Vanderbilt University
Department of Biomedical Engineering
Senior Design Project
NCIIA Grant Proposal for a Pacemaker Detection Protocol for MR Suites
6 December 2012
“The Coil Kids”
Zach Eagleton
Josh Shannon
Michael Shannon
Josh Stewart
Sam Walling
Abstract:
The radio frequency currents produced by MR scanners pose a serious risk for
patients with implantable metallic objects, especially pacemakers. Many of the
adverse events that result from inadvertent scans of patients with pacemakers
could be avoided by proper screening protocol. In response to this need, the aim
of this project is provide a protocol to reliably detect the presence of a pacemaker
implanted in the patient before beginning the MR scan. The most important
objectives of this project are:
 To develop a detection device sensitive to implanted pacemakers that
can be used to screen patients prior to a scan
 To develop a tissue phantom to evaluate the accuracy and efficiency of
this detector
 To create a protocol to be utilized by radiology technicians that
employs the aforementioned detector and reliably ensures that no
patient with a pacemaker undergoes an MR scan
Introduction
While artificial cardiac pacemakers have certainly enhanced the quality of life of millions
of individuals, they also subject these individuals to certain adverse effects. MR scanners pose a
serious risk for this population because the strong electromagnetic fields associated with the
radio frequency currents produced by the scanner disrupt the pacemaker’s electric impulses and
render it ineffective or detrimental to the health of the patient. According to the FDA’s
Manufacturer and User Facility Device Experience (MAUDE) Database, the magnetic gradients
of the scan in one case undesirably caused a pacemaker to reduce its pacing rate from 75 to 35
beats per minute and in another, the gradients caused a pacemaker to reset completely and stop
pacing the patient’s heart. These adverse events are caused by the induction of current in the
circuitry of the pacemaker, which alters the device’s function. Additionally, patients have been
internally burned by the induction of electrical current in the pacemaker’s metallic leads.
In response to these life-threatening implications, hospitals have devised individual
protocols to prevent patients with pacemakers from undergoing MR scans. These safety
protocols, however, are highly subject to human error. In most hospitals, including the
Vanderbilt University Medical Center, screening is accomplished solely by a paper
questionnaire, which relies on patients to self-report that they have an implanted pacemaker.
Additionally, a small number of independent companies have developed a market in
ferromagnetic detectors specifically for MR suites. However, these detectors are not sensitive
enough to reliably detect pacemakers and other implantations. As is evident from the incident
reports present in the MAUDE Database, in many cases, the present protocols have not
prevented affected patients from being scanned. It is obvious that more stringent safety
protocols are necessary to prevent these harmful events.
This need to reliably detect pacemakers could be met with many distinct solutions,
including a detailed pre-scan review of the patient’s medical history to crosscheck for history of
a pacemaker implantation or a pre-scan physical exam of the patient’s chest to check for the
presence of a pacemaker. More technologically advanced solutions could also include sensing
the pacemaker’s integrated radio frequency signals, which are used for programming, or using an
electrocardiogram to identify the distinct patterns of a pacemaker in the electrical potential of the
heart. While each of these solutions could be used to meet the present need, we propose that the
most efficacious and promising method involves the development of a metal detection system
capable of detecting a pacemaker implanted inside a human body and a systematic protocol that
employs this detector to ensure no patients with pacemakers are unknowingly scanned. This
detector would be a handheld device that uses alternating magnetic fields to detect the presence
of metal. It would be utilized by the radiology staff during the pre-scan procedure, and if a
pacemaker was detected, the staff would report the finding to a radiologist for further instruction.
History and Context
Accidents related to MR scanners and pacemakers have been on the rise in recent years
