Tag Archives: MR

New Joint Commission Environment of Care (EC) Requirements

Starting in January of 2009, the drought of MRI safety regulation will begin to end.

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.

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

MRI Patient Pre-Screening

Ferromagnetic detection is a vital part of the pre-screening for persons about to enter the MRI magnet room, but it’s only one part of the overall sequence.

First, before we jump into the issue of where in the sequence ferromagnetic detection is best deployed, it’s important to break pre-MRI screening into its two constituent parts: clinical screening and physical screening.

Clinical Screening:

Before being brought to the MRI magnet, everyone (and this means patients, visitors and staff) needs to be screened for contraindications. Most often we think of pacemakers, but other contraindications include nerve stimulators, insulin pumps, prosthetics, halo vests, and a number of other objects. The screening is typically accomplished through the use of forms to help the subject identify any clinical risks for the MRI provider. The screening form is then to be reviewed between the patient and the MRI Technologist.

Once clinically cleared of contraindications for the MRI exam, then the subject should proceed to the next step…

Physical Screening:

Contrasted with the widespread uniformity of the clinical screening, the physical screening takes very different forms at different provider. However, all have the same objective, namely, to remove ferromagnetic materials from the subject and keep them away from the MRI scanner. Even small quantities of ferromagnetic material can cause artifacts in the MRI scan when near the imaging volume. Small ferromagnetic items, such as bobby pins and nail clippers, have caused serious harm when propelled by the magnetic force of an MRI magnet. And obviously, large items such as oxygen cylinders and floor polishers can have catastrophic consequences if brought to the MRI room.

Some MRI providers have outpatients simply empty their pockets, others provide gowns or scrubs for MR patients to change into, and all should use ferromagnetic screening to help verify patients’ compliance with screening instructions.

When performed in the above order, providers avoid gowning patients only to find out that the patient can’t receive the MR exam. Additionally, when clinical screening is accurately completed first, the Technologist has done everything within his or her human capabilities to mitigate the contraindication risks associated with exposure to magnetic fields. Although it is impossible to completely eliminate the chances of accidents, by following the recommended industry-standard procedures of  conscientious clinical and physical screenings followed by properly-performed ferromagnetic detection, the safety of your MRI center has been significantly enhanced.

Some of the most sensitive ferromagnetic detectors currently available use passive magnetic fields to improve sensitivity. These GS (Greater Sensitivity) detectors use a localized DC field (i.e. stronger versions of a similar type of the permanent magnet that holds your notes on your refrigerator door). While the magnetic field strength very close to the GS detector can exceed the 5-gauss threshold, that limit is for persons who haven’t been successfully cleared for MRI contraindications (a step which was just completed if the pre-MRI screening was conducted in the proper order).

While patients and caregivers should be concerned about exposing unscreened persons to the extraordinarily powerful magnetic fields around the MRI, momentary exposure of post-screened persons to the passive “fridge-door” magnetic fields of a GS ferromagnetic detector is very, very small on the relative risk-o-meter. And this minute risk comes with an enormous potential safety upside…

No ferromagnetic detection system on the market from any manufacturer is intended (or approved) for finding objects internal to the body of the patient. However as an incidental finding, ferromagnetic detectors have alarmed on the ferromagnetic content of implants (including pacemakers) that were disavowed by the patient in the clinical screening process. While ferromagnetic detection should never be used in lieu of conscientious clinical screening, they have helped to identify critical contraindications that may have otherwise jeopardized the safety of the MR patient — had they not been found by the ferromagnetic detector.

And the relative risk of being exposed to 5, 10 or even 100 gauss as a part of a physical pre-screen (particularly when already cleared of clinical contraindications) is microscopic, when compared to either the risk of the planned exposure to 15,000 / 30,000 gauss, or the potential benefit of identifying a contraindication that the patient themselves didn’t communicate.

The take-home messages from this are these:

  • MRI providers should provide as thorough and comprehensive clinical screening as humanly possible for everyone approaching the MRI.
  • Once the clinical screening is complete, the provider’s standard physical screening (emptying pockets, changing into scrubs, etc…) should be conducted as appropriate to the MR patient / visitor.
  • And following the clinical and physical screenings, patient / visitor compliance should be verified with a ferromagnetic detector.
  • If these industry-standard procedures are correctly followed, there should remain only minute (accepted) risks associated with exposure to any magnetic field, either the enormous field of the MR or the comparatively tiny field present in GS detectors.

Clearly, providers should feel free to use whatever ferromagnetic detection they wish – from their choice of manufacturer – in order to conform with ACR, VA and Joint Commission guidance, whether it be an instrument which relies on only the trace-magnetism of the Earth’s own magnetic field, or one in which the detection sensitivity has been enhanced through the use of a locally-provided, passive DC magnetic field as found in GS ferromagnetic detectors.

My recommendation is always to use a detector with the greatest possible sensitivity. Because, while they are wonderful instruments that can make a substantial improvement in a provider’s MR safety protocols, ferromagnetic detectors are dumb. They can’t differentiate ‘good’ ferromagnetic material from ‘bad’. These sorts of value judgments should be made by a trained MR technologist and not by a machine.

In my opinion, ferromagnetic detectors should be used to help find every piece of ferromagnetic material that they can, so that the Technologist knows what is about to enter their magnet room (and can make re-screening decisions as appropriate). The greater the sensitivity of the detector, the more informed those Technologist decisions will be.

Pass-through ferromagnetic detection systems, such as the newly released Mednovus Sentinel® GS 2.0 portals, also have user-adjustable sensitivity settings, so that the system can be ‘dialed back’ as needed for special circumstances, further supporting the concept of having the instrument with the greatest sensitivity, and tuning it to meet your specific needs.

As evidenced by repeated, and increasing MRI projectile accidents, there is enormous room for improvement from the prior standards. Effective pre-screening of MRI patients, including the use of ferromagnetic detection at the appropriate point, can make an significant difference in the safety of the MR exam. Providers should turn to the current best practice guidance and compare their pre-MRI screening processes, making any indicated changes to help assure the safety of their patients, visitors, and staff.

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

Video Excerpt From Dr. Kanal’s AHRA MR Safety Presentation

As mentioned in an earlier post, noted MR safety guru Dr. Emanuel Kanal gave a brilliant presentation at the 2008 annual meeting of the American Healthcare Radiology Administrators (AHRA). While his session, “MR Safety Update, 2008” addressed several different MR safety issues, below is a video excerpt, which marries the audio recording with his presentation slides, showing information on ferromagnetic detection that Dr. Kanal presented.

[display_podcast]

Among the ACR Guidance Document on Safe MR Practices: 2007, the recent Joint Commission Sentinel Event Alert #38 on MRI Accidents and Injuries, and other standards and expert recommendations, it is abundantly clear that ferromagnetic detection is a potent part of an effective MR screening program.

A PDF transcript of the above video is available for download at http://MRImetaldetector.com/blog/wp-content/uploads/Transcript_of_Dr_Kanal_Edited_video.pdf.

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

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