 This is FDA Patient Safety News, brought to you by the U.S. Food and Drug Administration. In this edition, a glucose monitor that doesn't stick the patient, a new defibrillator that can be used on small children, a story about how to avoid tragedies in the MRI room, a report on how to prevent fatal mix-ups when you administer medical gases, and more. Welcome to this edition of FDA Patient Safety News. I'm Mark Barnett with the U.S. Food and Drug Administration. And I'm Anita Reiner. In this series of broadcasts, we're talking about patient safety when it comes to using medical devices from diagnostic kits to surgical implants. About new devices that can improve patient care and prolong life, 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 a special FDA website. The address is going to appear at the end of the program. Let's start with our new products bulletin board and tell you about some of the devices FDA recently approved. One device recently cleared for marketing is an external defibrillator system with a special pad that's designed to be used on infants and young children who experience cardiac arrest. The system is made by the Heartstream Division of Phillips Medical Systems. Like other defibrillators, this system delivers an electric shock through the chest wall to the heart. The difference is that other defibrillating devices on the market are restricted to adults or to children over the age of eight. The pads on this device deliver about a third of the electrical energy of an ordinary pad so they can be used on infants and children up to 55 pounds. Now these pads aren't used in quite the same way as adult pads. When defibrillators are used on adults, both pads are positioned on the chest. But with these pediatric pads, one of them goes on the chest and the other one on the back. To be sure that the user selects the right pads in an emergency, the pediatric pads are imprinted with a picture of a child and they show how the pads are to be positioned. Likewise, the connector is pink and it's shaped like a teddy bear. Another product that we recently approved is designed to periodically monitor glucose levels in diabetic patients. The good news is that it does it without a needle stick. It looks something like a wrist watch. In fact, it's called the Glucow watch biographer and it's made by a California company named Cygnus. The way it works is that 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 levels in this fluid every 20 minutes for 12 hours. These glucose measurements are stored in the device and can be read by the patient if the patient's glucose level reaches dangerously high or low levels and alarm sounds. A couple of important things to remember. First, this device isn't intended to replace the regular blood glucose meter. In fact, it's supposed to be used with it to help detect trends and patterns in glucose levels. Finger stick tests will still be needed to calibrate the device and at other times to cross check a patient's glucose levels. And for now, the device should only be used by patients over 18 since it's only approved for adults. Another new device recently cleared for marketing by the FDA is designed to help prevent complications when angioplasty or stenting is done in coronary saphenous vein bypass grafts. This new device prevents debris such as thrombi and cholesterol crystals from being swept down the vein graft into the heart where it could block downstream vessels. During the angioplasty and stenting procedures, the device occludes the vessel and then blood and debris are aspirated into a syringe. The device is made by Perky Surge Incorporated, a division of Metronic AVE. Occasionally on FDA patient safety news, we report on medical devices recalled by their manufacturers for safety reasons. We do this mainly for what FDA calls class one recalls, that is those that represent the highest level of risk. In these cases, the manufacturer has already notified users about the recall and we cover it during the broadcast just to be even more certain that users of the device have heard about it. The recalls we cover during these broadcasts have already been posted on a special FDA website on recalls. Today we want to tell you about the recall of certain dialysers made by Baxter Healthcare Corporation. These dialysers were distributed widely around the world and they may have been involved in over 50 patient deaths in various countries, including the U.S. Most of the patients who died experienced shortness of breath, chest tightness, cardiac arrest or stroke symptoms within hours of being dialyzed. The FDA has been working closely with Baxter and with the other nations involved to identify the problems and recall the product. You should know that in mid-October, Baxter notified all its customers to stop using these dialysers immediately and return any unused inventory. Baxter also reports that they have permanently ceased manufacturing these particular dialysers. The recalled dialysers are labeled either Baxter or All-Thane and they were manufactured between 1998 and 2001. You can find the specific model numbers of the recalled dialysers on the Patient Safety News website. Now let's talk about specific ways to protect patients. The FDA recently issued a warning about the possibility of patient injuries and deaths from mix-ups with medical gases, particularly oxygen, that come in cryogenic containers. We issued the warning because we've received a number of reports of deaths and injuries that occurred when patients were accidentally given the wrong gas. That is, another gas, like nitrogen or carbon dioxide, was connected to the oxygen supply system. That occurred despite the fact that the gas supply systems that deliver gas to patients have special connectors that only fit the appropriate gas containers. That means that an oxygen container will only fit onto the oxygen connector on the gas supply system. So there's supposed to be a built-in safeguard. But in these cases, this safeguard was bypassed, and a gas other than oxygen was mistakenly hooked up to the oxygen connector on the supply system and then delivered to the patient. Considering the safeguard, what went wrong? In the cases we looked at, two errors were usually made in sequence. First, in most of the cases, a container of gas other than oxygen was mistakenly delivered to the facility, and sometimes it was misidentified as containing oxygen. Then someone tried to connect this gas container, the one they thought contained oxygen, to the oxygen supply system. Of course, this didn't work because of the safeguard we talked about. And so they then overrode the safeguard by changing the connector on the gas container so it would fit the oxygen connector on the gas delivery system. There are things you can do to prevent such things from happening. First of all, never use adapters or change the connectors or the fittings on gas containers. If