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0:39

Today we are honored to welcome Toby gilk for a lecture on preventable

0:43

MRI tragedies.

0:45

Toby gilg is a two-time member of the American College of radiology's MRI

0:49

Safety Committee and a co-author of that group's 2007-2019

0:52

and 2020 Publications.

0:57

He is one of the founding board members of the American Board of Mr. Safety

1:00

and a pasture of the organization and holds

1:03

both their mrso and mrsc certifications.

1:07

He also has his own Consulting service and offers the Advanced MRI safety

1:11

seminar in Dubai.

1:13

At the end of the lecture, please join Toby in a Q&A session where he

1:16

will address questions you may have on today's topic. Please remember

1:19

to use a Q&A feature to submit your questions so we can get to

1:22

as many as we can before our time is up.

1:25

With that we're ready to begin. Today's lecture Toby. Please take it

1:28

from here.

1:29

Thank you very much. And I am Overjoyed at

1:32

the opportunity to share this with you.

1:36

so preventable MRI tragedies

1:41

As mentioned I'm your presenter Toby Tobias gilk.

1:47

A couple of disclosures. So in addition

1:51

to my own consulting company gilk

1:54

Radiology Consultants. I work for a company called

1:57

Radiology planning to architectural equipment planning

2:01

design firm as the name suggest specializes specifically

2:05

in Radiology facility planning design

2:08

construction. Most of the

2:11

work that I do through guilt Radiology Consultants is sort

2:14

of limited time frame Consulting with individual facilities

2:17

or groups. I do have one ongoing

2:20

relationship and that is with a company

2:24

called metrocens that makes feral magnetic detection

2:27

equipment some of the

2:30

information that I'll be presenting was actually developed for

2:33

mattresses and and

2:36

you'll see that when we get to it.

2:39

In addition to that because of my relationship

2:42

with the board of the abmrs. I

2:45

have access to my help

2:48

right the certification questions for the

2:51

exams for Mr. Medical director, Mr.

2:54

Safety Officer and Mr. Safety expert. So whenever

2:58

I give a talk that touches on the subjects of

3:01

MRI safety, I include this disclaimer which essentially

3:04

says that I'm not

3:07

only allowed to I'm encouraged by the ABM arrest to

3:10

talk about MRI safety, but the

3:14

talks are always related to MRI safety Concepts

3:17

and and general principles and are

3:20

not particular to exam content

3:24

for any of the abms exams.

3:27

So

3:28

Today, we're really going to touch on three topical areas.

3:32

We're going to talk about the trajectory

3:35

of MRI safety and MRI accidents

3:39

in the US because to the

3:43

best of my knowledge. We only really have good access to data on

3:46

this in the US. We're going to

3:49

explore some of the

3:53

early MRI accidents are the one that sort of

3:56

really galvanized MRI safety as a discipline and

4:00

then look at some of the stuff that's happened in

4:03

the very recent past and we're gonna

4:07

look at

4:09

Accreditation and accreditation criteria and

4:12

it's promise of safety and

4:16

and how effectively accreditation standards

4:19

within the realm of MRI how effectively

4:22

they withhold their promise of delivering

4:26

safety at the point of care practice.

4:31

So to start off MRI the safe

4:34

modality, right? So

4:38

there are lots of different ways that we could potentially Define safety. But

4:41

in my opinion the the lowest common

4:44

denominator of how we

4:48

might Define that is prevention of injury.

4:52

If we're allowing injuries to occur We are failing in

4:55

really any definition of maintaining

4:58

safety or achieving safety.

5:02

So

5:04

How are we doing historically with respect to

5:07

to MRI and MRI safety?

5:10

Again, we have data from the US. Let's I

5:14

think you can't look at safety or Adverse

5:17

Events or accidents or injuries in a bubble.

5:20

We have to kind of put them in context and I think one of

5:23

the most important pieces of context is what

5:27

has been happening to the number of MRI

5:30

imaging studies that we do and if

5:34

we use the year 2000 as a starting point and we

5:37

look at changes in MRI procedure volume

5:40

in the US over time. It has

5:45

been for the most part over the last couple of decades a

5:48

story of slow and steady growth.

5:52

2000 when covid hit and MRI volumes

5:56

dropped off a cliff and we are still in

6:00

the the rebound phase following the the covid

6:03

disruptions in MRI procedures. So

6:08

this is Imaging volume growth over time.

6:13

What does MRI accident growth over

6:16

time look like so if we were

6:19

doing a better job over time managing reducing

6:23

accidents and injuries then and

6:26

accident curve would be below the blue line.

6:30

if we were doing no better or no worse than the accident curve would

6:33

essentially be overdrawn immediately on top of

6:37

the Blue Line showing procedure volume growth

6:41

Unfortunately, neither of those two things are true.

6:44

And if we look at percentage change of MRI accidents

6:47

using the year 2000 as a baseline And if

6:51

you

6:53

Go forward a few years or backwards a few years you find out that

6:56

even though I only picked the year 2000 because it's a

6:59

nice round number the fact remains. It's pretty

7:02

representative of the decade or

7:06

so that it's in the middle of but if

7:09

we look at this

7:11

If you do a linear regression of both.

7:15

procedure volume growth and accident volume

7:18

growth

7:20

You find that.

7:22

The linear regression shows almost three times the

7:25

rate of growth on average across

7:28

this time frame of MRI accidents

7:31

as opposed to procedure volume.

7:35

Said simply whatever it is that we're growing in MRI

7:38

volumes. We're growing almost three

7:41

times that much and MRI accidents.

7:46

That is an unsustainable pathway.

7:50

It's important to note that the red line the accident

7:53

data in that previous graph. There

7:56

are a couple of really important things that

7:59

aren't included in that when there's

8:03

an adverse event acting, you know,

8:06

an MRI acting upon a medication pump

8:09

or a pacemaker an implant or

8:12

medical device and somehow the interaction between the MRI and

8:16

the medical device causes the medical device

8:19

to malfunction or behave inappropriately

8:23

that adverse event

8:26

is categorized under the medication pump

8:29

or the pacemaker or whatever the device is. It's not

8:32

categorized under MRI. So all of

8:35

those Adverse Events involving

8:40

Interaction interference with implants and

8:43

devices. Those are not counted in that

8:46

red line data. We saw in the previous slide similarly drugs

8:49

are tracked separately. So any

8:52

adverse reactions with contrast agents

8:56

delivered in MRI also not included in the

8:59

red line, which means the actual

9:02

number of real MRI specific

9:05

accidents and injuries is actually greater than

9:09

what we see in that red line data from the

9:12

previous slide.

