 This is FDA Patient Safety News brought to you by the U.S. Food and Drug Administration. In this edition, we'll take a look at a new home monitoring system that transmits data from a pacemaker to the physician's office, an update on a recall of potentially dangerous OBGYN devices, and a warning about how patients with certain implants can be injured by diathermy treatments. These stories and more on this edition of FDA Patient Safety News. Welcome to FDA Patient Safety News. 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 the stories in this broadcast from our FDA Patient Safety News website that addresses www.fda.gov.cdrh.psn. Let's start with our new products bulletin board and tell you about a new device FDA recently approved. The FDA recently approved a home monitoring system that's used in conjunction with a cardiac pacemaker. It's made by Biotronic Incorporated of Lake Oswego, Oregon, and it automatically transmits data from an implanted Biotronic pacemaker to the patient's physician. The way it works is that the pacemaker contains a short range radio frequency transmitter. This transmitter sends the data from the pacemaker to a device that's similar to a cell phone. The patient carries it on a belt or in a pocket or in a handbag and places it on a charging stand next to the bed at night. This cell phone-like device automatically sends the data to the company's service center where it's stored in a computer database. The information is then faxed to the physician's office at preset intervals ranging from once the data once a month. The company also accumulates the data and can provide the physician with trend information on the patient's heart over a period of time. The physician can also program the device so that it sends the data whenever the patient places a magnet over the pacemaker. That way the patient can notify the physician when unusual symptoms are occurring. This home monitoring system is not a substitute for regularly scheduled office visits. It's designed to provide the physician with supplementary data between those visits. And it can't be used in areas that aren't covered by cell phone service. Now here's more on a breaking story we told you about during our last broadcast. When we notified you about an urgent recall of certain medical devices manufactured by ANA Medical, Incorporated, of Alpharetta, Georgia. This company also does business under the names RocketUSA and LifeQuest and it manufactures many types of OBGYN and surgical devices. The reason for the recall is that devices labeled as sterile or ethylene oxide processed actually may not have been sterilized. As a result, using these devices could cause serious and possibly life-threatening infections. This recall includes all products manufactured under those three names, ANA, RocketUSA and LifeQuest that are labeled as sterile or ethylene processed. The recall includes a wide variety of OBGYN products such as flexible and rigid curettes, uterine dilators, fetal blood samplers and laparoscopy accessories. You can find more information on the affected products on our website. It's important to note that these devices were also sold by distributors other than the manufacturer and that in some cases the distributors name may appear on the product, not the manufacturers. FDA is contacting these distributors and asking them to contact their customers who received these affected products. Here's how to handle this recall in your facility. First, do not use ANA Medical, RocketUSA or LifeQuest products that are labeled as sterile or ethylene processed. And second, periodically consult our website for updates on this recall. Now since the last broadcast, people have asked about re-sterilizing these devices on-site. You should not attempt to do this. Instead, FDA is encouraging facilities to voluntarily destroy existing stocks by burning or pulverizing them. Now we want to alert you to a serious problem that can occur when patients with neurostimulator implants receive diathermy therapy. If a patient has an implanted neurostimulator, treatment with diathermy can cause heating at the interface where the neurostimulator electrode comes in contact with the body. That can cause tissue damage that can lead to permanent injury or even death. In 2001, two patients who had been implanted with deep brain stimulators and later received diathermy treatment died as a result. One of them had the diathermy following oral surgery, the other to treat chronic scoliosis. In both cases, the energy from the diathermy treatment caused severe brain damage where the electrodes were implanted in the brain. Medtronic, the manufacturer of the device, subsequently issued a safety alert to physicians, patients and facilities. The alert strongly warned against using diathermy on patients with any of the company's implanted neurostimulation systems. That includes those for the brain, the spinal cord, peripheral nerves or the sacral nerve. And that also includes diathermy of any kind, shortwave, microwave or therapeutic ultrasound. Other manufacturers of implanted neurostimulators have also warned about the dangers of using diathermy on patients implanted with their neurostimulation devices. These firms include cyberonics and ANS or advanced neuromodulation systems. Cyberonics makes the neuro-cybernetic prosthesis system that stimulates the vagal nerve to help reduce the frequency of epileptic seizures. And ANS makes the ANS-renewed neurostimulation system which stimulates the spinal cord to treat chronic pain. With all of these neurostimulators, the message is clear. Patients with these devices should not have diathermy. And remember, the hazard exists even when the implanted device is turned off. And because diathermy can concentrate or reflect its energy off implants of any size, this warning extends to individual components of a neurostimulation system that might remain implanted even after the device is no longer being used. Anita? Here's another example of patients being endangered because of an interaction between two devices or treatments, even though each one is working properly. This involves gases that are injected into the eye to treat retinal tears and detachments. If patients who have received this treatment later receive nitrous oxide in dental or surgical procedures, severe eye injury and even blindness can occur. The two gases are perfluoropropane, PFP, and sulfur hexafluoride. They're distributed by alkan and escalon. These gases are injected directly into the vitreous cavity where they produce a gas bubble that can help heal retinal tears. The gas bubble gradually diffuses from the eye over a period of about one to eight weeks. But while the gas bubble is still in the eye, patients must be careful to avoid