a connector on a container won't readily attach to the connector on your gas supply system, it's probably the wrong gas. Don't try to connect it. Second, when connecting a medical gas container, check the label carefully to ensure that it contains the right gas. Third, be sure that all personnel who handle medical gases are properly trained to examine and recognize medical gas labels. Finally, if your facility receives both medical and industrial-grade gases, store them separately. Now we'd like to discuss a widely publicized incident. First of all, because it serves as a stark reminder of what can happen when our medical systems fail. And second, because talking about tragic events such as this one may help prevent the same kind of thing from happening again. In this case, an oxygen tank the size of a fire extinguisher became magnetized in an MRI room. It flew across the room and killed a six-year-old boy who was in the MRI machine. Oxygen tanks aren't the only problem. Any object made of metal that can be magnetized can become a deadly projectile if it's near an MRI machine. And that includes scissors, traction weights, even hair pins. Also, if the MRI patient has a metal implant, it can twist and cause damage. People sometimes don't even think about it, but tattoos and tattooed eyeliner sometimes contain iron compounds, and they can become magnetized and burn the patient. And so can EKG leads and other cables that might be lying near the patient. There are lots of things you can do to avoid these kinds of accidents. Some of the most obvious are to screen everyone entering the MRI room and check on what they're bringing in with them. Of course, you have to understand which items might contain even small amounts of metals that can be magnetized. You can also hang posters in the MRI suite reminding patients and personnel about the hazards. We also wanted to alert you to the possibility of two potentially serious safety problems when you're using central venous catheters or CVCs, in fact, they're sometimes called the deadly duo of central venous catheterization. We're talking here about cardiac perforation and tamponade. According to a recent FDA article in the International Journal of Trauma Nursing, those two events account for almost half of the reported deaths associated with CVCs. What causes the problem? One of the experts quoted in the article points out that the tip of a CVC could potentially perforate any surface it lies against, and so it's important to keep the tip away from certain areas, such as the right atrium, where it can damage the endocardium. This expert also notes that CVCs placed in the anti-cubital veins are more likely to produce cardiac perforation because the catheter can move into the right atrium, and that movement occurs when the patient moves. In fact, patient movement is a key element in explaining this problem. Another expert quoted in the article estimates that the CVC tip can move as much as 8 centimeters when the patient raises his catheterized arm. Still another expert in the article says that cutting off the tip of the CVC, which is sometimes done in an effort to make cannulation easier, can actually increase the risk of perforation. The article also points out how difficult it can be to recognize cardiac perforation and tamponade in a patient with a CVC. Symptoms can occur suddenly, or they can take days to show up, and they can be confused with other illnesses and traumas. And to make matters even more difficult, there may not be any symptoms at all. In fact, sudden death can occur in the absence of any clinical warning signs. And so one of the experts in the article advocates considering a diagnosis of tamponade in any patient with a CVC who suddenly develops deterioration and cardiorespiratory status. That's important because although these incidents are often fatal if they're left untreated, early diagnosis and prompt intervention can often save the patient's life. And that treatment has three key elements according to one of the experts. First, stop all fluid infusions through the existing CVC if you suspect perforation or tamponade. Second, try to drain fluid out through the CVC. And third, remove the CVC slowly. But the best solution to this problem is avoiding it in the first place. So the question is how do you prevent perforation and tamponade in patients who have CVCs? And here are two key elements. First of all, locating the catheter properly and secondly, keeping it from migrating. When it comes to location, the article says to keep the tip of the catheter out of the right atrium, preferably locating it in the distal superior vena cava. One of the experts suggests that the tip of the CVC should be no lower than two centimeters below an imaginary line between the lower surfaces of the ends of the clavicles. And to keep the catheter from migrating, the article caution is to keep the patient's movements to a minimum. Every time the cannulated arm or head or neck bends and flexes, the catheter tip can advance a little more towards the right atrium. And now let's go to our journal scan feature where we report on articles that are particularly relevant to patient safety. This time we wanna call your attention to an editorial in the September 5th, 2000 issue of JAMA entitled, Ethical Issues and Whistle Blowing by Dr. Norman Faust. The author discusses the reasons people sometimes give for not reporting medical errors when they happen. And he counters those with ethical reasons for reporting. The editorial focuses largely on incidents involving human error, but the underlying ethical issues would also apply to adverse events caused by problems with equipment. And now we're gonna ask you to help us by sharing with us your knowledge and expertise. For many years, FDA has relied on the recommendations of outside advisory committees to help us make sound decisions on medical devices. Advisory committee members are experts in a given specialty who take time out from their own professional lives to provide us with independent scientific and medical advice on the safety, effectiveness and appropriate use of medical devices, sometimes under controversial circumstances. Our medical device panels need expertise in a wide variety of clinical specialty areas, including cardiology, orthopedics, radiology and immunology. If you or someone you know would be interested in serving on an FDA advisory panel, please go to our website for more information. Well, that just about wraps up this edition of our FDA Patient Safety News series, but we'll be back with more, so watch for us. Until then, this is Anita Rainer. And this is Mark Barnett with the US Food and Drug Administration. Remember, you can get more information on all the stories you've seen here today and also find out how to purchase videotapes of these broadcasts 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. See you next time.