 This is FDA Patient Safety News. In this edition, the first test approved to screen blood donors for West Nile virus, bacterial contamination of vapor-firm humidifiers, glucose monitoring errors in patients receiving certain sugars, and another case of confusion between drug names that look and sound alike. These stories and more are in 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 a newly approved test that can find out whether donated blood and tissue contain the West Nile virus. FDA recently approved the first test to screen blood donors for the West Nile virus. The test, called the Procleus WNV assay, can also be used to screen donors of organs, cells, and tissues. The test was developed by Genprobe Incorporated and will be marketed by Chiron. Now this test does not check for West Nile in a patient, right? That's right. It tests blood samples from donors of blood, tissue, and organs for the presence of the virus. You said the test was used to screen donated blood for West Nile, but in fact, don't people get West Nile primarily for mosquito bites? That's right. It is primarily a mosquito-borne disease. But there have been about 30 documented cases where people most likely acquired the infection through a blood transfusion and nine of them died. Most people infected with the virus don't have symptoms and aren't aware of their infection, so they might unknowingly try to donate blood. This test can help to protect patients who receive blood and other products against West Nile infection. Baxter Health Care has alerted dialysis clinics about cases of hemolysis occurring in patients being treated with the company's Meridian hemo-dialysis instrument. The hemolysis was caused by kinking in the blood tubing sets that are used with the Meridian units. One patient died and at least one other patient sustained serious injury. Here's how the kinking can occur. The front of the Meridian instrument has a clip that has two channels. The original device labeling instructed users to root the blood tubing through both of these channels. But doing that increases the risk that the tube will kink. So the company advises users to root the tubing through only one of these channels and also to continuously inspect the tubing to be sure that it isn't kinked. In addition, the notification includes diagrams and labels that display the right way to use the clips. You should attach these labels to the front of the instrument. The affected devices are all Meridian instruments with model numbers 5M5576 and 5M5576R. Baxter will be providing users with modified tubing clips to correct the problem. For additional information, you can contact Baxter at 1-800-4-Baxter. FDA has issued updated information about an association between the Vapotherm 2000i device and the occurrence of positive Rolstonia cultures. Rolstonia are gram-negative bacteria that were formerly included in the genus Pseudomonas or Bercholaria. The Vapotherm device is used to add moisture and warm breathing gases through a nasal cannula in patients receiving supplemental oxygen. Reports to FDA and CDC from hospitals in 16 states indicate that some Vapotherm devices are colonized by Rolstonia and the bacteria have also been isolated from patients exposed to these devices. FDA is continuing to work with CDC to determine the source and scope of the Rolstonia contamination, find out whether other organisms may be involved, and evaluate disinfection protocols. In the meantime, FDA is advising clinicians and institutions to use alternative devices. You'll find a link to a list of those alternative devices on our website. FDA is also advising that patients who have been exposed to the Vapotherm system be monitored for signs and symptoms of infection. These can include changes in temperature, poor feeding, irritability, and blood count changes. Clinicians may want to consider Rolstonia infection in symptomatic patients who have been exposed to a Vapotherm device even if the organism has not been isolated. FDA has issued a reminder about the potential for falsely elevated glucose readings in patients who are also receiving products that contain other sugars. These products include oral xylose, parenterals that contain maltose or galactose, and peritoneal dialysis solutions that contain icodextrin. Now, a patient recently died because of this problem. That's right. His glucose readings were very high. He was given aggressive insulin treatment. And the problem is that the glucose readings were falsely high and too much insulin was administered. The patient suffered irreversible brain damage and died. So in this case, the glucose meter was responding to other sugars. That's right. It was responding to the glucose in his blood, but it was also responding to the maltose that was contained in an IV immune globulin that he was receiving. The readings were falsely elevated because the glucose monitoring device couldn't distinguish between glucose and other sugars. Now, all glucose meters don't suffer from this problem. No, there are four kinds of enzymatic glucose monitoring methods that are used, and only one of those has this problem. The problem occurs only with a monitoring method that uses an enzyme called GDHPQQ. This method is employed in some glucose monitoring devices that are used by diabetics at home and in point of care settings. The other three test methods currently used in glucose monitoring systems are called GDHNAD, glucose oxidase, and glucose hexokinase. And those are capable of distinguishing between glucose and other sugars. So how do you know which of the four monitoring methods your glucose meter is using? Well, it's important to know that information and you can get it in the package insert that comes with the glucose test strips. And it's also available from the manufacturer. The most important thing to remember is not to use the GDHPQQ method if the patient recently received other sugars. And that includes oral xylose for a desylose absorption test, or an IV solution containing maltose or galactose, or a peritoneal dialysis solution containing icodextrin. Boston Scientific is recalling certain vena cava filter systems. The recalled devices are small cone-shaped filters used to help prevent pulmonary embolism. The filters are implanted in the inferior vena cava to capture blood clots before they're carried to the lungs. The devices are being recalled because in a small number of cases a certain part of the filter's delivery system has become detached while the device