aapm 2012 summer school on medical imaging using ionizing ... · sb-p 28 ceiling track location....

AAPM 2012 Summer School on Medical Imaging using Ionizing Radiation

SB-P 1

Fluoroscopy/Interventional Laboratory Design

and Equipment Specification

Stephen Balter, Ph.D.Professor of Clinical Radiology (Physics) (in Medicine)

Columbia University, New York


SB-P 2

Disclosures

Nothing to disclose


SB-P 33

Disclaimer• This lecture can not be given without equipment photos

and supplier materials. (my photos or from the web) – General Electric– Philips– Siemens– Toshiba

• The use of these photographs and other materials does not imply either endorsement or criticism of any specific equipment or manufacturers.


SB-P 44

Notes:

• This presentation focuses on fixed C-arm systems designed for interventional procedures.

• Most of the material is also applicable to other forms of fluoroscopic equipment.

• Special safety issues apply to systems with the X-ray tube located above the patient.

• NCRP Report 168 is a useful reference and resource.


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Types of fluoro equipment

• Interventional*• Multi-purpose

– Urology

• Conventional GI• Mobile


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Departmental considerations• Fluoro labs seldom exist in isolation,

departmental workflow is critical.• How does the proposed room fit into departmental

and facility architecture?• What will the room be used for?

Have you observed such procedure(s)?

• What other equipment is likely to be installed in the lab or department?

• What is the planned and potential maximum workload?


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A prospective client


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Interventional room use

• Sample broad classifications– Coronary diagnosis and intervention– Electrophysiology diagnosis and intervention– Interventional radiology– Neuroradiology– Hybrid: fluoroscopy + operating room

• Expected patient population– Adult– Pediatric– Both


SB-P 99

Procedure room requirements

• What clinical uses are anticipated• Staffing levels• Architecture• Necessary equipment• Radiation shielding design• Radiation protection details


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Space requirements

• Procedure room• Control room• Local equipment space• Other equipment space• Clinical support space


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Hybrid operating room


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Reality (trans-catheter aortic valve)


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Some other items to consider

• STORAGE• WORKTABLES• Anesthesia• Contrast delivery• Secondary imaging• Patient life support• Treatment devices• Procedure support equipment


SB-P 1414

Ample space is important


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Environment

• Adjacent spaces (shielding design)• Patient flow in department and hospital• Staff and material flow in department• Power and other utilities.• Dedicated medical physics space


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Architectural plans (prelim & final)

• Preliminary– Facility plans by architect (including adjacent).– Potential vendors have typical plans; these include

minimum and recommended architectural requirements.

– Are there incompatibilities?

• Semi – Final– Integrated facility and vendor drawings– Floor and ceiling construction specifications– Lighting layout– Doors and windows


SB-P 1717

Interventional radiology laboratory


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Cardiovascular laboratory


SB-P 1919

Hybrid operating room


SB-P 2020

Shielding design

• Regulatory limits are typically 50 mSv/y for workers and 1 mSv/y for others.– A design goal of 1 mSv/y

outside the lab is often achieved with 1.5 mm (1/16 in) Pb.

– Thinner shielding does not save much after installation costs are considered.

– Thin low-density concrete floors and ceilings may be a problem.


SB-P 2121

Walls

• Required shielding should extend at least 7 feet above the finished floor.– For labs with raised control-room floors, this is based on

the height of the control-room floor.– Consider floor-ceiling shielding for isocentric systems.

• Wall penetrations often require additional shielding.– As many wall penetrations as possible should be at least

7 feet above the finished floor.– Wall penetrations above 7 feet may not require

additional shielding


SB-P 2222

Construction checks


SB-P 2323

Floors

• Calculated concrete thickness must be based on the specified concrete density with due allowance for conduit diameters and trough dimensions.

• Adding lead to the bottom of junction boxes and troughs is often prudent.


