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Magnetic Resonance Imaging Scan Safety

Terry D. Vincent

University of San Diego

HCIN-559: Management of Health Care System Quality Outcomes and Patient Safety

Dr. Kathleen M. Stacy

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Magnetic Resonance Imaging Scan Safety

Medical technology, specifically magnetic resonance imaging (MRI), has advanced

significantly since its inception in the 1970s. This imaging system was developed to reduce the

number of ionizing radiation patients would receive during standard radiographic exams using x-

rays. The MRI is now a mainstay in the healthcare industry, with more than sixty million being

performed worldwide since 2012 (Tsai et al., 2015). The MRI system uses large static and

magnetic fields to produce a digital image onto a computer monitor representing the internal

workings of the human body or body part being examined by the physician. Although much

safer than x-rays, the system has its own set of patient safety issues as well. According to the

research conducted by Tsai et al. (2015), each of the parts can cause injuries related to the

equipment's operation function or disfunction. Also, injuries can be caused by the magnetics

producing projectiles, extreme radiofrequency absorption, neurostimulation, noise injuries,

burns, and have adverse outcomes due to interaction with implanted metal devices in the body.

According to the Emergency Care Research Institute (ERCI) in their special report of the

"Top 10 Health Technology Hazards of 2020", missing the presence of an implantable device

during the MRI screening process is their eighth leading cause of patient injuries in the United

States (ERCI, 2020). The ERCI Institute goes on to say, "information about patient implants is

often scattered throughout various information systems or records" (ERCI, 2020), or not there at

all. Thus, making it difficult for health care workers to determine the presence of such a device

before the MRI procedure. The ERCI has also determined that not even the screening interviews

with the patient and or their family members are a reliable source of information before the MRI.

This lack of information makes performing this sometimes life-saving exam more dangerous

than the issue the patient is getting the scan for.

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The use of MRIs and the increased number of patients requiring implantable life-saving

devices is growing exponentially globally. And a process must be developed to ensure that the

proper documentation of such devices is listed in the patient's electronic health record (EHR).

The purpose of this paper is to propose a possible solution for assessing and documenting a

patient's history of implanted medical devices within the EHR and make it easily accessible by

all that need to know. Developing a designated note or page within the EHR would decrease the

likelihood of patient injuries, reduce lag times, and improve patient's medical outcomes.

Literature Review

Medically screening each patient prior to conducting a magnetic resonance imaging

(MRI) scan is an indispensable step in ensuring patient safety for this procedure. Each medical

professional involved in the patient's care is responsible for their safety during their care in that

medical facility. The ownership in their care starts with the physician ordering the procedure,

the nursing at the bedside caring for the patient, and the MRI technologist performing the

procedure. Their jobs collectively are to review the patient's EHR for any evidence that the

patient may have had any metallic equipment or machine instilled in the body.

We know from the ERCI (2020) report that reviewing the EHR for a history of any metal

implants sometimes yields nothing during the chart review. And the same result is often

obtained when each medical professional in the chain of care conducts a verbal interview with

the patient and the family. When these reviews show no written or oral proof of an implantable

device history, what do we do? Before an MRI, the first thing to do is make changes to

documentation and teach the family members how important it is to share this information to all

caregivers when a possible scan is scheduled. Finally, it would be to teach proper documentation

procedures to the appropriate healthcare providers to ensure each implantable device is

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documented in the EHR correctly. To look for additional MRI safety measures, I conducted a

literature review looking specifically at other safety measures that could be implemented at an

MRI site.

To start my literature review, I used the University of San Diego's Copley Libraries to

assess multiple literature and journal databases. My research keywords were centered around

"MRI patient safety" with advance searches using "Implantable devices" and "EHR

documentation." I used the Cumulative Index of Nursing and Allied Health Literature (CINAHL)

database to query articles related to my topic. The search resulted in 1186 research articles but

was shortened to 177 when my research limiters were added. The query limiters were articles

written in the last five years and were specifically related to MRI patient safety with no specific

disease or body abnormality listed in the title.

The first research article, titled "Magnetic Resonance Safety" by Sammet (2016),

discussed the importance of doing a very detailed MRI physical and electronic records exam

prior to the procedure to ensure no implanted metallic devices are present. Sammet emphasized

that this endeavor lies in the hands of all the medical professionals, the patient, and any family

members involved in the patient's care. This entire process must be reviewed and monitored by

all to ensure the correct protocols for documentation and screening for each patient is followed to

the letter. Safety is paramount in this procedure. Sammet (2016) also recommended that each

patient be placed in a hospital-provided MRI safe gown that contains no metallic buttons or

threading.

