U.S. Access BoardAccessibility for Diagnostic Medical

Equipment

Computed Tomography / Nuclear Medicine

May 8, 2012John JaeckleGE HealthcareChief Regulatory Affairs StrategistMITA – Chair, CT GroupMITA - Co-Chair MI Dose Task ForceChair of IEC MT-30 – CT safety and performance standards.

Eduard ToerekPhilips HealthcareDirector, Quality & RegulatoryCT/NM Imaging SystemsMITA – Vice Chair, CT Group

May 8, 2012 1

United States Access BoardGoal 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

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

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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.

CT Systems

May 8, 2012

Tilting Gantry

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Nuclear Medicine PET/CT Scanner

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General Nuclear Medicine, SPECT/CT

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General Nuclear Medicine / SPECT

General Nuclear Medicine accessible via:– Wheelchair– Seated– Standing– Gurney/bed

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

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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

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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

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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

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Avoid requirements that would compromise the functionality, features, and clinical utility of the scanners.

Patient Lifts

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Ref. Americans with Disabilities Act / Access to Medical Care for Individuals with Mobility Disabilities

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Patient Transfer

May 8, 2012

Ref. Americans with Disabilities Act / Access to Medical Care for Individuals with Mobility Disabilities

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Siting Requirements Large capital equipmentFixed installation (not portable)Room layout can require up to 400 sq. ft. or

moreScan room limitations, shielding requirementsADA requirements are considered during site

layout and planningOptional custom facility room layout could

incorporate patient lifts, accommodate patient mobility devices, etc.

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Patient Communication

Intercom Window between

control & scan rooms

X-Ray On visual and audible indicators

Voice Commands Breathing

Lights/timers

Patient Breathing Lights

InhaleHold with count-

down timer and progress bar

Exhale

Demo Mode

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

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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

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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

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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

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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.

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APPENDIX

U.S. Access BoardAccessibility for Diagnostic Medical Equipment

Step & Shoot Gated Aorta CTA of Renal Arteries of the kidney

General Nuclear Medicine / SPECT

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Patient Lifts

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Site Layout

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Breathing Lights & Voice Commands

2-way intercom

Visual contact with patient

Patient Positioning Aids

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