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Doors and windows

• Shielded doors are heavy.– Consider unshielded doors if there is no line-of-sight between

the x-ray field at the patient and the door.

• Windows– Large control room windows are necessary.– Shielding should match the surrounding wall.


SB-P 2525

Doors (operational)

• Door swing direction should be based primarily on fire-safety considerations.

• Door swing direction can contribute to radiation shielding when the door is open.

• Door interlocks can interrupt procedures at critical times. – Do not install unless absolutely necessary.

(NCRP-168 shall not for interventional rooms)– Fluoroscope must have an X-ray disable function.– X-ray warning lights are needed (inside and out)


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Ancillary radioprotective devices

• Table-side shields• Eye shields• Mobile shields• Warning lights• Required interlocks• Radiation disable control.


SB-P 2727

Staff in-lab shielding

• In many cases fixed or mobile shielding will help minimize worker irradiation.– In-lab physiological monitoring– Anesthesia

• When practicable in-lab shielding is preferable to total reliance on personal radioprotective garments.(NCRP-168 recommendation)


SB-P 2828

Ceiling track location


SB-P 2929

Workloads

• NCRP estimated workloads for a ‘busy’ facility are a good starting point.

• Heavy workloads usually occur when a lab is in use for more than 8 hours/day.Consider actual staff working hours

• Actual workloads may be available in the next few years as a byproduct of patient dose reporting.


SB-P 3030

Use factors

• Pure fluoroscopic rooms typically apply a use factor of 1.0 for all barriers.– Primary beam is always totally intercepted by

the image receptor assembly– All barriers are therefore secondary barriers

• Classical design is based on the same scatter intensity at 1 m in all directions.– Instantaneous scatter intensity at any barrier actually

changes with changes in gantry angle.– Classical design rules have sufficient safety margins

to absorb this variability.


SB-P 3131

Occupancy factors

• Standard NCRP-149 public occupancy factors (or greater) should be used for all adjacent spaces.– Present or potential offices should have a public

occupancy of 1.0

• Control room occupancy = 1.0 (public)– Avoids keeping track of radiation status of individuals

in control rooms. Some may be present for extended periods of time.

– Requires protected access to control room.


SB-P 3232

Radiation protection workflow

• Initial planning and review• Visual inspection during construction.

– Materials– Workmanship– Penetrations

• Preliminary scan for shielding integrity.– 99mTc preferred– Missing shielding (around penetrations).

• Formal testing with installed equipment and an appropriate scatterer.


SB-P 3333

Equipment requirements

• Fluoroscopic System• Radiation Protection Components• Other Equipment in Lab• Audio and Video• Informatics


SB-P 3434

Economics 001

• Not included– Construction and shielding– Ancillary equipment– Infrastructure– Labor (physician and support staff)

Item Simple DX Simple RX Aortic ValveEquipment and lifetime 1,000,000

10 y1,000,000

10 y2,000,000

5 yService at 10%/y over life of equipment

1,000,000 1,000,000 1,000,000

Procedures over life of equipment 10,000 10,000 5,000X-ray cost per procedure 200 200 600

Consumables cost per procedure 300 3,000 30,000


SB-P 3535

General considerations

• Geometry– Single plane, biplane, or robotic

• Construction– Image receptor type and size– Generator and control hardware often ‘universal’– Table and X-ray tube may be procedure type specific

• Applicable standards– All: IEC 60601-2-54– Interventional: Also IEC 60601-2-43– Hopefully NEMA XR-24 (user interface)


SB-P 3636

Pediatric patients

• Will the lab be used for pediatrics?• Hardware considerations

– Mechanical size and motion– Grid removal

• Configuration considerations– Pediatric specific programming

• Additional patient protective devices


SB-P 3737

Staff and other equipment in lab

• Staff– Minimum– Typical– Busy Case

• Equipment– Physiological monitors– Life support devices– Ancillary imaging devices– Informatics devices