9:13

So MRI accidents then and

9:17

now let's let's start with then. Let's

9:20

start at the very beginning what a very good place to

9:23

start. We're gonna start with the mother of all MRI

9:26

accidents the Michael colombini

9:30

accident. Now if the name doesn't

9:33

sound familiar to you, that's okay. You may be

9:36

more familiar with it as the young boy who died

9:39

when an oxygen cylinder was brought into the magnet room.

9:44

What we're looking at right now is a floor plan of the facility where

9:47

this?

9:49

Bellwether accident actually happened, right?

9:53

And if you're not familiar or not comfortable looking

9:56

at floor plans architectural drawings, this is

10:00

essentially a one meter

10:03

thick coronal slice through the building and if

10:06

that helps you sort of visualize the building that's that's

10:10

exactly what a floor plan is.

10:12

So I'm gonna walk us through very quickly and

10:15

and not a whole lot of detail this particular accident.

10:18

So we're gonna start with the anesthesiologist. I'm

10:22

just I'm dropping him in the MRI scanner room.

10:25

That's where he winds up. But he

10:29

begins where the boy Michael colombini

10:32

the blue star and he's in the induction Bay,

10:35

right? And the anesthesiologist gives him

10:39

a sedative before bringing him

10:42

into the MRI scanner room in addition to the anesthesiologist and

10:46

the boy himself. We have two technologists on

10:49

duty. One of them is about to run the study the other of

10:52

which is doing post-processing from a previous study.

10:56

Now as I say with the anesthesiologist gave the

10:59

boy a sedative they move him into the

11:02

MRI room. Now as they're moving in from

11:06

the gurney onto the MRI exam table. He pushes

11:10

through that first dose of her said and they give him a second dose.

11:13

And and then they put the nasal cannula on him and

11:17

they're coming putting the top half of the

11:20

head coil on him and he pushes through his

11:23

second dose of her said and so they give him a third dose.

11:27

At this point the MRI technologist who was assisting with positioning

11:30

goes back into the scan room. The anesthesiologist.

11:33

Is there waiting for the study to

11:37

start and sees the pulse ox beginning to

11:40

drop

11:41

it would appear that they have over sedated the

11:44

boy and it's suppressing respiratory function and

11:47

anesthesiologist goes over to the wall outlet

11:50

to adjust the flow of oxygen going

11:54

to the cannula.

11:55

But there's no flow. There's no air. There's no

11:58

Oxygen coming out of the wall outlet. So the

12:02

anesthesiologist knocks on the window and goes to the door having.

12:07

Called for the technologist. There was no intercom in this setup. The

12:10

technologist comes around and says, what's up,

12:13

doc. What can I do for you?

12:16

Anesthesiologist says, you know, my patient is

12:19

desatting. The oxygen is not working. I need you

12:22

to fix the oxygen now.

12:26

This Tech was a very new hire to the

12:29

MRI facility and she knew that there

12:32

was something odd about the oxygen it wasn't piped in

12:36

from the main hospital Central Supply, but you wasn't exactly

12:39

sure so she went back to the more senior

12:42

Tech who was doing the post processing and the

12:46

more senior Tech said, this is something that's really important for

12:49

you to understand how it works at this facility. You don't

12:52

know let me show you let's do this together.

12:56

So the two of them go into the equipment room or system component

12:59

room of the MRI where there's a bulk cylinder

13:02

that feeds a line that goes through

13:05

the wall into the magnet room and that bulk cylinder had run dry.

13:09

So more senior Tech is showing the more Junior Tech how

13:12

to go about swapping out the bulk cylinders.

13:16

In the meantime the patient's oxygen sat continues to

13:20

drop and drop and drop in the anesthesiologist becomes more

13:24

and more agitated.

13:26

And he's at the door and he's Yelling to the technologist who

13:29

now are essentially in an acoustically separated

13:33

room and they can't hear anything that the

13:36

radiologist. Excuse me. The anesthesiologist is saying

13:39

so they're oblivious to his increasing levels

13:42

of agitation. So he's yelling and

13:45

yelling and yelling for oxygen and yelling in

13:49

frustration that the texts are responding to him.

13:52

And In This Moment a nurse who had left something

13:55

in the department from a previous patient lets herself

14:00

into the the MRI area and she

14:03

hears the anesthesiologist calling for oxygen

14:06

for this dating child.

14:09

The nurse remembers from her earlier trip

14:12

down to MRI that she saw portable

14:16

cylinders. Where did she see them?

14:19

She goes into the induction Bay and she sees a

14:22

few portable oxygen cylinders.

14:25

She picks one of them up and hands it to the radiologist. The

14:28

radiologist turns around takes two steps into the room and

14:31

the cylinder flies into the

14:34

MRI scanner where the boy is positioned strikes the

14:37

boy in the head and face the injuries,

14:41

ultimately fatal, but the

14:44

immediate reaction of the anesthesiologist on

14:48

the nurse is they call the code Team Code team

14:51

comes and sees this and they Panic a

14:54

little bit because while they know how to treat

14:59

Trauma, they don't know how to extricate the

15:02

boy out of the MRI because he's somewhat pinned by

15:05

the cylinder. The code team actually calls a

15:09

paramedic team who was responding dropping a patient off

15:12

and together the code team and the

15:15

paramedics and the anesthesiologist and

15:19

a nurse. They extricate the boy and they're Wheeling

15:22

into the ER and about this moment the

15:25

two technologists appear from the equipment room

15:28

and announce that everything is fine because

15:31

they've swapped the cylinders and now the oxygen is

15:35

working fine.