This leads us to the next safety issue; training. Sammet (2016) believes that all personnel

working in the MRI setting must go through a comprehensive safety training course before

working in that environment. He states that it should include the proper usage of an MRI
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scanner, and this training should be conducted on an annual basis. Sammet says the training

should include detailed screening procedures with a questionnaire. The questionnaire address

ferromagnetic (iron) objects instilled in the body, implants, piercings, burns, projectile

production, all medical conditions, and the emergency procedures that might be needed in case

of an accident or adverse reaction. Again, this training must be done annually to maintain

departmental competencies (Sammet, 2016).

An additional MRI scanning safety issue is the ability to keep non-MRI personnel free

and clear of the strong main MRI environment to reduce their possibility of magnetic field

injury. According to Tsai et al. (2015), a greater safety issue with MRIs is caused by non-MRI

personnel that bring in ferromagnetic objects into the exam rooms by accident during emergency

situations. Therefore, he believes in dividing the MRI exam area into four specific zones, with

demarcation lines, that have progressively more restrictive requirements when moving from one

zone to another. Zone I, the less restrictive, allows everyone to enter this area to start processing

for their MRI procedure. Zone IV, the most restrictive. At this point, all ferromagnetic has been

removed from the patient, EHR review completed, and a complete exam has been conducted.

The patient is now ready to proceed with their scheduled MRI.

The final two articles retrieved from the query also addressed prescreening patients prior

to their procedure. However, in these articles, the use of just a screening questionnaire is backed

by adding in a ferromagnetic detection system (FMDS) for metal screening. In 2013, Shellock

and Karacozoff conducted a study utilizing this detection device to determine if it could be used

to prescreen before an MRI. They discovered that the ferromagnetic device had a 92%

sensitivity to the ferromagnetic objects and had a 100% specificity in detecting 67 different
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implantable and external metallic devices on a patient. Although this was a very small study, it

laid the groundwork for further studies to evaluate the reliability of FMDS.

In 2014, Orchard conducted a study of his own on the efficacy of an FMDS system in

preventing MRI injuries by detecting ferromagnetic objects. His study consisted of 977 patients

with a total of 1032 MRI screenings performed on his sample of patients. The cohort study

showed that the FMDS had a specificity of 98% and 100% sensitivity to metallic objects. Thus,

providing confidence that it can identify any hazardous metallic products, large or small, that

could find their way into the scanner.

After reviewing the literature, performing the initial chart review and an in-depth

physical exam completing the MRI questionnaire are procedure mainstays for MRIs. This part

of the screening lays the groundwork for adding an FMDS system in cases where there are

unknowns. Any addition of a safety layer that would reduce any possible harm to the patient

would be a welcomed step in treating patients with a minimum delay in care.

Solution Description

To increase the safety of all patients with a pending MRI, the inclusion of a

ferromagnetic detection system (FMDS) is recommended. The system would be used only in

cases where there is a questionable history of an implanted electronic device, shrapnel, or an eye

injury related to metal shards, patients, and their family members with a diminished memory of

medical history (Orchard, 2015). It will be used in conjunction with the standard screening

protocol and not as a stand-alone screening tool.

The FMDS system is a vertically mounted wand that is comprised of multiple sensitive

magnetometer sensors. These sensors can pick up up the smallest of ferromagnetic objects when

scanning a patient from head to toe. To have it performed, the patient must be ambulatory and
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able to stand under their own power. When the scan begins, the patient must start turning in a

360-degree circle until the scan is completed (Shellock & Karacozoff, 2014).

The system would be installed in the MRI suite in-between Zones II and III just after the

patient has removed their street clothing and gotten dressed in a hospital gown (Sammet, 2016).

This placement is most optimum because it will line up with the patient assessment phase and

patients' standard progression and movement towards the MRI scanner. If there are any

discrepancies or questions about the safety of the patient at this juncture, they can be returned to

Zone I and wait for further instructions from the radiologist.

Installation of an FMDS system in the MRI suite will require a bit of financial obligation

by the healthcare facility initially. However, that obligation is nothing compared to the amount

of money the facility will have to pay in the event of an MRI medical error or accident. There is

no price you can place on added assurances that your performing procedures are incredibly safe

for all involved.

Failure Mode and Effect Analysis

Implementing the FMDS system ensures that each patient is safe from any mishaps that

may occur due to human action or inaction during the process. The process flow map for each

MRI, as seen in Figure A1, depicts the steps that must be accomplished before any patient

receiving an MRI. Although it seems simple, the flow can lead to an error that can cause death

or significant permanent loss of function of a body part. So, it is crucial that every step is

followed without deviation, no matter the status of the working environment or the number of

staff members available to carry out the orders. Keeping safety in mind, it is imperative that

each staff member involved in the care of a patient must remember that the process of screening

for implantable devices is the most important of all the steps.

