The other two have had modality-specific accreditation programs for years, so what was the TJC going to do? Well, they’ve released their accreditation criteria, and one of the most wonderful surprises is that MRI safety is more prominent than it is in either of the other two ‘imaging’ accrediting bodies!

That’s right, the ACR, despite having been the name behind three publications of the ‘White Paper on MR Safety’  (now the ‘Guidance Document for Safe MRI Practices’), has no physical safety standards for their MRI accreditation program. And at last check, ICAMRL didn’t even have the contemporary terminology for MRI safety-tested medical devices in their standards. So, in an amazing ‘come from behind’ showing, TJC has now bested the veteran agencies in patient safety protections.

From the perspective of MRI patient safety, one of the most wonderful things is the addition to the Joint Commission’s Environment of Care (EC) standard. In this updated version (effective immediately), TJC explicitly mandates MRI safety protections:

Excerpted from EC 02.01.01, EP 14

At a minimum, the organization manages safety risks in the magnetic resonance imaging (MRI) environment associated with the following:
- Patients who may experience claustrophobia, anxiety, or emotional distress
- Patients who may require urgent or emergent medical care
- Metallic implants and devices
- Ferrous objects entering the MRI environment

OK, I might have chosen a slightly different list, but these four items nail some of the greatest environmental threats to the safety of patients and staff in the MRI suite. And given that it’s the first requirement from an accrediting body (the recent MRI safety changes to the healthcare building code, Guidelines, are regulatory / licensure requirements), I’m more than happy to give JCAHO a little slack.

If you would like to download your own PDF copy of the changes to the ambulatory accreditation program’s Environment of Care standards, which includes the explicit MRI safety requirements, identified above, please click here.

In a nutshell, these new standards echo many, many prior recommendations, including JCAHO’s own, for MRI safety. Namely, these are to plan for emergent situations, screen patients more effectively for contraindications, and screen for ferromagnetic materials.

With the new EC standards it is no longer acceptable to simply say, ‘yeah, we have a policy and procedure manual that outlines how to handle each of these.’ Now, as a part of regular accreditation, providers will have to provide risk assessments and explain how their actions are proportionate responses to those risks.

Earlier in that same EC standard, it makes specific mention to seeking external sources of information to establish risks and responses. For MRI, that list would likely include the ACR Guidance Document, the VA’s MRI Design Guide, the ASHE monograph ‘Designing and Engineering MRI Safety’, the ECRI Institute’s Top-10 Medical Technology Hazards, and perhaps even the MHRA MRI risk assessment.

What recommendation is common to all of these industry-standard-setting publications (that explicitly addresses one of the 4 new EC requirements)? The use of ferromagnetic detection systems.

As you conduct your risk assessments, and determine a path to MRI safety and regulatory conformance, I hope that you’ll contact the people at Mednovus regarding their ferromagnetic MRI screening systems. When your next state or accreditation surveyor comes around, you’ll be so very glad you did.

Click here for Tobias’ Twitter Profile

You see, back in 1983 when GE was going through their pre-market approvals with the FDA for their first commercial clinical MRI system, they indicated that MRI suite safety minimally required ferromagnetic detection pre-screening. The only problem was, it hadn’t been invented yet!

During R&D the physicists at GE discovered that the MRI scanner could be tuned in such a way to create something of a ‘worm hole’ and permit time-travel. Anyone who has spent 2 or 3 hours in an MRI, only to have their wristwatch tell them they’d only been in it for 30 minutes, won’t have a hard time believing that there’s still some vestige of time-warp still left, even in contemporary MRI scanners.

What did the GE physicists see during their clandestine time-traveling jaunts into the 21st century? We suspect that they saw MRI’s everywhere – hospitals, imaging centers, strip malls – and each and every one of them was protected by ferromagnetic detection pre-screening devices. When they returned to 1983, it seemed such a natural thought, to protect patients, staff and these marvelous machines, that the requirement for ferromagnetic detectors actually made it into their safety submittals to the FDA.

Admittedly, I’m taking (more than a little) artistic license here. What GE actually stated in their November, 1983 ‘Hazard Analysis’ that accompanied their MRI device application to the FDA was that metal detection (for prevention of ferromagnetic projectile accidents) was a “minimum requirement” for safety in the MRI suite.

As described in my exhaustive summary of a couple weeks ago, conventional “airport” style metal detectors are actually horribly counterproductive to pre-MRI screening for most patients, particularly when screening for ferromagnetic materials. Operationally, this is a truth that simply couldn’t be known to GE at the time that they were preparing their recommendations for MRI safety, a concern that never really existed before they brought this product to market.

