Tag Archives: Mednovus

Is Siemens Medical ‘On Board’ With Ferromagnetic Detection?!?

MRI equipment vendor executives generally must be guarded about what they say to the media. We’ve all seen the cartoon depictions of the mini-angel and devil sitting on opposite shoulders of a person, lobbying for their own moral agenda. When I meet an executive from the MRI vendors, I imagine a very similar scene, only instead of angels and devils, I imagine a gaggle of attorneys advising the person as to what can and can’t be said, particularly in the realm of MRI safety.

So, it surprised me, more than a little, when I came across this gem…

“There must be metal detectors at the entrance to every room with a MRI device.”

Realizing that the speaker meant ferromagnetic detection, these words sound like ones that have passed my own lips, or those of noted MRI safety guru Dr. Emanuel Kanal. Imagine my surprise to learn that this statement was issued by none other than Walter Marzendorfer, CEO of Siemens’ MRI business unit.

The interview, which appears in the Israeli business publication ‘Globes’ [click here to go to the Globes interview], includes the statement about the magnetic field risks and the necessity of projectile detection to help mitigate the safety concerns.

Walter Maerzendorfer, CEO of Siemens MRI Business Unit “The 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.”

–Walter Marzendorfer, CEO of Siemens’ MRI business unit

I believe that Siemens Medical worldwide views this statement with the same unequivocal eye with which I read it, and that ferromagnetic detection will be offered for Siemens MRI installations.

Stay tuned as the MRI vendor situation develops!

Tobias Gilk, President & MRI Safety Director
Mednovus, Inc.
Tobias.Gilk@Mednovus.com
www.MEDNOVUS.com

News From Lisbon – ISMRM / SMRT MR Safety Workshop

I was tremendously honored to have been asked to give a presentation to the ISMRM / SMRT MR Safety Workshop which was held a couple weeks ago in Lisbon, Portugal. Mine was actually the second-to-last of two days of back-to-back-to-back presentations and I was worried that all of my content would have been covered by prior presenters. I mean MR safety is a pretty broad area, but still, having about 30+ notable MR authorities from around the world go before me, would my material be so well-worn before it was even my turn that my presentation would push the entire audience into a boredom-induced coma?

Turns out that I needn’t have worried…

ISMRM is a fabulous organization, but the long form of the organization’s name (the International Society for Magnetic Resonance in Medicine) gives a bit of indication about their perspective. The conference wasn’t broadly about MR safety (at least before they got to my presentation), it was about implants, dynamic field affects and heating… essentially safety at or inside the bore of the MRI.

  • There was no discussion about staffing numbers or qualifications.
  • There was no discussion of screening techniques or their effectiveness.
  • There was no mention of access restrictions or 4-zone implementation.
  • There wasn’t anything about whether or not MRI exams are actually getting any safer for patients… nothing provided as a metric as to whether the workshop’s efforts were providing any positive feedback to the MR industry.
  • And certainly there was nothing about ferromagnetic detection.

Despite the fact that I was invited to speak on my perspective on MR safety issues before I joined Mednovus, a company which manufactures ferromagnetic detection (FMD) systems, and had planned on speaking about the technology, I thought that anything I said on the subject might be viewed as being motivated by personal financial interests. So I actually said nothing to the group about FMD. Instead I presented information on the official record of MRI accident rates in the US from the FDA MAUDE database over the last several years…

Table showing MRI accident rate increases

And I talked about how the physical design of the MRI suite can mitigate a number of risks that are inherent (and growing) in the MRI environment.

As MRI scanners are made more and more powerful, the projectile / missile effect increases. As we use MRI for older and more acutely ill patients, the risks associated with medical device contraindications grows. As we grow the interventional applications for MRI, we bring more people and more stuff into the MRI suite, increasing all sorts of risks. As the financial pressures increase the demand for greater throughput, the time allotted for preparation and pre-screening of patients may suffer, if not protected.

In short, the clinical, financial and technical forces on MRI are all combining to ratchet-up the risks in the MRI environment. MRI has a well-earned reputation as the safest and most informative diagnostic tool available, but that reputation is eroding and is at risk of being catapulted backward when another high-profile fatality is splashed across CNN.

I am deeply honored to have been asked to present at the ISMRM MR Safety Workshop and I hope to have many more opportunities to share my thoughts and experience with the group. My opinion, however, is that we’ve got a long way to go to get the professional, regulatory and accrediting bodies to address MRI safety in the holistic way that is necessary to bring about the substantial change needed to protect both MRI patients and providers.