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Table B1, the Failure Mode Effect and Analysis (FMEA), continues with the screening

theme and how important it is to ensure that every action is taken to place the MRI scan order,

reviewing the patient's EHR for device implantation history, the physical exam, and screening

form is the only way to prevent injuries. The table emphasizes how potential causes of injuries

are due to staff being overworked, understaffed, and undertrained to perform the screening

process. The FMEA shows that these careless errors or mistakes can be remedied by employing

safety protocols, such as a checklist, that must be followed before the patient reaches the MRI

examining the area. In addition to holding annual training and periodic process reviewing to

look for any areas of weakness that can be improved upon for patient safety.

Quality Measurement Plan

The purpose of implementing the Ferromagnetic detection system (FMDS) is to ensure

that every MRI scan performed on a patient is done as safe as possible. To ensure that this

happens, installing the FMDS device between Zones II and III in the MRI suite would optimize

patient screening and increase patient safety. To determine the effectiveness of the FMDS, the

use of the system for scanning each patient will be tracked daily.

To accomplish the tracking, two performance measures will be used to track the

effectiveness of the system. That data will be reported to ECRI to compare with their annual

collected data. First, a Process Measure will show who uses the system to detect ferrous metals

in each patient before an MRI, the known and unknown presence of metal. Secondly, an

Outcome Measure will be used to quantify each patient's health status after each MRI scanning

compared to their status before the scan. But most importantly, the data can be used in every

health facility to increase each patient's MRI scan safety.

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The data will be collected in the FDMS system every scan and documented in the

electronic health record of each patient. The data will be compiled weekly by the lead

radiologist, or a delegated radiology department staff member, to show how effective the system

was at detecting metallic objects in all patients. The report must also include any items that were

not seen in each scan and any patient, staff, or equipment injuries due to that error. This report's

data will also be used to compare previous years of scans without using an FMDS system. The

comparison of data will help each facility determine if the system is a viable means of protecting

their financial well-being.

Conclusion

The purpose of installing the Ferromagnetic Detection System is to decrease the

likelihood of any patient, equipment, or staff injury due to undiscovered implanted or instilled

metal devices or shards. We know that the ECRI (2020) has collected data that shows that

missed implanted devices are the eighth leading cause of patient injury in hospitals. The FMDS

can be the ultimate safety stop for all patients before the MRI scan. It will be a supportive tool

secondary to an effective EHR search, patient physical exam, and patient and family screening

form completion.

Finally, the inclusion of the FMDS in the MRI screening process suggests that the error

and injury rates would decrease drastically if the actions listed in the FMEA are implemented in

conjunction with the system. This could lead to an almost zero percent injury rate in the

radiology department for MRI scans. To make this happen, additional research and installation

must be conducted by health facilities that show the process works. However, they must be

brave enough to bear the expense of the upfront costs of installation. But, understand that they
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will save thousands, or even millions, in the long term due to preventable injuries in the MRI

suite.
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References

Emergency Care Research Institute. (n.d.) Top 10 Health Technology Hazards for 2020.

Retrieved form https://www.ecri.org/search- results?phrase=top%2010%20health

%20technology%20hazards%20of%202020

Tsai, L., Grant, A., Mortele, K., Kung, J., & Smith, P. (2015). A Practical Guide to MR

Imaging Safety: What Radiologists Need to Know. Radio Graphics, 35, 1722-1737.

https://doi.org/10.1148/rg.2015150108

Emergency Care Research Institute. (n.d.) Top 10 Health Technology Hazards for 2020.

Retrieved from

https://www.ecri.org/search-results?phrase=top%2010%20health

%20technology%20hazards%20of%202020

Orchard, L.J. (2015). Implementation of a ferromagnetic detection system in a clinical MRI

Setting. Radiology, 21, 248-253. http://doi.org/10.1016/j.radi.2014.12.007

Sammet, S. (2016). Magnetic resonance safety. Abdominal Radiology, 41, 444-451.

http://doi.org/10.1007/s00261-016-0680-4

Shellock, F.G. & Karacozoff, A.M. (2013). Detection of Implants and Other Objects Using

a Ferromagnetic Detection System: Implications for Patient Screening Before MRI.