This metal detector “minimum requirement” soon became an unwelcome nuisance, and GE’s promotion of it as a safety tool withered to near-nothingness.

That’s not to say that the hazard that the metal detector was to help mitigate withered, too. In fact, as GE (and Siemens, and Philips, and Toshiba, and Hitachi…) made stronger and better MRI systems, the risks of ferromagnetic projectiles kept ratcheting upward, too.

Today we’re faced with sticky situation… The entire FDA approval of MRI can be traced back to this GE application, which recognized – and required – projectile protection. The only available tool (at the time) turned out to be far less effective than hoped, so its use was discontinued. After a tragic, headline-grabbing MRI projectile fatality in 2001, real ferromagnetic (only) MRI pre-screening instruments were developed, and have been available for a number of years. However, these new tools, which respond specifically to the needs identified by GE almost 30 years ago, haven’t been appointed by manufacturers and regulators to the safety role that they’re meant to play.

Perhaps it’s all a product of the ongoing effort on the part of the government to keep the secret of time-travel… well… secret, but nobody seems interested in revisiting patient protections called for in 1983.

And what became of those GE physicists who originally stumbled upon the secret of MRI time-travel? Well, after collecting data on the forthcoming 20 years worth of Superbowls, World Series’, and PowerBall jackpots, they each decided that working for a living was, simply, too much work.

But you can bet, whatever private island-paradise they own today, when their doctor proscribes them an MRI, they find one with ferromagnetic pre-screening.

; )

Click here for Tobias’ Twitter Profile

According to the news accounts, her concerns about something having been left in her from the surgery were laughed-off: “The times of leaving instruments inside you are long gone.”

Returning to her own hospital, she got an X-ray which showed just how wrong that statement is…

X-ray Image Showing Forceps. Image From www.thesun.co.uk

Many people in the medical industry, even within radiology, are quick to dismiss stories of accidents in the MRI suite as ‘fish stories’ which, though they may be based on a kernel of truth from the original telling, grow and grow as the story gets passed along the line. What may have begun as a pager getting drawn into the MRI scanner, winds up becoming a telephone repairman… or so goes the rationalization. And some seem to think that most MRI accident stories aren’t even really exaggerations, but rather pure fiction, akin to what you would see on some nighttime television medical drama. To these people, any account of a patient bed hitting the MRI could only have come from an episode of ER (as opposed to a real accident having become the basis of the TV show’s fictionalized version)…

Not that there haven’t been cases of gurneys drawn to MRI scanners before, because the MRI professional communities are awash in stories of all manners of ferromagnetic materials inadvertently becoming MRI-homing magnet missiles. Everything from personal computers, iPods, pagers, cell phones, anesthesia machines, ‘sand’ bags, medical gas (oxygen) cylinders, welding tanks, rolling carts, wheelchairs, hand-tools, canes & walkers, furniture, filing cabinets, hand-trucks, and the list goes on, and on, and on (to see pictures of a number of items, please check out this prior post). And yes, even hospital gurneys…

MRI Scanner Eats an ICU Patient Bed

Much to my chagrin, I’ve heard people dismiss the above as somebody’s Photoshop fantasy. Those sorts of statements, sadly, work to diminish all efforts toward MRI safety. But a recent account should, permanently, put to rest any question of whether this sort of thing can really happen. Late last year I posted a story that included links to a number of FDA MRI accident reports. One of the reports to the FDA’s MAUDE database described an incident in which a patient had their foot-ankle-leg injured when they were transported into the MRI scanner room on a conventional gurney (click here to download the PDF file from the FDA’s data). The date in the FDA’s anonymized report coincides very nicely with this somewhat-less-than-anonymous newspaper article that just came out…

Hoag Hospital has been fined $50,000 by the state Department of Public Health after an MRI patient on a metal gurney was magnetically pulled into the imaging machine, the hospital said Friday.

[Dr. Richard] Afable, [chief executive officer of Hoag Memorial Hospital Presbyterian], said that last January a woman was taken into an MRI room on a metal gurney that was not compatible with the machine. The powerful magnet in the MRI pulled the gurney into the machine and the patient’s leg was trapped for about three minutes. She was taken to the emergency room and spent three days in the hospital for treatment of fractures in her lower leg and foot.

