 This is FDA Patient Safety News brought to you by the U.S. Food and Drug Administration. In this edition of FDA Patient Safety News, we'll take a look at a new video camera small enough to swallow and visualize the small intestines. Also, a skin substitute used to close wounds of diabetic foot ulcers. Add a new pacemaker for congestive heart failure. These stories and more on this edition of FDA Patient Safety News. Welcome to the program. 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 the FDA Patient Safety News website. The address is going to appear at the end of this program. First up today are new products bulletin board where we talk about some new devices that FDA has recently approved. The FDA has recently cleared a tiny video camera that a patient can swallow and that will take video pictures of the small intestine. It's called the Given Diagnostic Imaging System and it's made by Given Imaging Limited of Norcross, Georgia. Here's how it works. What the patient swallows is actually a capsule a little more than an inch long that contains the camera, a light, a transmitter, and batteries. As the device passes through the small bowel, it takes video pictures and transmits them via radio signals to a small recorder on the patient's belt. The images can then be interpreted by the physician. The capsule, which is not reusable, passes out of the body during normal defecation in about 8 to 72 hours. The clinical use for this device is to visualize the small intestine when there's chronic or unexplained rectal bleeding and small bowel disease is a concern. It should only be used after the patient has received other imaging procedures to visualize the small bowel. It's interesting to note that endoscopes can only visualize the upper part of the small intestine whereas the camera can see its entire length. In another recent action, FDA approved a skin substitute that's used to help in the wound closure of diabetic foot ulcers. It's called derma graft and it's made by advanced tissue sciences of La Jolla, California. Basically, the product consists of human fibroblasts that are incorporated in a dissolvable mesh material. When the product is placed on the ulcer, the mesh material is gradually absorbed and the human fibroblasts grow into place and replace the damaged skin. As they grow in, those fibroblasts produce many of the same proteins and growth factors that are found in healthy skin and this helps in replacing and rebuilding damaged tissue in the ulcer. In the cardiovascular area, FDA recently approved a pacemaker that can treat some of the symptoms of moderate to severe congestive heart failure. In some heart failure patients, the left and right ventricles don't contract simultaneously as they should. This device corrects that condition by providing specially timed electrical impulses to the ventricles. It's called the in-sync biventricular cardiac pacing system and it's made by Medtronic Incorporated of Minneapolis. The system includes a pulse generator implanted in the patient's chest which is connected to three lead wires that deliver the electrical impulses. One lead goes to the right atrium, the other two are placed in each of the ventricles where they stimulate those chambers to beat simultaneously. Even though this device may relieve some of the symptoms of congestive heart failure, it's not been shown to be useful in all heart failure patients. It should be used only in patients with moderate to severe symptoms of congestive heart failure, whose ventricles are not contracting simultaneously and aren't likely to improve with additional drug therapy. And it shouldn't be used in patients whose congestive heart failure is reversible. Now let's talk about some specific ways to protect patients. The FDA recently sent a public health advisory for radiologists, hospital risk managers and radiation health professionals alerting them to the need to keep radiation doses during CT procedures as low as possible, particularly for children and small adults. Unless the settings on the CT unit are adjusted to accommodate to a small body, the child or the small adult can receive more radiation than needed to get the diagnostic image. And of course there's special concern about children getting unnecessary radiation exposure because they're generally more sensitive to the harmful effects of radiation than adults. To compound the problem, the overexposure of children and small adults during CT procedures can go unnoticed. With conventional x-rays, overexposing the patient generally means overexposing the film, and that results in an image that's too dark. So it's obvious to the operator that there's a problem. But with CT, the quality of the image may not be compromised, so the operator may have no idea that the patient is getting needless radiation. The FDA advisory recommends several things. First of all, take several steps to optimize the settings on the CT scanner based on the patient's size. Second, when it's medically indicated, reduce the number of scans taken before the injection of contrast media. And third, when it's medically appropriate, consider using other imaging modalities that can sometimes provide the same information with less or no radiation exposure, things like conventional x-ray or ultrasound or MRI. This FDA advisory recognizes the important benefits of CT scanning in diagnosing disease and trauma and guiding interventional procedures, and so it doesn't suggest curtailing the use of this modality. What it does do is suggest ways to retain those benefits while minimizing the possible risk to a sensitive part of the population. Now for a follow-up to a story we covered in an earlier broadcast. That story was about reports we'd been receiving on medical gas mix-ups in which deaths and injuries occurred when patients were accidentally given the wrong gas. That happened when a gas like nitrogen or carbon dioxide was mistakenly connected to the oxygen supply system. And it happened despite the fact that oxygen containers are designed so that they'll only fit the oxygen connector on the patient's gas supply system. The reason it happened was that someone altered or changed the connector on the gas container so that it would fit. In other words, they overrode the systems built in Safeguard, and the result was that the patient got another gas instead of oxygen. In that first story, we cautioned people not to use adapters or change the connectors or fittings on gas containers to make them fit the oxygen connector on the patient's gas delivery. We said, if a gas container doesn't fit the connector, it's probably the wrong gas, so don't try to connect it. Shortly after that broadcast, two more patients died because they received