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It is Time For The Government to Regulate Magnetic Resonance Imaging (MRI) Safety

By Troy Ashford 12/2014Loyola University MJ Thesis Project 95

The radiology community has failed to police itself in regard to MRI safety. There is a need for uniform MRI safety protocols, We can achieve this through government intervention, regulating MRI safety standards for all providers. MRI produces images using an EXTREMELY powerful superconducting magnet.The magnetic field produced from a 1.5 Tesla or 1.5T scanner is 30,000 times stronger than the earths magnetic field. However, the magnetic field produced from a 3T scanner is 60,000 times stronger than the earths magnetic field. As of today the highest field strength MRI magnet the FDA has approved for clinical use is a 3 Tesla (3T) magnet. GE hopes to have their 4T magnet out on the market before the end of 2015.Although it is used strictly for research, Ohio State University has had 7T magnet since 1988.And at the time the University of Chicago had the bragging rights of having the world's most powerful MRI scanner when it received their research magnet in 2008, a 9.4 Tesla magnet.The world's most powerful magnet is strong enough to lift up tank. This 45 Tesla research magnet is over 400,000 times stronger than the Earth's magnetic field, science is pushing the limits.1

The Dangers Of Magnetic Resonance Imaging

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Fatal Accidents CAN Happen!

During the summer 2001 Michael Colombini, fell off his bicycle and was taken to Westchester Medical Center in New York State.A CAT scan exam was performed although there were no findings associated with Michaels fall. Unfortunately, the results of the CT exams showed that the six-year-old boy had a brain tumor.After the surgical procedure to remove Michael Colombinis brain tumor, a postoperative MRI exam was ordered.Michael Colombini was only six years at the time he was killed, his MRI exam was to be performed under anesthesia.Michael Colombinis oxygen saturation levels quickly dropped after he was sedated and positioned in the head cradle of the MRI scanner.The incredible force from the magnet immediately ripped the oxygen canister from the anesthesiologists hands as he turned and faced the magnet.The anesthesiologist called out to one of two MRI.a nurse, who had accompanied a patient from a previous MRI procedure and had returned to the MRI suite to pick up something she left behind, heard the anesthesiologists cries for help and proceeded to hand the anesthesiologist a metal oxygen canister she retrieved from an out cove in the MRI department.The oxygen cylinder oscillated in the bore of magnet, striking the six-year-old boy repeatedly in the head. The county medical examiner's office said the boy's death was caused by blunt force trauma, a fractured skull and a bruised brain.3

Event 1.TIMELINE OF THE LEGAL PROCEEDURES IN THE WRONGFUL DEATH CASE OF MICHAEL COLOMBINI July 2001 Michael Colombini Died.Event 2.New York state department of health, fined Westchester Medical Center $22,000 for failure to ensure patient safety door and MRI procedure.Event 3.In 2002, Michael, Colombini's family filed a $20 million lawsuit against Westchester healthcare Corporation ( WMC), General Electric (GE), University imaging medical Corporation (UIMC), /staff.Event 4.2003 through 2009 was a period of pretrial discovery and various motions were brought, including summary judgment that favored several defendants, to dismiss case against them and some for the argument.Event 5.In 2006, the appellate court held that respondeat superior did not apply in the case therefore, MRI technologist Patricia Latria and Paul Daniels were not entitled to summary judgment on the grounds that their employer what the proper defendants. Event 6.2006 the same appellate court held that punitive damages against Ms. Latria, Mr. Daniels, and their employer UIMA was a triable issue. However, the court concluded that punitive damages against GE, Dr. Hou, and Valhalla anesthesia and Associates was not warranted. In addition the court ruled that Mr. Colombini's emotional distress claim could also proceed.

