 This is FDA Patient Safety News. In this edition, we'll take a look at a glucose monitoring device that doesn't use a needle stick, which is now approved for children. The recall of a gonorrhea test kit that may lead some patients to being retested. How to prevent burns when using forced air patient warming systems and a new FDA website and liposuction. 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 previous program, we talked about a new glucose monitoring device for adult diabetics that's worn on the wrist like a watch. Now this device is also approved for adolescents and for children aged 7 and older. It's called the Glucow watch G2 biographer, and it's made by a California company named Cygnus. This device is different from the usual glucose monitor because it doesn't use blood drawn through a finger stick. Instead, a small electrical current from the device extracts a tiny amount of fluid through the skin. Then a sensor on the back of the watch measures the glucose level in this fluid every 10 minutes for up to 13 hours. These glucose measurements are stored in the device and can be read by the patient. A built-in alarm can be programmed to go off if the patient's glucose level reaches dangerously high or low levels. By supplementing regular finger stick measurements, this device provides information on glucose trends, and that may help patients and their health care providers better manage their disease. But remember, this device is not intended to replace the regular blood glucose meter. Finger stick tests are still going to be needed to calibrate the device, to cross-check a patient's glucose levels, and to make treatment decisions like changing insulin doses. In a recent talk paper, FDA announced the approval of a device that treats degenerative disc disease by helping to fuse vertebrae in the lower spine. What's different about this device is that it uses a genetically engineered protein to help build bone tissue during the fusion process. Conventional devices generally use a bone autograph taken from the patient's own hip. This device is made by Medtronic sophomore Danek of Memphis, Tennessee, and it's made up of several components. One component, called the LT cage, maintains the spacing between the vertebrae and it temporarily stabilizes the diseased area of the spine. The other component, called the infused bone graft, contains the genetically engineered protein that will eventually form bone and grow into the vertebral space, permanently fusing that area of the spine. It also contains a scaffold made of bovine collagen for the protein to grow on. The decision to approve this device was based on a clinical study that showed that the device was as safe and effective as the same fusion cage component filled with autographed bone. Both methods produced successful fusion in approximately 90% of patients at 24 months. The manufacturer will continue to investigate the product to check for possible long-term side effects, including those on the immune system. The study was performed at multiple sites and it consisted of a randomized arm which included 143 patients who were given the infused bone graft LT cage device and 136 patients who were given the same cage and the standard bone graft. This device should not be used on patients who have an allergy to titanium, titanium alloy, or bovine type 1 collagen, patients who have had a tumor removed from the area of the implantation site, or patients who are still growing. And since the effects of the genetically engineered human protein on a developing fetus are not well understood, the device should not be used on patients who are or may be pregnant. Here's news about a product recall. Abbott Laboratories has initiated a worldwide recall of some of its laboratory kits used to diagnose gonorrhea. The kits are unreliable because they may give false negative results. The recall includes 32 lots of gonorrhea test kits that were distributed to hospitals and laboratories in the first six months of 2002, from January 11th to June 24th. About 750,000 tests are affected. Abbott has notified clinical labs to stop using the affected test kits and to destroy any remaining product. These labs are also advised to contact the health care providers they serve and have them determine if their patients need to be retested. A retest should be offered to patients whose test results were negative and who were not already treated. Repeat testing should be performed on fresh specimens, not on retained specimens. Abbott Labs will reimburse expenses associated with repeat testing. If you're a physician and you have questions about this recall, you can reach Abbott Labs at 1-866-233-0471. Consumers or laboratories with questions can contact the company at 1-800-527-1869. Our website has more information on this recall, including a list of the affected lot numbers. In our last broadcast, we told you about a recall of human allograft tissues processed by Cryolife Incorporated. 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. You'll find the newest information on the specific products affected by this recall and on product availability by going to our website. Forestair warming systems are often used to maintain normal body temperatures in patients before, during, and after surgery. They're an effective way to keep patients warm and prevent complications from hypothermia. These systems deliver heated air through a hose to an inflatable blanket that covers the patient. With the blanket attached, the heated air is evenly distributed across the patient's body. But serious burns can occur when the hose isn't attached to the blanket. Without the blanket, the heated air can be extremely hot and concentrated at the hose nozzle and blow directly onto the patient's skin. Burns can also occur if the patient's skin comes in direct contact with the hose surface. This practice where forced air warming is applied without a blanket is called hosing or freehosing. Hosing has caused first, second, and even third degree burns. The most serious report we've received to date describes a burn that resulted from the process that was so severe that the patient's leg had to be amputated above the knee. This kind of injury can occur with any forced air warming system that's supposed to be used with a blanket but isn't. There are plenty of warnings about the risks of hosing in manuals, in