15:36

right

15:38

so

15:40

if you want more information about a more in-depth root cause

15:44

analysis if you have your phone shoot this

15:48

QR code, I've got a few more QR codes in the in the presentation.

15:54

Ask yourself in this particular story. What were the

15:57

contributors to this accident? Right was

16:00

it the the training or the knowledge level of

16:03

the anesthesiologist where the training and knowledge level

16:07

of the nurse was at the

16:10

technologists a lot has been made today of lesser

16:13

Staffing at the

16:16

point of care. This was an instance where we had two technologists at

16:20

the point of care and this accident still occurred.

16:23

Was it a question of who

16:26

had access to the MRI suite was

16:29

it a problem with the cylinders?

16:32

I would argue that each and every one of those elements actually plays a

16:35

contributing role and if you compare those

16:39

elements to existing licensure

16:42

regulatory accreditation standards,

16:45

I think that you will find that it

16:48

would really not be that difficult to be in full

16:51

compliance with your state licensed your requirements and perhaps

16:54

your Enterprise or modality level

16:58

of accreditation minimum requirements and still have

17:01

this accident occur to keep again, we're going

17:05

to look at accreditation requirements specifically here

17:08

a little bit later in the presentation.

17:11

So that was in 2001 that

17:15

accident happened.

17:18

Have have we learned our lessons?

17:22

Short answer that is no.

17:25

Just this past weekend. I had

17:28

to rebuild this entire presentation because this past weekend somebody sent

17:31

me the image on the left, which is

17:35

a scooter for somebody who's had

17:38

foot or ankle surgery and can't put weight on it. And so

17:41

you essentially put one leg on the scooter and wheel yourself

17:44

around.

17:46

A patient wield this scooter into the MRI scanner

17:50

room. This is

17:52

Friday of last week six days ago

17:56

the Imaging Center where this occurred apparently rallied all

17:59

of their staff and got everybody all around and

18:02

they were trying to yank the the scooter out of the bore

18:06

of the MRI when the patient informed them the

18:09

patient police officer informed them

18:12

that in the little bag that hangs on

18:15

the handlebars was a pistol at that

18:19

moment. The Imaging Center stopped trying to

18:22

pull the scooter out of the MRI and

18:26

subsequently called for ramp down

18:29

from the manufacturer.

18:33

We can't for the life of us. We might not have seen the

18:37

pistol the handgun but we can't

18:40

for the life of us pretend that we didn't see a giant metal

18:43

scooter and recognize it

18:46

as as a potential risk.

18:50

So that was an image that I got this weekend. I posted

18:54

it and I said, oh my goodness these things are still happening.

18:59

And I opened the floodgates immediately after

19:02

I got this picture which I understood was

19:05

also an MRI accidents transport chair that happened

19:09

last week. Somebody sent me that

19:12

picture of I posted it immediately after I

19:15

got this picture which is a wheelchair stuck

19:18

in an MRI. I

19:24

heard from somebody who understood that

19:27

at least the initial cost estimate and this may

19:30

have included interrupted patient care services, but the

19:33

initial estimate what ran in seven figures

19:36

for what it was going to cost to restore

19:40

this service.

19:42

So I posted this and then I got this one. It's

19:45

a little difficult to see because this photo

19:48

is taken through the control room window, but there's

19:51

an oxygen cylinder in one of those little

19:54

wheeled dollies and the

19:57

person who sent this to me said I happened to know what Imaging

20:02

company one of your previous

20:05

images was from this is from a different location

20:08

same Imaging company as one of the other images.

20:13

Just add one of their different locations from a few weeks ago. I posted

20:17

it and I got this one, which is a syringe

20:20

pump on a non Mr. Conditional

20:23

syringe pump. It would appear inside the

20:26

bore of the magnets. I posted that one.

20:29

I got this one, which is a floor cleaner in an

20:32

MRI. I got this one which

20:35

was an MR conditional infusion

20:39

pump that had mistakenly been

20:42

attached to a conventional IV poll.

20:46

And while the pump was safe. This is

20:50

a couple of folks with bed sheets wrapped around the pole trying

20:53

desperately to keep it from going into the bore of

20:57

the magnet.

20:59

They had already removed the pump on when this picture was taken

21:02

and then I got this picture, which is

21:06

a ventilator up against the MRI.

21:10

So the notion that somehow these MRI

21:14

accidents are a relic

21:17

of our distant past.

21:20

These pictures that I'm just shared with you. This little

21:23

photo montage is a collection

21:26

of accidents that have happened most of

21:30

them within the last couple of weeks in different

21:33

locations. Most of these are throughout the US. I know

21:36

at least one of them is outside the US

21:41

These are not in our rear view mirror. This is not ancient

21:44

history this continues to occur

21:47

on a regular and frequent basis.

21:52

and if that is news to you, it's because

21:56

We do an excellent job of hiding our

22:00

dirty laundry in this profession. It is

22:04

a rarity that we see any of these much less,

22:07

you know a flurry of them. Like I just shared with

22:10

you of recent history.

22:14

One of them that got buried.

22:18

Tried to get buried but Western incident

22:21

in which a prisoner in

22:25

handcuffs and shackles and a

22:28

corrections officer both.

22:32

Went into an MRI scanner room and both got

22:35

stuck to the magnet. I've written sort of

22:38

a

22:41

preliminary investigative article if you

22:45

shoot the QR code on the screen it will take you to that.

22:49

I posted it on LinkedIn so you if you

22:53

find me on LinkedIn, you can also just find that article.

23:00

so

23:01

What is the state of MRI safety right? We

23:04

know how accidents happen now. I

23:08

just showed you a whole bunch of projectile accidents because those are

23:11

the ones that make the best pictures but those are by no means the only

23:14

type of MRI accidents or injuries that occur.

23:18

We have a really good understanding of

23:21

virtually all of the the means

23:25

by which.

23:27

People get injured in MRI the means by which

23:30

accidents occur in MRI.

23:33

in addition to that we know how to prevent them

23:36

and we know that those preventions are

23:40

remarkably effective when properly deployed. So

23:43

if we know how to

23:46

prevent or we know how the accidents occur we know how to prevent them.

23:51

Why do I have a photo montage to

23:54

show you right?