CONTINUED: TIMELINE OF THE LEAGAL PROCEEDURES IN THE WRONGFUL DEATH CASE OF MICHEAL COLOMBINI Event 7.Event 8.In 2009, the parties went back to court; Colombini v. Westchester County healthcare Corporation. The plaintiffs argued that there was negligence in the design and manufacturing of the MRI scanner. In addition the plaintiffs argued that GE was also negligent for failure to warn, breach of warranty, and strict product liability.In their defense GE cited Riegel v. Medtronic, Inc., 128 capital S. Ct. 999 (2008). The US Supreme Court ruled that certain state laws claims were preempted by the Medical Device Amendment (MDA's) preemption clause. Therefore the court ruled the cause of action was preempted by federal statutes. In addition the court ruled that GE had proven that it had no responsibility for the MRI scanner surroundings. The court dismissed GE as a defendant in this case.Event 9.In addition the same appellate court dismissed punitive damages against all defendants except for UIMA. The court stated that none of the other defendants were responsible for overseeing the daily operations of the MRI suite, safety protocols, training of staff, and they did not demonstrate malicious intent, willfully or wantonly neglect or recklessness.Event 9.John Colombini's claim for negligent infliction of emotional distress was also dismissed. Although the court acknowledge that Mr. Colombini feared for his son's safety, the court held that Mr. Colombini failed to prove he suffered any serious mental distress stemming from his own fear of injury to himself.Event 10.After nine years of pretrial discovery, the wrongful death case Michael Colombini settle for $2.9 million.

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accrediting bodyJoint Commission (JC) American College of Radiology ACR

The joint Commission's MRI safety recommendations.The American College of radiology (ACR) 2013 MRI safety guidelines. The ACR and the JC Commission do not have any regulatory authority over health care providers that own and operate MRI scanners, therefore, providers are not legally compelled to follow any of the MRI safety recommendations issued by either entity.However, The Centers for Medicare & Medicaid Services (CMS) approved three national accreditation organizations -- the American College of Radiology, the Intersocietal Accreditation Commission, and The Joint Commission - to provide accreditation services for suppliers of the TC of advanced diagnostic imaging procedures.

IMRI Accreditation Is Mandatory

All providers that bill for MRI under part B of the Medicare Physician Fee Schedule must be accredited in order to receive technical component reimbursement from Medicare.

As of January 1, 2012 ACR accreditation is required for all providers that bill for CT, MRI, breast MRI, nuclear medicine and PET under part B of the Medicare physician fee schedule must be accredited in order to receive reimbursement for the technical component from Medicare.

MRI scanners that are in licensed spaced are not required to participate in the ACR accreditation process. However, this is where the JC survey process comes into play in regard to MRI safety. On February 14, 2008 the JC issued Sentinel Event Alert, Issue 38: Preventing accidents and injuries in the MRI suite.

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Since THE death of MICHAEL COLOMBINI mri accidents have risen over 500%

Tobias Gilk, M.Arch, HSDQ, is President & MRI Safety Director for Mednovus, and also serves as Senior Vice-President of RAD-Planning. He previously sat on the ACR MR Safety Committee and has contributed to many contemporary MRI suite design standards.

Tobias Gilk, M.Arch, HSDQ,

A. President & MRI Safety Director for Mednovus B. serves as Senior Vice-President of RAD-Planning C. Previously sat on the ACR MR Safety Committee

In October of 2011, the US Food and Drug Administration (FDA) called a special meeting on the issue of MRI safety.

The U.S. Food and Drug Administration's (FDA) has a data base that tracks accidents, Manufacturer and User Facility Device Experience (MAUDE) database.

Overall the number of administered MRI exams increased by approximately 90%. This means the accident rates grew more than five-times the utilization rate. A clear indicator that MR safety protections need to be strengthened

(MRI) accidents in the US have risen more than 500% between 2000 and 2009.

Approximately 9000 MRI accidents occur each year and the majority of them can be prevented if the 2013 MRI Safety Guidelines are followed.

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If the 2013 ACR MRI SAFETY guidelines were followed.......94%

97%24%

92% of the reported MRI accidents for which causes were identified fall into three categories

MRI -induced projectile accidents would be reduced by as much as 94% if the following ACR 2013 guidelines were followed.

Any facility that has a MRI scanner on its premises must implement strict screening practices.Implement the ACR's four zone concept.

Patient Burns during MRI exams would be reduced by 97% if the following 2013 ACR guidelines were followed.

