1. ©ECRI 2007 1 XXVI. Imaging Equipment TRAINING SEMINAR ON MEDICAL DEVICE ACCIDENT INVESTIGATION for Kingdom of Saudi Arabia Saudi Food & Drug Authority Riyadh 11-14 February, 2007 Presenter: Mark E. Bruley Vice President, Accident and Forensic Investigation ECRI 5200 Butler Pike, Plymouth Meeting, PA, 19642 USA Tel: +1 610-825-6000, ext. 5223 E-mail: mbruley@ecri.org Web Sites: www.ecri.org www.mdsr.ecri.org

2. ©2007 ECRI 2 Imaging Equipment Common Cause of Accidents in RS Mechanical Failures with RS MR Environment Accidents

3. ©2007 ECRI 3 Common Cause of Accidents Radiology Systems Overuse Abuse Poor/inadequate maintenance

4. ©2007 ECRI 4 Mechanical Failures Radiology Systems Carriage Supports Table Footrest Falling parts Impacts

5. ©2007 ECRI 5 Hazards in the MR Environment Projectile effect Torque Burns Image artifacts Support device malfunctions

6. ©2007 ECRI 6 Projectile Effect MR system O cylinder 2

7. ©2007 ECRI 7 Projectiles we have seen: Oxygen cylinders Forklift parts Chairs IV poles Ladders Scissors Infusion pumps Oscilloscopes Pens Pillows Pulse Oximeters Laundry Carts Handguns Sandbags Stethoscopes Hand tools Floor Buffers Hair barrettes

8. ©2007 ECRI 8 Torque Problems Magnetic implants Tiny magnetic particles

9. ©2007 ECRI 9 Burns Coiled or looped devices. Pulse oximeter sensors ECG electrodes Tattoos and cosmetic tattoos Implantable infusion pumps Nitroglycerin patches Metal-containing tissue expanders Pacing electrodes Contact with bore walls or RF coils

10. ©2007 ECRI 10 Image Artifact Reference: Patola W, Coulter B. MRI Artifacts [online]. 1997 Sep. Available from Internet: http://www1.stpaulshosp.bc.ca/stpaulsstuff/MRart/Belt.html.http://www1.stpaulshosp.bc.ca/stpaulsstuff/MRart/Belt.html Metal-studded belt during a coronal T1-weighted abdominal scan

11. ©2007 ECRI 11 Device Malfunctions Reference: Kaut-Roth, C. MRI Safety [online]. 1996. Available from Internet: http://www.t2star.com/safety_1/MR_Safety.pdf.http://www.t2star.com/safety_1/MR_Safety.pdf Note increase in the T-wave or ST- segment amplitude. Static Field Effects on ECG

12. ©2007 ECRI 12 Device Malfunctions Pacemakers Mimicking of physiologic signals Analog gauges Electric motors Electronic circuits Implanted devices Magnetically attached device ECG waveforms

13. ©2007 ECRI 13 Look for the label MR Safe MR Compatible

14. For Safety Information... Refer to the December 2001 Health Devices article, “The Safe Use of Equipment in the Magnetic Resonance Environment.” Visit the following Web sites: –www.fda.gov/cdrh/safety/mrisafety.html –www.mrisafety.com –www.radiology.upmc.edu/Mrsafety/

15. ©2007 ECRI 15 QUESTIONS? XXVI. Imaging Equipment