ASTM_F_2978_-_13.pdf

Designation:F297813Guide toOptimize Scan Sequences for Clinical Diagnostic Evaluationof Metal-on-Metal Hip Arthroplasty Devices using MagneticResonance Imaging1This standard is issued under the fixed designation F2978;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This guide describes the recommended protocol formagnetic resonance imaging(MRI)studies of patients im-planted with metal-on-metal(MOM)devices to determine ifthe periprosthetic tissues are likely to be associated with anadverse local tissue reaction(ALTR).Before scanning a patientwith a specific implant,the MR practitioner shall confirm thatthe device is MR Conditional and that the scan protocol to beused satisfies the conditions for safe scanning for the specificimplant.This guide assumes that the MRI protocol will beapplied to MOM devices while they are implanted inside thebody.It is also expected that standardized MRI safety measureswill be followed during the performance of this scan protocol.1.2 This guide covers the clinical evaluation of the tissuessurrounding MOM hip replacement devices in patients usingMRI.This guide is applicable to both total and resurfacingMOM hip systems.1.3 The protocol contained in this guide applies to wholebody magnetic resonance equipment,as defined in section2.2.103 of IEC 60601-2-33,Ed.3.0,with a whole bodyradiofrequency(RF)transmit coil as defined in section 2.2.100.The RF coil should have quadrature excitation.1.4 The values stated in SI units are to be regarded asstandard.1.5 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.The user mayconsider all precautions and warnings provided in the MRsystem and hip implant labeling prior to determining theapplicability of these protocols.2.Referenced Documents2.1 ASTM Standards:2A340 Terminology of Symbols and Definitions Relating toMagnetic TestingF2503 Practice for Marking Medical Devices and OtherItems for Safety in the Magnetic Resonance Environment2.2 IEC Standard:3IEC 60601-2-33,Ed.3.0 Medical Electrical EquipmentPart 2:Particular Requirements for the Safety of MagneticResonance Equipment for Medical Diagnosis,20103.Terminology3.1 DefinitionsFor the purposes of this standard thefollowing definitions shall apply:3.1.1 Magnetic Resonance Imaging(MRI)diagnostic im-aging technique that uses static and time varying magneticfields to provide tomographic images of tissue by the magneticresonance of nuclei.3.1.2 MR-Conditionalan item that has been demon-strated to pose no known hazards in a specific MR environmentwith specified conditions of use.Field conditions that definethe specified MR environment include field strength,spatialgradient,dB/dt(time rate of change of the magnetic field),radiofrequency(RF)fields,and specific absorption rate(SAR).Additional conditions,including specific configurations of theitem,may be required(Practice F2503).3.1.3 Metal-on-Metal(MOM)hip replacementa hip ar-throplasty device in which the articulating surfaces of thefemoral head and the acetabular cup are fabricated from metal.4.Summary of Protocol4.1 Surface coil fast spin echo(FSE)sequences of theaffected hip in three planes and a larger field-of-view(FOV)short tau inversion recovery(STIR)sequence to include both1This guide is under the jurisdiction of ASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.22 on Arthroplasty.Current edition approved Dec.1,2013.Published May 2014.DOI:10.1520/F2978-13.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.3Available from International Electrotechnical Commission(IEC),3,rue deVaremb,P.O.Box 131,CH-1211 Geneva 20,Switzerland,http:/www.iec.ch.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 hips and the surrounding pelvis are recommended.A largeFOV sequence of the entire pelvis should be included to assessfor remote causes of pain,such as pelvic or sacral fractures,which may be referred to the hip.4.2 With regards to the FSE surface coil imaging,anintermediate echo time,water-sensitive fast spin echo tech-nique is effective in highlighting osteolysis and detectingwear-induced synovitis.The fluid-sensitive inversion recoverysequence helps outline fluid collections and will demonstratethe presence of marrow edema in the setting of implantloosening or peri-prosthetic frac