 This is FDA Patient Safety News brought to you by the U.S. Food and Drug Administration. In this edition, we'll take a look at a device to treat the symptoms of Parkinson's disease, tips on how to avoid adverse events when vacuum extractors are used in childbirth, and information on electrical muscle stimulators that claim to improve your appearance. These stories and more are on this edition of FDA Patient Safety News. Welcome to FDA Patient Safety News. For the U.S. Food and Drug Administration, I'm Mark Barnett. And I'm Anita Reiner. In this series of broadcasts, we're talking about patient safety when it comes to using medical devices from surgical implants to diagnostic kits. About new devices that can improve patient care and affect patient safety. About potential safety problems and tips on how to avoid them. You can get more information about any of the stories in this broadcast from our FDA Patient Safety News website. That's www.fda.gov.cdrh.psn. Let's start with our new products bulletin board and tell you about some of the new devices FDA recently approved. FDA recently approved the expanded use of an implanted device that's used to control the symptoms of Parkinson's disease. The device, which is a deep brain stimulator, is called the Activa Parkinson's Control System and it's manufactured by Medtronic Incorporated of Minneapolis. The device sends a constant stream of electrical impulses to the brain and this can alleviate the symptoms of Parkinson's disease in some patients. The product was previously approved for unilateral implantation in the thalamus and that meant that it could control tremors on one side of the body only. The new approval allows bilateral implantation, which will help control symptoms on both sides of the body. The device is used in patients with advanced, levodopa responsive Parkinson's disease who have movement related symptoms that are not adequately controlled with medications or who experience intolerable side effects for medications. The Activa System consists of two sets of four electrodes that are implanted bilaterally in the brain. They're connected by leads that run beneath the skin to pulse generators implanted on each side of the chest. Electrical pulses are sent by the pulse generators to the globus pallidus or subthalamic nucleus where they block signals from the brain and thus may alleviate the symptoms of Parkinson's disease. The patient can turn the Activa System on or off by holding a small magnet over the area where each pulse generator is implanted. The generators will need to be surgically replaced every few years depending upon the stimulation needs of the patient and this can usually be done under local anesthesia. In clinical studies with this device before it was approved, some patients derived significant benefits, but the individual results varied a great deal and so the results for any individual patient can't be predicted in advance. Almost all the patients enrolled in the study experienced one or more serious adverse events which ranged from bleeding into the brain and device-related infection to weakness and hemoclegia. The manufacturer is going to conduct a three-year study to evaluate long-term clinical results. Now we want to talk about two recently approved devices used to treat congenital heart defects. Both devices are occluders that close an abnormal opening between two chambers of the heart and both are positioned using catheters. That means they can provide an alternative to open-heart surgery. Although these devices are used mainly in young children, they have also benefited adult patients. The first device is the cardioseal septal occlusion system made by NMT Medical Incorporated of Boston. It's intended to treat complex ventricular septal defects in patients who are at high risk for standard surgical closure because of anatomical conditions or their overall medical condition. This device had already been approved for limited marketing under the FDA's Humanitarian Device Exemption. This is a special clearance that makes devices available for patients with rare medical conditions. The new approval removes the limitation on marketing of this device. The cardioseal system has two parts, a delivery catheter and a permanent implant. The implant is actually an occluder that closes the defect and prevents blood from the two ventricles from mixing. It looks like two little umbrellas set edge to edge. Each umbrella has special spring coils. This allows the device to be collapsed and advanced into the catheter, which is then threaded through the blood vessels to the defect in the heart. When the occluder is in the correct position, the two umbrellas are opened so that there's one on each side of the defect. The spring coil design creates a slight tension that helps hold the umbrellas in place around the defect. And over time, tissue grows into the fabric of the umbrellas and the implant becomes part of the heart. The other device is the amplacer septal occluder made by AGA Medical Corporation of Golden Valley, Minnesota. This device is used to repair atrial rather than ventricular defects. The device consists of two disks of wire mesh linked by a short connector with the same diameter as the defect in the heart. The device is filled with polyester fabric, which promotes the formation of clots and thus helps to close the defect. Using a special delivery system, the device is fed through a small catheter inserted through a vein in the groin. When the device is passed through the defect, the distal disc is released, the device is pulled against the defect, and then the proximal disc is released. This sandwiches the defect between the disks. After deployment, the device is released by unscrewing it from the delivery cable. Eventually, tissue grows over the device, and that closes the defect. Although a variety of factors influence proper patient selection for these two devices, in general, they should not be used in patients with thrombus formation near the implant site or with certain active infections or coagulation disorders. The FDA is requiring both companies to continue to study their products for five years to better assess long-term safety and effectiveness. Now let's talk about specific ways to protect patients. FDA has alerted health professionals to the possibility of serious adverse events after the use of vacuum extractors to assist in childbirth. A vacuum extractor applies suction to the fetal scalp during childbirth to facilitate delivery. An FDA article in the January issue of Nursing 2002 notes that infants delivered with this device commonly developed fluid in the scalp or a limited subperiosteal hemorrhage, and that these