Tobias Gilk, President & MRI Safety Director
Mednovus, Inc.
Tobias.Gilk@Mednovus.com
www.MEDNOVUS.com

Ferrous Metal Detectors – The Technologist’s Best Friend

Change is often difficult, especially when we’re asked to change the ways in which we do things and the change doesn’t appear to have any direct, personal benefit.

Employees will be required to park in “Lot K” beginning on September 1st.’

The company has switched health insurance providers and you will receive your new card in the mail in 4 – 6 weeks.’

All persons entering the MRI scanner room must successfully clear a ferromagnetic screening.’

Except that sometimes, things that don’t appear to be in our best interests in fact are to our personal benefit, and ferromagnetic detection is one of them.

First, let’s dispel the myth that ferromagnetic detection is somehow there to ‘grade’ the screening effectiveness of the Technologist. The fact is that most of the time when ferromagnetic material makes it through the screening process it is because the person bringing it failed to comply with instructions that they’d been given!

Yes, there are differences among Technologists and some are more thorough than others, going beyond the standard screening forms. But time and time again we find that projectile accidents are compliance lapses on the part of patients, visitors, contractors, transport, housekeeping, anesthesiology and the myriad of others who come to the MRI suite.

If you had a tool to verify that patients complied with your critical safety instructions, wouldn’t you want to use it?

So, ferromagnetic detection is – first and foremost – present to make sure that patients, staff and visitors comply with the MR Technologist’s instruction. An alarm on your ferromagnetic detector should be viewed as a patient compliance issue.

Second, ferromagnetic detectors help to protect Technologists (and medical directors, and radiology administrators) from liability. The civil lawsuit resulting from the death of the young boy in a 2001 MRI accident personally names the two Technologists and the medical director for the MRI provider. Even if they aren’t found to have any individual civil liability in the trial, they’ve already had a multi-million dollar lawsuit hanging over their heads for the last 6 years or so.

While the presence of a ferromagnetic detector won’t transform an MRI provider into a guaranteed accident-free site, when used effectively these instruments can dramatically improve compliance with the Technologist’s instructions and help reduce the likelihood of future ferromagnetic projectile / missile accidents.

Maybe there’s a silver lining to having to walk the extra two blocks from the newly designated employee parking lot or switching healthcare insurance companies (then again, maybe there isn’t), but there should be no question that ferromagnetic detectors are definitely in the best interests of Technologists, radiology administrators, and MRI medical directors.

Tobias Gilk, President & MRI Safety Director
Mednovus, Inc.
Tobias.Gilk@Mednovus.com
www.MEDNOVUS.com

Ferromagnetically ‘Naked’, A Risqué Mouthful

Band-Aids are great for skinned knees, but Band-Aid solutions are lousy for MRI safety. There is no book, training video, seminar, tool, product or gizmo which, by its inherent ‘MRI-safetude’ is going to make MRI appreciably less risky in practice. We all look for the silver-bullet solutions, but in a realm as complex as MRI, they simply don’t exist… at least when divorced from operations and procedures.

Yes, that book listing every tested medical device and implant is a tremendous tool, but does nothing for patient safety if it never emerges from the bottom of the file drawer in which it lives. If the book is not integrated into the practice of screening patients, it’s little more than reconstituted dead-tree.

Enter ferromagnetic detection, an enormously potent tool for helping to verify the compliance of MRI patients and visitors and quality control of Technologists’ screening protocols. But if simply plunked-down and plugged-in, even the most sensitive and accurate ferromagnetic detector won’t meet its full potential. As with any tool, effectiveness has a lot to do with how well the ferromagnetic detector is integrated within operations and protocols.

Very recently the magazine Patient Safety & Quality Healthcare ran an article I wrote on precisely this… the integration of ferromagnetic detectors into the operations at New York Presbyterian’s Weill Cornell Medical Center. The article offers a look at one of the most effective deployments of ferromagnetic detection and what it took to achieve such a high safety return on their investment. [spoiler alert: the changes were modest, but very effective]

Fortunately, PSQH makes the full text of their articles available online and you can read this one on their website:

http://www.psqh.com/julaug08/mri-safety.html

I also have PDF copies of the complete article, which I’d be happy to share with you. You can download a copy of the PDF simply by clicking on the link below:

http://www.Mednovus.com/downloads/Ferromagnetically_Naked_Print.pdf

Why ‘Ferromagnetically Naked’? Well, if the title alone has piqued your interest, don’t you think you owe it to yourself to read the piece and see what it’s all about?