The above quote is taken from the January 22nd, 2009 article appearing on the Orange County Register’s website (click here to go straight to the article). Based on the dates, the description of the accident, and the patient injuries, it sounds as if the FDA account is the same incident as what is described in this newspaper article. The $50,000 fine may sound like steep punishment, but considering the cost to restore the magnet after the quench (described in the FDA account), the cost of downtime and lost revenue between the accident and the time the MRI was returned to service, the cost of care to treat the patient, the cost of internal safety / quality / regulatory investigations, the legal costs for the hospital, and any lawsuit settlement costs, the state’s penalty is likely to just be icing on the cake. The cost to the hospital for this transgression could very easily be into 7-figures! All of this simply demonstrates two critical points about MRI safety.

1. MRI accidents do happen, and at greater frequency and cost than many are led to believe.
2. The costs of the safety provisions to help prevent these accidents are peanuts when compared to the costs of accidents.

My soap-box pontificating on this point will likely become moot over the next many months. In a ‘perfect storm’ of regulatory and accreditation attention to MRI safety, we’re very likely to see requirements for MRI safety provisions, such as ferromagnetic detectors (which could have been instrumental in helping to avoid this gurney accident). I will share more about each of these efforts, as I’m able. In the meantime, MRI providers should put a great deal more stock in the validity of MRI accidents accounts and ask themselves, “Do I have adequate physical protections in place, beyond what’s written in my policy manual, to help prevent this sort of accident?” The likely answer is “No.”

Click here for Tobias’ Twitter Profile

External fixation and braces are typically very carefully screened for contraindication for MRI examination, but what may not be as frequently screened is the clothing underneath. We’ve received a report of a patient who received a burn from the specialty T-shirt, worn under their brace! The T-shirt, which included electrically-conductive silver fibers, purportedly acted as an RF antennae and produced focal heating.

This incident, like so many others, goes to show how so many risks in the MRI environment, such as concealed ferromagnetic threats, can be difficult to find if you don’t have the proper tools and knowledge with which to look for them.

Every MRI provider should avail themselves of the latest MRI safety information, standards, recommendations and peer accounts of accidents and near-misses in order to deploy the greatest protections, both for their patients and for their own risk management. For burn risks, this means diligent screening of everything that accompanies the patient into the bore. For ferromagnetic (projectile) risks, this includes the use of ferromagnetic detection systems.

Click here for Tobias’ Twitter Profile

One of the most effective means of screening for external ferromagnetic materials, particularly those that may be integrated with non-ferromagnetic MR Conditional objects or devices, is through the use of a ferromagnetic only detection system.

Halo vests are just one of huge number of potential ferromagnetic threats which endanger MRI patients, visitors and staff. Effective pre-screening for these risks should include the appropriate use of ferromagnetic detection systems, and this is more than my personal opinion.

To date, the ACR, JCAHO, the Department of Veterans Affairs and many MRI safety experts have called for the use of ferromagnetic screening to help mitigate just this sort of hazard.

Halo vests are just one of the innumerable objects that can pose grave threats to patients, staff, and MRI equipment if brought within the MRI scanner room. To protect people and scanner up-time, ferromagnetic detection is a wise investment.

]]> http://mrimetaldetector.com/blog/2009/12/rsna-aapm-identify-halo-ferromagnetic-risks/feed/ 2 http://mrimetaldetector.com/blog/2009/12/ecri-top-10-medical-technology-hazard-includes-mri-projectiles/ http://mrimetaldetector.com/blog/2009/12/ecri-top-10-medical-technology-hazard-includes-mri-projectiles/#comments Wed, 02 Dec 2009 19:14:23 +0000 Tobias Gilk http://mrimetaldetector.com/blog/?p=688 Every year the ECRI Institute publishes their Top 10 health technology hazards, identifying the 10 most serious (and unintended) risks posed by our ever-increasing use of sophisticated medical devices to diagnose and treat patients. In November, the Institute released their 2010 watch list, which dedicated a Top 10 slot, and an entire page, to ferromagnetic projectiles in MRI.

The ECRI report references a publication from the Pennsylvania Patient Safety Authority that identified 148 reported cases of inadequate screening for ferromagnetic materials in 2008 in that state alone. Based on what we know about ferromagnetic material risks, my suspicion is that this 148 number is only a drop in the bucket of the actual rate.

Though, if we simply accept the 148 incidents, and multiply times 50 to get a rough approximation for the whole US, that indicates that we have 7,400 annual failed screenings for ferromagnetic material, each of which has the potential to injure patients, staff, or incapacitate a million-dollar MRI scanner.

What to do about this silent safety epidemic that is almost wholly avoidable? Well, it wouldn’t hurt to follow the recommendations of the ECRI Institute, number one of which is:

“Consider installing ferromagnetic detectors to screen patients and equipment. These are handheld wands and walk-through/wheel-through or walkby/ wheel-by detector systems positioned before the entrance to the MR environment.”