as a result of the increasing prevalence of pacemakers in the general population, but still, many
incidents go unreported. According to one study, as of 2004, ten deaths had occurred as a result
of adverse effects of MR scanning on patients with pacemakers (Martin et al, 2004). While there
is little reliable data concerning the incidence of non-mortal consequences, much concern has
been raised in the medical community. Regardless, much of this problem is due to discrepancies
in hospital protocol on screening, as current laws do not require a metal detector test for patients.
This leaves many patients with pacemakers unscreened before entering the machine which poses
severe harm to their health. In our efforts to address this problem, we have discussed possible
solutions with radiologists and biomedical engineers and as a group, have decided to focus on the
device and protocols that we propose here. Attached is a sketch of the device that we currently
envision. Upon completion of a prototype, we hope to form a relationship with the Vanderbilt
University Medical Center to test our protocol in a clinical setting.
Our Team
Our team was created with the goal of taking five intelligent, but different individuals,
and putting them in an environment where their strengths could be maximized. For example,
Zach has had over two years of hands on experience working in a hospital. His understanding of
hospital dynamics will prove vital in creating a device that will be well managed and properly
used in a hospital setting. Mike’s experience with programming will provide technical support
to a team in need of programming savvy engineers. Josh Shannon has great technical skill
having worked in a research lab for over two years. The analytical thinking often employed in
such research will help nail down specific functionalities of our device. Good communication
skills will likely play a role in facilitating progress. Josh Stewart has held positions in the past
where his success was dependent on his ability to communicate effectively. Lastly, Sam’s
leadership has been noted on this project guiding the innovation and brainstorming process.
Furthermore, he has gone through the patenting process multiple times having a greater
understanding of the cost-benefit analysis examined when looking at new devices.
Dr. Will Grissom is our primary advisor and with his expertise in MRI and
electromagnetics, he will be able to guide us through the entire design process. While Dr.
Grissom is our advisor, it will be important in the ensuing months to speak with radiologists and
radiology technicians to give us further insight into the problem.
Work Plan
In order to attain a solution to the needs of this project within the present time constraints,
it is necessary to establish an overall work plan to ensure that progress is being made at an
appropriate pace. As is seen in the Gantt chart in Appendix A, the initial two months of the
project will be spent on the ideation and planning stages of the project. In October and
November 2012, the problem will be identified and the needs declared, which will allow us to
brainstorm possible solutions. In November and early December 2012, these solutions will be
narrowed down to a single design approach. With this design in mind, the appropriate parts and
supplies will be ordered and procured. Once the necessary components are in place, an initial
prototype will be produced by the end of January 2013, which will be modified as necessary
until a final product is developed by the beginning of April 2013. Simultaneously, a tissue
phantom will be produced for testing purposes under the same timeline as above. With this work
plan, milestones will be reached when the ideation process brings us to a single solution
(December 2012), a prototype is developed for both the detector and phantom (January 2013),
and the final design of the detector is implemented (April 2013). By the end of this period, we
expect to have a commercially marketable product that could be used in any radiology clinic to
detect the presence of metal. Because this system approaches the problem at hand in a novel
fashion, its commercial implications could allow the project to continue if MR manufacturers
express interest in incorporating this technology into their scanning systems. Because of the
novelty of our approach and its simplicity in implementation and use, its prospect of attaining
commercial success seems very high.
Evaluation and Sustainability Plan
