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According to a United States Food and Drug Administration (FDA) database, 2008 saw a 30% increase in the number of reported magnetic resonance imaging (MRI) accidents. In the four years following 2004, a FDA’s database catalogues a 270% increase in MRI accidents. But what may be even more troubling than the dramatic increase in reported accidents are the numbers not included in the FDA’s data.
The extreme power of the magnets used for MRI imaging (typically tens-of-thousands of times greater than our exposure to the Earth’s own magnetic field) can readily draw ferromagnetic materials to the scanner, sometimes with deadly results. These types of accidents, frequently referred to as ‘projectile’ or ‘missile’ accidents, are the most common MRI accident and yet comprise a slim minority of the FDA’s accident reports, according to the FDA’s MAUDE (Manufacturer and User Facility Device Database Experience) database.
The failure to report projectile accidents is one reason why many experts believe that the FDA’s data may represent only 1% of the actual number of MRI accidents that occur, suggesting that the frequency and variety of accidents is far greater than is widely believed by the industry. Most MRI accidents, including missile events, are the type of accidents that are frequently classified as “never events.” These are negative outcomes, such as wrong-site surgeries, that could readily be avoided by adherence to contemporary best practices, according to Tobias Gilk, president and MRI safety director of Mednovus, Inc. (Leucadia, CA, USA), a company that provides products and service in the MR safety industry.
Effective screening of patients, visitors, and even staff, is of critical importance prior to allowing the individuals near the MRI scanner. This screening is comprised of both a clinical screening, intended to find potential complications or contraindications for the MRI exam, such as pacemakers or intolerance for contrast agents, and a physical screening to help assure that ubiquitous ferromagnetic materials are not brought into the MRI scanner room.
The single revolution in pre-MRI screening, providing new protections above traditional verbal screening and medical record review, is the ferromagnetic detector. Whereas conventional “airport-style” metal detectors alarm on aluminum, titanium, and other non-magnetic metals of which many appliance for the MRI suite are made, the new generation of ferromagnetic-only detectors alarm exclusively on those materials that are attracted to the immense magnetic field of the MRI scanner.
In the interest of enhancing MRI safety, ferromagnetic detection prescreening systems have been recommended by the UK Medicines and Health Regulatory Agency (MHRA; London, UK), FDA, the Joint Commission (Oakbrook Terrace, Il, USA), the American College of Radiology (Reston, VA, USA), and other professional bodies. But the benefits to the MRI provider in reducing the likelihood of injurious accidents are not solely altruistic.
In 2008, the US Department of Veterans Affairs (VA; Washington, DC, USA) published their average cost of a MRI projectile accident, exclusive of equipment downtime overhead costs, at US$43,172 per incident. Providers that depend on perprocedure reimbursement would likely compound the VA’s direct costs with significant additional costs associated with lost patient throughput. Whereas ferromagnetic detection products can considerably reduce the risks of projectile accidents when used appropriately, they should be viewed as an integral adjunct to thorough and conscientious conventional screening practices and not a replacement for traditional methods, according to the MAUDE database.
With the profound increase in MRI accident rates and the high costs of MRI system repair and downtime, there are coincident professional and financial imperatives to reduce the likelihood of adverse outcomes in the MRI environment. One solution that should be first at every MRI provider’s list should be the ferromagnetic detector, according to Mr. Gilk.
MAUDE data represent reports of adverse events involving medical devices. The data consist of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996.
Mednovus has a pre-MRI screening development project with the National Research Council, Canada (NRC)--the Canadian government research organization comparable to National Institutes of Health (NIH) in the United States.
Mednovus is a corporation that provides products and service in the MR safety industry.
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发表于 2009-3-13 10:58:59