–’2010 TOP 10 TECHNOLOGY HAZARDS,’ ECRI Institute

So, we can add the ECRI Institute to the chorus of voices that includes the ACR, VA, JCAHO, and MR safety experts that all call for ferromagnetic detection as a part of pre-MRI screening.

If you would like your own copy of the ECRI publication, they are graciously making it available as a free download from their website.

If you would like information on the Mednovus SAFESCAN® ferromagnetic detection products, these are available on the company’s website.

For those of you who aren’t familiar with the Guidelines, they are the design requirements that are cited by the Joint Commission and, at last count, 42 of the 50 U.S. State Departments of Health. Technically, they aren’t a building code, but the function in almost the exact same way. For the first time, the Guidelines are going to have specific MRI suite design requirements for patient safety.

2010 Guidelines

The 2010 edition of the Guidelines are purported to codify the single most often cited MRI suite safety design criteria, the 5-gauss line (or three-dimensional bubble, more accurately). The design must necessarily control access to locations where the static magnetic field is present at strengths of 5-gauss or more.

the 2010 Guidelines will also define situational-awareness requirements for suite layouts. These will include a requirement that the patient can be seen inside the scanner from the operators’ console location, and that the operator has direct visual control of the entrance to the MR scanner room.

The unique challenges of infection control and handwashing in the MRI environment are also explicitly addressed, for the first time, in the new Guidelines.

And one of my favorite provisions is the new requirement that MRI suites be designed to follow the ACR 4-Zone model for screening and access controls, including ferromagnetic detection systems!

The Guidelines publication is undergoing a significant organizational overhaul along with the regular content update, so I don’t have specific section citations to where the new MRI safety design requirements will be (though MRI probably won’t have the same section numbers as the current, 2006, edition has). My understanding, however, is that the publication will be released on schedule in January, so it is only a very short time until we can verify the specific contents and section numbers.

It is particularly encouraging that these new requirements validate what the some of the best MRI providers have been doing for years. Clearly MRI site-safety, including ferromagnetic detection, can no longer be regarded as simply “a good idea.” With the 2010 edition of Guidelines, we will have one more codified example of how these elements are truly part of the contemporary standard of care.

If you would like more information about the Guidelines, including information on how to order a copy of the document, please click here.

Link

Our company, Mednovus, is making the annual pilgrimage to Chicago after Thanksgiving for the biggest of all radiology trade shows, the Radiological Society of North America (RSNA) annual meeting. In my prior post I indicated why I thought MRI safety would be a ‘hot topic’ at this year’s RSNA, and gave an itinerary for the North Hall (the Philips Hall) for stops at relevant vendors.

Continuing on that original theme, and to facilitate your review of MRI safety products and vendors, I’d like to suggest an itinerary for visiting a select group of exhibitors, this time in Lakeside Center (Exhibit Hall D)…

Lakeside Center includes exhibitors with booth numbers from 100 – 2225. And while I won’t pretend to know what each exhibitor offers (so, clearly I won’t be able to identify all relevant MR safety products that might be featured at each exhibitor, please forgive any oversights), I would like to provide you with a short-list of stops that I recommend that you make.

Some of these are on my list because I know and recommend their products (look for the •), others are there because they’re new (to me at least) and I’m curious to learn more about them.

108 Polyform – With RF burns being one of the fastest-growing sources of MRI patient injury, positioning / insulating pads have recently become far more important. I’m interested to see what this vendor has to offer.

115 Advanced Imaging Research – A specialty RF coil manufacturer with pediatric and cardiac coils. They also offer non-magnetic accessories.

124 LMT Lammers – Manufacturers of special infant / neonatal MR imaging devices, an MR-friendly incubator.

803 • West Physics Consulting – More than just a ‘necessary evil’ for accreditation, a good physicist can help extend the life of your MR system and improve clinical image quality. West is one of the top providers out there.

820 IMRIS – OK, not specifically about safety, but how neat is an MRI that travels into the operating room!

825 • Siemens – Siemens is now offering not only the Mednovus ferromagnetic detectors (see Mednovus at booth 7801 in the North Hall), but MR safety packages of support equipment! Seek out Siemens’ accessories representatives and ask them.

1202 Optoacoustics – Manufacturers of fiberoptic video and audio systems for the MRI environment.

1209 American Association of Physicists in Medicine – Let’s start a groundswell. AAPM published a guide on MRI siting and safety about 25 years ago, back when we still called it nMRI. Let’s get 100 people to ask them when they’re updating that publication (publication #20)!