The first step in developing a device to detect the presence of a pacemaker would be to
first design it so that it would be sensitive enough to detect some aspect of the pacemaker,
whether it be the wires or the main body of the pacemaker. The pacemaker has to be able to be
accurately detected by the device. The ability to develop a prototype that is sensitive enough to
accomplish this is an optimal first measure of the initial success of the device. After this is done,
the next step would be to implant a pacemaker or an object that adequately mimics a pacemaker
into an anthropomorphic tissue phantom to test the ability of the device to detect a pacemaker
while it is implanted. The development of a tissue phantom that sufficiently mimics the area that
the pacemaker will be implanted is the next criteria for success since a well-made phantom will
ensure that the device can accurately detect the pacemaker under the skin. At this point, the
device may have to undergo several iterations of prototyping to reach the desired level of
accuracy. The next measure of success would be when the device reaches the necessary
sensitivity level to detect the pacemaker inside the phantom. After this is accomplished, the
device could then be used on actual people to see how well it can detect the presence of
pacemakers. When the device reaches the capability to detect pacemakers in people at sufficient
accuracy, then this will be the point at which we know that we have succeeded in the design of
the device.
Appendix A.
Works Cited
Martin, Edward T., James A. Coman, Frank G. Shellock, Christopher C. Pulling, Robert Fair,
and Kim Jenkins. "Magnetic Resonance Imaging and Cardiac Pacemaker Safety at 1.5Tesla." Journal of the American College of Cardiology 43.7 (2004): 1315-324.
ZACHARY EAGLETON
Current Address
444 Elmington Avenue
Apt. 536
Nashville, TN 37205
zachary.e.eagleton@vanderbilt.edu
217-494-7097
Permanent Address
1605 Claude Drive
Springfield, IL 62704
EDUCATION
Vanderbilt University, School of Engineering Nashville, TN
Bachelor of Engineering May 2013
Major: Biomedical Engineering
GPA: 3.10/4.00
Dean’s List: Spring 2012
EXPERIENCE
Vanderbilt School of Engineering Nashville, TN May, 2012 - Present
Research Assistant
• Contribute to development of low-resource diagnostic assay for malaria.
• Apply Optimal Coherence Tomography to characterize flow profiles in colloids.
• Model evaporation of water droplet using COMSOL.
• Acquire lab techniques and characterization skills such as fluorescence microscopy, macro writing, and
Dynamic Light Scattering.
Memorial Medical Center Springfield, IL May - August, 2010-2011
Emergency Room Unit Support Assistant
• Performed EKGs, collected specimens, obtained vital signs, stocked rooms, transported patients, and
carried out a variety of necessary ER tasks.
• Assisted nurses with patient care and completed regular rounding on rooms to ensure quality patient
experience.
• Communicated patient needs effectively and accurately to 20 nurses and 5 physicians in a 50 bed, level
1 trauma center.
Franklin Middle School Springfield, IL August, 2010-2012
Basketball Camp Coach
Led teams of 15 middle school students in exercises which taught fundamental basketball skills and
teamwork.
Southern Illinois University School of Medicine Springfield, IL May - August, 2008-2009
Research Assistant
• Assisted with study that sought to determine correlation between REM sleep and chronic obstructive
pulmonary disease in patients with sleep apnea.
• Collected and analyzed data from polysomnographs and spirometry tests.
VOLUNTEER SERVICE
Vanderbilt Student Volunteers for Science Nashville, TN September - April, 2010-Present
Team Leader
• Organize a small group of volunteers to teach a weekly science lesson to students in Nashville area
middle schools.
PROFESSIONAL SKILLS
• Proficient in MATLAB, PowerPoint, Excel, Mathematica, ImageJ, ImagePro, and COMSOL.
Joshua Shannon
Current Address:
Vanderbilt University, PMB 343924
Nashville, TN 37235
joshua.m.shannon@vanderbilt.edu
(352)410-1741
Permanent Address:
5092 Mentmore Ave.
Spring Hill, FL 34606
Education
Vanderbilt University, Nashville, TN
Major: Bachelor of Engineering in Biomedical Engineering
May 2013
Current GPA: 3.4/4.0
Honors/Activities - Dean’s List
- Alpha Lamba Delta Honor Society, Phi Eta Sigma Honor Society, National Society of Collegiate Scholars,
Biomedical Engineering Society, Lotus Eaters
Research
- Vanderbilt University, Advanced Therapeutics Laboratory

