Updated Comment: Our article came out in October of 2009, being one of the first to report on MRI safety and the MRI accidents statistics reporting those dangers was increasing nationally. Since our 2009 article was published, in 2011 the FDA has since met with the American College of Radiology, among other MRI safety experts, including the expert interviewed in the article below, Tobias Gilk. Wayne Forrest, an Aunt Minnie correspondent reported an even higher statistic based on new numbers that surfaced in 2011. Here is that article that came from Aunt Minnie about that FDA meeting.
MRI Optimize Consultants can understand how MRI accidents might occur with the reduction in staff that has transpired over the past few years, and the increased demand in volume and responsibility on the MRI Technologist team. Part of the pressure that comes from this demand on the processes surrounding MRI has resulted in a documented increase in MRI accidents of over 523% from year 2000 to 2009. This concluded statistic, however, is only from those incidences that went reported. Many MRI Safety experts in the industry believe less than ten percent of the MRI accidents even get reported to make up the above statistic. This is alarming indeed.
What about the possible thousand upon thousand of incidents that transpired and never got reported? How do those numbers get figured into the final statistic? How about the elderly patient who got into the MRI scan room, and forgot to tell any of the staff they had a urinary stimulator, until the first localizing sequence fired up and they felt the device create a stimulating vibration during that first scan? This aged individual may have signed off on a safety checklist, but nobody interviewed the patient evaluating each question. Does your department have a policy in place that mandates a follow-up for events of this nature? How did the patient get to this point without somebody jogging their memory, or even getting a history from the referring physicians’ office?
So many questions go unanswered until an event affecting a patient and staff shakes up the stability of a site. Let us help you educate your entire team, enforce practices that mandate accountability, and keep you out of court.
“A Deadly Trend/ Statistics Show MRI Accidents up 277%” – Medical Dealer Magazine October 2009
The following is a conversation between MRI Optimize Consultants and Tobias Gilk, the President and Safety Director of MedNovus. Gilk’s company provides several different formats of ferromagnetic-detection products, which conform to recommendations from the American College of Radiology, the U.S. department of Veterans’ Affairs and the Joint Commissions Sentinel Event Alert #38.
MRIO: The heading above was no misprint. When we heard Tobias Gilk, of Mednovus mention this statistic at the recent 2009 AHRA (The Association for Medical Imaging Management) annual meeting in Las Vegas, we were mortified. A deadly trend, statistics show MRI accidents are up 277% according to reports released by the FDA.
T.G.: Mortified is probably the appropriate response! FDA reported MRI accidents have indeed increased over 277 percent since 2004. And the numbers behind that statistic grossly underestimate the real quantity of accidents that occur. The FDA’s only objective criterion for mandatory medical device accident reporting is when someone dies as a result. All other outcomes are subject to interpretation as to whether reporting is mandatory. Certainly when measured against this ambiguous litmus test, the frequent adverse events, such as ferromagnetic chairs drawn into the bore, are profoundly underreported.
MRIO: In recent years with DRA’s and reduced reimbursements, there is compounding pressure from management on all staff to do more with less. When this reaches the tipping-point, side effects will occur, and it seems these are taking place in two specific areas pertaining to one of the most valued reimbursement modalities in the radiology business venue, the MRI department. The first will be addressed in this article regarding MRI Safety and hardware; the second portion will be addressed in next month’s article pertaining to MRI Safety involving Infection Control.
T.G.: And it’s not simply a question of ‘doing the right thing.’ There are some very real, very large costs associated with MRI accidents. Not discussing those costs ignores the elephant in the room. The US Department of Veterans Affairs typical (and limited) estimate of accident costs from an MRI projectile accident is $43,172 based on repairs, and costs associated with paying alternative providers, although repairs can range from $20K to $500K. (http://www.va.gov/ncps/SafetyTopics/mrihazardsummary.html)
MRIO: Add to the statistics the ever increasing rate of MRI utilization, and the willingness of managers to save money with on-the-job training of their new MRI staff, which further increases the opportunities for MRI safety disaster. When MRI scanners entered the radiology arena in the 1980’s, the staff were required to be superstars, only the best and brightest went into the modality. Early on in this modality, the manufacturer’s Applications Specialists were PhD’s who had a clear understanding of MRI physics, safety and sequences. In the past two decades, the expected level of MR expertise has been downgraded to what many deem as procedural “button pushers”, with just enough knowledge to get them through. If you are fortunate enough to have a superstar MRI technologist, support and guard them fiercely. Many exist, despite the mandate for them to do more with less, while expected to teach newer technologists what years of experience has taught them.
T.G.: MR suite design can help or handicap efforts at throughput and safety. From responding to technical issues, such as short bore scanners increasing the attractive force, to simply making sure that the technologist has awareness and control of who’s approaching the magnet room, layout and design can have a huge impact.
MRIO: To check for implanted devices safety, websites such as MagResource.com, which houses the largest database of MR Online safety references, and mrisafety.com, which Dr. Frank Shellock has nurtured for many years; both are available resources for implant compatibility.
T.G.: Per the Joint Commission’s Sentinel Event Alert #38, the following is a recommended list of points regarding safety that should be addressed in every MRI department:
1. Control access per ACR recommended MRI Safety Guidelines
2. Provide ferromagnetic screening of patients, implant devices
3. Obtain complete medical history for contraindications
4. Provide trained MR Professionals
5. Annually renew training for ancillary staff
6. Establish procedures to prevent RF burns
7. FDA label all devices in MRI Suite
8. Plan for patients requiring clinical support
9. Provide hearing protection
10. Establish Code Procedure for MRI suite
We expect that some elements of MRI safety will become mandatory components of both Joint Commission and ACR surveys in the months ahead.
MRIO: To set your MRI department apart from others with a noticeable difference to your patients (and conform with JCAHO and ACR calls), you might get the SAFESCAN® Intercept Pillars™ and the SAFESCAN® Target Scanner™ to check patients for ferromagnetic materials.
T.G.: At this very moment, we’re watching the pre-trial litigation play out in the infamous Michael Colombini case (where the young boy died when a steel oxygen cylinder was brought into the MRI scanner room). Whatever else you may think about contemporary calls for greater MR safety, it’s clear that both individuals, such as techs and administrators, as well as the institutions they represent, have individual and institutional responsibility to the safety of the MRI service.
MRIO: In conclusion, MRI Safety is not to be taken lightly and these statistics demonstrate great concern. Accidents are dangerous, expensive and life threatening.
- Safescan Intercept Pillars will be noticed by your patients!
For an update on how to help your staff and department be the safest and attain an impeccable safety record, contact the experts at cleyen(at)mrioptimize.com.