
Joint Commission Releases
MRI Safety Sentinel Event Alert (SEA).
The Joint Commission has just issued a Sentinel Event Alert #38 on MRI accidents.
http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_38.htm
Based on the FDA’s accident reporting database (believed to represent significantly less than 10% of events), accidents in the MRI suite have experienced a dramatic increase. This increase is believed to reflect a number of combined risk factors including (1) greater attractive forces from newer magnet systems, (2) higher patient acuity levels, (3) increasing interventional applications and (4) growing numbers of sedation / anesthesia patients.
The current Sentinel Event Alert identifies risks associated with several issues, including heating, implants that are contraindicated in the MR environment, and projectile / missile events.
Heating:
Heating incidents can arise from improper positioning of the patient during the exam or incorrect settings on the MRI for a particular scan. Corrective actions can include providing insulation between the patient and the MRI, proper body positioning, and review of scan parameters.
Implants:
A number of implants, both active devices such as pacemakers and passive implants such as aneurism clips, can present significant dangers to patients when exposed to either static (unchanging) or time-varying magnetic fields. Other implants, such as the leads used in cardiac devices or nerve stimulators, can experience significant local heating as a product of the normal radiofrequency (RF) energies used during the MRI examination process. Corrective actions to prevent scanning of patients with contraindicated implants include a careful review of the patient’s medical record, patient interviews, education of referring physicians, and scrutiny of all identified surgical procedures. (For up-to-date information on the safety of implants, please visit http://www.MRIsafety.com or http://www.doctordoctor.biz )
Projectiles:
Despite the near-universal awareness of MRI magnets’ extreme power of attraction, objects containing steel are regularly brought into MRI rooms where they are ‘sucked’ into the MRI scanner. Often, these objects are small enough to be removed by hand, but larger objects often require very expensive service calls to have them removed from the scanner. Small objects such as bobby pins and nail clippers, however, can and do cause injuries when drawn into MRI magnets, striking patients and/or staff. Corrective actions to prevent projectile accidents include increased vigilance in screening patients and objects, as well as the gowning of all patients. One specific recommendation of the Sentinel Event Alert is for the use of contemporary ferromagnetic detection (FMD) systems specifically designed to find projectile threats in the MRI suite. (For links to all three manufacturers of FMD systems, see http://www.MRI-Planning.com/vendor_links.html )
Throughout the clinical history of MRI, the modality has been largely unregulated in practice. There are no current building codes or standardized operational requirements for MRI facility safety. Joint Commission site surveys in many MRI facilities, in fact, have often been little more than a check of the fire extinguisher.
Is that all changing? The new Sentinel Event Alert references standards set by the American College of Radiology (ACR) White Paper on MR Safety and its recently issued replacement, the ACR Guidance Document for Safe MR Practices: 2007 ( http://www.acr.org/SecondaryMainMenuCategories/quality_safety/MRSafety.aspx ). Though initially established in 2002 as a recommended standard, by being referenced within the current Alert the ACR document’s position as the industry ‘standard of care’ has been further cemented.
While it remains to be seen in which ways this will impact Joint Commission surveys and accreditation, patient safety coordinators and risk managers should pay close attention to the Sentinel Event Alert and to the referenced ACR Guidance Document to evaluate the provisions for the safety of patients and staff in the MRI environment. The February 2007 issue of the Joint Commission publication, Perspectives on Patient Safety, features an article on interdisciplinary approaches to MRI safety ( http://www.jcipatientsafety.org/24695/ ). The full online version of that article, available only to subscribers to Perspectives on Patient Safety, includes a number of checks that facilities can use to preliminarily assess the state of their MRI safety provisions.
When you consider the fact that lost throughput resulting from poor practices costs a U.S. MRI facility close to $20 per minute in technical fees alone, or that serious incidents start at over $20,000 in vendor engineering costs, or that accidents involving equipment damage easily reach the six-figure range, the R.O.I. on safety improvements in the MRI suite can be very quick! Poor operational practices and accumulated minor safety events can easily wind up costing a facility tens-, if not hundreds-, of-thousands of dollars in annual lost revenues. Larger accidents, such as the 2001 death of a young boy at Westchester Medical Center in New York ( http://www.cbsnews.com/stories/2002/01/31/health/main327256.shtml ) can result in multi-million dollar lawsuits and years of litigation.
The ‘take away’ message for MRI facilities, particularly accredited facilities, is that accidents which jeopardize patients, staff and million-dollar investments are far more common than reported. Site surveys are likely to begin to focus unprecedented levels of attention on your MRI facility so staff should be prepared for questions such as...
- When was your last Code drill?
- Does your cryogen venting system conform to the MRI manufacturer’s current engineering standards?
- When was the last time you physically inspected the cryogen venting / exhaust systems?
- Is each piece of clinical and incidental equipment appropriately labeled with the current ASTM standards for MR safety?
- What methods are in place for identifying the safety of patient implants?
- What are your provisions for physically screening patients, visitors and objects entering the suite?
- Do you adhere to the ACR recommendation for ferromagnetic detection screening of patients?
- Does your facility provide the ACR 4 zones of safety / screening?
- Is access to your MR suite effectively controlled for unscreened patients and staff?
- How do you handle medical gasses in the scanner room?
If nothing else, the Sentinel Event Alert increases the degree of ‘foreseeability’ of many common accidents and incidents for all MRI facilities. ‘Foreseeability’ is one legal indicator of how likely an event is and directly relates to the reasonable steps that ought to be taken to prevent accidents and injuries. The presence of this Alert coupled with available best practice standards for patient safety such as the ACR Guidance Document for Safe MR Practices: 2007 are likely to increase an MRI facility’s liability exposure in the event of an accident if they do not take appropriate preventative steps!
Given the newly-elevated profile of these persistent MRI safety issues, providers are urged to have evaluations of each MRI suite’s safety provisions. These pre-emptive ‘MRI suite surveys’ or ‘safety audits’ will allow you identify, plan and remediate any safety deficiency prior to your next Joint Commission or state survey.
To measure the safety ‘score’ of your MRI installation, you may find it useful to use the MRI Suite Safety Calculator. A printable version of this scored questionnaire is available for download from our www.MRI-Planning.com website ( http://www.mri-planning.com/jcr/MRI_Suite_Safety_Calculator_booklet.pdf ) and an online version can be accessed at AuntMinnie.com ( http://www.auntminnie.com/index.asp?Sec=sup&Sub=mri&Pag=dis&ItemId=74489 ).
If you would like any further information on physical safety provisions in support of safety in the MRI suite, please visit our website at http://www.MRI-Planning.com for further information.
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