23:56

So let's start by

24:00

by addressing the point that I was just making that, you

24:03

know, the projectile accidents are the ones that are most photogenic,

24:06

but overall. How do people

24:09

get injured in MRI?

24:12

They're actually.

24:14

A handful of different injury types that are the most

24:17

common and then within each injury type. They're

24:20

actually a few different causal Pathways

24:24

that can wind up producing that

24:27

injury type.

24:29

So not only do we need to look at injury type, but we need to look at causal

24:32

pathway.

24:34

And again, as I said at the beginning there are lots

24:37

of ways that we can talk about safety or Define safety, but

24:40

I think prevention of injury should be

24:44

the lowest common denominator the thing upon which

24:47

we can all agree.

24:51

So how do we cause injury and MRI? This is

24:55

and and the QR code will be on the

24:58

next several slides. So if you don't make it quite in

25:01

time on this one, you'll have a few

25:04

more shots. This is a study that I

25:07

did got published

25:10

by metrosense. This is actually a repeat of a

25:13

study that I did with Dr. Emmanuel kanal that got

25:17

the paper behind this got turned

25:20

into a scientific presentation at the 2012. Rsna.

25:25

So I did that.

25:27

Study with Dr. Canal that got presented at rsna

25:30

in 2012 with two years of data. This is

25:33

a repeat of that study with two years of more contemporary data.

25:38

In general 95% of

25:42

the injury accidents that we evaluated fell

25:45

into one of three categories Burns

25:48

projectiles and hearing damage 5%

25:51

of the reported injury accidents.

25:56

Are everything else? So if we can address Burns projectiles

25:59

and hearing damage, we can actually successfully address

26:03

95% of injury accidents

26:06

in MRI.

26:08

So when?

26:11

Dr. Canal and I and then later me on my own looked at.

26:17

Projectile accidents we'll start there because they're the most photogenic. What

26:20

are the steps existing best

26:24

practices now?

26:27

When Dr. Canal and I did this for the 2012 rsna

26:30

meeting we used the then most recent

26:33

most up-to-date ACR guidance document on

26:36

safe Mr. Practices the 2007 edition of that.

26:40

So we took three best practices that

26:43

came directly from that ACR 2007

26:46

document utilizing the

26:49

acr4 Zone which links Access Control to

26:52

screening and supervision. Number one. Number two,

26:56

the use of feral magnetic detection systems to alert

26:59

us for objects that are potential projectile

27:03

threat objects and number three

27:06

conspicuously labeling the Mr. Safety status

27:09

of objects and device that reside inside

27:12

the MRI suite, right?

27:15

If you applied those three protections 69%

27:18

of all the injury accidents

27:21

in the more recent evaluation 69% of

27:25

them.

27:27

Could have been prevented by one or a combination of these three.

27:33

existing best practices

27:35

Now the 69% has asterisks next to it because the 31%

27:38

in the two years of data that we looked at where

27:41

it wouldn't have prevented that entire 31%

27:44

of the cohort was service Personnel. So

27:48

another way of looking at this is it would have been these three

27:51

preventions would have been a hundred percent effective in clinical

27:54

scenarios, and it was only in a service situation

27:58

where they begin to get weaker,

28:01

right?

28:03

So that's projectiles. What about Burns same thing

28:06

Dr. Canal? And I identified three existing best

28:09

practices taken directly from the ACR 2007 document

28:13

and they were utilizing either an

28:17

air gap or padding. We said one centimeter, but

28:20

really it was whatever the Mr. System manufacturer specifies

28:23

for that particular system, but provide an air gap or

28:27

padding between the patient and the transmitting RF element

28:30

remove unneeded electrically conductive material and

28:33

prevent large caliber body Loops skin

28:36

to skin contact.

28:39

You do those three things individually or in

28:42

combination and they would have likely prevented 94% of

28:46

the burn injury cases that were evaluated

28:49

in that two-year period 94% prevention of

28:53

burning injuries with these three protections, right?

28:58

The third most frequent form of reported

29:01

injury MRI classified injury is

29:04

hearing damage. Unfortunately only

29:09

about 11% of the hearing damage

29:12

cases were identified the

29:15

patient not having been provided with hearing

29:18

protection. So

29:21

low hanging fruit the first thing we can suggest and again this comes

29:24

directly from that 2007 ACR document

29:27

require the use of hearing protection.

29:32

And that will fix the 11%

29:35

Now these next two were not

29:38

parts of that 2007 document they have

29:41

been added in to subsequent additions and

29:44

they are at a verify fit and function

29:47

of provided hearing protection and having

29:50

at least one alternative means if you

29:54

normally provide patients with the compressible foam earplugs

29:57

make the over the

30:00

ear muffs available for patients. If they

30:03

can't or won't use the compressible foam plugs

30:06

give them an alternative.

30:10

So of that more recent study that I did

30:13

with metrosense if we take those three Burns

30:16

projectiles and hearing damage.

30:20

The injury accidents and we apply the

30:24

three.

30:26

Preventions for projectiles the three preventions for Burns and

30:29

the one that we measured from the 2007

30:32

document of providing hearing protection for auditory injury.

30:38

Those would prevent 74% of the

30:41

Mr. Injury accidents.

30:45

Which is nothing to sneeze at and if we exclude

30:48

the service Personnel from this that

30:51

same data essentially turns into 80% prevention

30:55

rate and that's even before we add

30:58

in our two additional protections for

31:02

hearing protection.

31:04

Now hearing protection or hearing injury cases is really the

31:07

smallest slice of those three. So the additional protections

31:10

may not have a huge impact on the overall numbers,

31:13

but they can help a significant

31:16

number of the patients who use hearing

31:20

protection incorrectly.

31:24

so

31:26

we have the expectation.

31:29

The expectation is actually given to us by accreditation

31:32

organizations, right the accreditation

31:36

organizations. What is it that they promise?

31:40

they promise assurances of

31:45

Industry standard minimum levels of image

31:48

quality and patient safety and

31:51

I'm talking here specifically about accreditation standards

31:54

as applied to Radiology.