was being implanted. And this has led to reports of patient injuries and one patient death. Now it's important to note that this recall applies only to devices that have not yet been implanted in patients. The recall affects the stainless steel greenfield vena cava filters with 12 French femoral introducer systems manufactured before March 10, 2004. These devices have a used before date of March 2007. For instructions on how to return any unused devices covered by this recall, contact Boston Scientific at 888-272-1001. Beringer Engelheim has notified healthcare professionals that a surgical condition called intraoperative floppy iris syndrome has been observed during FACO-mulsification cataract surgery in some patients who are taking alpha-1 blockers such as Flowmax or Tamsulicin. These drugs are used to treat benign prosthetic hyperplasia and hypertension. Most of the cases occurred in patients who were taking alpha-1 blockers at the time of the eye surgery, but in some cases the drug had been stopped prior to the surgery. Healthcare practitioners should ask patients considering cataract surgery about whether they've taken Flowmax or other alpha-1 blockers. If so, the ophthalmologist performing the procedure should be informed so that the surgical technique can be modified if necessary. Biogen IDEC has notified healthcare professionals that the drug Amovib or Alephicept, which is used to treat severe chronic plaque psoriasis, is contraindicated in patients affected with HIV. Amovib reduces CD4T lymphocytes, and this might accelerate HIV progression or increase complications. Today we want to remind you about an important FDA program called MedWatch. MedWatch allows healthcare professionals and consumers to report serious problems that they suspect are associated with the medical products they prescribe, dispense, or use. These reports, along with follow-up investigations, can help to identify important safety concerns. Take the example of the antibiotic Xivox. Within the first six months of Xivox's marketing, FDA began getting MedWatch reports of myelosuppression from clinicians who suspected that the drug might be responsible. After investigating the problem, we worked with the manufacturer to change the Xivox labeling to warn about the potential for myelosuppression. Sometimes MedWatch reports highlight errors in prescribing or administering medications. For example, FDA received reports of patient injuries due to name confusion between lanoxin, a heart medication, and what used to be called lavoxin, which is a thyroid medication. As a result, FDA asked the manufacturer to change the name of lavoxin, and now it's known as lavoxol, which is less likely to be confused with lanoxin. The MedWatch system can also help detect problems with medical products other than drugs. For example, FDA received two reports of pneumococcal eye infections in patients who'd received corneal transplants. An FDA inspection identified numerous manufacturing problems, which led the company to recall the implants. Of course, MedWatch reports by themselves can't usually establish a causal relationship between an adverse event and a medical product. It may take a formal epidemiologic study to do that. Still, MedWatch reports are vital in making sure that medical products are safe because they provide a rapid signal to FDA that a problem may be occurring. It's important to keep the MedWatch system working, and we can't do that without your help. Here are the kinds of reports we need from you. First of all, we're asking that you report any serious adverse event that might be associated with a drug or a biologic or a medical device or a dietary supplement. And by serious, we mean fatalities, hospitalizations, and medically significant events. And we're especially interested in serious adverse events that are not listed in the product labeling. Secondly, report therapeutic failures, cases where the drug or device failed to work as it should. For example, let us know if a patient has to switch from one brand of a drug to another because the original one was ineffective. Third, tell us about cases of use errors with medications or devices, including situations where the error may have been due to poor communication or to ambiguities in product names or directions for use or packaging. And finally, we'd like to know about product quality issues such as suspected counterfeit products, defective components, potential contamination, device malfunctions, and poor packaging. We encourage you to report these problems to MedWatch even if you're not sure that the product was the cause. It's easy to report by internet, phone, fax, or mail. You'll find more complete information on what to report and how to report on our website. The Institute for Safe Medication Practice has recently described several cases where the brand name of one drug was mistaken for the generic name of another. Salogen, a brand name for pylocarpene, is used to treat the dry mouth symptoms caused by Sjogren syndrome or radiation therapy. Cilegoline is an MAO inhibitor used to treat Parkinson's disease. Those drugs are available in five milligram tablets. In the first case, the mixup occurred because the names sounded alike. A home health nurse received a telephone order from a dentist for an elderly patient with problems related to a dry mouth. The dentist prescribed salogen five milligrams, but the nurse misheard the order and called the pharmacy to request cilegoline five milligrams. About two weeks later, another pharmacist was processing a prescription for a fentanyl patch for the same patient when the pharmacy computer system signaled an alert about a drug interaction between fentanyl and cilegoline. When the pharmacist contacted the prescriber, he discovered the error. In the second case, a pharmacist reported that the similar spelling of the two drug names led him to enter cilegoline into the computer instead of salogen. The error was recognized only after the patient complained that the medication was not helping his dry mouth and this caused the pharmacist to check the patient's profile. In order to minimize these kinds of mixups, ISMP says to list both the brand and generic names on prescriptions. And patients who use these drugs regularly should be alerted to report any change in the appearance of their medications. 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 medical products. That's 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 Rayner. See you next time.