Ready? OK…

Let’s start at the very beginning (“what a very good place to start”). Back in the 80′s, when GE was seeking FDA approval for their new-fangled ‘nuclear magnetic resonance’ scanner, they were keenly aware of the risks of things going flying into the giant magnet. It turns out to be extremely difficult to have a giant, super-powerful electromagnet (one that doesn’t have an on/off switch) that doesn’t draw in every conventional ferromagnetic wheelchair, oxygen tank, gurney, mop bucket, rolling cart, etc… that comes near.

New Ferromagnetic Detector Requirement to Mitigate Magnetic Projectiles Risks In MRI Suites

In an effort to help identify these threats before they were brought into the room, the GE application to the FDA called for mandatory metal detectors for screening patients and equipment as a part of each and every MRI installation.

Well, it turns out that this well-intentioned gesture was not very practical. As sites that have foolheartedly ventured down this path can tell you, darn near everything that is brought to the MRI suite has metal in it. This means that darn near everything, including objects that are at no risk of flying into the MRI, will set off the conventional metal detector. If the objective is to find only those things that would like to go flying into the MRI scanner, your conventional ‘airport style’ metal detector is of no use.

In the 1980′s there weren’t alternative means of detecting only ferromagnetic materials (those that become magnetized and get drawn to the MRI scanner), so the GE requirement for metal detection atrophied to nothing, becoming a forgotten (well-intended) bad idea.

Fast-forward about 20 years. At this point MRI technology is ubiquitous at hospitals (those with at least a couple hundred beds) across the country. Estimates were that there were somewhere around 8,000 MRI scanners in the US, and that most of them were GE products.

Concurrent with the growth in numbers of MRI scanners were increases in the magnetic strength and improvements to the ‘active shielding’ systems. Each of these enhancements had the coincidental effect of increasing the forces that draw magnetic materials into the scanner. When coupled, these factors actually multiplied the attractive force applied to magnetic objects, meaning that the risks associated with magnetic-projectiles flying into MRI scanners increased dramatically as the imaging technology advanced.

There have been magnetic-projectile accidents that jeopardize patients and staff in the MRI suite as long as there have been MRI scanners. The overwhelming majority of these remain ‘under the radar’ of safety, regulatory and accreditation bodies. One event occurred in the summer of 2001, however, that exploded through the veil of embarrassment that typically keeps these types of accidents secret.

In 2001, a young boy was anesthetized for an MRI scan and required oxygen during the exam. When the wall-outlet O2 didn’t work, the anesthesiologist called for oxygen. The technologists administering the exam left the control room to try and fix the oxygen supply problem and, while they were out, a nurse entered and told the anesthesiologist that there were oxygen tanks right there in the control room. Immediately upon bringing one of the portable tanks into the MRI scanner room, the magnetic field of the MRI ‘grabbed’ the tank and pulled it into the center of the doughnut-shaped scanner, where it struck the boy.

That six-year-old boy, Michael Colombini, died from the injuries a couple days later.

Splashed across the media and throughout radiology journals & trade publications, this event reignited the interest in metal detectors, many of the lessons learned from the prior experiments with ‘airport style’ detectors having been forgotten.

“If only there was a metal detector that only alarmed on magnetic materials,” was a common refrain. In 2001, there wasn’t (at least not an effective commercial product for pre-MRI screening). Ever the ‘mother of invention,’ the necessity for a magnetic-projectile screening tool prompted several companies, including Mednovus, to develop ferromagnetic only detection systems.

These products started becoming commercially available just a few years after the 2001 Colombini tragedy, and initially struggled to differentiate themselves from the failed legacy of’ ‘airport style’ detectors. In the years since, however, ferromagnetic detectors have become viewed as a valuable tool for safety in the MRI suite.

Would GE have mandated ferromagnetic detection (instead of the ‘airport style’ metal detectors) with their FDA application if the products had been available 20 years ago? Since the stated intention was to prevent projectile accidents, it would seem logical that they would have. They’re not the only MRI manufacturer to have indicated that choice, either.

In a 2008 interview with the Israeli business publication, Globes, Walter Marzendorfer, CEO of Siemens Medical Systems’ MRI Business Unit, was quoted as saying, “[t]he main safety issue where MRI is involved is the fact that it is a magnet. Accidents happen when a doctor enters the MRI room with a scalpel in his pocket and bends over the patient. People forget. There must be metal detectors at the entrance to every room with a MRI device.”