31:57

So

31:59

if we take that and we look specifically at MRI

32:02

safety and we look specifically at those

32:05

preventions that

32:08

take them together are going to give us somewhere between 74 80% Effectiveness

32:11

in terms of reducing injury accidents.

32:16

That's evaluate the degree to which existing accreditation

32:19

standards actually fulfill their

32:22

promise of safety when it comes to MRI, right?

32:28

So we're gonna look at tables for

32:31

the next three slides. So on

32:35

the left are the two most popular Hospital parenz

32:38

age accrediting organization and

32:41

the two most popular parents Opie

32:45

outpatient accrediting organizations Radiology specific

32:49

accrediting organizations, and I have

32:52

gone through their site accreditation requirements

32:55

for our best practice

32:59

protections for projectiles Burns and

33:02

hearing injuries. Now before I give you my results,

33:06

I want you to identify and think

33:09

for yourself.

33:10

Requiring the four zones requiring ferromagnetic detection

33:14

and requiring conspicuous device

33:17

labeling for Mr. Safety properties. How many

33:21

of these three do you think your accreditation

33:24

organization requires? And if

33:28

you're at a hospital site and you have both for example Joint

33:31

Commission or DMV and ACR

33:37

Find them. How many do you think they require?

33:43

Joint Commission has a requirement that more or

33:46

less describes zones three and four without invoking

33:49

the acr4zone. So they

33:53

they get two thirds of a point for

33:56

the four zones the ACR

33:59

which developed the four zone

34:02

model doesn't require it as a minimum

34:05

site required element of their MRI and

34:09

breast MRI accreditation programs.

34:14

Apart from The Joint Commission getting partial credit for one answer and the

34:18

accreditation organization minimum performance

34:22

for for protecting MRI patients.

34:26

from projectiles is is

34:30

pretty poor

34:32

pretty awful. In fact now let's repeat this exercise. We're

34:35

going to do the same for crediting organizations. But now

34:38

we're going to do it for burns right again in

34:41

your mind. I want you to think how many

34:44

of requiring padding between

34:47

the patient and the transmitting RF element

34:50

Removing electrically conductive material from the bore or

34:53

using EMR conditional if it has to be there and preventing

34:57

large caliber body Loops or padding the patient's tissues

35:00

from it themselves. How many of these

35:03

three are minimum requirements from Joint Commission

35:06

DMV ACR and IAC?

35:12

None of them require any of them.

35:15

Now I should say that joint commission

35:18

requires training on Burn risks

35:22

ACR requires the

35:25

existence of a policy on thermal injuries.

35:30

None of them actually require the explicit actions

35:33

the the direct preventions that would stop these

35:37

injuries from occurring requiring a

35:40

policy requiring training when you

35:44

don't require the specific actions is

35:49

clearly not effective if we look at the trajectory over time. All

35:52

right, so that was projectiles and burns. What

35:56

about hearing protection, right?

35:58

Requiring hearing protection verifying the fit and function

36:01

of the hearing protection providing an alternative means of

36:04

hearing protection again identify your

36:07

crediting organization. Tell me how many of these you

36:11

think are explicitly required as minimums

36:14

for your accreditation.

36:17

And if you were noticing a trend in the previous couple

36:20

of slides and you probably won't be terribly

36:23

surprised to see that Trend continue again. None

36:27

of these four crediting organizations

36:30

have explicit requirements for

36:33

these injury prevention

36:36

actions.

36:39

Pulled from best practice documentation

36:42

and the verify fit

36:46

and function and provide alternative means I know

36:49

verify fit and function has been Incorporated in subsequent ACR MRI

36:53

safety guidance, and I think provide alternative means

36:56

has as well. So

37:00

These are best practices. None of these are our you

37:03

know from outer space Bizarro suggestion.

37:07

They're in the

37:10

industry standard best practice for MRI safety.

37:14

Just don't use them. We don't

37:18

incorporate them.

37:21

right, so

37:23

For our three injury types and

37:26

the three preventions for each injury type three times

37:30

three nine total preventions.

37:33

How do our accrediting organizations Fair?

37:37

Specific to MRI accidents and injuries Joint Commission

37:40

gets partial credit for one of the nine criteria the

37:43

other three evaluated accrediting criteria

37:47

or organizations and their criteria. They strike

37:52

out three times zero for

37:55

nine on on the remainder.

37:58

And I can't help but point out how the

38:02

ACR.

38:03

which has I absolutely unequivocally

38:07

applaud the ACR for their MRI

38:10

safety best practices documentation it is

38:14

It is a world standard because it is earned that

38:17

position.

38:19

Their accreditation however goes to Great

38:22

Lengths to dance around the idea that we're

38:25

actually going to require the practices identified

38:28

in now the manual on Mr. Safety

38:31

as a part of the accreditation.

38:35

We know how injury accidents occur. We know what

38:38

the effective preventions are. No body

38:41

on the outside is requiring them.

38:47

In fact this starting this weekend is

38:50

the ACR annual meeting. I'm actually I'm gonna

38:53

be there on Sunday. I got a poster accepted which

38:57

is how to QC MRI

39:00

safety standards accreditation standards. And

39:04

essentially I'm going to talk through

39:07

and if you hit the QR

39:10

code, you're going to see sort of the long form

39:13

article and included in that will be the copy

39:16

of the poster. You're more than welcome to

39:19

take a look at it. If you're attending the ACR annual

39:22

meeting. I'm invite

39:25

you to seek me out on Sunday. The only

39:29

day that I'm gonna be there unfortunately and ask your

39:33

colleagues about why ACR accreditation

39:37

why no accreditation

39:40

organizations really have the established

39:44

best practice prevention that would prevent

39:47

types of injuries

39:50

So the I talked about the data in the

39:54

study that I did with Dr. Canal and then the study repeated

39:57

with mattresses more recently

40:00

that data is actually

40:03

sort of captured in table format

40:06

right here and then

40:10

the information on the accreditation

40:13

of those

40:15

Top four accrediting organizations and their performance on

40:18

those injury prevention criteria on the

40:21

right hand side.

40:26

So

40:27

to summarize and

40:30

Just as a thought if you have questions spurred by

40:33

this now is the time to try and get them in. So to

40:36

start typing your your questions in the Q&A but to

40:40

summarize.

