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U.S. Department of Health and Human Services

Show #5, June 2002

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Show #5, June 2002

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 New Medical Products

June2002FDA Patient Safety News Homepage
New Device for Bilateral Control of Parkinson Symptoms (Video, print, and e-mail functions)
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FDA recently approved the expanded use of an implanted device used to control the symptoms of Parkinson's disease. The device, a deep brain stimulator, is called the Activa Parkinson's Control System, and it's manufactured by Medtronic, Inc., 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.

This product was previously approved for unilateral implantation in the thalamus. 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. This 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 from 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 generator 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 on the stimulation needs of the patient. This can usually be done under local anesthesia. In clinical studies with this device before it was approved, some patients derived significant benefits, but individual results varied a great deal, and so the results for any individual patient can't be predicted in advance.

Almost all of 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 hemiplegia. The manufacturer is going to conduct a three-year study to evaluate long-term clinical results.

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June2002FDA Patient Safety News Homepage
Two New Devices to Treat Congenital Heart Defects (Video, print, and e-mail functions)
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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, Inc., 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 the 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. Over time, tissue grows into the fabric of the umbrellas and the implant becomes part of the heart.

The new approval was based on a clinical study that included mostly pediatric patients with a variety of hemodynamically significant defects. In suitable patients, 72% had improved clinical status at 6 month follow-up and 84% of the patients had a reduction in flow through the defect or a reduced defect size. Adverse events occurred frequently, but all serious or moderately serious events had resolved by six months after the procedure.

The other device is the Amplatzer 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 discs 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 discs. After deployment, the device is released by unscrewing it from the delivery cable. Eventually, tissue grows over the device, closing 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 5 years to better assess long-term safety and effectiveness.

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 Recalls and Safety Alerts

June2002FDA Patient Safety News Homepage
Problems After Vacuum-Assisted Childbirth (Video, print, and e-mail functions)
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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 develop 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 subgaleal 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'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 web site.

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 Preventing Medical Errors

June2002FDA Patient Safety News Homepage
Misconnection of Tubes and Ports (Video, print, and e-mail functions)
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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 Medication Practices in November 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 his 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, or the patient is high-risk, double check all line attachments with another practitioner. And monitor patients so as to detect errors quickly and minimize their consequences.

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 Advice for Patients

June2002FDA Patient Safety News Homepage
Electrical Muscle Stimulators (Video, print, and e-mail functions)
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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 health care professional. They're used for such things as muscle re-education, 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 have been cleared by FDA, go to our web site.

Now let's get back to whether these kinds of products work. They've certainly generated a lot of advertisements and infomercials. Some of the ads claim that they tone, firm and strengthen 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 won't 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 safety? Patients should be advised that there have been reports of shocks, burns, bruising, skin irritation and pain while the device was 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 FDA, some 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 associated with one of these devices, please visit our website.

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 Related Article

June2002FDA Patient Safety News Homepage
Device Safety; Problems After Vacuum-Assisted Childbirth (Video, print, and e-mail functions)
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By Diane Dwyer, BSN, And Sonia Swayze, RN,C, MS
Nursing2002, Volume 32, Number 1; p74

TWO HOURS AFTER DELIVERY assisted by a vacuum extractor, an infant developed shortness of breath, poor perfusion, hypotension, and head swelling. The infant later died of subgaleal hemorrhage.

A vacuum extractor applies suction to the fetal scalp during childbirth. Infants delivered with this device commonly develop caput succedaneum (a fluid collection in the scalp) or cephalohematoma (a limited subperiosteal hemorrhage)—injuries that typically resolve without complications. However, the FDA has received reports of two much more serious complications:

* Subgaleal (subaponeurotic) hematoma can occur when emissary veins in the skull are damaged during extraction, causing blood to accumulate between the galea aponeurotica and the skull. Diffuse swelling may extend from the orbital ridges to the nape of the neck. The swelling shifts dependently with head position and indents easily on palpation. Occasionally, the infant develops hypotension and pallor without significant cranial findings. Subgaleal hematoma can trigger life-threatening subgaleal hemorrhage and hypovolemic shock at delivery or within a few days.

* Intracranial hemorrhage may be subdural, subarachnoid, intraventricular, or intraparenchymal. Signs and symptoms, which may not appear for several hours, include convulsions, lethargy, obtundation, tachypnea, a bulging fontanel, poor feeding, increasing irritability, tachycardia, and shock.

If you care for neonates, be aware of the possible complications of vacuum extraction. If an infant has undergone this procedure, closely monitor her for several days. Teach the parents how to monitor her and what signs and symptoms to report—especially if subgaleal hematoma or intracranial hemorrhage has already been identified. And be sure to report any adverse reactions to vacuum extraction to the FDA.

See the FDA Public Health Advisory “Need for Caution When Using Vacuum Assisted Delivery Devices” at http://www.fda.gov/cdrh/safety.html by scrolling to 5-21-98.

Although you need to support the adverse event-reporting policy of your health care facility, you may voluntarily report a medical device that doesn’t perform as intended by calling MedWatch at 1-800-FDA-1088 (fax: 1-800-FDA-0178). The opinions and statements in this report are those of the author and may not reflect the views of the Department of Health and Human Services. Device Safety is coordinated by Beverly Albrecht Gallauresi, RN, MPH, BS.

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FDA Patient Safety News is a product of the US Federal Government, and as such is NOT copyrighted or restricted in any way. We encourage the further use and distribution of the video or text of the program by anyone – either in its entirety or as individual stories.

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