It would seem that Siemens has exactly the same take on the necessity for projectile safety in the MRI environment that GE had, namely that there should be some form of automated screening. I’ll chalk-up the use of the term “metal detector,” instead of the projectile-specific screening provided by a ferromagnetic detector, to the multiple languages likely involved in ultimately arriving at an English text. Both GE and Siemens have stated the necessity for some form of automated projectile screening, but it doesn’t end with the equipment manufacturers.

GE and Siemens aren’t alone in the calls for some form of  requisite screening for projectile risks…

• In 2007, the ACR Guidance Document for Safe MR Practices amended language from prior publications which recommended against ‘airport style’ detectors to include the explicit recommendation for using ferromagnetic detection systems.
• In 2008, the US Department of Veterans Affairs (VA) MRI Design Guide echoed this recommendation.
• In 2008, the Joint Commission’s Sentinel Event Alert #38 offered ferromagnetic detection systems as an example of a conformance tool for their objective of verified patient screening.
• In 2009, the American Society of Healthcare Engineering (ASHE) published a monograph entitled Designing and Engineering MRI Safety which explicitly called for ferromagnetic screening.
• In 2009, ECRI Institute published their Top-10 Medical Technology Hazards watch-list for 2010. On that list is MRI projectiles and among the ECRI Institute’s recommendations are ferromagnetic detection systems.

There are others, but you get the gist. The technology of the ferromagnetic detector answers the need for MRI projectile protection which was identified nearly 30 years ago. It fits precisely with the intention of GE’s original FDA application for approval of MRI as a clinical device, and with the much more recent statement by Siemens’ top MRI guy. It has been recommended by major institutional standards and both professional and accrediting bodies, so it must be a ‘done deal,’ right?

Unfortunately, there has been one missing element… a requirement for MRI projectile safety protections.

It turns out that ‘perfect fits’ with manufacturers’ intentions and a ‘who’s who’ list of recommending bodies wasn’t enough. Yes, there have been many adopters of ferromagnetic screening tools, but estimates are that most of the MRI providers in the US still don’t use ferromagnetic screening for people entering the MRI suite. If they’ve been waiting for a requirement, that wait is just about over.

42 of the 50 US states, the Joint Commission, and many, many other health regulatory bodies around the world, use the Guidelines for Design and Construction of Health Care Facilities, originally jointly produced by the American Institute of Architects (AIA) and the US department of Health and Human Services (HHS). With updates to the standard published every 3 to 4 years, Guidelines is, in effect, the building code that governs most licensed and accredited MRI providers in the US. The 2010 edition of Guidelines just came out last month.

In the 2010 edition, for the very first time, Guidelines includes MRI safety protection requirements in the design criteria. Here’s one excerpt from the new code:

2.2-3.4.4.2 Design configuration of the MRI suite

(1) Suites for MRI equipment shall be planned to conform to the four-zone screening and access control protocols identified in the American College of Radiology’s “Guidance Document for Safe MR Practices.”

(2) The layout shall include provisions for the following functions:

(a) Patient interviews and clinical screening
(b) Physical screening and changing areas (as indicated)
(c) Siting of ferromagnetic detection systems
(d) Access control
(e) Accommodation of site-specific clinical and operational requirements

That’s right, the inclusion of ferromagnetic detection systems is a requisite element of MRI suite design in the 2010 Guidelines!

Since the 2010 edition of Guidelines has only just been published, it hasn’t (as of this writing) yet been adopted by the various authorities that use Guidelines, but that’s only a question of time.

And while the Guidelines, as a building code, might only apply to new MRI facilities and newly-sited MRI equipment, it appears that this may be just the first requirement-domino to fall.

In 2006 (yes, four years ago), the ACR’s MR Safety Committee issued a formal request to the ACR’s MR Accreditation Committee, include the Safety Committee’s Guidance Document principles as requirements for MR site accreditation. The MR Accreditation Committee has agreed that it will do something relative to MR safety in the accreditation process, but has yet to specify what this will be. It makes sense to me that the ACR MR Accreditation Committee would (minimally) appropriate existing physical safety requirements put forward by other entities (preserving the ability to deflect criticism with, ‘it’s not our standard, it’s just one that many of our accredited providers will be held to by other agencies and we felt it prudent to include it in our accreditation standards to make sure that they weren’t otherwise caught unaware.”).

