reducing unnecessary medical imaging...
TRANSCRIPT
Reducing Unnecessary Medical Imaging Exposure
U.S. Food and Drug AdministrationU.S. Food and Drug AdministrationCenter for Devices and Radiological HealthCenter for Devices and Radiological Health
April, 2010April, 2010
Initiative MotivationOver the past three decades, there has been an increase in the U.S. population’s total exposure to ionizing radiation, largely due to medical imaging.
(Source: National Council on Radiation Protection & Measurements. Report 160: Ionizing Radiation Exposure of the Population of the United States. March 3, 2009.)
Initiative ScopeIn 2006, the majority of medical imaging exposure was from CT, nuclear medicine, and interventional fluoroscopy.
(Source: National Council on Radiation Protection & Measurements. Report 160: Ionizing Radiation Exposure of the Population of the United States. March 3, 2009.)
Initiative Scope
High-dose medical imaging procedures– Computed tomography– Interventional fluoroscopy– Nuclear medicine
Initiative Goal
Each patient should get the right exam, Each patient should get the right exam, at the right time, with the right doseat the right time, with the right dose
Dose optimizationDose optimization–– Minimize the individualMinimize the individual’’s exposure to radiation for s exposure to radiation for
each exam while maintaining image qualityeach exam while maintaining image quality
Exam justificationExam justification–– Ensure that only medically necessary Ensure that only medically necessary
examinations are performedexaminations are performed
Initiative Overview
Promote Safe Use of Medical Imaging Promote Safe Use of Medical Imaging DevicesDevicesSupport Informed Clinical Decision Support Informed Clinical Decision MakingMakingIncrease Patient AwarenessIncrease Patient Awareness
Promote Safe Device Use
Establish safety requirements for CT Establish safety requirements for CT and fluoroscopic devicesand fluoroscopic devices–– Dose display, recording, reportingDose display, recording, reporting–– Access controlsAccess controls–– AlertsAlerts–– Optimized default settingsOptimized default settings–– Training for usersTraining for users
Promote Safe Device Use
Partner with CMS to enhance facility quality Partner with CMS to enhance facility quality assurance practicesassurance practices–– Refine accreditation criteria, interpretive Refine accreditation criteria, interpretive
guidelines and conditions of participationguidelines and conditions of participation–– Incorporate dose optimization and justificationIncorporate dose optimization and justification
Promote efforts to develop diagnostic Promote efforts to develop diagnostic reference levels locally and nationallyreference levels locally and nationally
Support Clinical Decision Making
Establish recordkeeping requirements for Establish recordkeeping requirements for CT and fluoroscopic devicesCT and fluoroscopic devices–– Linking dose information with patient recordsLinking dose information with patient records–– Transmission of imaging data to local or Transmission of imaging data to local or
national databasenational database–– Incorporation of exam ordering systemsIncorporation of exam ordering systems
Promote efforts to develop appropriate Promote efforts to develop appropriate referral criteriareferral criteria
Increase Patient Awareness
Provide patients with tools to track their Provide patients with tools to track their personal medical imaging historypersonal medical imaging history
Future State
A new medical center A new medical center is built in Californiais built in CaliforniaRadiology clinic Radiology clinic purchases a new CT purchases a new CT systemsystemGains accreditation to Gains accreditation to perform CT and other perform CT and other medical imaging medical imaging examsexams
Facility QA
Staff are trained to Staff are trained to properly use equipment properly use equipment and its dose reduction and its dose reduction featuresfeaturesThe facility routinely The facility routinely reviews data and reviews data and assesses dose protocols, assesses dose protocols, taking action to ensure taking action to ensure exams are justified and exams are justified and that dose is optimizedthat dose is optimized
Patient awareness
Patients and their Patients and their caregivers come for caregivers come for exams with a medical exams with a medical imaging history card imaging history card in hand in hand Staff are trained to Staff are trained to discuss risks and discuss risks and benefits of medical benefits of medical imaging procedures imaging procedures and answer patient and answer patient questionsquestions
Equipment features
A hospital exam ordering A hospital exam ordering system evaluates system evaluates appropriateness of the appropriateness of the exam before it beginsexam before it begins–– Based on referral criteria Based on referral criteria
established by facility, established by facility, medical professional medical professional organizationsorganizations
Imaging protocols and Imaging protocols and settings are reviewed in settings are reviewed in advanceadvance–– System requires System requires
verification of settings, verification of settings, controls access to changes controls access to changes and tracks modifications and tracks modifications made by staffmade by staff
Equipment features
The system automatically The system automatically retrieves information from retrieves information from hospital data systems hospital data systems and/or other dose registryand/or other dose registry–– Verifies that settings and Verifies that settings and
dose are within expected dose are within expected rangerange
–– Alerts users when outside Alerts users when outside the range or if the patient the range or if the patient recently had another recently had another medical imaging exammedical imaging exam
Equipment features
During each exam, During each exam, the system the system automatically collects automatically collects imaging settings and imaging settings and dose datadose data–– Transmits data to Transmits data to
hospital PACS system, hospital PACS system, the patientthe patient’’s electronic s electronic health record and a health record and a National Dose National Dose RegistryRegistry
Questions
More information at:More information at:http://www.fda.gov/Radiationhttp://www.fda.gov/Radiation--EmittingProducts/RadiationSafety/RadiationDoseReduction/ucm19990EmittingProducts/RadiationSafety/RadiationDoseReduction/ucm199904.htm4.htm