Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery · 2014
MRI information for commonly used otologic implants: review and update.
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Azadarmaki Roya, Tubbs Rhonda, Chen Douglas A, Shellock Frank G
Аннотация
OBJECTIVE: To review information on magnetic resonance imaging (MRI) issues for commonly used otologic implants.
DATA SOURCES: Manufacturing companies, National Library of Medicine's online database, and an additional online database (www.MRIsafety.com).
REVIEW METHODS: A literature review of the National Library of Medicine's online database with focus on MRI issues for otologic implants was performed. The MRI information on implants provided by manufacturers was reviewed.
RESULTS: Baha and Ponto Pro osseointegrated implants' abutment and fixture and the implanted magnet of the Sophono Alpha 1 and 2 abutment-free systems are approved for 3-Tesla magnetic resonance (MR) systems. The external processors of these devices are MR Unsafe. Of the implants tested, middle ear ossicular prostheses, including stapes prostheses, except for the 1987 McGee prosthesis, are MR Conditional for 1.5-Tesla (and many are approved for 3-Tesla) MR systems. Cochlear implants with removable magnets are approved for patients undergoing MRI at 1.5 Tesla after magnet removal. The MED-EL PULSAR, SONATA, CONCERT, and CONCERT PIN cochlear implants can be used in patients undergoing MRI at 1.5 Tesla with application of a protective bandage. The MED-EL COMBI 40+ can be used in 0.2-Tesla MR systems. Implants made from nonmagnetic and nonconducting materials are MR Safe.
CONCLUSION: Knowledge of MRI guidelines for commonly used otologic implants is important. Guidelines on MRI issues approved by the US Food and Drug Administration are not always the same compared with other parts of the world.
IMPLICATIONS FOR PRACTICE: This monograph provides a current reference for physicians on MRI issues for commonly used otologic implants.
DATA SOURCES: Manufacturing companies, National Library of Medicine's online database, and an additional online database (www.MRIsafety.com).
REVIEW METHODS: A literature review of the National Library of Medicine's online database with focus on MRI issues for otologic implants was performed. The MRI information on implants provided by manufacturers was reviewed.
RESULTS: Baha and Ponto Pro osseointegrated implants' abutment and fixture and the implanted magnet of the Sophono Alpha 1 and 2 abutment-free systems are approved for 3-Tesla magnetic resonance (MR) systems. The external processors of these devices are MR Unsafe. Of the implants tested, middle ear ossicular prostheses, including stapes prostheses, except for the 1987 McGee prosthesis, are MR Conditional for 1.5-Tesla (and many are approved for 3-Tesla) MR systems. Cochlear implants with removable magnets are approved for patients undergoing MRI at 1.5 Tesla after magnet removal. The MED-EL PULSAR, SONATA, CONCERT, and CONCERT PIN cochlear implants can be used in patients undergoing MRI at 1.5 Tesla with application of a protective bandage. The MED-EL COMBI 40+ can be used in 0.2-Tesla MR systems. Implants made from nonmagnetic and nonconducting materials are MR Safe.
CONCLUSION: Knowledge of MRI guidelines for commonly used otologic implants is important. Guidelines on MRI issues approved by the US Food and Drug Administration are not always the same compared with other parts of the world.
IMPLICATIONS FOR PRACTICE: This monograph provides a current reference for physicians on MRI issues for commonly used otologic implants.
Предметные рубрики MeSH
Auditory Brain Stem ImplantsCochlear ImplantationCochlear ImplantsEar, MiddleFemaleHearing LossHumansMagnetic Resonance ImagingMaleOssicular ProsthesisPractice Guidelines as TopicProstheses and ImplantsProsthesis ImplantationRisk AssessmentSafety ManagementUnited StatesUnited States Food and Drug Administration