1
33. on for New or Controversial Implants and Devices Although a summary of the MRI test data that are available for the more than 1 800 im plants and devices is not within the scope of this article a selection of items evaluated in AJR 191 October 2008 Screening Patients for MRI the MRI environment is presented to illus trate new or controversial findings for these objects with an emphasis on electronically activated implants as well as 3 T information ActiPatch The ActiPatch BioElectronics is a med ical drug free device that delivers pulsed electromagnetic frequency therapies to ac celerate healing of soft tissue injuries The ActiPatch has an embedded battery operat ed microchip that delivers continuous pulsed therapy to reduce pain and swelling The ActiPatch must be removed before a patient undergoes an MRI procedure to prevent possible damage to this device and the potential risk of excessive heating Body Piercing Jewelry Ritual or decorative body piercing is pop ular as a form of self expression Different types of materials are used to make body piercing jewelry including ferromagnetic and nonferromagnetic metals as well as non metallic materials 12 14 29 31 The pres ence of body piercing jewelry made from ferromagnetic material presents potential problems for a patient referred for an MRI examination or an individual in the MRI en vironment Risks include uncomfortable sen sations from movement or di
34. or Devices and Radiological Health Website A primer on medical device interactions with mag netic resonance imaging systems www fda gov cdrh ode primerf6 html Published February 7 1997 Updated May 23 1997 Shellock FG Crues JV 3rd MR safety and the American College of Radiology White Paper AJR 2002 178 1349 1352 Armstrong ML Elkins L Body art and MRI Am J Nurs 2005 105 65 66 DeBoer S Fishman D Chwals W Straus C Amundson T Body piercing tattooing and trauma diagnostic imaging medical myths vs realities J Trauma Nurs 2007 14 35 38 Muensterer OJ Temporary removal of navel piercing jewelry for surgery and imaging studies Pediatrics 2004 114 e384 e386 Ceballos EM Parrish RK Plain film imaging of Baerveldt glaucoma drainage implants Am J Neu roradiol 2002 23 935 937 Dahan E Carmichael TR Implantation of a min iature glaucoma device under a scleral flap J Glaucoma 2005 14 98 102 Hong CH Arosemena A Zurakowski D Ayyala RS Glaucoma drainage devices a systematic 35 Shellock and Spinazzi literature review and current controversies Surv 36 Sidoti PA Baerveldt G Glaucoma drainage im Ophthalmol 2005 89 645 Ophthalmol 2005 50 48 60 plants Curr Opin Ophthalmol 1994 5 85 98 38 Raju GS Gajula L Endoclips for GI endoscopy Jeon TY Kim HJ Kim ST Chung TY Kee C MR 37 Traverso CE De Feo F Messas Kaplan A et al Gastrointest Endosc 2004 59 267 279 imaging features of giant
35. or concern BEFORE you enter O Yes the MR system room 1 attest that the above information is correct to the best of my knowledge I have read and understand the entire contents of this form and have had the opportunity to ask questions regarding the information on this form Signature of Person Completing Form _ Form Information Reviewed By O MRI Technologist O Radiologist BEFORE entering azardous to you in the MR environment or tem room if you have any questio oncem Al IMPORTANT INSTRUCTIONS Date O Other E Fig 1 continued Forms with latest information used for screening patients before undergoing MRI procedures and for screening nonpatient individuals before entering MRI environment e g MRI technologist physician relative visitor allied health professional maintenance worker custodial worker fire fighter security officer Forms may be downloaded for use atwww MRlsafety com E Form used to screen individuals prior to entry into MRI environment specified conditions of use The safety of MR conditional items must be verified with the specific scanner and MR environment in which they will be used Importantly this statement refers to ter minology that has only been used for label ing of implants and devices since approxi mately August 2005 12 14 24 25 and fails to recognize that these terms have not been applied retrospectively by the U S Food and Drug Administration FDA