40:43

We talk about MRI as the quote unquote

40:46

safe modality.

40:51

The way in which we Define it as the safe modality really

40:54

appears not

40:57

to take into consideration the thought the

41:01

fact that we can and

41:04

do injure people.

41:06

On the regular we impale people

41:10

we Crush people we burn people we

41:14

interfere with the operation of

41:17

their medical devices that wind up poisoning them

41:20

or delivering therapy when it shouldn't or not delivering

41:24

therapy when it should.

41:27

We in MRI we injure

41:30

and kill people.

41:33

and almost every single instance where we

41:36

do that those injuries are preventable through

41:39

existing best practices

41:42

and if you look over time,

41:47

We have been doing a poorer and poorer

41:50

job keeping up with increases in

41:54

volume and managing MRI safety and

41:57

keeping it at worst.

42:00

On par with the growth in MRI. Imaging

42:04

Regulation and accreditation organizations really haven't

42:09

kept up when they

42:12

were never really there to begin with but they certainly haven't given

42:15

us the tools the the minimum requirements to

42:19

help protect patients.

42:24

And when we protect patients, we protect the

42:27

institution we protect the individual caregivers

42:30

as Radiologists.

42:33

You are captains of

42:36

the ship with respect to radiologic services.

42:41

Legally that means your responsible for the

42:44

safe execution of the studies. We beat

42:48

on Radiologists all the time for Quality

42:51

accuracy and timeliness of interpretation.

42:55

And yes, those are really important and those are you know

42:59

rvued if I can make that a verb.

43:04

In addition to that you have a legal responsibility to the

43:07

safe execution of the exam which means the

43:10

actions of the technologists or

43:13

nurses or Tech AIDS or others who

43:17

operate within the MRI environment?

43:20

so

43:23

as it stands today.

43:25

licensure regulation accreditation does not despite

43:28

its promises does not promise

43:31

MRI safety and the

43:36

the individuals the organizations that are responsible for

43:39

safety, which is the development

43:42

and implementation of standards of practice.

43:47

The responsible party is you is the radiologist

43:50

is the hospital is the imaging centers. And

43:53

so each of each of

43:57

us is on the hook for our part

44:00

of MRI safety.

44:04

With that I very much want to thank you for your time and

44:07

attention. We'll take as many

44:11

questions as time allows for if you

44:14

have questions that we can't get to or that you would

44:17

rather not ask in a public forum here is some of my contact information

44:20

you're free to reach out to me. If you

44:24

have an ongoing interest in MRI safety, I would

44:27

very strongly recommend if you're on Facebook

44:30

join the Facebook MRI safety group page. It

44:33

is an amazing resource of

44:37

more the 27,000 peers from around

44:40

the world and Incredibly helpful

44:43

resource for answering MRI safety questions.

44:47

and with that

44:48

speaking of questions

44:51

Toby we have quite a few questions, so we will try to

44:54

get to them all.

44:56

First one is what's the best form of hearing protection or highly

45:00

recommended one?

45:03

Um

45:05

I will give you my personal preference and that is

45:08

for the over-the-ear sound suppression sound

45:11

suppressor muffs. Obviously, you have to get the

45:14

ones that are all plastic and they don't work

45:18

on many patients inside a

45:21

head coil. So

45:25

This this has limited utility larger patients

45:29

in head coils. You're going to have to use in the ear types

45:32

of hearing protection. The reason

45:35

that I suggest First Choice being the

45:38

muffs is actually two reasons one.

45:41

There's actually

45:45

Technique involved in properly applying the compressible foam

45:49

ear plugs and if the patient

45:52

doesn't understand the technique you they

45:55

may look like they've put them in correctly,

45:58

but they may not be getting anywhere close to the sound protection that

46:01

the packaged indicates over the

46:05

ear muffs really require almost no technique. I mean if you

46:08

can put on a Parry earmuffs you you are protected right

46:11

so

46:14

Technique is is one advantage of the muffs. Number two generally

46:17

speaking. The muffs will provide equal if

46:21

not better sound suppression or noise reduction then

46:24

the in the earplugs. So if

46:28

you can use the over the

46:31

earmuffs, that's that's my preferred recommendation,

46:34

and I recognize that's not going to work in all situations.

46:39

Between the compressible foam earplugs and something a none

46:43

over the year muff sound suppression. There's what's

46:47

called swimmers putty and it says silicon putty and

46:50

you put it on the outer aspect or outer anatomy

46:53

of the ear and it essentially creates an airtight seal,

46:56

but it doesn't migrate down into the outer Canal

46:59

quite so much. There's some patients who just get the

47:02

heebie jeebies about putting things in their ears and for

47:05

them that swimmers putty may be an

47:08

acceptable alternative. It's they're

47:12

more expensive than the compressible foam plugs. So you probably

47:15

don't want to make that your first choice but as an alternative

47:18

means it will be the best choice

47:21

for some patients great question.

47:28

right

47:29

let's see who are MRI accidents reported

47:32

to who follows the

47:35

them up and how how is it that so many go

47:38

unreported?

47:43

The problem is that nobody reports these accidents. We actually

47:49

As a part of that that 2012 study that Dr. Canal and

47:52

I did we actually compared an 18-month

47:55

period of FDA accident reports

47:58

with

48:01

the state of Pennsylvania has a mandatory accident reporting.

48:06

Requirement and so we looked

48:09

at Pennsylvania accident reports MRI accident

48:13

reports versus National us

48:16

FDA accident reports and modeling

48:19

the Pennsylvania data out to sort of a national

48:22

scale. It suggests

48:25

to us that the the FDA

48:28

reported accidents are maybe two

48:32

percent of what actually occurs.

48:37

the reporting structure to the FDA it

48:41

if a patient if somebody not just a patient if anybody dies

48:44

as a result of an interaction with an FDA regulated

48:48

device the hospital or or medical

48:51

provider has to report it directly to the FDA short

48:54

of killing somebody.