Similarly, the Joint Commission (TJC), having just received ‘deemed status’ and the ability to accredit advanced imaging providers (CT, MRI, PET) for the 2012 Medicare requirements, is purportedly working on imaging-specific patient safety standards. While TJC will adopt the 2010 Guidelines as their physical facility standard, that may also provide them with the ability to develop their own MR safety specific accreditation standards. I would expect to see a flurry of imaging-specific guidance and standards coming from TJC starting this summer / fall.

What does this all mean if you’re an MRI provider? One of the things it means is that if you don’t already have a ferromagnetic detection system, you should get one, and get it soon. Setting aside the ‘best practice’ standards, loss-reduction, safety improvement, and throughput benefits, ferromagnetic detectors will be requirements of accreditation and licensure.

If I can be of any assistance to you, navigating the new requirements or addressing questions about ferromagnetic detection, please do contact me.

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As far as the MRI machine is concerned, there are two different types of metal, ferromagnetic and non-ferromagnetic. You may remember back to high school chemistry and the periodic table of elements where many of us learned (and then promptly forgot) that Fe is the symbol for iron.

Fe - Iron from the Periodic Table

“Fe”, the symbol, is derived from ferrum, the Latin word for iron. Ferromagnetic does not mean that a metal contains iron, but rather that the material has magnetic properties as iron can.

Ferromagnetic metals are iron, cobalt and nickel. These raw ingredients are common in many, many things made from metal, including (likely) the steel grommets in your shoes, to the zipper in your pants, to components in your wristwatch. Another common area to find these metals is in batteries, such as those found in your hearing aid, cell phone and iPod. There are a few non-metal ferromagnetic materials, but these are not very common.

Alright, alright, already… enough chemistry. What does this mean?

When exposed to magnetic fields, ferromagnetic materials become magnets themselves. You can prove this yourself with a fridge-door magnet and a few paper clips. You’ll probably find that paper clips right out of the box aren’t capable of magnetically ‘sticking’ to one another. If you stick one to a chunky fridge-door magnet, however, that paper clip is now magnetized and will likely be able to magnetically ‘stick’ to another paper clip. The length of the magnetic chain of paper clips you can create is a function of how strong the fridge-door magnet is and the magnetic properties of the paper clip steel.

Now, the exact same thing happens with ferromagnetic metals approaching the MRI, but a crucial difference is the distance at which the materials get attracted. With your fridge-door magnet test, the paper clip needs to be touching (or very nearly so) the magnet before the attractive effects are felt. MRI’s, by virtue of the fact that they’re both 1,000′s of time stronger and larger than your fridge-door magnet, can exert profound attractive force at a good distance away from the magnet.

The size and strength of MRI magnets is so great that people have been trapped, injured, and even killed by the force of ferromagnetic objects attracted to the MRI. From concealed roller-skate tennis shoes, to steel-reinforced furniture, to conventional hospital wheelchairs and gurneys, to steel oxygen cylinders, all of these normally harmless (outside the MRI suite) items become life-threatening when subjected to the enormous pull of the MRI’s magnet.

Not all metals are ferromagnetic. In fact, in an MRI suite a concerted effort is usually made to rid the area of ferromagnetic materials and use non-ferromagnetic replacements whenever possible. Non-ferromagnetic metals include aluminum, titanium, brass, copper, and many others. These (and other) non-ferromagnetic metals can present other problems and hazards during MRI imaging, but that’s a topic for another day.

It is almost impossible to determine whether a material is ferromagnetic just by looking at it. In fact, even sometimes when you know what an object is made of, it still isn’t enough to know whether it’s ferromagnetic or not. Stainless steel, is one of these examples.

Stainless steel is not a metal, but rather a family of recipes for metal. Some stainless steel ‘recipes’ (alloys) call for ingredients with ferromagnetic properties. Others which include ferromagnetic ingredients are specially formulated to change the structure of magnetic materials into non-magnetic versions of the material. These special ‘de-magnetized’ stainless steels can become ferromagnetic if the steel is manipulated (shaped, bent, heated, or stressed), so even magnetically ‘safe’ stainless steels can become ‘unsafe’ under certain circumstances (a change that isn’t observable to the eye).

