Playing it Safe

The accident prevention approach for MRI

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As the janitor's buffer remains lodged in the MRI unit, more damage is occurring until complete demagnetization takes place. (Andre Pascal, MS, RT(R))

In general, medical equipment is built primarily for a specific purpose. It is also built to address all the safety concerns that may arise upon its use and application. Safety of the patients, workers or anyone else – such as users, consumers, stakeholders, distributors, suppliers – is of great concern to a facility. An MRI unit is no different when it comes to safety, maybe even more so. However, despite our best efforts, some people argue that all accidents cannot be prevented. Others may say we should always err on the side of caution. Because of this, education as a preventative measure should be emphasized.

MRI equipment is ferro-magnetically built. In and around any MRI unit, anything that is attracted to a magnetic environment is contraindicated. In October 2005, at Diagnostic Imaging Resolution (DIR) (Note: The name of the facility has been changed for confidentiality purposes) in Pennsylvania, the MRI unit was damaged. The damage inflicted to the MR equipment was the failure of an outside cleaning crew that decided to clean the floor of the MR unit without any authorization to do so. From the rear, the magnet violently pulled the vacuum buffer from the janitor, thus causing the damage to the unit. Furthermore, this accident could have been prevented had the unauthorized cleaning person not failed to read the warning signs posted on the entrance door. The damage sustained resulted in a host of losses, including but not limited to: productivity, income and revenue.

Fortunately, there was no human tragedy involved. In its many years of history, DIR has had no prior accidents. Thus, it is fair to say that it is a very safe place for all. Management, administration and personnel alike are facing, most importantly, what steps need to be taken to prevent this type of accident from ever happening again.

Setting the Stage

DIR, a division of the Digital Revolution Group, opened six and a half years ago. Since it opened its doors, DIR has become a pillar in the community, not only for quality of care and diagnostic images provided to those in the immediate environment and from afar, but also for being a good citizen in the community.

DIR is affiliated with many colleges and universities in the area. DIR provides all imaging services including, but not limited to CT, ultrasonography, nuclear medicine, bone densitometry and MR. All studies are performed with state-of-the-art equipment by fully licensed personnel.

Of all the imaging equipment available at DIR, the MRI unit is the most recent. Nearly six months ago, the MRI unit was updated to a 1.5 Tesla (T) system from Toshiba America Medical Systems, Tustin, Calif. This unit is operator dependent, which allows technologists to fine-tune in the course of an exam. Baselines are provided, as with every other MRI unit, but nothing is set in stone. The Toshiba 1.5T unit is versatile enough so that the technologists can make changes that may enhance the outcome of a study.

Screening and Safety

Experts generally agree that MRI is safe, whether or not from a clinical standpoint. However, if something goes wrong, it can go very wrong. Patient screening and safety are serious endeavors at DIR. Patients are generally screened at least twice. Patients must first fill out a health screening form. Then during pre-examination preparation, the patient is questioned about his/her answers to those questions on the form. The patient continues to be screened by the technologist performing the study/exam upon entering the MRI dedicated room prior to being helped on the examination table. Standard safety issues involving all ferromagnetic materials are addressed and emphasized by all involved with MRI. Visual aids of most of everything contraindicated to a magnetic field are posted on the entrance door of the exam room.

An article in the Aug. 14, 2005 New York Times reported MRI architect Tobias Gilk saying that the safety guidelines drawn up by the American College of Radiology (ACR) in 2002 and later revised, have no teeth. Emmanuel Kanal, MD, FACR, professor of MR services, department of radiology, at the University of Pittsburgh Medical Center, agrees with that assertion in principle, due to the escalating number of errors and the indifference of some scanner operators he has encountered.

It should be noted, however, that examination safety is not at issue. Rather, the issue at hand is the occurrence of accidents reported and unreported in the MRI examination rooms around the country. According to that same New York Times article, no one knows the true number of accidents that has occurred involving MRI in the United States.

Notwithstanding, the "close calls" in MR centers are neither documented nor reported. Kanal says that MR accident reporting is so lacking that lawyers are usually the source of that knowledge and the U.S. FDA database is far from being the tip of the iceberg.

Casting Blame

Accidents happen for a variety of reasons. Chief among them, according to Kanal, is mentality. He contends that people, to a great extent, are not fully aware of the potential problems that can occur and their severity in MR-related accidents. He also says people tend to have a callous or laissez-faire attitude with regard to safety. It is safe to say that DIR's safety track record is outstanding. There has never been an accident involving a patient, a staff member, operator/technologist or third-party personnel until recently. A review of the occurrence of this accident involving the third-party personnel clearly corroborates Kanal's assertion of mentality. Lapse of judgment and failure to heed properly displayed warnings signs comprise the list of reasons that led to this accident.