typically resolve spontaneously. But the FDA has received reports of much more serious complications, including sub-galeal hematoma and intracranial hemorrhage. And although these are rare, they can be fatal. To protect patients from harm, two things are important. First, in order to minimize the chance of an adverse event happening, it's important that people using these devices do so properly. And second, in order to minimize the possibility of serious damage to the infant when an adverse event does occur, it's important that people caring for vacuum extracted newborns monitor them for warning signs. First, let's talk about safe use. FDA stresses that users should be trained properly and that they follow the manufacturer's instructions regarding things like positioning the vacuum cup, how much vacuum strength to use, and how long to continue the treatment. Also, the recommended technique for these products is to apply steady traction in the line of the birth canal and not to rock or twist the device, which can be dangerous. And now let's talk about monitoring. Here, FDA recommends alerting an infant's caregivers that vacuum extraction was used and instructing them to watch the infant for several days for possible problems. One way to be sure that that's done is to note the use of a vacuum extractor in the infant's chart. And remember, parents should be instructed to look for warning signs, too. These signs include swelling of the head and neck, hypotension and pallor, lethargy, irritability, convulsions, rapid breathing and tachycardia. For a more complete list and discussion, look under this story on our website. And now for the portion of the broadcast that we call Journal Scan, where we talk about recent publications that are particularly relevant to patient safety. This time, we want to call your attention to an alert issued by the Institute of Safe Medical Practices in November of 2001. This alert described a patient who died when his IV tubing was mistakenly connected to the inflation port on the cuff of his tracheostomy tube. It should have been connected to the central line IV catheter. When the IV infusion pump was turned on, the tracheostomy cuff filled with fluid. This caused the tracheostomy tube to become obstructed and the patient suffocated. The ISMP report discusses how such an unusual event could occur. In other words, how could someone mistake a tracheostomy inflation port for a triple lumen IV catheter? Among the factors they listed were the fact that the patient had just been transferred to a medical unit where tracheostomy tubes were rarely used, that the light in the room was dim to avoid waking the patient, and that the patient's triple lumen catheter was not secured so the tubing hung down at the same level as the tracheostomy cuff tubing. The report notes that this case belongs to a larger class of errors that can be called wrong tube, wrong hole, wrong connector. And it gives several recommendations to avoid these kinds of errors. For example, when the patient has more than one kind of tubing that could be attached to a port of entry into the body, attach an identifying label to each tube near the end that's inserted. Before administering drugs or other products, trace the tubing from the source to the connection port to be sure the connections are correct. If you're administering high alert medications where the patient is high risk, you'll check all line attachments with another practitioner and monitor patients so as to detect errors quickly and minimize their consequences. And now for a new segment in FDA Patient Safety News. It's called Patients Are Asking, and it gives information that you may want to pass along to patients about medical products they may be using at home or at work. Today we want to talk about electrical muscle stimulators, the kinds of devices that are sold over the counter to tone the muscles, particularly those in the abdomen. Some of your patients may be asking about whether these products work and whether they're safe. Because these muscle stimulators are considered to be medical devices, FDA is responsible for regulating them. Most of the ones FDA has reviewed are for use in physical therapy and rehabilitation under the supervision of a healthcare professional. They're used for such things as muscle reeducation, relaxation of muscle spasms, increasing range of motion and preventing muscle atrophy. If a company chooses to sell its device directly to consumers, it must show FDA that the device is safe and effective for its intended use. For up-to-date information on which of these over-the-counter products has been cleared by FDA, go to our website. Mark? Thanks, Anita. Now let's get back to whether these kinds of products actually work. They generated a lot of advertisements and infomercials. Some of the ads claim that they tone and firm and strengthen the abdominal muscles and that they'll give you rock-hard abs. Some of them also claim to provide weight loss and a smaller waist size. If a patient asks about these claims, you should advise them that although these devices may strengthen or tone muscles to some extent, they're not going to produce a major change in your appearance all by themselves. And none of these products have been cleared for weight loss or for reducing waist size. Now what about the issue of safety? Patients should be advised that there have been reports of shocks, burns, bruising, skin irritation, and pain while the device is being used. There have also been several incidents where the muscle stimulator interfered with implanted devices such as pacemakers and defibrillators. It's also possible that among the muscle stimulators not cleared by the FDA, some of them might not comply with electrical safety standards and, of course, that raises the possibility of shock or electrocution. To learn more about electrical muscle stimulators or to report a problem with one of these devices, please visit our website. Anita? Thanks, Mark. Well, that's all for this edition of FDA Patient Safety News, but 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 Reiner. And I'm Mark Barnett. Remember, you can get more information on all the stories you've seen here today and also find out how to purchase video tapes of these broadcasts by visiting our website. You can also use the website to tell us what you think of these broadcasts. We really want your comments. Tell us what you like, what you don't like. Tell us what kinds of things you'd like to see more of. You know, we want these broadcasts to be useful and we're going to use your comments as we design future ones. 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. See you next time.