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Audio and video

• Intercoms• Wired telcom• Wireless telcom• Data networks (wired and wireless)• Display of local video• Display of remote video• Real-time audio and video export


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Informatics

• Electronic Medical Record• Clinical Monitoring System• PACS• Dose Reporting (soon)• Value added processing


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Lighting


SB-P 4141

Lighting conflict


SB-P 4242

Medical physicist participation

• Initial specification• Review and refinement of quotes

– Equipment– Service

• Radiation protection– Design– In-progress checks– Formal verification

• Acceptance testing and commissioning


SB-P 4343

Initial specification

• Vendors usually offer complete lab packages focused on a main clinical use.– A range of options may be included or excluded.– Direct attachment of other devices requires compatibility statements.– Special specifications and performance requirements should be

requested with care.

• Sources of information– Professional society documents– Manufacturers’ documentation

• Conformance with standards• Watch for disclaimers


SB-P 4444

Specification review

• The QMP should understand the proposed clinical use well enough to evaluate quotes.– How well do competing proposals match?– Are there any missing or unnecessary items?– Do service proposals meet institutional needs?– Are necessary planning materials available?

• Time line– Documentation - well in advance.– Sufficient time for acceptance testing, including

necessary repairs.– Additional time for commissioning.


SB-P 4545

Questions to vendors

• Describe all available fluoroscopes– Why is this model recommended?

• Describe all available hardware and software options– Why did you recommend each option in the quote?– Why did you omit other options from the quote?

• What is in the pipeline?


SB-P 46

Additionaland

Future Items


SB-P 4747

Some (available) extras to consider

• Cone beam CT capability• Image co-registration

– External CT

• Value added processing– Quantitative measurements– Stent visualization

• Multi modality displays• Advanced radiation indicators• Tools and toys for physicists


SB-P 4848

Radiation Dose Structured Report

• DICOM• IHE REM Profile• IEC Dose Reporting

– PAS available now– Full IEC standard in a few years

• Availability of outputs– Post procedure– Streaming

• PACS – EMR compatibility


SB-P 4949

Service questions

• Who will service the unit during and after the warrantee?

• What are standard and extended service hours/days?

• Training for service engineers• Training for medical physics• Access to service level controls• Access to additional documentation


SB-P 5050

Physicists as service engineers?

• How much can you really do well?• Some physicists have negotiated service level

access to support necessary physics activities• MITA QA mode is expected to provide necessary

access without needing full service level access.


SB-P 5151

MITA QA Mode {in process draft}

• Manual control of parameters• Audit trail for configuration• Inputs for TG-190 factors• Outputs of digital images for QA


SB-P 5252

FDA Good Manufacturing Practices

• System assembled and tested prior to shipment.• Installation is an extension of assembly.• Manufacturers are required to file reports

of assembly (Form FDA 2579): The system or component(s) are of the type called for by the Standard, have been assembled according to the instructions provided by the manufacturer, and meets the requirements of the applicable Federal standards (within 15 days of completion).

• Copies must also be provided to State agencies and the purchaser.


SB-P 5353

Documentation

• Full user manuals (PDF preferred)• Short-form hard copy instructions• Copies of manufacturer’s installation

documentation.• Complete set of configuration data

– As delivered by factory– At the completion of installation– At the completion of clinical tuning.


SB-P 5454

Testing time schedules – per plane

Event Time Revisit

Visual inspection during shielding installation

½ h Likely

Shielding verification using radionuclide source (99mTc)

2 h Possible

Monitor system installation ½ h 1 – 2 x per Week

Formal survey using phantom 2 h Unlikely

Acceptance testing(verify correction of deficiencies)

1 day Likely

Application training ½ day Unlikely

Commissioning evaluation ½ day Possible


SB-P 5555

Goals

• A laboratory that is a safe and efficient venue for both patients and workers.

• Equipment capable of optimally performing the intended range of procedures.

• Regulatory compliance• Baseline data for continuing acceptability testing.


SB-P 56

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