For those in the unenviable role of having to make tough decisions about which safety features to invest in and which to forgo, one key factor to these decisions is compliance.
For those administrators stuck between ‘legal liability’ and ‘budgetary constraints’, sometimes the decision of which safety improvement to invest in has a lot to do with who recommends (expects) it. Regulatory compliance is an imperfect litmus test of safety, to be sure, but like it or not, when the accrediting bodies speak, people listen. In the past year there has been a growing chorus of accrediting and regulating bodies that have all called for ferromagnetic detection in MRI patient screening.
Let’s start at the very beginning (“What a very good place to start.”), with last summer’s publication of the ACR Guidance Document for Safe MR Practices: 2007…
“[F]erromagnetic detection systems are currently available that are simple to operate, capable of detecting even very small ferromagnetic objects external to the patient, and now, for the first time, differentiating between ferromagnetic and nonferromagnetic materials. While the use of conventional metal detectors is not recommended, the use of ferromagnetic detection systems is recommended as an adjunct to thorough and conscientious screening of persons and devices approaching Zone IV.” [Emphasis mine.]
Just a few months later, the UK’s MHRA released their 2007 MHRA Device Bulletin – Safety Guidelines for Magnetic Resonance Imaging Equipment, which included ferromagnetic detection in the document’s MR Suite Recommendations section. In the MHRA document, a two-stage ferromagnetic screening process is recommended, one near the door to the MRI room for large threats and a patient screening, capable of finding even smaller threats…
“As well as reducing the likelihood of small projectile incidents, the systems are designed to reduce the likelihood of an MRI scan having to be repeated e.g. due to the presence of an object distorting the MRI scan image.”
In February of 2008 the Joint Commission added their thoughts with something of an omnibus MRI safety Sentinel Event Alert (their highest patient safety alert). The top recommendations of the SEA included access controls and enhanced screening for threats…
“Use trained personnel to screen all non-emergent patients twice, providing two separate opportunities for them to answer questions about any metal objects they may have on them, any implanted devices, drug delivery patches, tattoos, and any electrically, magnetically, or mechanically activated devices they may have… [U]se other means to determine if the patient has implants or other devices that could be negatively affected by the MRI scan (e.g., look for scars or deformities, scrutinize the patient’s history, use plain-film radiography, use ferromagnetic detectors to assist in the screening process, etc.).” [Emphasis mine.]
And most recently, earlier in July of this year, the US Veterans Administration released a sweeping revision to their MRI Design Guide which offers design input on technical, operational and safety factors for MRI suites. The new MRI Design Guide covers a LOT of material, but included in its provisions is the use of ferromagnetic detection screening for all persons approaching the MRI magnet…
“It is recommended that MRI facilities install ferromagnetic detection systems for use in screening persons and equipment entering Zones III and IV to interdict potential threat objects.” [Emphasis mine.]
For the moment, this chorus of official recommendations are not yet requirements, but that is about to change. The Joint Commission is said to be implementing a new risk-management requirement for accredited facilities which will demand that Joint Commission accredited facilities perform their own risk analysis using, as one of the criteria, the Joint Commission’s own Sentinel Event Alerts. Accredited MRI providers will need to demonstrate how it is that they provide quality-control review and redundancy of their MRI screenings.
The ACR’s MR Accreditation Committee is also entertaining a formal request to incorporate safety provisions of the ACR’s Guidance Document as a part of ACR MR Accreditation. Both the form and timeline of any changes in ACR accreditation are, as yet, unknown, but the current chair of the MR Accreditation Committee, Dr. A. Joseph Borelli, believes strongly in the principles of the Guidance Document.
So if the decision to embrace ferromagnetic detection or postpone it is influenced by what the regulatory / accrediting bodies think of it, the message is quite clear… ferromagnetic detection helps make a positive impact on patient safety and its use, at least among these four agencies, is universally called for.
Tobias Gilk, President & MRI Safety Director