 This is FDA Patient Safety News. In this edition, we'll take a look at a new use for implanted defibrillators in patients who've had heart attacks, the possible relationship between cochlear implants and bacterial meningitis, the recall of certain human allograft tissues, and a case study about an invasive procedure performed on the wrong patient and what can be learned from it. These stories and more on this edition of FDA Patient Safety News. Welcome to the program. For the U.S. Food and Drug Administration, I'm Mark Barnett. And I'm Anita Rainer. Let's start with our new products bulletin board and tell you about some devices FDA recently approved for marketing. You can find information on all FDA-cleared medical products on FDA's website. In a recent talk paper, FDA announced the approval of a new indication for certain already existing implantable defibrillators. These devices made by Guidant Corporation of St. Paul, Minnesota were previously approved for patients who had survived cardiac arrest. In those cases, they're intended to prevent subsequent episodes of serious arrhythmias. These defibrillators are now also approved for patients who've had a heart attack that's caused them to be susceptible to serious arrhythmias in the future. Specifically, in order to be a candidate for these defibrillators, an MI survivor should have an ejection fraction of 30% or less. FDA's approval was based on a large clinical trial in which heart attack patients with compromised heart function were given either standard medical treatment or the defibrillator. The death rate among patients with a defibrillator was 31% lower than in the other patients. It's important to understand that FDA's approval of this expanded use for the Guidant devices does not necessarily mean that it's the only defibrillator that will prevent serious arrhythmias in heart attack patients. Other defibrillator manufacturers may submit clinical data showing the same benefit for their devices, and this can form the basis for expanding their approved indications, too. The FDA is notifying health professionals about a possible association between cochlear implants and bacterial meningitis. Cochlear implants are devices that are permanently positioned in the inner ear of death patients to help improve their hearing. The implants activate auditory nerve fibers, allowing sound signals to be transmitted to the brain. Several dozen cases of meningitis have occurred in patients with cochlear implants and 12 known deaths have occurred. Most of the patients have been children under the age of five, but some adults have also been affected. The time between the implant and the illness has ranged from 24 hours to more than five years. At this point, it's not certain whether the implants themselves are raising the risk of meningitis by serving as a focal point for infection, or whether some predisposing factor may be responsible. For example, some death patients may have congenital abnormalities of the inner ear, which make them more susceptible to meningitis. In other cases, patients might have had otitis media prior to the surgery. Nonetheless, in response to this issue, one manufacturer, Advanced Bionics, has recalled its Clarion model cochlear implants. Here's what the FDA notification recommends to deal with this problem. First, it encourages physicians to consider prophylactic antibiotic treatment prior to implanting these devices. Second, it encourages physicians to promptly diagnose and treat otitis media in patients who already have the implants. And third, it suggests that people who are going to receive cochlear implants, as well as those who already have them, might benefit from vaccinations against the organisms that commonly cause bacterial meningitis. The notification gives some suggested immunization schedules, and you can find it on our website. Here's news about a recent recall. FDA is notifying health professionals about a recall of human allograft tissues processed by Cryolife, Inc. of Kennesaw, Georgia. FDA ordered this recall because Cryolife had not validated procedures to prevent infectious disease contamination during processing. Therefore, it could not ensure that its processed human tissue was free from fungal and bacterial contamination. Tissue processed by Cryolife has been associated with the death of a patient who received a soft tissue implant during reconstructive knee surgery. FDA's recall order describes manufacturing deficiencies that could result in contamination of soft tissues, such as cartilage and tendons. If bacterial or fungal infection were to occur following tissue implantation, the signs and symptoms would usually appear within days to weeks after surgery. If you're caring for a patient who was recently implanted with Cryolife processed tissue, the notification recommends that you carefully monitor the patient for both fungal and bacterial infections. If you have Cryolife processed tissue that's covered by the recall order and you haven't used it yet, FDA recommends that you first quarantine it and then follow disposal instructions from Cryolife. You should consider using processed allografts from other manufacturers or processors. The reason that heart valves aren't included in the recall order is because these devices are essential in treating congenital cardiac lesions in children and there's no satisfactory alternative device. So even though Cryolife's heart valves carry the same potential contamination risk as the company's other allograft tissues, FDA's notification says that the benefit of using the heart valves under these circumstances may outweigh the potential risk. Even though heart valves aren't covered by the recall order, FDA is still concerned that the patients who receive them may be at increased risk of infection. If you're caring for a patient who was recently implanted with a Cryolife allograft heart valve, you should carefully monitor the patient for bacterial and fungal infection. Report all adverse reactions to both FDA and Cryolife. FDA has recently reached an agreement with Cryolife that will allow the company to begin limited distribution of some of its human allograft products provided that the use is medically urgent and that all alternative treatments have been exhausted or are unavailable. Under these circumstances, certain specific conditions must be met in order for the product to be used. Go to our website for more information. Now for the part of the broadcast where we let you know about recent articles on patient safety or medical error. This time we want to tell you about an article in the June 4, 2002 issue of the Annals of Internal Medicine by doctors Mark Chasson and Elise Becker. It describes a wrong patient procedure in which a 67-year-old woman admitted for cerebral angiography, mistakenly underwent an invasive cardiac electrophysiology study. Depending on the outcome of that study, this patient could have been subjected to a surgical procedure in which a defibrillator would have been implanted. The woman was brought to the EP lab because her name was