Example of a Pacemaker Pulse-Generator Which Could Present Dangerous Contraindications For MRI Exams

The review has been requested by Robert Russo, MD, with Scripps Research Institute. A copy of Dr. Russo’s request can be viewed here.

The public comment period is open through July 28, 2010, and I strongly encourage anyone with questions or concerns about the safety of MR imaging for patients with implanted cardiac devices (Dr. Russo correctly points out that CMS’ restriction fails to speak directly to implanted cardio-defibrillators, or ICD’s) to offer their comments to CMS.

The full explanation of the current restrictions on MR imaging of pacemaker patients (also aneurysm clip patients, and pregnant patients), as well as the instructions for reviewing other public comments or submitting your own, can be found here.

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The National Council on Aging just released a study which details these alarming numbers. The matter-of-fact language of their release did nothing to diminish my welling fear as the study went on to detail chronic failures in our healthcare system to educate, alert, and prevent the dangers inherent in MR imaging of medical implant patients. Here are a few of the particulars:

• Medical implant patients over age 65 have between a 50% and 75% chance of requiring imaging during the useful life of their implant.
• While 90% of physicians knew of MRI risks for some pacemakers, over half of doctors say that they aren’t informed about imaging limitations when a patient is implanted.
• Nearly a third of patients who receive medical implants are not informed of MRI restrictions.
• After exposed to the MRI risks to their implant, nearly 20% of these device patients experience some sort of problem or malfunction with their implant.

Example of a Pacemaker Pulse-Generator Which Could Present Dangerous Contraindications For MRI Exams

The near universal opinion (98%) of healthcare providers is that they require additional information and training on these MRI safety risks.

Let’s hope that regulatory (FDA and States) and accreditation (JCAHO, ACR, and IC) bodies for MR imaging look at ways that they can take a more active role in promoting education and protecting these patients.

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One of the most effective means of screening for external ferromagnetic materials, particularly those that may be integrated with non-ferromagnetic MR Conditional objects or devices, is through the use of a ferromagnetic only detection system.

Halo vests are just one of huge number of potential ferromagnetic threats which endanger MRI patients, visitors and staff. Effective pre-screening for these risks should include the appropriate use of ferromagnetic detection systems, and this is more than my personal opinion.

To date, the ACR, JCAHO, the Department of Veterans Affairs and many MRI safety experts have called for the use of ferromagnetic screening to help mitigate just this sort of hazard.

Halo vests are just one of the innumerable objects that can pose grave threats to patients, staff, and MRI equipment if brought within the MRI scanner room. To protect people and scanner up-time, ferromagnetic detection is a wise investment.

]]> http://mrimetaldetector.com/blog/2009/12/rsna-aapm-identify-halo-ferromagnetic-risks/feed/ 2 http://mrimetaldetector.com/blog/2009/11/fdas-maude-database-appears-to-be-restored/ http://mrimetaldetector.com/blog/2009/11/fdas-maude-database-appears-to-be-restored/#comments Wed, 18 Nov 2009 14:59:20 +0000 Tobias Gilk http://mrimetaldetector.com/blog/?p=652 For a couple of months, at least, the FDA’s MAUDE database wasn’t displaying all of the accident narratives online… This appears to have been fixed!

A number of the MRI accident reports, when the narratives weren’t appearing, were little more than the name and mailing address of the MRI manufacturer. Today, if you want to read about the MR Technologist who had a pair of scissors magnetically-impelled into his forehead, you can do so.

MAUDE report of MRI + scissors vs. Tech.

Though I must admit to indulging sinister fantasies that the FDA was trying to ‘cover up’ some of these accidents, so I requested the information that wasn’t being displayed through the online MAUDE database through a good-old-fashioned Freedom of Information request. The result is that I have PDF copies of many stunning, alarming, and disconcerting accidents. And if you’re so inclined, you can download PDF copies of them, too…

• Rolling cart seriously injures Siemens Apps Specialist (facial fractures & brain trauma)

• Flat-screen monitor hits research subject (facial fractures & surgery)

• Patient on gurney gets more of a ride than planned (foot, ankle, leg fractures)

• IV cart nearly strikes patient (near-miss)

• Knife slices patient (laceration requiring stitches)

• ‘Sand’ bag injures patient (brain hemorrhage, tongue laceration and facial injuries)

• Scissors seriously injures tech (embedded in forehead, surgical removal required)

• Bed tray-table (ambiguous injuries, including facial lacerations)

And the above accidents only represent a proportion of the collected number of accidents for little more than half of 2009!

The above list should not scare anyone out of getting an MRI exam. It is meant to illustrate just how far we have yet to go to eliminate the ‘pilot error’ types of accidents which continue to jeopardize patients, staff, and millions of dollars of MRI equipment.

Sometime in February or March, we should have access to the complete 2009 MAUDE data. Early indications already suggest that we’re on track for a dismal year-end report, with a 20% (or more) growth in accident numbers.

Continue to stay tuned for the latest information on MRI accidents and – more importantly – the tools and protocols that can help reduce the risks.

