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 diagnostic 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 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 

CT Systems

[Photo: Overall view of CT system/equipment.]

[Photo: Tilting gantry of CT system.]
Nuclear Medicine PET/CT Scanner

[Photo: View looking down on a Nuclear Medicine PET/CT Scanner with two medical staff 

people assisting a patient during a scan.]

[Photo: Overall view of Nuclear Medicine PET/CT Scanner.]

General Nuclear Medicine, SPECT/CT

[Photo: Overall 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. Equipment scanner is positioned 

against the front of his upper body.]

[Photo: Woman lying on a gurney undergoing a SPECT scan. Equipment 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 across 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: First image shows a patient with most of the skeletal anatomy 

removed to better demonstrate the chest, abdomen and lower extremity vasculature. The 

second and third images show the abdomen from the 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 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

Technical Criteria

 CT, MR, PET, SPECT, PET/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, M303 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 couch/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 Intercom 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 Lifts

[Illustration: Drawing shows a portable patient lift being used to transfer a man to an exam 
table. 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 examination surface.]

[Illustration: Drawing 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 custom facility room layout could incorporate patient lifts, accommodate 

patient mobility devices, etc. 

[Slide of CT workstation layout]

[Illustration: Plan drawing of a CT scanner room and adjoining control area and equipment 

room. A space is shown, represented 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

[Photo: 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: Close 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 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

 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: Scan of step and shoot gated aorta]

[Photo: Scan of renal arteries of the kidney]

General Nuclear Medicine / SPECT

[Photo: Medical staff person conducts a SPECT scan of a woman on a gurney. ]

[Slide of SPECT scanner equipment]

[Photo: overall view of a SPECT scanner]

Patient Lifts

[Photo: Overall view of a portable floor lift]

[Photo: Overall view of a portable overhead track lift]

Patient Positioning Aids

[Photos: A series of images showing patient positioning cuffs, mats, wedges transfers sheets, 

and tape.]

Site Layout

[Illustration: Plan drawing of a workstation/scanner equipment area. The drawing indicates 

that the technician has visual contact with the patient from the control room and that a 2-way 

intercom, breathing lights, and voice commands are available.]