It is remarkably difficult to distinguish magnetically ‘safe’ metals from magnetically ‘unsafe’ metals, either by simply looking at them or, sometimes, even if you know what the metal is. As a result, MRI facilities must assume all metals to be magnetically unsafe unless and until they’ve been verified to be non-magnetic.

So, how do MRI facilities distinguish magnet-unsafe metals? They can use magnets, which shouldn’t be used on patients or sensitive equipment, limiting their applicability. The safer option (and arguably more effective, to boot) is to use a ferromagnetic detector, at least on patients and sensitive equipment.

Ferromagnetic detection instruments, such as the Mednovus products, should be used to help identify magnetically-unsafe materials. This is the standard established by the American College of Radiology, the VA’s MRI Design Guide, and even recommended by the Joint Commission in Sentinel Event Alert #38.

As a patient, it is vital to take seriously the admonitions against wearing or carrying metal into the MRI suite. If you have shrapnel, penetrating metal injuries (particularly in the eye), or any surgeries, implants or prosthetics, it’s critical to have the full information on each to share with your MRI provider. Metal inside the body may not fly across the MRI room like a loose oxygen cylinder (don’t believe what you see on House), but the twisting an pulling that the magnet will exert on an internal ferromagnetic object can be just as dangerous. Active implanted devices, such as pacemakers or nerve stimulators, present particular problems because of both the magnetic attraction and potential interference with the normal function of the device.

Patients should also actively seek out MRI providers that conform with the contemporary safety recommendations, including the use of ferromagnetic detection. You can even contact Mednovus when you want to find providers near you who have this technology available.

Providers of MRI services should make sure that the pre-screening and safety services they provide are in accord with the contemporary best practices, including the use of ferromagnetic detection. With available ferromagnetic detection products equal in cost to only a few hours worth of technical revenue, there’s no financial rationale for not providing this valuable safety benefit to patients and staff. Plus, when weighed against the costs of ferromagnetic object accidents, these instruments of safety are clearly effective risk-management investments.

In all cases, metal brought to the MRI suite (either inside or outside the body of the visitor) should be scrutinized by a trained MRI staff person. This investigation should be aided through the use of ferromagnetic detectors, both to help characterize the hazards of any particular object and to help find ferromagnetic materials that weren’t caught in the prior screening process.

What, you’ve only heard it referred to as ‘Autumn‘ before? Well, that’s not terribly surprising. We’re so inundated with honorary days, weeks, and even months, that the season of MRI Safety Planning fails to get its fair share of media time. But here’s why MRI Safety Planning season should be tops on your list right now.

First, while there is a growing awareness of MRI Safety Week, a single week doesn’t really afford the time needed to plan for improvements to MRI safety. Real improvements come from refinements in operations and process, coupled with effective tools and training. That sort of interdisciplinary approach often requires more than a couple days to put together.

Second, MRI Safety Week falls in the middle of summer when budget-wrangling loses the attention-span battle to thoughts of barbecues and coco-butter suntan lotion. It is precisely now, when so many organizations are hammering out their financial priorities for next year’s budget, that MRI safety planning should be in full-swing.

By combining the operations planning with the budgeting, you can reap some real multi-task benefits from these synergistic efforts, and – buoyed by the support of our whole Mednovus organization – I’m here to help you make it as productive as possible.

When making your MRI safety plans, it’s important to know what new criteria are going to be expected of your facility. Accrediting bodies are all looking at MRI safety in a new way, and this is starting with the Joint Commission’s Environment of Care requirements, effective January of 2009.

There is also the flurry of recent MRI safety Best-Practice recommendations from a number of documents, all of which should be part of the Administrator / Technologist library of reference materials. One common element to the Joint Commission’s Sentinel Event Alert #38, the ACR’s Guidance Document for Safe MR Practices, and the recent Veterans Administration MRI Design Guide, is the recommendation for the use of ferromagnetic detection (see below).

While ferromagnetic detection systems can be readily incorporated into both new and operational MRI facilities with minimal muss & fuss, even the most easily-installed and cost-effective systems typically require advanced budgetary planning.