48:58

the

49:00

Standard pathway for reporting accidents is through the OEM

49:03

the original equipment manufacturer of that object

49:06

or device your MRI scanner. So

49:09

for MRI, that's your Siemens is your

49:12

Philips is your GE is your cannons your

49:15

Those groups so somebody from the organization from

49:18

the hospital or Imaging Center reports it to the manufacturer the

49:22

manufacturer then beams whether or not it hits a

49:25

mandatory reporting trigger to then report to the

49:28

FDA. So if the

49:31

hospital doesn't

49:34

Share the information with the the OEM the service Personnel, then

49:37

it will never make it to

49:40

that reporting party. Also, if

49:44

an accident occurs, and even

49:47

if somebody is injured, but if the injury is

49:50

not to a level that it requires hospital admission, technically,

49:54

it doesn't meet the minimum.

50:00

Requirements the minimum threshold for mandatory reporting

50:03

so we can hit somebody,

50:06

you know in lacerate them and require stitches

50:09

we can give them a concussion we can break their arm. But as

50:12

long as that person that injured party is not

50:15

admitted to a hospital.

50:18

Technically, we're not required to report it to the FDA.

50:22

So who reports and and why too few

50:25

of us because there are too many loopholes in in

50:29

the reporting structure and process and we

50:33

really need to just like

50:36

my photo montage. We need to share this information because

50:39

all MRI providers Radiologists technologists

50:42

need to have a better understanding of what

50:46

the frequency of these types of accidents are and what

50:49

the potential consequences and in terms of injury and

50:52

liability.

50:54

We need to report more so that we all have a better understanding and

50:57

take the appropriate steps.

51:03

As a building regulator, I'd like to know more about the four zones and

51:07

the MRI suite where can I find that information? Oh, that's

51:10

a great question.

51:14

So

51:17

Probably the best places the original source, which is the acr's

51:20

Publications. So

51:24

They published a draft version of a 2023 manual on

51:28

MRI safety. I think they pulled it back from their website. So

51:31

at the moment the the most up-to-date information

51:34

you can get.

51:37

Is from the 2020 ACR manual

51:40

on Mr. Safety and it describes

51:43

the four zones, and actually there's an appendix within the

51:46

document.

51:48

that narratively walks you through sort of the patient's

51:51

experience of an MRI facility in MRI suite,

51:54

right and it talks about reception and patient prep

51:58

and changing and secured access and it

52:02

there are diagrams in the document. But in addition to that in this

52:05

appendix, there is sort of this narrative that explains what

52:10

What happens at what point in the patient experience and

52:13

how that relates to the physical environment

52:16

safety?

52:21

And your research do the accreditation and regulations reflect

52:24

the increased caseload of higher acute patient types having

52:27

Mr. Imaging.

52:34

Joint Commission I think

52:37

has in their standards something about you know managing risks

52:42

associated with patient acuity.

52:47

but that's

52:49

That's kind of a throwaway statement in the absence of any

52:52

sort of specific criteria. In my

52:56

opinion. I think what providers

53:00

really need are sort of

53:03

explicit statements of

53:05

What does increased patient Acuity look like

53:08

and what additional demands should that put on

53:11

us in terms of maintaining patient safety?

53:16

Um, there is a building code

53:19

document called fgi, facilities

53:22

guidelines Institute and fgi, publishes

53:27

hospital and outpatient facility design

53:30

criteria.

53:32

And from the 2018 edition of

53:36

fgi, and the more recent ones they actually

53:39

introduce a concept called patient Acuity.

53:43

Classifications. Right? An MRI

53:47

is not an MRI is not an MRI. We're not going to deal with

53:50

the same patience in the same clinical demands of a

53:53

magnet that is in an orthopedists office

53:57

versus a magnet that's

54:00

adjacent to the trauma. They have a level one trauma center,

54:03

right? They can be the exact same MRI scanner.

54:06

But what we are going to demand of

54:09

those in terms of Clinical Services are going

54:13

to be totally different we're going to have different patients different

54:16

patient levels of Acuity or intervention or

54:19

anesthesia sedation.

54:23

The whole patient care environment is going to be radically different

54:26

one to the next. So why would

54:29

we design or plan MRI facilities that

54:32

are cookie cutters of one another shouldn't

54:35

we be looking at? What are we

54:39

doing to this patient? What condition is the patient in when they

54:42

arrive they come in from the ICU? Are they a walkie-talkie,

54:45

you know elective knee exam.

54:49

We're gonna have different infrastructure needs different staffing needs different

54:52

patient monitoring needs different clinical support needs for

54:56

the higher Acuity patient or patients with

54:59

greater invasive demands for their study. So

55:02

in the 2018 fgi documents

55:06

it essentially built a Class 1

55:09

Class 2 class 3 that roughly corresponds with

55:12

exam procedure and surgery.

55:17

so

55:18

when it comes to that the the accrediting organizations really have

55:21

not touched this issue not effectively

55:25

any way to my way of thinking but if

55:29

you look at the fgi it at least

55:32

gives us sort of a framework and gives us some minimum criteria for

55:35

equipment and personnel and

55:38

infrastructure and that sort of thing that maybe really helpful. That's

55:41

a great question.

55:44

Okay, there's a couple questions regarding the shorter time

55:48

slots and whether that has had an impact on some of these accidents in

55:51

your opinion and maybe what you've seen in your research.

55:54

Do you feel like that's a safe correlation to

55:57

make

56:00

um

56:02

I think we can look at that and intuitively sort of

56:05

say this feels like it's it's a contributing factor. I

56:08

I

56:11

would share that feeling I

56:15

I personally think that the greater contribution more

56:19

so than than short.

56:23

Schedule Windows is all of the additional responsibility

56:27

that we've been layering on MRI technologists,

56:30

you know, 20 years ago.

56:34

MRI technologists, sat and scammed and

56:37

that was their job.

56:40

In a lot of facilities today, it's scan while

56:43

you're scanning your actively looking up

56:47

and implant or device or contraindication for a patient

56:50

who's you know future on the schedule you're dealing

56:53

with add-ins you're trying to rejuggle the schedule because

56:56

somebody knows showed if you're in a hospital environment, you know,

57:00

you've got the the neurosurgeon whose barking

57:03

at the technologist because clearance for their Neurosurgical patients,

57:07

you know in the device or implant that was poorly documented.

