 This is FDA Patient Safety News. In this edition, we'll take a look at two new devices for diabetics that combine a glucose meter with a handheld computer. We'll give you tips on how to prevent patient burns from disinfectant residues. And we'll talk about avoiding potentially fatal overdoses from patient administered analgesia. 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 Rayner. 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 our stories from the FDA Patient Safety News website. The address will appear at the bottom of your screen in the program. Let's start with our new products bulletin board and tell you about some of the new devices FDA recently cleared for marketing. FDA recently cleared a new laboratory test that measures the amount of cholesterol in the skin using the palm of the hand. It's called Cholesterol 123 and it's made by International Medical Innovations Incorporated of Toronto. The test is based on the fact that skin contains about 11% of all-body cholesterol. When severe coronary artery disease is present, the values obtained with the skin cholesterol test increase. This test is intended for patients who have a history of heart attacks or those suspected of having severe coronary artery disease. In those cases, the skin cholesterol measurements can be part of the patient's risk assessment along with standard tests, clinical evaluation and consideration of other risk factors. But this new test is not intended to be a substitute for standard blood cholesterol tests. In fact, the values obtained with the skin test don't necessarily correlate with blood cholesterol values. Here's how it's used. An adhesive foam pad is placed on the palm of the hand. Drops of an indicator solution are added to a test well in the pad. A handheld spectrophotometer is used to read the amount of blue color. The results are displayed on a computer screen. The deeper the blue, the more cholesterol is detected. In clinical studies, 649 patients scheduled for coronary angiography were tested for skin cholesterol and blood cholesterol levels. The skin cholesterol and HDL levels combined helped identify patients who have the most severe coronary artery disease. This test was not shown to be useful in identifying people with less severe coronary artery disease. Therefore, it's not intended to be used as a screening tool to determine risk for coronary artery disease in the general population. And it shouldn't be used on patients with any skin disease on the hands or on people using skin medications or hand lotions. Here's another new diagnostic product. This one sold over the counter for people with diabetes. FDA recently cleared for marketing two glucose test meters for use in conjunction with handheld computers. Computer technology allows diabetics to do a better job of tracking and managing their blood sugar levels. The devices are the Freestyle Tracker Diabetes Management System by Therosense Incorporated of Alameda, California, and the AccuCheck Advantage Module by Roche Diagnostics Corporation of Indianapolis. These products for the first time combine a glucose test meter with a handheld computer, in this case, a compatible personal digital assistant or PDA. The new system not only measures and tracks glucose levels, it's also able to monitor and record other important data, such as insulin usage, food intake, exercise, and medications. The patient uses the device by first inserting a glucose meter module into the handheld computer. Then a test strip is inserted into the meter, and a blood sample is collected and placed onto the test strip. The glucose levels are then read by the meter. The computer displays the results and saves them in a database which has the ability to store up to 2,500 entries. The results can be uploaded to a PC and printed out or viewed at a later time. Of course, it's important that patients know how to operate a PDA before they use the system. FDA recently gave marketing clearance for an electrosurgery device that shrinks the size of tonsils in adults and teenagers. For these patients, it offers a minimally invasive alternative to conventional tonsillectomy. The procedure takes about 30 to 45 minutes, and it's usually done on an outpatient basis under local anesthesia. The device is called the somnoplasty tissue coagulating electrode. It's made by the gyros group of Bartlett, Tennessee. It was previously cleared by FDA for general use in coagulating and reducing tissue in the head and neck in conditions such as obstructive sleep apnea. The device works by emitting radiofrequency energy through a special probe. This energy produces small lesions beneath the surface of the treated tissue. As those lesions heal, they shrink the tissue while leaving the surface intact. Remember, this device is cleared for tonsil reduction only in patients 13 years of age and older. Now let's talk about specific ways to protect patients. If you or your patients use ventilators, you should know that pulmonetic systems of Colton, California has recalled some of its LTV series ventilators over the past several months. There have been several problems with these devices. One of them could result in a situation where no audible alarm would sound if the ventilator stopped working. Not all LTV series ventilators are affected by these recalls. Pulmonetic systems is contacting the purchasers of the affected ventilators. If you think ventilators in your facility could be covered by these recalls, you can go to our website. We'll post more information as it becomes available. FDA has received a number of reports of internal irritation and chemical burns in patients who were treated with devices processed with high-level liquid disinfectants. Most healthcare facilities use these products to disinfect heat-sensitive medical devices. They can be highly effective in killing microorganisms. But they can also cause injuries to patients if you don't follow instructions and warnings. The problem occurs when the disinfectant isn't completely removed in the rinsing process. One manufacturer, Advanced Sterilization Products, the maker of Psydex brand disinfectants, recently sent a letter to its customers emphasizing the importance of proper rinsing for all of its high-level disinfectants. If you use Psydex products, be sure to watch for the letter. But the problem of residual disinfectant causing injuries isn't limited to just this one company's products. These sorts of injuries can occur with any high-level disinfectant if users don't follow proper rinsing procedures. Regardless of the particular disinfectant being used, there are several steps that must be followed for effective rinsing after disinfection. Completely immerse the device