colombini: 10 years later, an mri safety update 10 years later, an mri safety update scott branton,...

Colombini: 10 Years Later, An MRI Safety Update

Scott Branton, AIASenior Project [email protected]

Tobias Gilk, M.ArchSenior VP | [email protected]

President / MRI Safety Dir.Mednovus [email protected]

Presenter

✤ Scott Branton, AIA

✤ Senior Project Manager, RAD-Planning

✤ Experienced Clinical / Research Imaging Architect

✤ Contributing Author to The RADIANT

Presenter

✤ Tobias Gilk, M.Arch

✤ Senior VP, RAD-Planning

✤ President & MRI Safety Director, Mednovus

✤ Editor of The RADIANT

✤ Former ACR MRI Safety Committee Member

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MRI Safety: It’s All Good

✤ 10 Years Later - Lessons Learned

✤ Accreditation & Regulation Assure Patient Safety

✤ MRI Safety Has Improved

✤ Future Looks Even Brighter

MRI Safety: It’s All Good

✤ Nobody Knows What The Lessons Were...

✤ 10-Years Later, No Regulatory / Accreditation Safety Standards

✤ MRI Accidents Have Skyrocketed

✤ Risk-Factors Make MRI’s Future Look Scary

Except

What Do We Know About It?

✤ Oxygen Tank

✤ Nurse

✤ Boy Died

✤ New York

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Blame the Oxygen Tank?

What Did Happen In 2001?

Westchester Medical Center

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Root Cause Analysis

✤ Start With Consequence… “Boy Died”

✤ Ask “How Could” to Find Prior Steps

✤ Work Backwards

✤ Drill Down to Latent Causes

Root Cause Analysis

Root Cause Analysis

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MRI Safety: It’s All Good Except

Future Risk Factors

✤ Aging Population

✤ Increasing Interventional / Emergent Imaging

✤ More Powerful Magnet Systems

✤ Declining Reimbursements

Future Risk Factors

✤ Aging Population

You Are Here

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Physical Environment

✤ MRI Suite Access

✤ Situational Awareness

✤ Magnetic Hazards



Safe MR Practices

AJR:188, June 2007 3

06_06_1616.fm — 3/1/07

c. Zone III: This area is the region in which free access by un-screened non-MR personnel or ferromagnetic objects or equip-ment can result in serious injury or death as a result of interac-tions between the individuals or equipment and the MRscanner’s particular environment. These interactions include,but are not limited to, those involving the MR scanner’s staticand time-varying magnetic fields. All access to Zone III is to bestrictly restricted, with access to regions within it (includingZone IV, see below) controlled by, and entirely under the super-vision of, MR personnel (see section B.2.b, below). Specificallyidentified MR personnel (typically, but not necessarily only, theMR technologists) are to be charged with ensuring that this MRsafe practice guideline is strictly adhered to for the safety of thepatients and other non-MR personnel, the health care personnel,and the equipment itself. This function of the MR personnel isdirectly under the authority and responsibility of the MR med-ical director or the level 2 MR personnel–designated (see sec-tion B.2.b, below) physician of the day for the MR site.

Zone III regions should be physically restricted from gen-eral public access by, for example, key locks, passkey lockingsystems, or any other reliable, physically restricting methodthat can differentiate between MR personnel and non-MR per-sonnel. The use of combination locks is discouraged as combi-nations often become more widely distributed than initially in-tended, resulting in site restriction violations being more likelywith these devices. Only MR personnel shall be provided freeaccess, such as the access keys or passkeys, to Zone III.

There should be no exceptions to this guideline. Specifi-cally, this includes hospital or site administration, physician, se-

curity, and other non-MR personnel (see section B.2.c, below).Non-MR personnel are not to be provided with independentZone III access until such time as they undergo the proper edu-cation and training to become MR personnel themselves. ZoneIII, or at the very least the area within it wherein the static mag-netic field’s strength exceeds 5 gauss, should be demarcated andclearly marked as being potentially hazardous.

Because magnetic fields are three-dimensional volumes,Zone III controlled access areas may project through floors andceilings of MRI suites, imposing magnetic field hazards on per-sons on floors other than that of the MR scanner. Zones of mag-netic field hazard should be clearly delineated, even in typicallynonoccupied areas such as rooftops or storage rooms, and ac-cess to these Zone III areas should be similarly restricted fromnon-MR personnel as they would be inside any other Zone IIIregion associated with the MRI suite. For this reason, magneticfield strength plots for all MRI systems should be analyzed invertical section as well as in horizontal plan, identifying areasabove or below, in addition to areas on the same level, wherepersons may be at risk of interactions with the magnetic field.

d. Zone IV: This area is synonymous with the MR scanner magnetroom itself, that is, the physical confines of the room withinwhich the MR scanner is located. Zone IV, by definition, will al-ways be located within Zone III, as it is the MR magnet and itsassociated magnetic field that generates the existence of ZoneIII. Zone IV should also be demarcated and clearly marked asbeing potentially hazardous due to the presence of very strongmagnetic fields. As part of the Zone IV site restriction, all MRinstallations should provide for direct visual observation bylevel 2 personnel to access pathways into Zone IV. By means ofillustration only, the MR technologists would be able to directlyobserve and control, via line of sight or via video monitors, theentrances or access corridors to Zone IV from their normal po-sitions when stationed at their desks in the scan control room.