36. placement within the gastrointestinal tract for endoscopic mark AJR 191 October 2008 ing hemostasis or closure of gastrointestinal tract luminal perforations within 20 mm as a supplementary method Currently the Quick Clip2 HX 201LR 135 and HX 201UR 135 is labeled as follows Do not perform MRI procedures on patients who have clips placed within their gastrointestinal tracts This could be harmful to the patient Additional information Olympus endo scopic clips have been shown to remain in the patient an average of 9 4 days but retention is based on a variety of factors and may result in a longer retention period Before MRI the physician should confirm that there are no residual clips in the gastrointestinal tract The following techniques may be used for confirmation 1 View the lesion under radiologic imaging Olympus clip fixing devices are radiopaque Using radiography the physician can determine wheth er any residual clips are in the gastro intestinal tract If no clips are evident under radiologic imaging MRI may be performed 2 Endoscopically examine the lesion If no clips remain at the lesion MRI may be performed QuickClip2 Long HX 201LR 135L and HX 201UR 135L The QuickClip2 Long HX 201LR 135L and HX 201UR 135L Olympus Medical Systems are indicated for placement within the gastrointestinal tract for endoscopic marking hemostasis or closure of gastrointestinal tract luminal pe
37. provides maximum signal voids artifact size for the standard imaging pulse sequences at 1 5 T per ASTM F2119 The effect of performing MRI procedures using higher static magnetic field or higher levels of RF energy on a patient with the Sleuth IMD has not been determined MRI health care professionals are advised to contact Transoma Medical to ensure that the latest safety information is obtained and is carefully followed to ensure patient safety relative to the use of an MR procedure Note that magnetic forces may act on the housing of the implanted Sleuth IMD and result in a tugging sensation that patients may feel This force does not pose a safety hazard but to mitigate patient alarm patients should be made aware of the possibility of such a sensation VeriChip Microtransponder The VeriChip Microtransponder VeriChip Corporation is a miniaturized implant Shellock and Spinazzi TABLE Maximum Signal Voids Artifact Size for the Standard Imaging Pulse Sequences at 1 5 T per American Society for Testing and Materials International F2119 Signal Void cm 68 T1 weighted spin echo 162 Gradient echo 280 Gradient echo Pulse Sequence 115 T1 weighted spin echo Imaging Plane Parallel Perpendicular Parallel Perpendicular Note Data apply to the Sleuth implantable ECG monitoring system Sleuth IMD model 2010 Transoma Medical able RF identification device The micro transponder is a passive device th
38. rforations within 20 mm as a supplemen tary method Currently the QuickClip2 Long HX 201LR 135L and HX 201UR 135L is labeled as follows Do not perform MRI procedures on patients who have clips placed within their gastrointestinal tracts This could be harmful to the patient Additional information Olympus endo scopic clips have been shown to remain in the patient an average of 9 4 days but retention is based on a variety of factors and may result in a longer retention period Before MRI the physician should confirm that there are no residual clips in the gastrointestinal tract The following techniques may be used for confirmation 1 View the lesion under radiologic im aging Olympus clip fixing devices are radiopaque Using radiography the physician can determine whether any residual clips are in the gastro intestinal tract If no clips are evident AJR 191 October 2008 Screening Patients for MRI under radiologic imaging MRI may be performed 2 Endoscopically examine the lesion If no clips remain at the lesion MRI may be performed PillCam M2A Capsule Endoscopy Device The PillCam M2A Capsule Endoscopy Device Given Imaging is an ingestible device for use in the gastrointestinal tract Peristalsis moves the PillCam M2A Capsule smoothly and painlessly throughout the gastrointestinal tract transmitting color video images as it passes The procedure allows patients to continue daily activities d
39. rocedure should be performed using an MR system operating at a static magnetic field strength of 1 5 or 3 T only The safe use of an MR system operating at a lower or higher field strength for a patient with a Foley catheter with temperature sensor has not been determined Special instructions The position of the wire of the Foley catheter with temperature sensor has an important effect on the amount of heating that may develop during an MRI procedure Accordingly the Foley catheter with temperature sensor must be positioned in a straight configuration down the center of the patient table i e down the center of the MR system without any loop to prevent possible excessive heating associated with an MRI procedure Additional MRI safety instructions Additional safety instructions include the following 1 The Foley catheter with temperature sensor should not be connected to the temperature monitoring equipment dur ing the MRI procedure 2 If the Foley catheter with temperature sensor has a removable catheter con nector cable it should be disconnected before the MRI procedure 3 Remove all electrically conductive material from the bore of the MR system that is not required for the procedure e g unused surface coils cables 4 Keep electrically conductive material that must remain in the bore of the MR system from directly contacting the patient by placing thermal and electrical insulation including air betw