Use RAFT polymerization to synthesize stimuli sensitive polymers for intracellular delivery of
biomacromolecular drugs.

Apply several methods to purify polymers including precipitation, dialyzing, and lyophilization

Characterize polymers using GPC, TEM, DLS and by analyzing GPC and NMR graphs

Applied cell culture techniques to grow fibroblast and stem cells

Presented and discussed selected research journals and collaborated across engineering disciplines
-
Dr. Pintauro’s Lab: The Development of New Proton Exchange Membranes for Fuel Cells

Characterized polymers using a Differential Scanning Calorimeter machine and x-ray diffraction

Learned the processes of annealing and testing the solubility of polymer membranes
-
Nelson CE, Gupta MK, Adolph EJ, Shannon JM, Guelcher SA, Duvall CL. Sustained local delivery of
siRNA from an injectable scaffold. Biomaterials, 33 (2012), pp. 1154-1161
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"Biodegradable Tissue Scaffolds for Cell and siRNA Delivery" BMES Conference poster presentation,
Hartford, Connecticut, October 2011.
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Vanderbilt University, Vanderbilt Students Volunteering for Science Leader

Lead a team of five undergraduates in weekly visits to local middle schools to promote an early
interest in science careers through an expanded curriculum and unique learning experiences

Create age appropriate experiments to teach hands-on learning and science fundamentals
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Vanderbilt University, V-Squared Mentor
Publications
Leadership
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Vanderbilt University, Biomedical Engineering Society Community Service Committee


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Mentor five first year undergraduate engineers
Help acclimate mentees to university life, aid in coursework selection, and provide other guidance
Organize and manage several engineering related community service events involving 20-30
volunteers
Research, make initial contacts, and coordinate volunteer events with non-profit organizations
BMEpulse Journalist


Write several articles for the BMEpulse, an engineering newsletter read by hundreds of
undergraduates, professors, and alumni
Made contacts, performed interviews, and summarized seminars with professors and alumni
Michael Shannon
Current Address:
Vanderbilt University, PMB 355011
Nashville, TN 37235
michael.j.shannon@vanderbilt.edu
(352)410-1641
Permanent Address:
5092 Mentmore Ave.
Spring Hill, FL 34606
Education
Vanderbilt University, Nashville, TN
Major: Bachelor of Engineering in Biomedical Engineering
May 2013
Current GPA: 3.55/4.00
Honors/Activities - Dean’s List
- Alpha Lamba Delta Honor Society, Phi Eta Sigma Honor Society, National Society of Collegiate Scholars,
Biomedical Engineering Society, Lotus Eaters Honor Society
Research
- Vanderbilt University, Biomedical Modeling Laboratory

Use a biomechanical model to work towards image guidance for breast surgery

Acquire data from tissue phantom using such equipment as a laser range scanner (LRS) and a CT
scanner

Become familiarized with the basics of an image guidance system

Use Matlab to analyze data gathered from LRS, CT scan, and a volume mesh to generate a model
with boundary conditions that can be used to predict deformation

Use a finite element model to simulate a retraction on a tissue phantom

Received SPIE Honorable Mention Award for poster presented on research

First author on paper published in SPIE Conference proceedings
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Vanderbilt University, Baudenbacher Lab: Design of a Nano-Liter Bioreactor for the Detection of
Norepinephrine
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Service
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Vanderbilt University, Global Medical Brigades



-
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Work in a resource poor setting to provide medical relief for impoverished families
Shadow local doctors and help provide medications to patients
Overcame language barriers to educate patients and children on personal hygiene
Vanderbilt University, Engineering World Health