similar to the name of the patient who was supposed to get the procedure. Once she was in the lab, the woman actually signed a consent form for the wrong procedure. The article identifies at least 17 distinct errors that led up to this event and it points out that no single one of those 17 errors by itself could have caused the problem. The errors began when a nurse took the patient from her room to the EP lab despite the patient's objections and without a consent form or an order in the chart. After the patient arrived in the EP lab, another nurse failed to verify the patient's identity against the lab schedule. The EP attending physician failed to understand her objections to the procedure An EP fellow ignored the fact that there was no pertinent clinical information in her chart that pertained to the EP study that she was going to receive. He also disregarded the fact that the patient had a fresh groin wound from the cerebral angiogram she had received the day before. Remember, that was the procedure she'd been admitted for. With us today is one of the authors of the article, Dr. Mark Chassan, Professor and Chairman of the Department of Health Policy at the Mount Sinai School of Medicine. Dr. Chassan, thanks for joining us. In the article, you characterized this incident as an organizational accident and you compared it to the Challenger disaster or Chernobyl. On the face of it, what happened to this patient doesn't really seem to relate to those disasters. What did you mean when you made that connection? We made the connection between this incident that happened to the patient in the hospital and accidents like the Chernobyl disaster and the Challenger explosion, primarily because the pattern of causes in this case is very similar to the pattern that accident experts have uncovered when they've looked at these bigger, more calamitous events. In particular, what we found is a series of very small mistakes that were made, no one of which caused the adverse event, and all of them had to happen in order for this event to have happened to this patient. You pointed out in the article that there are trends in our present healthcare system that you call environmental factors that increase the likelihood that these kinds of errors are going to occur and that these are the kinds of factors that we really can't control in our individual institutions. What are those factors? Well, we thought it was important to point out that there are a number of forces that are acting on all hospitals and on all physicians that have an influence on whether or not this kind of event is likely or not likely to happen. So what we pointed to were things like the increasing subspecialization within medicine, in particular in healthcare in general, that lead specialists to have a rather tunnel vision view of the world and not encouraged to look at the whole patient. We pointed to things like shorter stays in hospitals, the tendency for invasive procedures to be done on a short stay basis, and all of those forces encourage the circumstance that we saw in this case where the nurses didn't know this patient very well, no doctor was really taking control of the entire patient, and the physicians and nurses were looking at just little slices of this patient's care, not really understanding the whole picture. Those are the overall trends in healthcare that we can't control at our own institutions. But what can we do on a personal day-to-day level to sort of mitigate those trends? Communication is clearly an essential part of giving good healthcare, particularly because we have so many different caregivers participating in that care. What we saw in this case, however, was a pattern of very poor communication where nurses didn't communicate with physicians, where physicians at the resident level were communicating incompletely with fellows and with attendings, and what we thought we were seeing, reading between the lines in this case, was a group of caregivers that had gotten habituated to poor communication. So instead of seeing the warning signs that were evident in this case in looking at it in retrospect, what they saw was just a pattern that had been repeated often in their experience. So for example, the nurse who took the patient down to the electrophysiology lab over the patient's objection with no consent in the chart, with no signed order for the procedure, probably said to herself, well, lots of my patients don't really understand the procedures they're supposed to undergo. That's not really unusual. They must have put this case on at the last minute without having a chance to put the order in the chart. And conclusions like that are easier to understand if the caregivers had gotten used to poor communication. One of the most discomforted things about this case is the fact that this patient who spoke English well and whose daughter was a physician signed a consent form for a procedure that she knew she wasn't supposed to get. Why did she do it? And what does it tell us about the value of a consent form in preventing this kind of an error? One of the most disturbing aspects of this case is the consent process. When we looked at the question of why the patient actually signed this consent, we thought that what had happened to her was pretty clear. She was awakened from a sound sleep. She was told first by a nurse, then another nurse, then a doctor, then another nurse, that she was to undergo a procedure that she had no knowledge of, that she objected to, but she was in a very vulnerable position being a patient in a hospital. And I think what happened to her when she finally got to the point of being confronted with this consent form is she was just worn down. And by that time, her objections having been ignored by all of the physicians and nurses in the case, she just capitulated and signed the consent form. Clearly, the consent process, both for the healthcare system and for the patient, should be a major defense mechanism preventing this kind of adverse event. But that only happens if it's done correctly by the healthcare provider, in this case by the physician. And clearly, when he administered the consent process to the patient, he did not inform her about the procedure, he didn't listen carefully to her, and he really did not obtain informed consent from her. Dr. Shassan, thanks very much for being with us. Again, if this discussion wets your appetite, go to the website and read the entire article from the Annals of Internal Medicine. We're going to be summarizing future articles in this series in upcoming broadcasts. That's all for this edition of FDA Patient Safety News. Remember, you can get more information on all the stories you've seen here today by visiting our website. We also urge you to use the website to report problems you've encountered with medical devices. That's how we learn about problems so we can alert others. We'll be back next month with another edition. So watch for us. Until then, for the U.S. Food and Drug Administration, I'm Anita Rainer. And I'm Mark Barnett. See you next time.