ARTICLE IN BRIEF
Safety practices at epilepsy monitoring units vary widely, which is why epileptologists are calling for formal national guidelines.
A seizure-related death at an epilepsy monitoring unit (EMU) in Colorado is raising the question: Should EMUs implement stricter safety policies?
Last October, a 64-year-old man with epilepsy died after having a seizure and suffocating in his pillow, Mark C. Spitz, MD, director of the Epilepsy Center at the University of Colorado Hospital (UCH) in Denver, told Neurology Today in a telephone interview.
The man was left unobserved for 65 minutes while the electrographic technologist monitoring the EMU attended to other responsibilities, said Steven P. Ringel, MD, professor and director of the neuromuscular division at the University of Colorado-Denver in Aurora. Dr. Ringel is also the vice president for safety outcomes at the UCH and associate editor in chief of Neurology Today.
The patient death prompted the UCH to change its policies to ensure patients are monitored at all times. Now, two technicians are required to be on duty in the eight-bed EMU so at least one of them will be watching the patients through video monitors at all times, Dr. Ringel said.
The hospital is also using finger oximetry respiratory alarms on patients, which will go off if their breathing decreases.
Before the incident, one technician was on duty to monitor patients. The technician was also responsible for hooking up and adjusting EEG equipment on patients in the EMU and in the Intensive Care Unit, a duty that would take the technician away from the monitoring screens for short periods of time, said Dr. Ringel.
The patient death at the UCH was the subject of an investigative report, which was broadcast July 10 on the local CBS television affiliate in Denver, after the family of the man gave a reporter there a video recording of the seizure and suffocation death.
The UCH case has not gone to court, though the family is considering a lawsuit, according to the televised report. Colorado law puts a $150,000 cap on liability lawsuits against government facilities, including the UCH.
NEED FOR NATIONAL STANDARDS
Dr. Spitz said he had heard of similar cases at other hospitals, but they are usually not publicized because hospitals typically settle medical liability cases out of court, with provisions preventing discussion of the case in the media.
“We need to get a better sense from a national perspective of how often these types of cases occur and, based on that, consider setting formal national standards,” he said. “That data should be readily available.”
Patients who go to EMUs typically suffer from seizures that can't be fully controlled by medication, Dr. Spitz explained. The seizures may prevent them from holding down a job, driving, or participating in other activities.
In an EMU, antiseizure medication is decreased so that seizures can be recorded. With the information, epileptologists can evaluate whether the patient might be a good candidate for ablative epilepsy surgery, a procedure that removes a part of the brain where the seizures are located in an attempt to stop or dramatically decrease seizures, Dr. Spitz said.
Dr. Ringel said he hopes the publicity surrounding the UCH case sparks a national conversation about monitoring procedures in EMUs.
“It's something epileptologists have to decide,” he said. “They need to talk about it and ask: is there more going on than the public knows? Is our current standard for observing patients dangerous? Should we insist on someone present at all times?”
Robert J. Gumnit, MD, president of the National Association of Epilepsy Centers (NAEC), agrees that medical liability concerns do make it difficult to track the incidence of seizure-related deaths in EMUs. He said he only hears about one case a year among the 130 members of the NAEC, which monitor what he estimates to be more than 5,000 patients a year (though not all of them have their medications withdrawn).
The NAEC guidelines for inpatient units at level four epilepsy centers, such as the one at UCH, state: “…for scalp video-EEG monitoring, continuous observation by EEG technologists or epilepsy staff nurses is highly recommended.” The guideline were published in 2001 in Epilepsia.
Dr. Gumnit said monitoring practices vary widely around the country. “In some places, someone's watching 24-7,” he said. “In others, the nurses are responsible for patient safety. Others have monitoring units for both nurses and technicians. Frankly I suspect there are some places that don't do any of the above.”
The NAEC guidelines are now undergoing revision to address safety concerns more specifically, Dr. Gumnit said.
SAFETY ISSUES DIFFICULT TO TRACK
The AAN has not issued guidelines or standards for patient monitoring at EMUs. “Unfortunately, this is not something that is particularly amendable to guidelines, which must be based on published studies,” said Jacqueline French, MD, professor of neurology at the New York University Comprehensive Epilepsy Center and the co-chair of the AAN Quality Standards Committee. “Safety issues are particularly difficult to study, and there are no high quality studies about adverse outcomes in monitoring units.”
One obstacle is the difficulty of gathering information on seizure related deaths in EMU, said Dr. Gumnit.
Thaddeus S. Walczak, MD, an epileptologist at MINCEP Epilepsy Care in Minneapolis and a member of the committee revising the NAEC guidelines, added that a second obstacle is the relative rarity of the problem. “When you have something that occurs so infrequently, gathering patients in a uniform manner and finding a group of patients to compare them to and following them over time — things you need in a class I study to generate evidence-based standards — is not going to happen,” he said.
Carl Bazil, MD, PhD, associate professor of clinical neurology and the acting director of the Comprehensive Epilepsy Center at Columbia University Medical Center, agrees that a class I study would be impossible — not only because of the rarity of the problem, but also because of ethical issues. “You would need to randomize centers and see if people in certain situations die more, and that's clearly not the right thing to do,” he said.
But he agrees that more discussion of safety issues and staffing at EMUs is needed. “In a monitoring unit, you're trying to get patients to have more seizures so you can record them,” he said. “So an EMU is always a somewhat risky proposition. For that reason, precautions need to be in place.”
Dr. Spitz said it's important to keep the risk in perspective. He pointed out that the risks of dying during ablative epilepsy surgery and as a result of a seizure at home are far greater than the risks of dying in an EMU. “When I discuss the risks and benefits with my patients, that's where I put my focus — on the real risk in the big picture,” he said.
One safety measure that is becoming increasingly common at EMUs is causing problems of its own. Respiratory alarms, in particular finger clip pulse oximeters, have a high false positive rate, according to Dr. Walczak.
“Pulse oximeters can be a pain because they go off a lot,” he said. “There is no data to guide us on this particular issue, but it's not clear to me that the whole system should put up with numerous false positives in the hope of preventing something that may happen only once or twice a year in the whole country. Ultimately the only way to completely prevent seizure related death is constant observation.”
Dr. Gumnit said the need for revised guidelines for EMUs is a sign both of the spread of epilepsy centers and an era of hospital belt-tightening. “Initially when there were only a few units in major places and money was not as tight, there was no need to issue any kind of a stricter guideline,” Dr. Gumnit said. “As reimbursements to hospitals are cut, hospitals are becoming more and more driven to reduce deficits, and the situation is changing.”
Dr. Gumnit added that it's crucial to make the risk — and the potential cost of it — clear to hospital administrators so they will agree to additional safety resources. “There's a constant tension between what the physician would see as the best possible treatment and what the hospital can practically provide,” he said. “I'm afraid it's going to take a lawsuit with a horrendous penalty attached before we can get the necessary attention. A concentrated national campaign usually doesn't get anywhere unless you can scare somebody.”