Provide a 1 cm air padding between the patient and an active coil element.Remove unneeded electrical conductors such as electrocardiogram cables even if those cables are MRI compatible.Present skin to skin contact to avoid current -induced skin Burns.

MRI Acoustic noise injuries would be reduced by 24% if the following ACR 2013 MRI safety guidelines are followed

Require that all patients having a MRI exam be provided hearing protection.Verified the effectiveness of the protective device.Provide alternative means of hearing protection.

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California-SB 1237. AB 510:

A two-year-old boy was brought to Mad River Community Hospital in Arcata, California where he endured over an hour of ionizing radiation exposure from a CT scan.

The F.D.A. has for weeks been investigating why more than 300 patients in four hospitals were overradiated by powerful CT scans used to detect strokes. The overdoses were first discovered last year at Cedars-Sinai Medical Center in Los Angeles, where patients received up to eight times as much radiation as intended

The laws intended to prevent such accidents.

Facilities have report incidents that occur, scanning the wrong body part, exceeding exam dose criteria, all unanticipated hair loss or erythema episodes must be reported. All female patient of child bearing age must be asked whether or not they are pregnant.

A female patient that answers no and later discovers that she was pregnant during the time of a CT exam or radiation therapy exam. The exposure to the embryo or fetus must be calculated and the incident must be report.

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THE PATH TO UNIFORMED MRI SAFETY STANDARDS!

Promulgated Regulations

In order to have truly uniform MRI safety policies, the regulatory mandate should be issued by the federal government. This can be accomplished through two means: the first is a direct method of regulating commerce between states (The Interstate Commerce Powers Act of 1887).

The second and most expedient way is, the federal government could also regulate local healthcare services through social programs like Medicaid and Medicare, whereby any organization that fails to comply with promulgated regulations would be ineligible to receive technical component reimbursement from Medicare for services rendered. 10

Conclusion

The FDA's Manufacturer and User Facility Device Experience (MAUDE) data supports that MRI accidents are increasing each year.

Emanuel Kanal, chair of the American College of Radiology's (ACR) MR Safety Committee

In a lecture Dr. Kanal a leading expert in MRI talked about a discussion he had with Tommy Thompson, who was then the secretary of health and human services. "He quite succinctly explained to me that we in radiology would need to police ourselves regarding MR safety, and that if we do not succeed in doing so, we could count on the government to step in to regulate us instead.

The FDA we soon approve 4 Tesla MRI scanner for clinical use. Manufactures have received permission from the FDA to proceed with clinical trails on a 7 tesla MRI scanner.

Tobias Gilt and Dr. Kanal, analysis found that the overwhelming majority of accidents (65% from Sentinel Event Alert #38 and 85% from the ACR Guidance Document) would have been mitigated if the their recommendation were followed. 11

Reference's

Keene, Jerrolds S Keene S. "MRI Safety at 3T versus 1.5T." Internet Scientific Publications. The Internet Journal of Radiology., 2009. Web. 14 Nov. 2014. Volume 11 Number 1.Orenstein, Beth W. "4T, 7T, 8T, and Beyond - High-Field MR Research Seeks a Closer Look Inside the Human Body." 4T, 7T, 8T, and Beyond - High-Field MR Research Seeks a Closer Look Inside the Human Body. Radiologytoday, 4 May 2009. Web. 14 Nov. 2014. Vol. 10 No. 9 P. 16Johnson, Dexter. "Nanometer-Scale Magnet Makes Tiny, Powerful MRI." IEEE Spectrum. N.p., 22 Apr. 2014. Web. 14 Nov. 2014.Cohen, Elizabeth. "Don't Get Hurt by an MRI." The Chart RSS. CNN News, 2011. Web. 14 Nov. 2014.NYHDOH, Tobias. "New York State Department of Health Office of Health Sysyems Management Article: 28 Statement of Deficiencies and Plan of Correction." 040325 MotionSPExhibits4.tif (n.d.): n. pag. MRISAFETY.COM. 31 July 2001. Web. 19 Oct. 2014.