Zone IV should be clearly marked with a red light andlighted sign stating, “The Magnet is On.” Except for resistivesystems, this light and sign should be illuminated at all timesand should be provided with a backup energy source to continueto remain illuminated for at least 24 hours in the event of a lossof power to the site.

In case of cardiac or respiratory arrest or other medicalemergency within Zone IV for which emergent medical inter-vention or resuscitation is required, appropriately trained andcertified MR personnel should immediately initiate basic lifesupport or CPR as required by the situation while the patient isbeing emergently removed from Zone IV to a predetermined,magnetically safe location. All priorities should be focused onstabilizing (e.g., basic life support with cardiac compressionsand manual ventilation) and then evacuating the patient as rap-idly and safely as possible from the magnetic environment thatmight restrict safe resuscitative efforts.

Further, for logistical safety reasons, the patient should alwaysbe moved from Zone IV to the prospectively identified locationwhere full resuscitative efforts are to continue. (See Appendix 2.)

Quenching the magnet (for superconducting systems only) isnot routinely advised for cardiac or respiratory arrest or other med-ical emergency, since quenching the magnet and having the mag-netic field dissipate could easily take more than a minute. Further-

Fig. 1—Idealized sample floor plan illustrates site access restriction considerations. Other MR potential safety issues, such as magnet site planning related to fringe magnetic field considerations, are not meant to be include herein. See Appendix 1 for personnel and zone definitions. Note—In any zone of the facility, there should be compliance with Health Insurance Portability and Accountability Act (HIPAA) regulations in regard to privacy of patient information. However, in Zone III, there should be a privacy barrier so that unauthorized persons cannot view control panels.

ACR 4-Zone



VA Design GuideFunctional Diagram

MRI Design Guide April 2008

Functional Diagrams 3-2

MRI FUNCTIONAL DIAGRAM:

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✤ Situational Awareness

VA Design Guide


d a t ei s s u e

© 2010

s t a m p

10.1.26

Lutheran MedicalCenter

150 55th StreetBrooklyn, NY 11220

HALFSIZE

ORIGINALCOPYRIG

HT

MRI-PLA

NNING

NOT FOR CONSTRUCTIO

N

OR RE-U

SE

www.MRI-Planning.com

802 Broadway, 5th floorKansas City, MO 64105

Tele 816 472 7722Fax 816 472 1822

CLIENT REVIEW

Dat

e: Fr

i, A

ug 1

2, 2

011

Tim

e: 12

:40:

52 P

MFi

le n

ame:

1012

6 11

0812

Lut

hera

n M

ed C

ntr.v

wx

-

FIRST FLOORMRI SUITE

OPTION A.2

A 01

Project Team

Equip / Vendor

Architect MRI Planning(816) 472-7722

M/E/P Engineer TBD

Contractor TBD

Structural TBD

Mech Contractor TBD

Elec Contractor TBD

Cost TBD

Siemens 1.5T AvantoMRI Suite

09/03/10

1.5 Avanto / SIEMENSWAITING

X-RAY

TOILET

W.C.TOILET RECEPTION

W. TOILET

OFFICE

STORAGE

OFFICE

J.C

COMPUTER RM.

M.R.I.

EXAM

1100

1101

1127

1124A

1152

1126

1107

11061105

SUPERV. & ASSIST. OFFICECHIEF DIET.

EXAM1104

OFFICE

ISO. STOR.

UP

CONTROL AREA

STATION: RADIATION ONCOLOGY 1-04

CONTROL ROOM106

AREA: 232 sq ftZone: 3

CONTROL ROOM106


WAITING ROOM100


WAITING ROOM100


MRI EQUIP ROOM108


MRI EQUIP ROOM108


SCAN ROOM107


SCAN ROOM107


SUB-WAIT101


SUB-WAIT101


DRESSING / TOILET103


DRESSING / TOILET103


INPATIENT TRANSFER/SCREEN104

AREA: 135 sq ftZONE: 2

CRASH RECOVERY AREA

INPATIENT TRANSFER/SCREEN104

AREA: 135 sq ftZONE: 2

CRASH RECOVERY AREA

LOCKED FERRO105


LOCKED FERRO105


LOCKED FERRO102


LOCKED FERRO102


30g

10g

0.5g

2g

1.5g

5g

FIRST FLOOR NEW PLANScale: 1/4" = 1'-0"

1A10

NEW LG METAL FRAMED WALL - LEAD LINED

NEW LG METAL FRAMED WALL

04NEW DOOR AND FRAME REF. DOOR SCHEDULE

W-02NEW WINDOW AND FRAME REF. WINDOW SCHEDULE

ITEMS TO BE REMOVED

EXISTING WALL/ITEM TO REMAIN

NEW MILLWORK ITEM

LEGEND / KEYScale: 1/4" = 1'-0"

2A12 0 1 2 3 4 FT

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✤ Ferromagnetic Detection: Freestanding or Wall / Door Mounted.