57:12

There's so many ancillary, you know

57:15

tertiary responsibilities sort of layered on

57:18

the MRI technologist.

57:21

If we look at what shorter appointment times mean, right what

57:24

we're taking

57:27

out from a longer appointment time is we're

57:30

just taking out additional sequences

57:34

or we're doing the same number of sequences. We're just

57:37

reducing the time that any one of them takes right? So we

57:40

still have to deal with exactly the same elements

57:43

in terms of getting patients on the table and off the table and

57:46

if a tech is scanning, that's what they should

57:49

be doing. So the reduced

57:53

time frame alone, I don't

57:56

think is is really the culprit. It's

57:59

the reduced time frame in concert with all of

58:02

these overlaid responsibilities on the

58:05

MRI technologist, and it's that

58:08

combination that is

58:12

In my opinion leading to distraction that

58:16

a number of the accidents that

58:19

we looked at pictures of and some other recent ones. If you

58:23

look at that article about the The Prisoner and

58:26

the guard that got stuck to the magnet

58:29

distraction also played a key role.

58:32

There was earlier a few weeks ago pictures of

58:36

a bed stuck to a magnet and that

58:40

again was an incidents of technologist

58:43

according to what I've heard so far the

58:46

technologist who was distracted in the moment and and

58:49

let that go in.

58:51

so

58:53

it's it's distraction exacerbated by shorter appointment schedules,

58:56

but it's distraction that is

58:59

is the the big key and that I

59:02

think is a function of expecting technologists to

59:05

multitask with just too many too many

59:09

balls to juggle in any given moment.

59:13

This last question. It'll be a double double

59:16

question.

59:18

Any recommendations on materials for understanding implants

59:21

better? And then the

59:25

Are there published guidelines around imris use

59:28

in a hybrid or Suite okay, um

59:32

implants and devices.

59:37

in many instances we are

59:43

More conservative than we need to be that in many instances.

59:47

There are ways to identify safe Pathways to

59:50

Imaging patients. They just

59:53

require some additional knowledge. I will

59:58

I'll put a plug-in for my friend and colleague Dr.

60:02

Manuel Canal runs an amazing course

60:05

geared towards both technologists and

60:08

Radiologists that he does several times in the

60:12

US every year. I've actually got

60:15

model my Dubai course largely on on his course

60:18

and that the knowledge

60:22

that you get from from those courses will

60:28

significantly change the way that you understand perceive

60:31

measure risk and help

60:35

you to understand ways in which you can

60:38

effectively manage those risks.

60:42

I am not aware of sort of

60:45

a print resource. That really does the same job as

60:48

the courses that Dr. Canal developed, but I

60:53

would encourage you please take a look at those if

60:56

they're at all, you know possible for you as a

61:00

tremendous resource.

61:02

doctor canal and others are working on a clinical guide

61:06

that will capture some of this information and

61:09

and help share it but that

61:12

publication is

61:15

aggressively a year out perhaps a

61:18

little more. So to the second part of

61:21

the question about interoperative MRI environments

61:28

Interoperative, Mr. Pet Mr. Mr. Linac,

61:31

you know where we are either putting MRI

61:34

in in very unusual for MRI environments

61:38

or we're hybridizing and

61:41

we're smashing it up with another modality that has in

61:44

the case of Pat and radio Pharmaceuticals or

61:47

Linux and you know, ionizing radiation

61:50

from the beams. We are superimposing

61:53

two different safety regimes on

61:57

top of one another and the

62:00

only advice that I can give is is kind of general and and

62:03

encompasses the inner operatives and the pet Mrs.

62:07

And they are Linux and that

62:10

is

62:11

start early and recognize that you know

62:15

MRI safety and infection control Provisions that

62:19

you would apply separately in an MRI

62:22

suite in an operating room. Now, you have to Overlay them and

62:25

you have to Overlay them in a way that actually

62:29

Supports best practices in the workflow and that

62:32

doesn't happen automatically that actually requires sort

62:35

of mapping out process and workflow and material and

62:38

that sort of thing similarly pet Mr. And identifying,

62:42

you know radio pharmaceutical and radiation

62:45

protection for traveling radio Pharmaceuticals versus

62:48

your acr4 zone model and that

62:52

sort of thing and Mr. Linac, how are we going to provide these

62:55

protections? You know, does it really change when

62:58

we go from?

63:01

walls that are eight inches of foot thick to walls

63:04

that are a meter thick and how

63:07

do we manage this in concert with you

63:10

know, non-mr Linux as a part of a

63:13

radon Suite

63:15

it really requires.

63:18

thinking about this prospectively trying to correct after the

63:21

fact is always

63:23

much more expensive much more invasive and much less

63:26

satisfying and then planning that out ahead

63:29

of time.

63:32

Get people who are expert at not only

63:36

the equipment siding signing. The equipment is difficult, but

63:40

it is comparatively the easy piece get people involved who

63:43

can integrate facility planning and design

63:46

with workflow planning and

63:49

design you want to build the workflow first

63:52

model out the best possible, you know,

63:55

workflow and operation and then

63:59

design and build the building to to kind of

64:02

crystallize that best case

64:05

workflow.

64:08

All great questions. I love these really great then there's there's tons more,

64:11

but we we have to wrap. So thank you everybody for participating in

64:15

this new conference and asking so many wonderful questions. Thank you

64:19

Toby for your lecture today. That was fantastic. I know I learned a lot

64:22

you can access the recording of today's conference and all our

64:25

previous new conferences by creating a free Mr. Online account and

64:28

the replay will also be sent out. If you are looking

64:31

for this later, be sure to join us next week on Thursday,

64:34

May 11th at 12pm Eastern. We're featuring

64:38

Dr. Mark Gosselin for a lecture on obstructive pulmonary physiology

64:41

from the Imaging perspective balloons Airway

64:45

inflammation and dynamic collapse. You can register for

64:48

this free lecture at MRI online.com follow us on

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social media for updates on future new conferences. Thanks again,

64:54

and have a great day. Thank you.