nitrous oxide instead of oxygen. This happened in a cardiac cath lab in a New Haven Connecticut hospital. According to a report from ECRI, an Independent Health Services Research Agency, this gas mixup probably did not occur because someone tried to change a connector or use an adapter. Instead, one of the small tabs on the oxygen fitting of the gas supply system was reportedly broken off. That would have allowed it to be connected to the nitrous oxide gas outlet without changing anything. According to the ECRI report, the way to prevent this kind of accident from happening is to routinely inspect medical gas and vacuum systems and also medical devices used to administer gases from ventilators to fittings. Those inspections, according to ECRI, should be done yearly or at a minimum every two years. And they should be performed more frequently in areas of high gas use such as the emergency department. Occasionally on FDA Patient Safety News, we report on medical devices recalled by their manufacturers for safety reasons. 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. This time, we want to tell you about a problem with an artificial hip component that prompted a widespread recall by the manufacturer here in the U.S. and abroad. The component of the implant is the femoral head. That's the ball portion of the hip process that connects the femoral stem to the pelvis. This particular femoral head is made of a zirconius ceramic and it's manufactured by a French company, Sangoban de Marquet. Now, the French company supplied the component to a number of other manufacturers who make the finished implants. This component was recalled because it was fracturing at a higher rate than expected within about two years after the hips were implanted. Eight U.S. companies that manufacture the finished implants are voluntarily recalling them as well because they contain this component. If you use hip implants in your facility and you want to find out about the products and batches that were recalled, you can get this information on our website. Now, the recall doesn't mean that all these components are expected to fail or that all patients are going to experience a problem. Unfortunately, there's no way to predict which implants are going to fail. FDA is not recommending surgery to replace any hip implants that have not fractured or aren't causing problems. But clinicians may choose to monitor the performance of these implants more closely and watch patients complaining of a sudden onset of pain in the implanted hip joint. Some patients have reported hearing a pop from their hip just before experiencing this pain. Now for the part of the broadcast that we call Journal Scan where we share interesting articles on patient safety with you. This time we want to call your attention to a study called Family Physician's Personal Experiences of Their Father's Healthcare by Dr. Frederick Chen and others. It appeared in the September 2001 issue of the Journal of Family Practice. This is a study in which several senior physicians were asked to report on the healthcare their fathers received during a serious illness. It's an unusual study made up of a series of in-depth interviews and it sheds a lot of light on how patients and their families interact with the healthcare system and particularly how they react to adverse events and medical errors. One recurring theme in this article, the one most closely tied to promoting patients' safety, is the need for each patient to have an advocate to act as a guide and a watchdog in negotiating the healthcare system. The article said, the physicians in this study felt strongly that patients needed an informed, accountable advocate. Each witnessed events and situations where such an advocate was absent when needed. And the article points out that this function should be the role of the patient's primary care physician. It says, healthcare systems could affirm the continued presence of one physician who is in charge of the patient's care and accountable to the patient and the patient's family. But the article also acknowledges that family members sometimes have to take on this role. It says, as a patient's medical care becomes increasingly complex, the advocate becomes more important and ironically more elusive. In many cases, the responsibility for being the advocate felt to the physician family member. In any case, there's food for thought in this article about whether the patient's family may have a role in helping to promote safety and prevent adverse events. We also want to call your attention to an interesting article by doctors Charles Billings and David Woods in the January 2001 issue of postgraduate medicine. It's called Human Error in Perspective. The article starts out with a little history of the so-called patient safety movement, including the influence of the famous report of the Institute of Medicine in 1999 with its disturbingly large estimate of patient deaths due to medical error. The article then goes on to stress that it's not enough to attribute the cause of an adverse event to human error. Here's what they say. Attributing adverse events to human error is too often the final step in the investigation when in fact it should be simply the first step in understanding how and why such failures occur. They close the article with five prescriptions for success in achieving patient safety. First, recognize that failures can and will happen in any system, no one is immune. Look for and find the vulnerabilities in your system through purposeful interdisciplinary effort. Second, understand the problem before you fix it. Applying apparent solutions before you understand the many facets of a problem ensures failure. Third, fix the whole system, not just the immediate problem. Chocking an incident up simply to human error will give you an incorrect, incomplete, or shallow explanation. Fourth, simplify, don't complicate. Make it easier for people to do it right and harder for them to do it wrong. Simplifying the operation of a system can dramatically improve its reliability by making it easier for the humans in the system to operate effectively. And fifth, instead of blaming people, help them to do it better. The authors close the article by saying that the most effective prescription for healthcare system improvement is to support people as they perform their day-to-day tasks. Well, that just about wraps up this edition of FDA Patient Safety News. We'll be back next month with another edition. Until then, I'm Anita Reiner. And I'm Mark Barnett with the FDA. Remember, you can get more information on all the stories you've seen here today and you'll find out how to obtain 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.