The upshot? Please start thinking today about your planned MRI safety improvements for 2009 and budget accordingly.

Whether you’re considering the newly-released Mednovus Sentinel® GS 2.0 portals (both the 24-inch Patient Sentinel® GS 2.0 and the 48-inch Entry Sentinel® GS 2.0) or our SAFESCAN® hand-held Target Scanner™ (or the optimal combination of both), it would be a privilege to be at your service.

We at Mednovus are delighted to announce our new association with Siemens Medical Solutions, a world leader in MR imaging, and we encourage you to contact your local Siemens sales rep to get product quotes for your budgeting purposes. Alternatively, simply let us know where you are located, and we will put you in touch with the appropriate Mednovus product expert from Siemens’ national accessories division. Contact us soon so that we can arm you with the information you need to secure MRI safety improvements in next year’s budget.

Yes! Please put me in touch with the right Siemens’ accessories product expert!

By reviewing your current MRI safety protocols against published best-practices, and soon-to-be accreditation standards, you can prioritize the areas for improvement in 2009. In many cases, no-cost operational changes will help you achieve your goals, but whether it’s a new MRI-friendly infusion pump, improved signage, or the thrice-recommended ferromagnetic detector, you will probably need to have a few MRI safety line-items in next year’s budget.

Please contact us if we can be of any assistance in helping you with your observances of MRI Safety Planning season.

It surprises many that the Joint Commission has no specific MRI safety accreditation standards. Surveys of accredited MRI providers have, over the past many years, focused largely on general safety standards, adapted for the MRI environment. Historically, a surveyor’s check for a non-magnetic portable fire extinguisher was the only MRI-specific safety check provided by the Joint Commission.

Despite the fact that many MRI-specific safety articles, recommendations, and, most recently, Sentinel Event #38 have been offered by the Joint Commission and its allied Joint Commission Resources educational arm, there have not previously been specific MRI safety standards for accreditation, and it is only through the new Environment of Care requirements that MRI safety will become an implicit standard for Joint Commission accredited facilities.

Starting this coming January 2009, inpatient and outpatient accredited facilities will need to abide by the new Risk Management provisions of the Joint Commission Environment of Care standard. The Standards Improvement Initiative will require facilities to prospectively define the physical hazards within the facility and develop specific responses to manage and mitigate those hazards.

The new standard specifically cites Sentinel Event Alerts as one external reference that must be considered in defining risks. For MRI, this automatically means Sentinel Event Alert #38. And since SEA #38 draws so heavily from the ACR Guidance Document for Safe MR Practices: 2007, it only follows that the ACR Guidance Document is the underlying industry standard document for defining MRI safety. Another external reference that specifically addresses MRI physical hazards which should be used as a basis for risk analysis is the VA MRI Design Guide.

What do Sentinel Event Alert #38, the ACR Guidance Document, and the VA MRI Design Guide all recommend? Well, lots of common elements, actually, but one of the key recommendations is for the use of ferromagnetic screening (click here to download a PDF document that outlines many of the recent recommendations for ferromagnetic detection).

While it is starting with the Joint Commission Environment of Care, my expectation is that MRI-specific patient safety requirements will spread to other accreditation requirements, building codes, and standards of practice. This will include not just recommendations, but requirements for the use of ferromagnetic detection for MRI pre-screening.

Over the next few months, all Joint Commission accredited MRI providers will need to review the standards of practice in the ACR Guidance Document for MR Safe Practices. Specific actions must be taken to identify, document, and respond to the unique hazards in the MR environment. One of those immediate actions should be planning for ferromagnetic detection at your MRI facility.

If you have any questions about the new MRI safety standards, the best-practice recommendations for ferromagnetic equipment siting, and incorporating these vital safety instruments in your MRI screening practices, I recommend that you heed the advice of the ACR Guidance Document, the VA MRI Design Guide, and other safety practice documents. If you still have questions about these standards, I invite you to contact me.

For those administrators stuck between ‘legal liability’ and ‘budgetary constraints’, sometimes the decision of which safety improvement to invest in has a lot to do with who recommends (expects) it. Regulatory compliance is an imperfect litmus test of safety, to be sure, but like it or not, when the accrediting bodies speak, people listen. In the past year there has been a growing chorus of accrediting and regulating bodies that have all called for ferromagnetic detection in MRI patient screening.

