## Computed Tomography / Nuclear Medicine Accessibility for **Diagnostic Medical Equipment** U.S. Access Board May 8, 2012 Atlanta, Georgia 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 **Computed Tomography / Nuclear Medicine**  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 diagno stic data for all patients for the area of interest in the head and body that are within the capabilities of the system **Computed Tomography (CT)**  X- Ray tube rotates around the patient. Multiple images tak en 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 **CT Systems** [Photo: O verall view of CT system/equipment.] [Photo: T ilting gantry of CT system.]**Nuclear Medicine PET/CT Scanner**

[Photo: V iew looking down on a Nuclear Medicine PET/CT Scanner with two medical staff people assi sting a patient during a sca n .] [Photo: Overall view of Nuclear Medicine PET/CT Scanner .] **General Nuclear Medicine, SPECT/CT** [Photo: O verall view of a SPECT /CT scanner .] **General Nuclear Medicine / SPECT**  General Nuclear Medicine accessible via: o Wheelchair o Seated o Standing o Gurney/bed [Photo: Woman sitting while undergoing a SPECT scan . Equipment scanner is positioned against her back] [Photo: Man in a wheelchair undergoing a SPECT scan . E quipment scanner is positioned against the front of his upper body.] [Photo: Woman lying on a gurney undergoing a SPECT scan . E quipment scanner is positioned horizontally above her body [ Slide of CT scans in 2
- dimensional, 3
- dimensional and planar viewing modes ] [Series of CT scan images consisting of a planar view of the cerebral/ brain vasculature, 3
- d images of the heart (side and front views), coronary vessels, and a planar and a cross sectional views of a chest. ] [Slide of a series CT images showing different vasculature and skeletal structures from a single scan, CT angiography] [Series of CT scan images: F irst image shows a patient with most of the skeletal anatomy removed to better demonstrate the chest, abdomen and lower extremity vasculature. T he second and third images show the abdomen from t he posterior projection followed by a view of the femoral arteries and surrounding vasculature and includes the skeletal anatomic structures] **Clinical Use of Equipment**  Equipment cannot be used independently by patient o Access must be through physician order or prescription (not used for routine, periodic, asymptomatic screening types of scans) o Technologist always present for the study. Discusses examination with the patient, assesses ability of the patient to complete the study, assists inplacement a nd 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 **Technical Criteria**  CT, MR, PET, SPECT, P ET/CT, SPECT/CT, PET/MR Scanners o M301 Supine, prone, or side
- lying position o M305.2 Transfer Supports o M306 Communication, 2 methods: audible, visible or tactile  General Nuclear Medicine Scanners o M301 Lying, M302 Seated, M 303 Wheelchair, M304 Standing o M305.2 Transfer Support o M305.3 Standing Support o M306 Communication, 2 methods: audible, visible or tactile  M307 Operable Parts o Does not apply **Typical Features of Current Systems**  Features of current design o Long c ouch/table for patient to lay on during diagnostic scans o Patient transfer from gurney to couch is very common o Couch vertical motion for patient load and imaging o Wide variety of patient positioning pads and straps o Patient Lift compatibility o Interc om system between the patient and technologist o Window between scan control room and scan room o Ability to conduct scan in
- room by technologist **Technical Considerations**  Transfer Surface Height o Structural and drive components in base of table  Transfer Supports o Design standards require safety factors of x4 to x12 for patient supports o May impact clinical utility or broader access Functionality, features, and clinical utility of scanners must be maintained with any new requirements **Patient Li fts**  [Illustration: D rawing shows a portable patient lift being use d to transfer a man to an examtable. Two medical staff people have positioned the support legs and casters of the lift

around the base of the table and prepare to lower the man onto the e xamination surface.] [Illustration: D rawing shows an overhead ceiling mounted patient lift being use to transfer a woman to an exam table. Two medical staff people assist as they prepare to lower the woman onto the examination surface.] **Patient Transfer** [Photo: Three medical staff people assist with the lateral transfer of a patient from a gurney using a transfer board.] **Facility 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 custo m facility room layout could incorporate patient lifts, accommodate patient mobility devices, etc. [Slide of CT workstation layout] [Illustration: P lan drawing of a CT scanner room and adjoining control area and equipment room. Aspace is shown, repres ented by a dashed line, shows the minimum envelope for the CT equipment to function properly.] **Patient Communication**  Intercom  Window between control & scan rooms  X- Ray On visual and audible indicators  Voice Commands  Breathing Lights/timers [Phot o: Two medical technicians are shown looking at monitors as a patient undergoes a scan . ] **Patient Breathing Lights**  Inhale  Hold with count
- down timer and progress bar  Exhale  Demo Mode [Photo: C lose up view of a breathing light display indicating four seconds left to hold in breath.]**Training**

 Onsite training using customer installed equipment o 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 **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 **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 **Considerations**  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  Manufacturers are eager to participate on the Advisory Committee and offer their expertise in the development of this standard **Future Opportunities**  As technology continues to advanc e, 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 d esign inputs for continuous improvements to products, services and accessories  Manufacturers are committed to providing safe and effective equipment, and welcome the opportunity to participate in standards development with the Access Board**Appendix**

U.S. Access Board Accessibility for Diagnostic Medical Equipment [Slide of several CT images] [Photo: S can of step and shoot gated aorta] [Photo: S can of renal arteries of the kidney] **General Nuclear Medicine / SPECT** [Photo: M edical staff person conducts a SPECT scan of a woman on a gurney. ] [Slide of SPECT scanner equipment] [Photo: o verall view of a SPECT scanner] **Patient Lifts** [Photo: O verall view of a portable floor lift ] [Photo: Overall view of a portable overhead track lift ] **Patient Posit ioning Aids**  [Photos: Aseries of images showing patient positioning cuffs, mats, wedges transfers sheets, and tape.] **Site Layout** [Illustration: P lan drawing of a workstation/scanner equipment area. T he drawing indicates that the technician has visual c ontact with the patient from the control room and that a 2
- way intercom, breathing lights, and voice commands are available.]