Webinar Questions and Answers
Our recent webinar with John Posh and Tobias Gilk included a Live “Ask the Experts” Q&A session. Below you will find details of all the MRI safety questions asked which we didn’t get chance to answer on the day, as well as responses from our expert panel.
Is the Joint commission standards mandatory law?
John: The Joint Commission (TJC) standards are not law. They are simply the guidelines to be followed by facilities who seek accreditation. An accredited site that stops following the guidelines risks losing accreditation. Accreditation with TJC or certain other agencies is required for reimbursement by certain insurance plans such as Medicare, Medicaide, and Tricare.
Are there any mandatory regulations for MRI?
John: Mandatory is a problematic word. The de facto guidelines for safe MRI operations are outlined in the ACR Guidance document. While not mandatory or laws, they are the standards to which a facility will be held if/ when an adverse event occurs. However, the FGI Guidelines are adopted in the building codes of around 23 states. These guidelines therefore do effectively become legal requirements including the requirement for: “…ferromagnetic (only) detection and warning systems”. You can download a free guide to the current regulatory environment relating to MRI Safety and Ferromagnetic Detection here.
Tobias: For the most part, the only regulations (in the US) regarding MRI safety are imposed on the MRI manufacturers. The one new requirement for point-of-care MRI providers is to provide medication information sheets for the first administration of any MR contrast agent.
We currently do not have an MRI safety committee. Is this a requirement or recommendation? We do however report any incidents occurring in MRI in an online system.
John: There is no requirement to have an MRI Safety Committee. The ACR recomends the appointment of an MR Medical Director and TJC specifies that you must manage risk in MRI. Some facilities have a Medical Director who does it all in consult with whomever he/she deems necessary, other facilities have formal MRI Safety Committees with regular meetings that include other departments like Risk Management, Nursing, Anesthesia etc. I think the best approach is to formalize whatever process you have in writing and keep notes of any discussions related to managing risk. By doing so, you will satisfy TJC. It is also a best practice to evaluate the process annually and adapt it to the changing needs of your department.
Tobias: The Joint Commission does not require the existence of an MRI safety committee. They do require that a provider actively manage MRI safety risks. If you have another mechanism for showing that there is a person (or people) who are doing this outside of a specific MRI safety committee structure, it is my expectation that the Joint Commission would see that as acceptable.
TJC asked about our documentation for projectile objects and how we measure those as well as thermal injuries. We had to show them our policies, MR safety committee minutes and asked us Techs to show them how we would enter an event.
John: TJC, in the early stages, had little interest in MRI Safety. As they have evolved over the years however, they have consulted industry experts on how to better manage MRI Safety. As such, they are getting much more focused and your experience is evidence of that. This trend of digging deeper into MRI Safety practices will continue, in my opinion.
Tobias: TJC has been increasing attention to MRI safety (and will likely continue to increase their attention to this area). The first couple of years after the TJC released their Diagnostic Imaging Standards, they did not survey the MRI requirements. They appear to be surveying for MRI safety much more now than in years past.
Should you keep track of events even if you don’t have to comply with The Joint Commision?
John: The logging and tracking of events to better understand their cause is a best practice regardless of certification status. Quality Assurance and Quality Improvement relies on data and the more details you record the better you will be able to identify the root causes of events and take steps to reduce their occurrence. Metrasens’ Safety Suite provides automated data capture, MRI-safety-metrics and reporting to help you achieve this.
Tobias: I think it is very important to keep track of how each site is doing on MRI safety initiatives, and the quality improvement requirements for TJC (tracking ferromagnetic intrusions, projectiles, and potential burn events) are a great start. Yes, I would recommend tracking these factors (and others that you think are particularly important for your facility).
When documenting ferromagnetic intrusions, is it required to document specifics? For example, if I took a ferromagnetic pen inside the room and felt it pull in my pocket. Do I need to be specific about that or just count it as an event? Also should we document it in a hospital Quality Assurance program, or can we just keep it in a book in MRI to show our compliance?
John: TJC requires you to document unintended ferrous penetrations into Zone IV. A simple notation of date, time, and that the event happened will satisfy this requirement. That said, Quality Assurance and Quality Improvement relies on data and the more details you record the better you will be able to identify the root causes of the events and take steps to reduce their occurrence.
