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