40. splacement that may be mild to moderate depending on the site of the body piercing and the ferromag netic qualities of the jewelry e g mass de gree of magnetic susceptibility In extreme cases serious injuries may occur In addi tion for body piercing jewelry made from electrically conducting material forming certain lengths or closed loops of a certain diameter there is the possibility of MRI re lated heating that could cause excessive tem perature increases and burns 12 14 Because of safety issues metallic body piercing jewelry should be removed before entering the MRI environment However patients or individuals with body piercing are frequently reluctant to remove their jew elry Therefore if it is not possible to remove metallic body piercing jewelry the patient or individual should be informed regarding the potential risks In addition if the body piercing jewelry is made from ferromag netic material some means of stabilization e g application of adhesive tape or ban dage should be used to prevent movement or displacement To prevent MRI related heat ing of body piercing jewelry made from con ductive materials e g the pierced body part will be in the area of the transmit RF coil gauze tape or other similar material should be used to wrap the jewelry in such a manner as to insulate it i e prevent contact as much as possible from the underlying skin 12 14 The patient should be instructed
41. to immedi ately inform the MR system operator if any heating or other unusual sensation is felt in association with the body piercing jewelry If this occurs scanning should be stopped immediately and steps should be taken to prevent possible patient injury Foley Catheter with Temperature Sensor MRI safety instructions The MRI safety instructions 14 for the Bardex Latex Free Temperature Sensing 400 Series Foley Catheter C R Bard Inc include the follow ing warning This product should never be connected to the temperature monitor or connected to a cable during an MRI procedure Failure to follow this guideline may result in serious injury to the patient Refer to Instructions for Use It is importantto closely follow these specific conditions that have been determined to permit the examination to be conducted safely Any deviation may result in a serious injury to the patient Nonclinical testing showed that these Foley catheters with temperature sensors are MR conditional A patient with one of these devices can be scanned safely immediately after placement under the following conditions e static magnetic field of 3 T or less with regard to magnetic field interactions e spatial gradient magnetic field of 720 G cm or less with regard to magnetic field interactions and e maximum MR system reported whole body averaged SAR of 3 5 W kg at 1 5 T or 3 W kg at 3 T for 15 minutes of scanning Importantly the MRI p
42. tromagnetic fields this per son must be screened using the same form and criteria applied to patients 12 14 For patient screening the process may be initiated when scheduling the examination Shellock and Spinazzi although this may not be possible in certain cases at that time it may be possible to determine whether the patient has an implant that may be potentially contraindicated or that requires special attention for the MRI procedure e g a ferromagnetic aneurysm clip pacemaker neurostimulation system or if the patient has an underlying condition that needs further consideration e g the patient is pregnant has a disability has a history of renal failure has a metallic foreign body Preliminary screening helps to prevent scheduling patients who may be inappropriate candidates for MRI Atthe MRI center the patient must undergo comprehensive screening in preparation for the MRI examination This preparation entails the use of the screening form to facilitate and to document the procedure a review of the information on the screening form and a verbal interview to verify the information and allow discussion of any questions or concerns that the patient may have The MRI safety trained health care worker must conduct these critical aspects of patient screening Additional detailed instructions for patient screening have been described previously 1 2 7 9 11 17 Importantly both the screening form designed