Tobias: For TJC, their standard only says that you record / document the event. It does not say that you must identify the object or circumstances. If your goal, however, is to reduce these types of ferromagnetic intrusions, I would recommend attaching whatever information you could that would be helpful in developing policies and refining practices to help prevent re-ocurrence.
Improving MRI safety awareness
Any suggestions to getting “buy-in” in adopting more of a safe culture?
John: Education is the first step in getting buy in from employees. Be sure that everyone is trained in all aspects of MRI safety initially and as part of an ongoing annual program. I also advocate allowing employees to make suggestions for the safety manual (or safety policies and procedures) as part of the annual review of that document. Making employees feel that they are part of the program goes a long way to creating a culture of safety. Lastly, be sure to regularly remind employees that safety is everyone’s responsibility. You may have a high functioning safety team with certified experts but the first opportunity to impact safety is almost always with the technologist.
Tobias: The two things I can suggest are education and helping people better understand potential consequences. Because we advertise MRI as “the safe modality,” sometimes it can be difficult for some to understand and accept that there are risks particular to MRI, and that those risks can have very significant negative outcomes, if not managed appropriately.
Have you got any suggestions for getting other health professionals outside the MRI department involved in MRI safety?
John: The best starting place for this is your MRI Safety manual. The manual is your operating rule book and everyone in the department or coming to the department must follow the rules. Once you set the rules then you can work on education. All casual MRI Personnel should be trained to Level 1 so they have an understanding of the magnet and the dangers. Once that is in place, they tend to be more compliant with the rules. That said, nobody other than the Level 2 personnel with have a primary focus on MRI Safety.
Tobias: If another profession needs to come to MR as a regular part of their job responsibilities for a patient (e.g. anaesthesia, nursing, respiratory, etc…) or for the enterprise (e.g. maintenance, housekeeping, administration, etc…) then, in my opinion, it should be mandatory that they have at least basic MRI safety training. If allied professions don’t come to MR, or only come once in a blue-moon, then I’m not convinced that MRI safety information will be relevant to them (and ‘stick’ when it’s taught) or be sufficiently ‘front of mind’ when they do come to MR to be useful. It’s great to build widespread awareness of the importance of MR safety, but I personally believe that teaching MRI safety skills to those who don’t come to MR with any regularity won’t be very productive.
What would you recommend frontline staff do when it appears that their management appear oblivious to risk management and mitigation in the MRI environment and seem to come down upon staff who try to be proactive in safety?
John: Education is always the first step in trying to improve situations like this. Build your case based on solid logic, industry guidelines, and peer reviewed literature. Document everything in writing and where possible involve your Medical Director or MRI Section Chief. If this fails you have few options short of going above your managers’ head to risk management or to the hospital’s legal counsel. Both of these options will not ingratiate you with your boss, however, and could cost you your position. Leaving is also an option depending on your career goals. Thank you for thinking proactively about MRI Safety. Though you are not feeling supported, you are doing the right thing for your patients and your profession.
Tobias: That is a very difficult question. I would repeat what I said about promoting “buy-in”, in my previous answer. In the end – ultimately – you will need to decide whether the safety practices of an employer are such that you are best leaving, or whether you feel that you can change their practices from the inside. Identifying best practices is easy when compared to the challenges of changing the priorities of someone resistant to change.
What is the minimum thickness suggested for padding/towels between patients and coils/wires or magnet bore or even skin to skin contact to prevent possible burns? Is just a thin layer of scrubs enough to prevent a burn, for example, between the thighs, or should padding be used also?
John: Skin to skin contact can be broken with a sheet, towel, or pair of scrub pants provided they are not damp or wet for any reason. It should be noted that while the scrubs are dry when the patient enters the bore, perspiration can change that rapidly. Padding between the patient and the bore of the magnet or a transmitting RF coil should be a minimum of 0.5cm. In general, the pads that are supplied with the scanner will suffice but you should always consult the Instructions For Use (IFU) for your scanner.
Tobias: Skin-to-skin contact can be disrupted with a dry article of clothing or sheet. In that instance, it’s just a question of breaking a possible electrical circuit (there have been instances of wet clothing / sheets allowing the circuit to be complete). Padding thickness to prevent ‘near-field’ effects should be outlined in your MR system manual. Generally speaking, the minimum padding thicknesses are in the range of 5mm – 10mm. These pads are also generally sufficiently thick to act as thermal insulators between the length of a potential conductor and the body of a patient.