1213C • SMRT – For MR Technologists, this is THE organization. Great educational opportunities, and one of our industry’s very few concerted efforts at advancing MRI safety.

1213E • AHRA – For radiology or MR managers, this is on-par with what SMRT is for Techs. (note: if you’re a lead-tech with one foot on either side of that line, get involved in both organizations!)

1213L AIA-AAH – The Architectural profession’s healthcare group really needs our help with regard to radiology. I’ll give you a dollar if you simply go up and ask them what the AIA’s position on the designer’s role in addressing a 277% increase in MRI accidents!

1302 Nova Biomedical – Offers a point-of-care blood tester for calculating eGFR for Gadolinium contrast safety screening. I’d like to see it.

1409 Brainlab – Like IMRIS, I just love the idea of intraoperative MR. I don’t know if they’re doing as much about intraoperative MR safety as I know IMRIS is doing. But I’ve gotta look at their latest toys.

1632E NORAS MRI Products – In RSNA’s ‘Germantown’ NORAS offers a number of specialty MR coils and support products.

As before, there are likely vendors not on this list because (1) I either forgot or didn’t know about their product offerings, (2) they’re ‘old standby’s’ that I’m already familiar with, or (3) they’re in a different exhibit hall.

Which segues, nicely, into my (repeated) disclaimer that the above list is just for the Lakeside Center, Hall D. If you’d like to read my proposed itinerary for the North Hall B, please click here. Time permitting, I’ll do the same for the South Exhibit Hall A (the GE Hall), though making that list will require reviewing the largest number of vendors thus far.

If you’d like to conduct your own virtual tour of the RSNA exhibit halls, they offer a wonderful interactive floor plan of the exhibit halls online. You can see which booths I failed to mention (and add your suggestions in the comment field, below), or plan your own itinerary for all three Halls.

I will, of course, be doing some duty in the Mednovus booth, 7801 (just inside the North Hall B entrance that is NOT right next to Starbucks), and I hope that you’ll stop in and say ‘hi’ to me or my colleagues. Depending upon how ensconced I get in those conversations, this list may turn out to be a bigger proportion of my RSNA experience than actually getting to the other exhibits!

Ferromagnetic detection doesn’t catch anything that existing screening protocols aren’t meant to catch.

That inflection makes a world of difference, as you’ll see in just a moment…

We’ve been screening for ferromagnetic materials as long as MRI has existed, but our historic technique of simply asking if someone has magnetic materials has not proven very effective. There are many accounts of magnet damage, injuries, and fatalities resulting from a failure to identify ferromagnetic materials before they were brought into the MRI room. And despite a universal familiarity with the risks of ferromagnetic materials, we as an industry seem unable to prevent them from recurring by using only these ‘old school’ screening protocols.

There was a policy in place to screen for ferromagnetic materials at this New York hospital in 2001:

And they had a policy to screen for ferromagnetic materials at this Seattle hospital in 2005:

They had a policy to screen for ferromagnetic materials at this hospital:

And here:

And here:

And here:

And here:

And here:

And here:

And here:

And here:

And here:

And here:

And here:

And here:

And here:

And here:

And here:

And here:

And lots, and lots of places that you can see here:

Honestly, I could drown you in pictures and accounts of ferromagnetic materials in the MRI suite. Suffice it to say that the accounts above are only the tip of the iceberg.

One of the most ironic (in light of what you’ve seen above) arguments against the need for ferromagnetic detection is that it isn’t foolproof.

Foolproof!?!? If that’s the standard, how can we reconcile the results of our conventional screening practices against this expectation of perfection? Clearly, we’re a very, very long way from that goal.

Instead of willfully disbelieving everything shown above… Instead of insisting on the infallibility of patient and visitor compliance with screening instructions, or the unblinking door-watching vigilance of the Technologists, or the guaranteed long-term effectiveness of MRI safety training for housekeeping, transport, engineering, security, anesthesia, ICU and respiratory staff, why can’t we accept that each of these protections, as valuable as they are, are imperfect, and that if maximum safety is our goal, we need to augment these long-standing – and incomplete – strategies with something new.

I freely state that ferromagnetic detection is not perfect. Under certain circumstances, it can miss things that we may want to find. It does, however, provide us with an entirely new feedback mechanism that helps us to more effectively monitor, train, screen, and protect people in the MRI environment. Imperfect though it is, it is remarkably effective at helping to improve the safety of everyone inside the MRI suite.

PS: I would like to thank the following people who have helped me by providing some of the images you’ve seen above, Moriel Ness Aiver, Raj Sangoi, and Keith Del Guercio.