Link

Some insurance payers are beginning to refuse reimbursement for care that is necessitated by certain ‘never events’, and that list is likely to grow. And while they may not always result in patient injury, I’d like to propose my own list of 5 MRI ‘never events’ which should at least trigger an investigation…

#5 Unauthorized Access: If any person, patient, visitor or staff member, gains access to the restricted areas of the MRI suite (Zones III and IV) without having been appropriately screened and supervised, this should raise red-flags and be the impetus for a review of the physical protections and operational protocols. Too often, because these safety-symptoms don’t immediately result in injury, they are disregarded as harmless, which couldn’t be further from the truth. If unscreened people or equipment are making it into the controlled access areas of the MRI suite, it’s only a matter of time before one of them is involved in a real accident.

#4 NSF / Renal Function Screening: A year ago, this may have appeared as the #1 item on this list, but the fact is that, today, many facilities are doing a great job of this. Essentially, we need to provide, at a minimum, a renal function risk-factor screening for every patient prior to being administered Gadolinium-based contrast agents. And, minimally, for patients identified as falling within one of the higher-risk profiles, a calculated eGFR should be taken for verification of patient risk and to inform the treatment of that patient. As with the #5 never event above, the failure to provide effective screening, even if it doesn’t result in an adverse outcome, is enough to warrant a review of operational protocols.

#3 Contraindicated Implants: There are times when, as a concurrent result of poor patient history / records, and inconspicuous (or absent) indicators for medical devices, patients (or visitors) enter the MRI scanner room with contraindicated devices. Nobody expects MR Technologists to be omniscient about what is on or inside their patients, but it is critical that we provide an appropriately thorough screening for the circumstances to try and ascertain whether the patient has any of the potpourri of shunts, pacers, stimulators, clips, pins, plates, etc… that may be dangerous to them. Any failure to use the appropriate means available to identify contraindications should, minimally, spur an evaluation of policies & procedures.

#2 RF Burns: This one factor may be the fastest-growing source of patient injury in MRI. By verifying that unneeded coils and leads are removed, that remaining leads are appropriately positioned and insulated from the patient, that the patient’s body is not positioned to form large-caliber loops, and that there is appropriate distance / insulation between the patient and any transmitting RF coils are all integral, requisite elements to minimizing the risks of MR burns. A failure to follow the appropriate steps to protect the patient, even if the shortcut doesn’t result in a visible burn, should (as with the proceeding never events) trigger a review of operational procedures.

#1 Projectiles / Missiles: Screening protocols should do everything to make sure that ferromagnetic materials are not brought into the MRI scanner room. Any discovered ferromagnetic material inside the MRI room indicates a breakdown in screening and presents all of the ingredients for injury or equipment damage. Particularly for MRI providers that don’t gown all of their patients, the use of a ferromagnetic detector is more than just recommended, it is codified in the ACR Guidance Document for Safe MR Practices as a part of the MR safety best practice. And as with all of the MRI never events before #1, any discovery of a ferromagnetic threat inside the magnet room should trigger a review of existing protections, operations and protocols.

While these 5 don’t encompass all of MRI safety, they do clearly represent 5 of the most common (and most avoidable) hazards in the MRI environment. MRI providers should have rigorous protocols and protections to minimize these risks to patients, staff, visitors and, in the case of projectile accidents, millions of dollars of MRI equipment.

It suggests that, legally, you’re out on your own.

Let’s contrast this with two situations, starting with an adverse Gadolinium contrast reaction.

If a site were to inject a patient with impaired renal function with Gadolinium contrast and that patient developed NSF (God forbid), and the damages were determined to be $10 million, that patient could conceivably sue the pharmaceutical manufacturer for failing to make the NSF warning sufficiently bold on the packaging (by the way, watch for news reports of lawsuits mimicking this hypothetical model following this decision). Yes, the provider would likely have a piece of the $10 million pie, but the liability would move up and down the ‘food chain’.

If, on the other hand, a catastrophic SAR accident in MRI facility were to critically injure a patient, and the damages for that accident were similarly determined to be $10 million, the Supreme Court decision suggests that the device manufacturer can not be held liable in a state suit. This reasoning concludes that the sum-total of any liability, malfunction, or negligence is laid at the feet of the MRI provider.

Personally, I think that these two decisions bracket the area where the law should be on this issue, but they are both so far from the rational middle-ground that it will require at least one more case before we can begin to make sense of this.

In the meantime, what this suggests to me is that MRI providers are out in the legal forest with no ‘Hansel and Gretel’ breadcrumb trail back to others who share their responsibility to patient safety.

What does this mean, in terms of how these facts should influence our behavior?

For a multitude of reasons (including the specter of legal liability), MRI providers should proactively look at their MRI safety protocols and provisions. All sites should follow the ACR and JCAHO recommendations and use ferromagnetic-only screening instruments. If you are Joint Commission accredited, take a look at the new EC Standards and Sentinel Event Alert #38. All MRI providers should also scrutinize the ACR Guidance Document as the basis for their own safety manuals.

A combination of these new 21st century MRI safety technologies, updated accreditation standards, and the industry-standard practices documents, should guide providers to help deploy the greatest protection for patients and staff (and liability protection for themselves).

Until this legal-liability disparity is resolved between pharmaceutical and device manufacturers, it seems to me that the most prudent course of action is to take the additional steps needed to provide the recommended safety solutions as indicated by the ACR and JCAHO. These would include careful adherence to established screening protocols and the use of recommended ferromagnetic detection systems.

PS: you might be interested in a similar article I wrote for The Health Care Blog