How do we know what hospital gowns are MR safe? Most are not tested and I have been told that often clothing does not state that it has metal fibres.
John: Your hospital sources their gowns and scrubs from a manufacturer / distributor. That entity will have the specifics of the materials used in their construction. Unlike garments sold in stores, the products used for patients in hospitals is more regulated. That said, there are definitely linens that are designed with antimicrobial properties and there have been incidents where those linens have heated to the point of concern. I strongly recommend you have a discussion with your materials management liaison and determine what your department uses. If you have an MRI Safety Committee, this individual should be on the meeting invite list for just this reason.
Would you recommend scrubs for patients to change into as opposed to gowns because of skin to skin contact?
John: As a general rule I prefer scrubs to gowns for patients who are able to change easily. They do offer a small measure of protection by separating skin surfaces as well as doing a better job of preserving the patients modesty, especially with the increasing need to remove patients undergarments.
Tobias: Yes. Scrub pants can help reduce skin-to-skin contact potential for medial thighs / calves.
Do you pad according to the manufacturer’s guidelines?
John: Following the manufacturer’s guidelines is always a best practice. All manufacturers spend considerable time crafting their Instructions For Use (IFU) to guide the end users on the safest operations for their systems.
Ferromagnetic Detection Systems (FMDS)
I have heard that FMDS are not able to detect implanted ferromagnetic devices, and only items close to the surface. How accurate is this?
John: I am unable to speak for all FMDS but peer reviewed literature has indicated that Ferroguard Screener can detect implanted devices*.
I have been to many different facilities and have never been padded! This is a huge problem for most places! I have 3 devices implanted in my spine, and never had a ferromagnetic detector check.
John: Padding is only required if the patent is in close proximity to the bore wall or it there is skin to skin contact. Depending on body, padding might be critical or not needed at all. Ferromagnetic Detection Devices are recommended by the ACR but there are still facilities that have not adopted them. In the absence of mandates or laws, there will always be those who hold off on adopting new technology regardless of the improved safety value it provides.
Tobias: If there is no meaningful risk of the patient’s tissues getting too close to the transmitting RF elements, then padding might not be requisite in some cases. Padding is also frequently not indicated by the manufacturer when using transmit / receive (T/R) anatomy-specific coils. So, depending on the patient, the MRI scanner, and the coils being used, padding may be super-important, or have no value at all.
In our iMRI setting where the magnet will move into the OR room along ceiling rails and standard OR instruments where a ferrous detection system is in place but the duties of the OR require multiple entries into the room how do we handle the resulting alarms from the ferromagnetic detection system?
John: Hybrid suites are always the most challenging configurations. There are numerous essential personnel, many of whom are not MRI technologists, lots of support equipment, and a Zone IV that some times changes rooms. The key to success with hybrid suites is to integrate technology into a well designed and customized workflow for your environment. Start with your suite layout and carefully assess your daily workflow. Write your policies specifically for your individual space. Lastly, there are tools to help minimize spurious alarms. Bi-directional alarms only alert on entry not on exit from Zone IV. Additionally the Metrasens’ Alert Management Unit (AMU) allows the users to suspend audible alarms in order to bring compatible but ferrous materials into the scan room. When properly integrated into the workflow, ferromagnetic detection units function equally well in hybrid MRI suites.
Tobias: Intraoperative MR environments are always much trickier than lower-acuity settings. Each site needs to look at their operational model, their bricks-and-mortar construction, their training regime, and their screening protocols collectively, and identify the best way to integrate each of these with the others. I wish there was a standard model for intraoperative environments, but I’m not aware of any that are meaningful.
What are your thoughts on utilizing a target scanner in addition to the FMDS?
John: Hand wands can be useful for confirming ferrous status of known implants and devices but are not recommended for screening for the presence of implants or devices. They have varying degrees of sensitivity, a large variability of reliability between users, and rely heavily on precise and deliberate use. As such, I do not see much value in their use given the option of whole body screeners, such as the Ferroguard Screener, which has been proven in the peer reviewed literature to be able to detect implants.