Let’s start at the very beginning (“What a very good place to start.”), with last summer’s publication of the ACR Guidance Document for Safe MR Practices: 2007…

“[F]erromagnetic detection systems are currently available that are simple to operate, capable of detecting even very small ferromagnetic objects external to the patient, and now, for the first time, differentiating between ferromagnetic and nonferromagnetic materials. While the use of conventional metal detectors is not recommended, the use of ferromagnetic detection systems is recommended as an adjunct to thorough and conscientious screening of persons and devices approaching Zone IV.” [Emphasis mine.]

Just a few months later, the UK’s MHRA released their 2007 MHRA Device Bulletin – Safety Guidelines for Magnetic Resonance Imaging Equipment, which included ferromagnetic detection in the document’s MR Suite Recommendations section. In the MHRA document, a two-stage ferromagnetic screening process is recommended, one near the door to the MRI room for large threats and a patient screening, capable of finding even smaller threats…

“As well as reducing the likelihood of small projectile incidents, the systems are designed to reduce the likelihood of an MRI scan having to be repeated e.g. due to the presence of an object distorting the MRI scan image.”

In February of 2008 the Joint Commission added their thoughts with something of an omnibus MRI safety Sentinel Event Alert (their highest patient safety alert). The top recommendations of the SEA included access controls and enhanced screening for threats…

“Use trained personnel to screen all non-emergent patients twice, providing two separate opportunities for them to answer questions about any metal objects they may have on them, any implanted devices, drug delivery patches, tattoos, and any electrically, magnetically, or mechanically activated devices they may have… [U]se other means to determine if the patient has implants or other devices that could be negatively affected by the MRI scan (e.g., look for scars or deformities, scrutinize the patient’s history, use plain-film radiography, use ferromagnetic detectors to assist in the screening process, etc.).” [Emphasis mine.]

And most recently, earlier in July of this year, the US Veterans Administration released a sweeping revision to their MRI Design Guide which offers design input on technical, operational and safety factors for MRI suites. The new MRI Design Guide covers a LOT of material, but included in its provisions is the use of ferromagnetic detection screening for all persons approaching the MRI magnet…

“It is recommended that MRI facilities install ferromagnetic detection systems for use in screening persons and equipment entering Zones III and IV to interdict potential threat objects.” [Emphasis mine.]

For the moment, this chorus of official recommendations are not yet requirements, but that is about to change. The Joint Commission is said to be implementing a new risk-management requirement for accredited facilities which will demand that Joint Commission accredited facilities perform their own risk analysis using, as one of the criteria, the Joint Commission’s own Sentinel Event Alerts. Accredited MRI providers will need to demonstrate how it is that they provide quality-control review and redundancy of their MRI screenings.

The ACR’s MR Accreditation Committee is also entertaining a formal request to incorporate safety provisions of the ACR’s Guidance Document as a part of ACR MR Accreditation. Both the form and timeline of any changes in ACR accreditation are, as yet, unknown, but the current chair of the MR Accreditation Committee, Dr. A. Joseph Borelli, believes strongly in the principles of the Guidance Document.

So if the decision to embrace ferromagnetic detection or postpone it is influenced by what the regulatory / accrediting bodies think of it, the message is quite clear… ferromagnetic detection helps make a positive impact on patient safety and its use, at least among these four agencies, is universally called for.

The new VA MRI Design Guide takes a quantum leap in addressing new technologies, new clinical practices and new tools and tactics for enhancing the safety of patients and staff. One of these new strategies includes the use of ferromagnetic detection systems for MRI patient screening.

The new Design Guide is fully downloadable in PDF form in four individual sections from the VA’s website:

http://www.va.gov/facmgt/standard/dg_imag.asp

Or, you can download the complete document, rolled into one PDF, from the Mednovus website:

http://www.Mednovus.com/downloads/VA_MRI_Design_Guide-08.pdf

The VA joins a growing list of professional bodies, accrediting agencies and organizations recommending the use of ferromagnetic detection for patient screening.

In a forthcoming entry I’ll feature quotes from and links to these various standards calling for the use of ferromagnetic detection to enhance MRI patient screening.

Regards,