American Journal of Radiology, 201, 720-725. http://doi.org/10.2214/AJR.12.10332

Tsai, L., Grant, A., Mortele, K., Kung, J., & Smith, P. (2015). A Practical Guide to MR Imaging

Safety: What Radiologists Need to Know. Radio Graphics, 35, 1722-1737.

https://doi.org/10.1148/rg.2015150108
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Appendix A

Figure A1

MRI Screening Process Map

Note. Patient MRI ordering process that includes the initial physician assessment, nursing, and

radiology screening.
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Appendix B

Table B1

Magnetic Resonance Imaging: Failure Mode and Effect Analysis

1 Process Step
MRI Recommended for patient's worsening
symptoms
2 Potential Failure Mode The physician Electronic Implantable
does not assess Health Record device history
the patient not reviewed not collected
3 Potential Cause(s) Physician
Physician Bypassed the Physician
overwhelmed review overwhelmed
4 Severity
Process Step #1

4 4 10
5 Probability
Occasional Occasional Uncommon
6 Hazard Score
4 4 10
7 Action (Eliminate, Control, or
Accept) Control Control Eliminate
8 Description of Action 1. Physician 1. Physician 1. Physician
reviews orders reviews orders education.
before sending. before executing 2. patient and
2. Nurse checks them. family education.
for orders. 2. Install an alert 3. Nurse and MRI
3. Remind the to have the Staff education on
physician to order physician review assessing before
the procedure. the order the procedure.
3. Nurse reviews
all orders.
Process Step #2

1 Process Step
The physician places the order for MRI
2 Potential Failure Mode The patient
Order not Order placed in refuses the
placed error procedure
3 Potential Cause(s) Physician work The physician Patient
overload placed the claustrophobic
wrong order
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4 Severity
4 4 1

5 Probability
Occasional Occasional Frequent
6 Hazard Score
4 4 1
7 Action (Eliminate, Control, or
Accept) Control Eliminate Accept
8 Description of Action 1. Physician 1. Physician 1. Educate the
reviews orders checks orders patient before the
before executing before procedure.
them. implementing 2. Pre-medicate the
2. Install an alert them. patient prior to the
to have the 2. Install a procedure to calm
physician review warning to have them.
the order the physician 3. Look for an
3. Nurse reviews review the order alternative
all orders. 3. Nurse reviews procedure to
all orders. assess.

1 Process Step
MRI Screening by the nurse
2 Potential Failure Mode Order not seen MRI screening Screening not
by the nurse not performed accurate or
done in error
3 Potential Cause(s) Patient unable
Nurse not to provide
Nurse familiar with medical
overwhelmed the process implantable
#3Process Step

device history
4 Severity
4 4 10
5 Probability
Frequent Occasional Occasional
6 Hazard Score
4 4 12
7 Action (Eliminate, Control, or
Accept) Accept Control Eliminate
8 Description of Action 1. Education and 1. Education and 1. Education and
training. training. Training on the
2. Add nursing 2. Add a process importance of MRI
assistants to help checklist for MRI screening.
reduce workload. orders. 2. Review of
3. Decrease nurse- history with the
patient ratios. family.
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1 Process Step
MRI screening by the radiology/MRI staff
2 Potential Failure Mode MRI staff Screening form
missed the completed in MRI not
screening error performed
process
3 Potential Cause(s) MRI staff
MRI staff doesn't review MRI staff
overwhelmed the patients' overlooked the
with full history ordered
procedures procedure
4 Severity
#4Process Step

10 10 4
5 Probability
Remote Uncommon Remote
6 Hazard Score
16 16 4
7 Action (Eliminate, Control, or
Accept) Eliminate Eliminate Control
8 Description of Action 1. Education and 1. Education and 1. staff education
training on the training on the and training.
process. process. 2. Implement a list
2. Install an alert 2. Install an alert for review of the
in the system to in the system to electronic medical
have MRI Staff have MRI Staff record for pending
look at the look at the procedures.
completed completed 3. Install an
screening form. screening form. electronic alert that
3. Implement a 3. Implement a informs the staff
procedure procedure that an order has
checklist. checklist. been placed.
Process Step #5

1 Process Step
MRI performed
2 Potential Failure Mode Patient body
Incorrect MRI screening not MRI not read
settings performed by Radiologist
3 Potential Cause(s) Staff not
MRI Staff familiar with Radiologist
overwhelmed the process overwhelmed
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4 Severity
10 10 1
5 Probability
Remote Remote Occasional
6 Hazard Score
8 8 3
7 Action (Eliminate, Control, or
Accept) Eliminate Eliminate Accept
8 Description of Action 1. Staff education 1. Staff education 1. Ensure the
and training and training. radiologist isn't
needed. 2. Two-person overwhelmed.
2. Ensure staff is review of each 2. Add radiologist.
not overworked. patient.
3. Post settings for 3. Installation of
procedures with a Ferromagnetic
secondary staff detection system.
member available
to review.

Note. The figure depicts the elements of the FMEA that can lead to process failures and patient

injuries in the MRI scanner. It also lists the severity, probability, and hazards associated with

those failures and lists actions to diminish the harm those failures have on patients, staff, and

equipment.