Other MRI safety questions
We have a keypad on the door to Zone IV (3T magnet). Are there other facilities that have this and is this best practice? My concern is not being able to get to the patient fast enough if the keypad fails. We do have ferromagnetic detectors on either side of the door and we do have a keypad on the door to Zone II/III.
John: Keypads are useful in many areas but are not my favourite on Zone IV. In an emergency, the normal adrenaline response can hinder the technologist’s ability to operate a precision keypad. Regardless of the type of Zone IV lock, there needs to be safeguards. The lock needs to drop off automatically in the event of fire or power failure and there needs to be an emergency release in case the keypad cannot be operated normally for whatever reason.
Tobias: Particularly in hospital settings, if there is a keypad to gain direct access to the MRI scanner room (Zone IV), then I would very strongly recommend some sort of bypass to guard against the possibility of being locked-out of the magnet room in an emergent situation. Access controls on patient-occupiable spaces also need to be very carefully designed and implemented because if the patient could wind up locked in the room, this would be a clear-cut violation of building and life-safety codes.
Do you have any insight in how to handle the zoning in a non-fixed intraoperative MRI suite, specifically screening between MRI and non-MRI cases?
John: Hybrid MRI Suites are extremely complex. As you noted, they can function as a normal MRI, a normal OR, or a blend of both. As such, the safety manual needs to be well crafted to meet the needs of all three functions and outline the specific policies and processes to be followed in all situations. Zoning should be defined, summarized, and specified as to who has access to what zone under what situations.
Tobias: Please see my earlier answer regarding iMRI suites. Zoning and physical environment safety needs to be very carefully coordinated with all of the other activities of the OR environment, and practices that support safety need to be institutionalized. This typically means a fingerprint-unique set of training, policies & procedures, organizational structures, and interdisciplinary collaboration.
We have experienced in the OR that heating of the drug patch can cause increased dosage. Any thoughts on this?
John: This is a known phenomenon. The potential heating of any patch can be concerning. If the patch is foil backed, or known to be sensitive to heating per the manufacturer, it may need to be removed before MRI, especially if it is in the volume of the RF field. Since the removal of a patch can only be ordered by a physician you should have a discussion with your radiologist before altering or removing any drug patches.
Is it required to have an emergency ventilation exhaust fan in case of a quench? If so, where can I find this information to show my employer?
John: The FGI hospital design codes recommend exhaust fans as do the VA Design guidelines if you are a VA Facility. Since cryogen volumes and room sizes vary, there is no single fan specification that will work for everyone. What your site needs will be specified in the installation guide supplied by your unit’s manufacturer. Between these three sources you should find what you need.
Tobias: Exhaust fans are typically called out in MR system manufacturer siting guides. They’re also indicated in the VA MRI Design Guide, and have been recommendations in the FGI hospital design codes for years.
If the employees do not stand in the scanner room during operation, then do they have to have hearing testing done?
John: There are no requirements for hearing testing for any MRI employees regardless of how they operate. That said, any employee remaining in the room during active scanning should wear hearing protection in the form of earplugs and or headphones.
Tobias: I’m not aware of any regular requirement for employee hearing testing in MR. Being outside the room during scanning may significantly reduce acoustic exposure, but I’ve also been in control rooms that are uncomfortably loud. If techs have a concern about the noise levels in control areas, this may be something to bring to the attention of your employer.
*1. Keene, M., Shellock, F.G., Karacozoff, A.M. Detection of ferromagnetic implants using a ferromagnetic detection system: implications for patient screening prior to MRI. American Journal of Roentgenology (2013) 201: 720-725
2. Linnemeyer, H., Shellock, F.G., Ahn, C.Y. In vitro assessment of MRI issues at 3-Tesla for a breast tissue expander with a remote port. Magnetic Resonance Imaging (2014) 32: 297-302
3. James, C.A., Karacozoff, A.M., Shellock, F.G. Undisclosed and undetected foreign bodies during MRI screening resulting in a potentially serious outcome. Magnetic Resonance Imaging (2013) 31: 630-633
4. Karacozoff, A.M., Pekmezci, M., Shellock, F.G. Armor-Piercing bullet 3-T MRI findings and identification by a ferromagnetic detection system. Military Medicine (2013) 178: 380-384