1. U.S. Access Board Accessibility for Diagnostic Medical Equipment Computed Tomography / Nuclear Medicine May 8, 2012 John Jaeckle GE Healthcare Chief Regulatory Affairs Strategist MITA – Chair, CT Group MITA - Co-Chair MI Dose Task Force Chair of IEC MT-30 – CT safety and performance standards. Eduard Toerek Philips Healthcare Director, Quality & Regulatory CT/NM Imaging Systems MITA – Vice Chair, CT Group May 8, 20121

2. United States Access Board  Goal has long been and continues to be to ensure access to diagnostic equipment for all patients.  Prescription only devices, must be cleared by FDA  Clinical objective of a study is to acquire diagnostic data for all patients for the area of interest in the head and body that are within the capabilities of the system

3. Computer Tomography (CT) –X-Ray tube rotates around the patient. Multiple images taken from different angles are combined to create detailed cross-sectional images. Nuclear Medicine/Multi-Modality –Nuclear Imaging includes PET and SPECT, Multi-modalities also exist for nuclear imaging which include combinations of PET/CT, PET/MR, or SPECT/CT –PET/CT is primarily used to diagnose, stage and monitor cancerous growths and metastases, SPECT and SPECT/CT is primarily for cardiac studies with a growing presence in early cancer detection; both modalities are used in neurology applications May 8, 20123 Patient are always assisted by trained staff during entire study – patient preparation for injections, entering the exam room, placement/positioning and removal from table, and exiting the exam room.

4. CT Systems May 8, 2012 Tilting Gantry 4

5. Nuclear Medicine PET/CT Scanner May 8, 20125

6. General Nuclear Medicine, SPECT/CT May 8, 20126

7. General Nuclear Medicine / SPECT  General Nuclear Medicine accessible via: –Wheelchair –Seated –Standing –Gurney/bed

10. Clinical Use of Equipment  Equipment cannot be used independently by patient –Access must be through physician order or prescription (not used for routine, periodic, asymptomatic screening types of scans) –Technologist always present for the study. Discusses examination with the patient, assesses ability of the patient to complete the study, assists in placement and positioning of the patient on the table and patient preparation for oral and IV injections of contrast material. Often comes into the scan room between series to check patient and reassure them.  Equipment designed to effectively image patients of all ages and sizes (up to table weight capacity/bore size)  Designed for virtually all situations including critical care, limited mobility patients, trauma/emergency room cases, unconscious & seriously ill patients May 8, 201210

11. Technical Criteria  CT, PET, SPECT, PET/CT, SPECT/CT, PET/MR Scanners –M301 Supine, prone, or side-lying position –M305.2 Transfer Supports –M306 Communication, 2 methods: audible, visible or tactile  General Nuclear Medicine Scanners –M301 Lying, M302 Seated, M303 Wheelchair, M304 Standing –M305.2 Transfer Support –M305.3 Standing Support –M306 Communication, 2 methods: audible, visible or tactile  M307 Operable Parts –Does not apply May 8, 201211

12. Typical Features of Current Systems  Features of current design –Long couch/table for patient to lay on during diagnostic scans –Patient transfer from gurney to couch is very common –Couch vertical motion for patient load and imaging –Wide variety of patient positioning pads and straps –Gantry tilt for patient positioning –Patient Lift compatibility –Intercom system between the patient and technologist –Window between scan control room and scan room –Ability to conduct scan in-room by technologist May 8, 201212

13. Technical Considerations  Transfer Surface Height –Structural and drive components in base of table  Transfer Supports –Design standards require safety factors of x4 to x12 for patient support –May impact clinical utility or broader access May 8, 201213 Avoid requirements that would compromise the functionality, features, and clinical utility of the scanners.

14. Patient Lifts May 8, 2012 Ref. Americans with Disabilities Act / Access to Medical Care for Individuals with Mobility Disabilities 14

15. Patient Transfer May 8, 2012 Ref. Americans with Disabilities Act / Access to Medical Care for Individuals with Mobility Disabilities 15

16. Siting Requirements  Large capital equipment  Fixed installation (not portable)  Room layout can require up to 400 sq. ft. or more  Scan room limitations, shielding requirements  ADA requirements are considered during site layout and planning  Optional custom facility room layout could incorporate patient lifts, accommodate patient mobility devices, etc. May 8, 201216

18. Patient Communication  Intercom  Window between control & scan rooms  X-Ray On visual and audible indicators  Voice Commands  Breathing Lights/timers

19. Patient Breathing Lights  Inhale  Hold with count- down timer and progress bar  Exhale  Demo Mode

20. Training –Onsite training using customer installed equipment Patient handling & positioning –Instructor-led classroom training at manufacturer’s training center –RT Certification/registration training includes training modules on proper patient handling/transfer –User facility based training in support of their required patient transfer protocols and procedures May 8, 201220

21. Other Standards  Application of existing Standards (IEC, ISO, AAMI Usability/Human Factors standards)  AAPM TG66 Positional Accuracy Requirements  21 CFR 1020.30 General X-Ray & 1020.33 Computed Tomography Equipment  IEC 60601-1-6 / 62366 Usability  IEC 60601-2-44 Particular requirements for the safety of X-Ray equipment for computed tomography May 8, 201221

22. Transition Time for Design Changes –Design changes require adherence to regulatory Design Controls and Verification & Validation (V&V) –Design changes to subassemblies are typically multi- year projects, and even longer for complete system redesign –Design changes incur significant up front investment which drives up the cost of re-designed medical equipment May 8, 201222

23. Recommendations  New requirements to be applicable to forward production only, field retro-fit and refurb may not be feasible  Communication via 2 methods is supportable  Enhance site planning guides with ADA and Access Board considerations  Other technical criteria should be relaxed or exempted for large/complex fixed equipment, not used for ambulatory screening, requires healthcare professional assistance, and is a prescription only device NOT for independent use May 8, 201223

24. Future Opportunities  As technology continues to advance, manufacturers continually incorporate features and capabilities to improve the patient experience & accessibility while optimizing and advancing the diagnostic capabilities of the equipment for all patients.  Feedback from clinicians is used as system design inputs for continuous improvements to products, services and accessories. May 8, 201224

25. APPENDIX U.S. Access Board Accessibility for Diagnostic Medical Equipment

26. Step & Shoot Gated AortaCTA of Renal Arteries of the kidney

27. General Nuclear Medicine / SPECT May 8, 201227

29. Patient Lifts May 8, 201229

30. Site Layout May 8, 201230 Breathing Lights & Voice Commands 2-way intercom Visual contact with patient

31. Patient Positioning Aids May 8, 201231