If you have any questions about the article, or if you’d like to contact Mr. Steve Herrmann (from New York Presbyterian who was interviewed in the article) and learn directly from him about his experiences reviewing, selecting and deploying ferromagnetic detection, please contact me.

Tobias Gilk, President & MRI Safety Director
Mednovus, Inc.
Tobias.Gilk@Mednovus.com
www.MEDNOVUS.com

“Ferromagnetic Detection? Yeah, Who Says So?”

For those in the unenviable role of having to make tough decisions about which safety features to invest in and which to forgo, one key factor to these decisions is compliance.

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.

Tobias Gilk, President & MRI Safety Director
Mednovus, Inc.
Tobias.Gilk@Mednovus.com
www.MEDNOVUS.com

VA Calls For Ferromagnetic Detection In New Design Guide

The last time the United States Veterans Administration issued an update to their MRI Design Guide was 1996, which seems to be about 50 years in the MRI world. Just this past week, however, they made up for lost time and did so in a big way!

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,

Tobias Gilk, President & MRI Safety Director
Mednovus, Inc.
Tobias.Gilk@Mednovus.com
www.MEDNOVUS.com

Not ‘Metal Detector’ But ‘Ferromagnetic Detector’

What a metal detector actually does is pretty self-evident by the name of the product… it detects metals. If you’re looking for gold doubloons on the beach or trying to find an underground gas pipe, a conventional metal detector is what you want. But if you’re screening people and objects before they go into the room with the giant magnet at the heart of a magnetic resonance imager (MRI), you’re likely concerned about finding those things  – like pocketknives, cell phones, iron-containing jewelry, wheelchairs, medical gas cylinders, etc… – that can be attracted to the magnet with such force that they can fly across the room.

Click To Read More About What We Look For And What These Instruments Find…

Welcome to the MRI Metal Detector Blog!

Welcome to this community where we will be sharing information on Magnetic Resonance Imaging (MRI) safety issues, namely ferromagnetic detection (FMD), which is a big-mouthful that means metal detectors built specifically for screening of visitors and equipment entering the MRI scanner room.

These are not ‘airport-style’ detectors that you’ve passed-through under the watchful eyes of the TSA workers… No, these are specialty detectors that have been developed for the sole purpose of finding ferromagnetic materials, those that become magnet-homing-missiles, to keep them out of MRI scanners.

“Why worry so much? I mean, can’t you just crawl in there and pull something out if it did happen to fly in?”

Well, when you consider that objects can zoom in at speeds up to (and beyond) 40 miles per hour, and that oxygen cylinders and floor polishers and many other objects have injured patients and staff and incapacitated millions of dollars of MRI equipment, the protection of both people and the sizable capital investment demands additional layers of safety.

MRI services are very expensive to provide and generate huge amounts of revenue (they have to in order to pay for themselves). Even if it weren’t a safety issue, when a MRI provider is faced with a loss of $1,000 per hour (revenue that they can’t earn while the scanner is inoperable) plus the ongoing overhead expenses that almost equal the hourly revenue, a ‘lost day’ of MRI scanning can result in tens-of-thousands of dollars in unrecoverable costs.

Above-and-beyond the financial arguments, this is a safety issue, one that has been endorsed by the American College of Radiology (ACR) Guidance Document for Safe MR Practices: 2007 and by the Joint Commission Sentinel Event Alert #38

“[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]
— p. 4

“Ferromagnetic detection systems have been demonstrated to be highly effective as a quality assurance tool, verifying the successful screening and identifying ferromagnetic objects which were not discovered by conventional screening methods. It is recommended that new facility construction anticipate the use of ferromagnetic detection screening in Zone II and provide for installation of the devices in a location which facilitates use and throughput.” [emphasis mine]
— Appendix 2, p. 21

ACR Guidance Document for Safe MR Practices: 2007

“[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]

Joint Commission Sentinel Event Alert #38

I can’t wait to share with you even more of the information I have on MRI safety issues and the simple and direct steps that MRI patients and providers can take to make sure that MRI continues to build upon its reputation as one of the safest medical imaging modalities available.

Tobias Gilk, President & MRI Safety Director
Mednovus, Inc.
Tobias.Gilk@Mednovus.com
www.MEDNOVUS.com