Skills
Develop a microelectrode and a master of a nano-liter bioreactor on a silicon wafer using standard
photolithography devices and techniques
Work in ISO5 clean rooms for photolithography and microfabrication of devices
Perform cyclic voltammetry measurements of norepinephrine concentrations using an iridium oxide
microelectrode
Trained student on proper protocol for working in clean room and performing appropriate
photolithography techniques for the design of a nano-liter bioreactor
Build and test electrosurgery unit (ESU) testers to give to developing country hospitals and to
ensure the functionality of these devices
Part of design team to develop a cost effective and reliable infant respiratory monitor to be used in
resource-poor hospitals
Programming Languages: Matlab (2 years including 1 year of in lab experience), C++, Java
Joshua Stewart
Home Address:
9 Revolutionary Road
Acton, MA 01720
joshua.m.stewart@vanderbilt.edu
c: 978-844-4038
School Address:
411 Village at Vanderbilt
Nashville, TN 37212
Education
Vanderbilt University, Nashville, TN
Bachelor of Engineering, Biomedical Engineering
Minor: Mathematics
GPA: 3.0
Spring 2013
Colby College, Waterville, Maine
2009-2010
Relevant Courses
Tissue Engineering, Analysis of Biomedical Data, Computer Programming, Biomechanics, Biomedical
Materials, Linear Algebra and Differential Equations, Circuits, Biomedical Instrumentation, Statistics and
Probability, Vector Calculus, Systems Physiology, Physical Transport Phenomena
Relevant Work Experience
Sung Laboratory, Vanderbilt University
Research Assistant (Winter 2012-Present)
 Synthesis and characterization of a vascular patch programmed for shape memory function and
reactive oxygen species (ROS) degradation
Allen Medical Systems - subsidiary of Hill-Rom, Acton, MA
Intern (Summer 2011)
 Helped design a modern “Jackson” spinal table for surgery
Volunteer Experience
Alternative Spring Break, Talladega, AL (Spring 2012)
James Eldridge, Democrat for Massachusetts State Senate Seat, Acton, MA (Summer 2008)
Relief Missions, Compassion for Hope, Jamaica, Gulfport, MS (Summers 2007-2009)
Campus Involvement
Vice President, Vanderbilt Health and Fitness Club (2011-present)
Team Leader, Vanderbilt Student Volunteers for Science (2011-present)
Member, Vanderbilt Biomedical Engineering Society (2010-present)
Teammate, Colby College Water polo Team (2009-2010)
Proficiencies/Skills
MATLAB, Mathematica, STATA, Logger Pro, Sage, some Solidworks, Microsoft Office products: Excel,
Power Point, and Word
Professional Membership
Biomedical Engineering Society – Student member
SAMUEL CLINTON WALLING
Current Address:
PMB #355714
2301 Vanderbilt Place
Nashville, TN 37235-5714
502.424.0703 (C)
502.897.3040 (H)
samuel.c.walling@vanderbilt.edu
EDUCATION
Vanderbilt University, School of Engineering, Nashville, TN
Bachelor of Biomedical Engineering, May 2013
Saint Xavier High School, Louisville, KY
High School Diploma, May 2009
GPA: 4.00/4.00 (unweighted) 5.09/4.00 (weighted)
Honors:
National Merit Scholar, Outstanding Leadership Award, Outstanding Scholarship Award, 2009
Father John Morgan Scholarship, 2009 Benn Family Fund Youth Volunteer Scholarship
RELATED EXPERIENCE
Vanderbilt Sports Medicine, August 2009 – Present
Clinical Intern
• Provide medical coverage for Vanderbilt University’s football team’s practices and competitions with a
team of certified athletic trainers and physicians accumulating over 2,000 hours of experience
• Create and implement individualized rehabilitation programs to treat athletes’ specific injuries and
conditions under the supervision of staff clinicians
• Observe and assist team physicians in their evaluation and treatment (including surgery) of injuries in
order to broaden my understanding of sports medicine and the healthcare industry
• Administer therapeutic modalities including electric stimulation, ultrasound, iontophoresis,
hydrotherapy, etc.
• Maintain medical records and ensure that required insurance, consent, and screening information is
obtained
SCR Development Group, May 2011 – Present
Director, Sports Science Applications
• Collaborate with a team of biomedical engineers and physicians to develop novel cryotherapy
technologies for athletic muscular recovery
• Lead initial design efforts and prototyping of new configurations and improvements on current
products
• Communicate with collaborative engineers and customers to improve the quality of our product
• Awarded United States Patent for “Athletic Cooling and Heating Systems, Devices, and Methods”
COMMUNITY INVOLVEMENT
Volunteers of America (Kentucky), May 2008 – May 2009
Founder and Director of Service Initiative
• Implemented a project involving over 100 volunteers that provided childcare and educational
opportunities for impoverished children