Colombini: 10 Years Later, An MRI Safety Update. Presenter. Presenter. Scott Branton, AIA. Senior Project Manager, RAD-Planning

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1 Colombini: 10 Years Later, An MRI Safety Update Scott Branton, AIA Senior Project Manager RAD-Planning Tobias Gilk, M.Arch Senior VP RAD-Planning President / MRI Safety Dir. Mednovus SAFESCAN TGilk@Mednovus.com 1 Presenter Scott Branton, AIA Senior Project Manager, RAD-Planning Experienced Clinical / Research Imaging Architect Contributing Author to The RADIANT 2 Presenter Tobias Gilk, M.Arch Senior VP, RAD-Planning President & MRI Safety Director, Mednovus Editor of The RADIANT Former ACR MRI Safety Committee Member 3

2 MRI Safety: It s All Good 10 Years Later - Lessons Learned Accreditation & Regulation Assure Patient Safety MRI Safety Has Improved Future Looks Even Brighter 4 MRI Safety: It s All Good Except Nobody Knows What The Lessons Were Years Later, No Regulatory / Accreditation Safety Standards MRI Accidents Have Skyrocketed Risk-Factors Make MRI s Future Look Scary 5 What Do We Know About It? Oxygen Tank Nurse Boy Died New York 6

3 Blame the Oxygen Tank? 7 What Did Happen In 2001? 8 Westchester Medical Center 9

4 Root Cause Analysis Start With Consequence Boy Died Ask How Could to Find Prior Steps Work Backwards Drill Down to Latent Causes 10 Root Cause Analysis 11 Root Cause Analysis 12

5 MRI Safety: It s All Good Except 13 Future Risk Factors Aging Population Increasing Interventional / Emergent Imaging More Powerful Magnet Systems Declining Reimbursements 14 Future Risk Factors Aging Population You Are Here 15

6 Physical Environment MRI Suite Access Situational Awareness Magnetic Hazards 16 Physical Environment MRI Suite Access ACR 4-Zone Fig. 1 Idealized sample floor plan illustrates site access restriction considerations. 17 Physical Environment MRI Suite Access VA Design Guide Functional Diagram 18

7 Y 19 Physical Environment Situational Awareness VA Design Guide Broadway, 5th floor Kansas City, MO Tele Fax CONTROL AREA Project Team T H J.C 1107 N O G I G Physical Environment I N CT I R N Y U N P R A O T L C -P S E N I S R CO U M E R R FO OR T 21 O X-RAY 1100 EXAM 1104 EXAM 1105 OFFICE 1126 OFFICE COMPUTER RM Equip / Vendor 1.5 Avanto / SIEMENS Architect MRI Planning (816) M/E/P Engineer TBD Contractor TBD Structural TBD Mech Contractor TBD Elec Contractor TBD Cost TBD STORAGE DRESSING / TOILET 103 AREA: 74 sq ft Zone: 2 ECEPTION 101 LOCKED FERRO 102 AREA: 13 sq ft Zone: 2 MRI EQUIP ROOM 108 AREA: 105 sq ft Zone: 1 SUB-WAIT WAITING ROOM OFFICE g 100 AREA: 147 sq ft Zone: AREA: 115 sq ft Zone: 2 0.5g G Physical Environment 5g 2g TOILET 30g 10g SCAN ROOM INPATIENT TRANSFER/SCREEN 104 AREA: 135 sq ft ZONE: 2 CRASH RECOVERY AREA CONTROL ROOM HALF SIZE AL R O IGIN stamp 107 AREA: 386 sq ft Zone: 4 M.R.I. W. TOILET 1124A 106 AREA: 232 sq ft Zone: 3 LOCKED FERRO 105 AREA: 18 sq ft Zone: 2 CHIEF DIET. SUPERV. & ASSIST. OFFICE CLIENT REVIEW issue 09/03/10 date Siemens 1.5T Avanto MRI Suite Lutheran Medical Center th Street Brooklyn, NY 11220

8 Physical Environment 22 Physical Environment 23 Physical Environment Ferromagnetic Detection: Freestanding or Wall / Door Mounted. 24

9 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 25 Operational Considerations Qualifications of Visiting Clinical (Support) Personnel Staff Safety Training Situational Authority Policies & Procedures Communications 26 MRI Safety Oversight o ver sight /ˈōvərˌsīt/ : The action of overseeing something. Food & Drug Administration Joint Commission American College of Radiology Medicare / Medicaid Conditions of Participation 27

10 MRI Safety Oversight o ver sight /ˈōvərˌsīt/ : An The unintentional action of overseeing failure to something. notice or do Food & Drug Administration Except Regulates MRI Device Only (Oh to be Mammo) Has No P.O.C. Authority Proper Exams ARE Profoundly Safe 28 MRI Safety Oversight o ver sight /ˈōvərˌsīt/ : An unintentional failure to notice or do Joint Commission Sentinel Event Alert #38 Except Despite Environment of Care Standard ( ) Despite Ambulatory Accreditation Standards Hospital MRI Safety Standards = [cricket sounds] 29 MRI Safety Oversight o ver sight /ˈōvərˌsīt/ : An unintentional failure to notice or do American College of Radiology Except 3 (Soon 4) MRI Guidance Documents Despite Requests from MRI Safety Committee Despite Promises for MRI Safety Standards MRI Accreditation Safety Standards = [cricket sounds] 30

11 MRI Safety Oversight o ver sight /ˈōvərˌsīt/ : An unintentional failure to notice or do Medicare / Medicaid Conditions of Participation Reconcile Meds for Safety Except 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 31 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 32 But What Can I Do, Today? Training Access Controls Screening Proper Equipment 33

12 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 34 Access Controls Locks (That Stay Locked) Keys, Not Combinations Tie Access Privileges to Training Add Remote Monitoring, If Needed 35 Screening I ll Screen You, And Your Fancy White Lab Coat, Too! Clinical Screening (Implants, Contrast) Physical Screening (Ferromagnetic Materials, Conductors) All Persons / Objects 36

13 Screening 37 Equipment If It s Not Meant To Be Used In MRI Look For The Label Do You Know Your Conditions? 38 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. 39

14 Bibliography / Resources Advance for Imaging Article On New MRI Building Code: MRI Excerpt of 2010 Hospital Building Code ACR Guidance Document For Safe MR Practices: Video on Colombini Root-Cause Analysis 40 Bibliography / Resources Department of Veterans Affairs - MRI Design Guide Use of Advanced Radiology During Visits to US Emergency Departments for Injury-Related Conditions, Statistics on the Aging US Population MRI Safety Training Resources 41 QUESTIONS? 42

15 Thank You! Colombini: 10 Years Later, An MRI Safety Update Scott Branton, AIA Senior Project Manager RAD-Planning Tobias Gilk, M.Arch Senior VP RAD-Planning President / MRI Safety Dir. Mednovus SAFESCAN TGilk@Mednovus.com 43

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