activities that can increase intraocular pressure, such as flying in an airplane or making other significant changes in altitude. It's the increase in pressure that causes the eye injury. The same effect can occur if a patient with one of these intraocular gas bubbles receives nitrous oxide as an anesthetic during a dental or surgical procedure. So if you use PFP or sulfur hexafluoride, it's important to warn these patients that until the bubble has diffused out of the eye, which could take up to eight weeks, they cannot have nitrous oxide. To help do that, you can get special cards to give patients explaining the situation. There's also a bracelet the patient can wear, warning any healthcare provider that might treat this patient about not using nitrous oxide, and you can get information on how to obtain these materials from our website. And remember, if you're at the other end of this process, that is if you use nitrous oxide in your practice, don't administer it to any patient who has one of these gas bubbles in the eye. And of course, that means asking patients about previous retinal procedures. In 1999, we issued a warning about the possibility of serious injury to patients from circumcision clamps. We were getting about 20 injury reports per year, and that included laceration, hemorrhage, urethral damage, and penile amputation. I'm glad to tell you that the number of reports has gone down since we issued the warning, but they continue to come in, and the injuries, rare as they are, continue to be serious. And so we want to remind you about the steps you can take to avoid these injuries. The 1999 warning explained what can go wrong with two widely used types of circumcision clamps, the Gomko type and the Mogan type. With the Gomko type clamps, the problem generally stems from mismatched parts. That is, from reassembling the clamp with parts from different manufacturers, or using parts from the same manufacturer that aren't meant to go together, or using parts that have become bent. What makes things difficult here is that the parts may appear to be interchangeable, but often they're not. And so here's what the FDA warning said about how to avoid injuries with Gomko type clamps. First, make sure that you reassemble a clamp only from its own parts. Mix up parts from different manufacturers, or even from the same manufacturer, unless the manufacturer has assured you that the parts are interchangeable. Second, if you can't be sure that a clamp component is part of the original clamp, or if any component is damaged, contact the manufacturer to obtain replacement parts, or discard the entire clamp. Third, when you request a replacement part, get the manufacturer's assurance that the part you ordered is compatible with the other components of your clamp. Secondly, if you choose to mark the clamp parts to assure that you correctly reassemble them, ask the manufacturer about the best way to do this. Some marking methods may weaken the device, or interfere with your ability to sterilize it. Now with Mogun type clamps, the problems arise when the jaws of the clamp are too large for the patient. This can allow too much tissue to be drawn through the opening in the clamp, so an excessive amount of foreskin or even a portion of the glanced penis is removed. That can happen either because the clamp is not within the manufacturer's specifications, or because the wrong size clamp is selected for the patient. Note that some manufacturers have two sizes of Mogun type clamps, one for infants and the other for adults. There are two ways to prevent problems with this kind of clamp. First of all, be sure that the clamp is the correct size for the patient. And secondly, periodically measure the gap between the clamping jaws to be sure it's within the manufacturer's specifications. Now we want to tell you about a new campaign kicked off recently by the Joint Commission on Accreditation of Healthcare Organizations. This campaign encourages patients to play an active role in their own healthcare. That's an important way to promote patient safety and prevent medical errors. The campaign is called Speak Up, and it's been developed in cooperation with the Centers for Medicare and Medicaid Services. Speak Up is actually an acronym in which each letter stands for something patients should do. S is for speaking up with questions or concerns about their healthcare. P is for paying attention to the healthcare they're receiving, for example, whether they're getting the right treatments and medications. E is for educating themselves about their diagnosis, as well as tests and treatments they will be undergoing. A is for asking a family member or friend to act as their advocate in negotiating the healthcare system. K is for knowing what medications they're taking and why they're taking them. U is for using an accredited healthcare organization or hospital. And P is for participating in all decisions that affect their treatment. Jaco has a brochure that's filled with information on each of these seven areas with very useful advice for patients and their families. You can get this brochure along with other promotional and educational materials by going to the story on our website. And now for the part of the broadcast that we call Journal Scan, where we report on articles that are particularly relevant to patient safety. This time, we're talking about a sentently ventilator issued on February the 23rd by the Joint Commission on the Accreditation of Healthcare Organizations. In it, Jaco summarized their review of a series of deaths and injuries in patients on long-term ventilation. Three major causes for these incidents stood out. First, an alarm on the ventilator that malfunctioned or was inadequate or misused. Second, a tubing disconnect. And third, a dislodged airway tube. The vast majority of these cases also involved inadequate training insufficient staffing levels or communication breakdown. Essentially, here's what Jaco recommended to help prevent these kinds of events. First of all, be sure that safety material on ventilators is included in training programs and in competency tests and that staff receive the training. Second, be sure that ventilator patients have adequate staff available at all times. Third, regularly check equipment and alarm systems. Fourth, be sure that alarms on ventilators are loud enough to be heard by the staff. And fifth, observe patients directly. Don't depend only on alarms to warn about problems. Well, that just about wraps up this edition of FDA Patient Safety News. But we're going to be back next month with more. So watch for us. Until then, for the US Food and Drug Administration, I'm Mark Barnett. And I'm Anita Rayner. 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.