printed instructions, and on-device labels. ECRI has published a hazard report specifically warning about this problem. Yet despite all these warnings, hosing still occurs. In one manufacturer, Augustine Medical has begun a campaign to help spread the word about the dangers of hosing. The company has developed a website called stophosing.com where you can get more information on hosing and you can request educational materials like pamphlets and posters and warning labels that you can put on the hoses. The website also gives tips to help prevent hosing, such as storing blankets in a location that's close to where they're going to be used. The primary message is clear and simple. Always use a blanket with forced air warming. These days, most health professionals have heard about the problem of electromagnetic interference, or EMI. That is, it's the hazard that's created when electronic devices like cell phones interfere with certain electrically powered medical devices like infusion pumps. Most hospitals already have signs warning patients and staff about using electronic devices in certain areas. Yet interference continues to occur, and although it's rare, patients can be injured. One interference incident is described in an FDA article entitled, Don't Answer That Cell Phone. It appeared in the June edition of the journal Nursing 2002. It explains how a patient in the ICU was receiving epinephrine through an infusion pump when a visitor received a call on her cell phone. When the call was answered, the pump increased the rate of the drip. This gave the patient an unintended bolus of medication that led to epinephrine toxicity. But cell phones are not the only source of electromagnetic energy that can cause interference, and infusion pumps aren't the only medical devices that can be affected. For example, interference has been reported with powered wheelchairs, monitoring equipment, hemodialysis devices, and cardiac devices. The article in Nursing 2002 summarizes the precautions you can take to avoid EMI related problems. First, educate yourself about the potential for electromagnetic interference with medical devices, and learn how to recognize problems when they occur. Urge your facility to use standard procedures to prevent EMI, particularly in areas where critical care devices are used. Be sure to supervise the use of radio transmitters near electrically powered medical devices. Place signs prohibiting cell phone where there are many critical devices in use. And when you do see an incident of EMI, be sure to report it. You'll find a lot more information on our website, including FDA's recommendations on preventing EMI problems. Now for the part of the program called Patients Are Asking, that helps you answer questions about medical products and procedures that are on people's minds. Today we want to let you know about a new FDA website for consumers on liposuction. It gives an overview of what patients can expect before, during, and after the surgery, as well as information they should have before making a final decision to have the procedure. The site explains what liposuction is, what type of doctor performs the procedure, ideas on how to choose the right doctor, the risks involved in the procedure, and FDA's role in regulating liposuction devices. There's also a liposuction surgery checklist intended to help a person determine if they're a good candidate for the procedure. The website encourages patients to educate themselves by knowing the potential risks involved and to ask their doctor questions if something isn't clear. The Liposuction website also links to other sources of information. For example, patients can link to professional organizations, such as the American Academy of Dermatology, the American Society of Plastic Surgeons, and the American Society for Aesthetic Plastic Surgery. Another link is to an article in the magazine FDA Consumer, in which the American Society for Aesthetic Plastic Surgery offers some additional guidelines for people considering liposuction. True or False, MedWatch is a special timepiece that's used to keep track of when patients take their medications. False, MedWatch is a system that health professionals or consumers can use to report adverse events with medical products to the FDA. You can reach MedWatch through our website. True or False, FDA conducts laboratory and clinical testing on a new medical product before allowing it on the market. False, FDA requires that the testing be conducted by the manufacturer who wishes to market the product. FDA's job is to review the results of these tests and decide on whether the product can be marketed. Now for the broadcast where we let you know about recent publications on patient safety or medical error. This time we want to tell you about recently updated guidelines on how to prevent infections when using intravascular catheters. The guidelines were published on August 9th, 2002 by the Centers for Disease Control and Prevention as part of CDC's MMWR recommendations and reports. If you insert intravascular catheters or if you're responsible for surveillance or infection control, you'll probably find this comprehensive report useful. The guidelines point out that intravascular catheters are indispensable in modern-day medical practice, particularly in ICUs. Although these catheters provide necessary vascular access, their use does put patients at risk for local and systemic infections. These guidelines provide background information and specific recommendations on reducing the incidence of bloodstream infections from intravascular catheters. Here are some of those recommendations. Train health care providers who insert and maintain catheters. Use maximal sterile barrier precautions during central venous catheter insertion. Use a 2 percent chlorhexidine preparation for skin antisepsis. Avoid routine replacement of CVCs in order to prevent infection. And if the infection rate is still high despite all these strategies, use short-term catheters that are impregnated with antiseptics or antibiotics. These guidelines also identify performance indicators that can be used by health care institutions to monitor success in implementing these recommendations. Well 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 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 Mark Barnett. And I'm Anita Rainer. See you next time.