in at least two gallons of water. Keep the device totally immersed for a minimum of one minute unless otherwise indicated by the device manufacturer. Remove the device and discard the rinse water. Repeat this procedure two additional times for a total of three full rinses. Take special care when reprocessing devices with lumens or channels, like endoscopic instruments. Be sure to flush these channels with plenty of water during each rinse. Check the device labeling for additional rinsing instructions that are specific to that device. There are two other precautions to keep in mind. First, it's important to clean devices properly before they're disinfected because patient material or other debris may make it harder to rinse off the disinfectant. An enzymatic cleaner is typically recommended in the product labeling. Also, don't keep devices in the disinfectant too long because this makes it harder to rinse off the disinfectant. Speaking about disinfectants, FDA now has a list of sterilence and high-level disinfectants that we've cleared for processing reusable medical devices. The list identifies manufacturers, active ingredients, and contact conditions for these products. You can find the list on our website. Now for the part of the broadcast where we tell you about recent articles that pertain to patient safety. This time we want to talk about three recent articles by the Institute of Safe Medication Practices, warning of the potential danger of using patient-controlled analgesia or PCA. The articles point out that when the patient is truly controlling the administration of the analgesic drug, there's a built-in safeguard because when the drug dose exceeds the amount needed for analgesia, the patient becomes sedated and then he or she can no longer push the button to administer more of the drug. The problem occurs when other people push the button bypassing this built-in safeguard. That can happen when well-meaning family members push the button and sometimes even when staff members do so. As the ISMP puts it, PCA means patient-controlled analgesia. It does not mean family-controlled, visitor-controlled or clinician-controlled. One of the articles cites the case of a 72-year-old woman who received morphine through PCA after surgery and who died of an overdose. Despite the patient's inability to verbalize pain and the fact that she remained uptunded after surgery, nurses pushed the PCA button and delivered frequent doses of morphine for 48 hours. The patient suffered a cardiorespiratory arrest and seizure and she died several months later without having her gain consciousness. ISMP points out that in this case, nurses did not recognize the signs of morphine toxicity and they continued to administer the drug despite serious hypertension and very shallow respiration. The ISMP articles don't say that nurses should never push the patient's PCA button. They say that nurse-controlled analgesia may be appropriate in critical care settings but only with guidelines for selecting patients along with tools to assess the level of pain and sedation. Here are the ISMP recommendations. First, establish selection criteria for patient-controlled analgesia. Note that some patients are not suitable for PCA because of their level of consciousness, their psychological state, or their intellectual capacity. Also, establish selection criteria for nurse-controlled analgesia. Decide in advance on risk factors that would call for increased monitoring such as age and concomitant medications. Develop protocols and standardized order sets for infusion devices, drugs, dosing, and lockout periods. Carefully monitor patients. Opiates can suppress respiration, heart rate, and blood pressure so patients must be observed and monitored. Pay particular attention to the first 24 hours since the effect of opiates on intellectual functioning can be unpredictable. Also, be sure to monitor and observe the patient at night since nocturnal hypoxia can be a serious side effect. Double-check the patient's ID and the dose setting before starting to use PCA and also before each pump refill. In other words, you should require two clinicians to perform this check independently. Educate patients and families about the proper use of PCA. Warn family members about the danger of pressing the button for the patient. Explain that this should only be done when the patient has clearly expressed a need for the medication and requires physical assistance to press the button. Finally, educate the staff about the proper use of PCA. Encourage them to think about the cumulative dose the patient could receive if the maximum dose were given and ensure that they fully understand the hazards of using analgesics. In a previous broadcast, we talked about the case of a six-year-old boy who was crushed to death in an MRI machine. It happened when a metal oxygen tank flew across the room attracted by the powerful magnet in the machine. This kind of problem where metal objects near MRI machines injure patients isn't going to go away. Dealing with it requires constant vigilance, but it also requires that MRI facilities set up detailed policies and procedures relating to safety. There's a new publication that does just that. It's the report on Magnetic Resonance Safe Practice Guidelines issued by the American College of Radiology. This is a comprehensive set of recommendations covering all aspects of MRI safety from the layout of the MRI suite to the training of personnel to emergency procedures. If you work in or near an MRI facility, this document is a must-read for you. Even if you're not directly involved with MRI, you'll probably find some of the questions addressed by the guidelines interesting. For example, should metal detectors be used in the MRI facility? Is it necessary for patients to remove eye makeup before having an MRI? Why should patients not cross their legs during the procedure? How can you tell whether an unconscious patient has a metal implant? What about a patient who requires EKG monitoring during the MRI exam? What about patients with tattoos? What if the patient is a prisoner wearing metal handcuffs? You'll find the answers to these and other questions on MRI safety in the ACR guidelines, and you'll find information on how to get the guidelines on our website. Well, that's all for this edition of FDA Patient Safety News, but we'll be back next month with another edition, so watch for us. For Drug Administration, I'm Mark Barnett. And I'm Anita Rainer. Remember, you can get more information on all the stories you've seen today by visiting our website. You can also use the website to view this and previous broadcasts again. 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.