Accidents are generally reported to the FDA by manufacturers, and not by the operating company, based on the degree of damage sustained by the equipment. Perhaps, there is no incentive for operating companies to both document and record MR accidents, missed or otherwise.

Whether the accidents involve the patient, operator or third-party personnel, the outcome is usually costly. The minimum cost of an accident, such as the one described in this article, is $250,000. This minimum of $250,000 may only cover repair costs. Administration must also factor in costs for loss of revenue during the system's downtime, litigation cost if necessary, salaries, insurance and inconvenience to patient in an attempt to determine the true cost of the accident.

Preventative Measures

In light of the severity of the accidents that have been reported thus far, the ACR seems to be leaning toward advocating federal guidelines that would strengthen existing preventative measures. Better architectural design is advocated, as well as continued training and education of key personnel, door mounted metal scanning devices and metal detectors.

Greater federal involvement may be necessary, according to Kanal, because operating companies, of varying degrees of credibility that are populating the market appear to lack the will to police themselves. Those measures, however, seem to imply, but they do not explicitly take into account any third-party personnel. Thus, it appears that DIR is well-poised ahead of the safety curve.

After the failure to follow clear instructions and heed warnings by contracted third-party cleaning personnel, DIR has issued and begun to implement the following safety procedures:

• Scheduled patients are called on the eve of their studies and given suggestions regarding the most appropriate way to dress for their studies
• Have patients change from street clothes to a clinic/hospital gown;
• Search the patient through patting, with permission;
• No person shall enter the MRI unit after screening without being accompanied by an MRI staff member;
• All cleaning personnel are prohibited to enter the MRI unit alone unless cleared by a MRI technologist.
• A lock will be placed on the door of the MRI room. At the end of the last shift the door will be locked with a key
• In between studies, the MRI exam room door will remain locked

No one should make assumptions about safety issues, be it personnel, patients or third-party contractor, in and around an MRI unit. Due to the strength of the magnet, MRI-related accidents, more often than not, can be violent. When safety is discussed in the realm of MRI diagnostics, patient safety is the primary concern. It appears there may be less concerns for non-MRI personnel or non-patients. A whole list of contraindicated elements, including but not limited to pacemakers, aneurysm clips, head surgery, implants and metal in eyes, is covered during patient assessment.

"We take a family-oriented approach in taking care of every single patient coming through our doors. We recognize that our success depends on the empathetic care we provide to each individual. Yet, we are not safe until every patient we serve enjoys the safety and comfort we provide ourselves," says Lonie Soroko, DIR practice manager.

Damage to the unit is not limited to the initial impact. In other words, further damage is occurring, until complete demagnetization takes place. That said, continued care and concerns must be exercised to avoid further damage upon entering the scene. Also, MRI accident is a very costly enterprise. The costs encompass the following: repair, salaries, litigation, lost revenue and insurance.

When it comes to patient safety, extreme caution is required. Technologists must be keenly aware of the patient demographics they serve. More often than not, the personal history gathered through pre-screening provides a sound basis for clues. A great number of those served are between the age of 40 and above. The reason for the study/exam is paramount. When considering that the majority of MRI studies are related to brain disease, it is of great importance to exercise extra care due to senility, dementia, forgetfulness, stress, depression and others.

Understanding the functional aspects of these related diseases can help better prepare the patients prior to entering the exam room. It should be emphasized that good patient preparation or assessment is inversely proportional to safety violation and accident. Therefore, MRI personnel should constantly strive to operate in a safe environment that will lead to the safety of their patients toward the production of images with great diagnostic for eventual planning and management of patient care.

References:

• Mercola J. (2005). Six-year-old Killed During MRI [Electronic version]. Retrieved October 31, 2005 from: www.mercola.com/2001/aug/15/mri.htm
• McNeill D.G. Jr. (2005). MRI's Strong Magnets Cited in Accidents [Electronic version]. Retrieved October 31, 2005 from: www.mindfully.org/Technology/2005/MRI-Magnet-Accidents19aug05.htm
• ABC News: MRI Scanner Accidents on the Rise [Electronic version]. Retrieved October 31, 2005 from: www.abcnews.go.com/GMA/story?id=1057960&page=1
• Safety Design Considerations for Magnetic Resonance Imaging [Electronic version]. Retrieved October 31, 2005 from: www.aia.org/aiarchitect/thisweek03/tw0103/0103tw5bp_mri.htm
• Can Metal Detectors Cut MRI Accidents? [Electronic version]. Retrieved October 31, 2005 from: www.personalmd.com/ news/n0928062615.shtml
• Metal Detector Promises Increased Safety in MR Suites [Electronic version]. Retrieved October 31, 2005 from: www.diagnosticimaging.com/dinews/2004041302.shtml