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New Building Code

✤ 2010 Edition of Guidelines

✤ Requires ACR 4-zone, Ferromagnetic Detection

✤ Dramatically Improves Physical Environment Safety

✤ But Doesn’t Apply to ~14,000 Existing U.S. MRIs

Operational Considerations

✤ Qualifications of Visiting Clinical (Support) Personnel

✤ Staff Safety Training

✤ Situational Authority

✤ Policies & Procedures

✤ Communications

MRI Safety Oversight

✤ Food & Drug Administration

✤ Joint Commission

✤ American College of Radiology

✤ Medicare / Medicaid Conditions of Participation

o·ver·sight /ˈōvərˌsīt/ : The action of overseeing something.

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MRI Safety OversightAn unintentional failure to notice or doo·ver·sight /ˈōvərˌsīt/ :

Except✤ Food & Drug Administration

✤ Regulates MRI Device Only… (Oh to be Mammo)

✤ Has No P.O.C. Authority

✤ Proper Exams ARE Profoundly Safe

The action of overseeing something.

MRI Safety OversightAn unintentional failure to notice or doo·ver·sight /ˈōvərˌsīt/ :

✤ Joint Commission

✤ Sentinel Event Alert #38

✤ Despite Environment of Care Standard (02.01.01)

✤ Despite Ambulatory Accreditation Standards

✤ Hospital MRI Safety Standards = [cricket sounds]

Except


✤ American College of Radiology

✤ 3 (Soon 4) MRI Guidance Documents

✤ Despite Requests from MRI Safety Committee

✤ Despite Promises for MRI Safety Standards

✤ MRI Accreditation Safety Standards = [cricket sounds]

o·ver·sight /ˈōvərˌsīt/ : An unintentional failure to notice or do

Except

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✤ Medicare / Medicaid Conditions of Participation

✤ Reconcile Meds for Safety

✤ Label Syringes from Multi-Dose Vials for Safety

✤ Double-Check Patient I.D. for Safety

✤ But Store 6 Steel O2 Tanks Next to an MRI Scanner

o·ver·sight /ˈōvərˌsīt/ : An unintentional failure to notice or do

Except

In The Works

✤ FDA is said to be planning a public meeting on MRI Safety

✤ Joint Commission is planning MRI safety training for hospital surveyors

✤ CMS is purportedly working on radiology safety interpretive guidelines, including MRI safety

“But What Can I Do, Today?”

✤ Training

✤ Access Controls

✤ Screening

✤ Proper Equipment

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Training

✤ Define Your Level I & Level II Needs

✤ Document Training Requirements in P&P

✤ Build / Buy Training Materials

✤ Tie Department Access to Successful Training

✤ Document Training Efforts Access Controls

✤ Locks (That Stay Locked)

✤ Keys, Not Combinations

✤ Tie Access Privileges to Training

✤ Add Remote Monitoring, If Needed Screening

✤ “I’ll Screen You, And Your Fancy White Lab Coat, Too!”

✤ Clinical Screening (Implants, Contrast)

✤ Physical Screening (Ferromagnetic Materials, Conductors)

✤ All Persons / Objects

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Screening

Equipment

✤ If It’s Not Meant To Be Used In MRI…

✤ “Look For The Label”

✤ Do You Know Your Conditions?

Summary

✤ 10-Years Later, the Colombini Accident Has Lots To Teach Us!

✤ Careful Evaluation Shows What We’ve Learned(...but how little we’ve changed...)

✤ Regulation & Accreditation Organizations Have Been Toothless With Respect To MRI Safety… But This IS Changing!

✤ There Are Steps You Can Take, Today, To Mitigate Risks.

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Bibliography / Resources

✤ Advance for Imaging Article On New MRI Building Code:http://imaging-radiation-oncology.advanceweb.com/Features/Articles/Eye-on-Safety.aspx

✤ MRI Excerpt of 2010 Hospital Building Codehttp://www.RAD-Planning.com/webinars/1103_code_officials/2010_Guidelines_code_changes_for_imaging-Article.pdf

✤ ACR Guidance Document For Safe MR Practices: 2007http://www.acr.org/secondarymainmenucategories/quality_safety/mrsafety.aspx

✤ Video on Colombini Root-Cause Analysishttp://www.reliability.com/mri/

Bibliography / Resources

✤ Department of Veterans Affairs - MRI Design Guide http://www.cfm.va.gov/til/dGuide.asp

✤ Use of Advanced Radiology During Visits to US Emergency Departments for Injury-Related Conditions, 1998-2007 http://jama.ama-assn.org/content/304/13/1465.full

✤ Statistics on the Aging US Population http://www.ageworks.com/course_demo/200/module2/module2.htm

✤ MRI Safety Training Resources http://www.mrisafetyvideo.net/

QUESTIONS?

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Colombini: 10 Years Later, An MRI Safety Update

Scott Branton, AIASenior Project [email protected]

Tobias Gilk, M.ArchSenior VP | [email protected]

President / MRI Safety Dir.Mednovus [email protected]

Thank You!

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