43. uring the endoscopic examination The PillCam M2A Capsule Endoscopy Device has been used to diagnose diseases of the small intestine including Crohn s disease celiac disease and other malabsorption disorders benign and malignant tumors of the small intestine vascular disorders and medication related small bowel injuries MRI safety information Undergoing MRI while the capsule is inside the patient s body may result in serious damage to his or her intestinal tract or abdominal cavity If the patient did not positively verify the excretion of the PillCam M2A Capsule Device he or she should contact the physician for evaluation and possible abdominal radiography before undergoing an MRI examination 12 14 Sleuth Implantable ECG Monitoring System The Sleuth Implantable ECG Monitoring System Sleuth IMD model 2010 Transoma Medical is an implantable patient activat ed and automatically activated monitoring system that records subcutaneous ECG and is indicated for patients with clinical syn dromes or at increased risk of cardiac ar rhythmias and patients who experience tran sient symptoms that may suggest a cardiac arrhythmia 12 14 MRI information This device is MR conditional at 1 5 T MRI The monitoring system does not need to be adjusted during MR scanning However MR scanning may cause electromagnetic interference that may cause the system to record ECG events MR scanning may also interfere with the quality
44. y bioef fects and patient management www mrisafety com Published 2001 Updated 2008 Accessed June 25 2008 Website for the Institute for Magnetic Resonance Safety Education and Research www IMRSER org Published 2001 2004 Updated 2008 Ac cessed 25 2008 Kanal E Barkovich AJ Bell C et al ACR Blue Ribbon Panel on MR Safety ACR guidance docu ment for safe MR practices 2007 AJR 2007 188 1447 1474 Sawyer Glover A Shellock FG Pre MRI proce dure screening recommendations and safety considerations for biomedical implants and de vices J Magn Reson Imaging 2000 12 92 106 Kuhl CK Traber F Schild HH Whole body high field strength 3 0 T MR imaging in clinical practice I Technical considerations and clinical applications Radiology 2008 246 675 696 Kuhl CK Tr ber F Gieseke J et al Whole body high field strength 3 0 T MR imaging in clini cal practice II Technical considerations and clinical applications Radiology 2008 247 16 35 Levine GN Gomes AS Arai AE et al Ameri can Heart Association Committee on Diagnostic and Interventional Cardiac Catheterization American Heart Association Council on Clinical Cardiology American Heart Association Coun cil on Cardiovascular Radiology and Interven tion Safety of magnetic resonance imaging in patients with cardiovascular devices an Ameri can Heart Association scientific statement from the Committee on Diagnostic and Interventional 2 pe 22
45. y be brought into or near the MRI envi ronment as well as in product labeling The icons may be reproduced in color or in black and white however the use of color is en couraged because of the added visibility The MR safe icon consists of the letters MR in green in a white square with a green border or the letters MR in white within a green square The MR conditional icon consists of the letters MR in black inside a yellow triangle with a black border The MR unsafe icon consists of the letters MR in black on a white field inside a red circle with a diagonal red band For MR conditional items the item labeling must include results of testing sufficient to characterize the behavior of the item in the MRI environment The new terminology is intended to help clarify matters related to biomedical im plants and devices to ensure the safe use of MRI technology Importantly as previously indicated this new terminology has not been applied retrospectively to implants and de vices that previously received FDA approved labeling using the terms MR safe or MR compatible Accordingly this should be un derstood to avoid undue confusion regard ing the matter of labeling for older versus newer implants To date relatively few im plants have the term MR conditional ap plied in comparison with those labeled using the previous labeling scheme MR safe and MR compatible 12 14 Informati
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