 This is FDA Patient Safety News. In this edition, a robot-like device to help in bypass surgery, new warnings in the labeling of antidepressant drugs, more recalls of patient lifts, and how to avoid mistakes when injecting long-acting penicillin. 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. Let's start with a medical product FDA recently cleared for marketing. The FDA recently cleared for marketing a robotic-like system to assist in coronary artery bypass surgery where there's direct access to the chest using either a minithoracotomy or a sternotomy. It's called the DaVinci Endoscopic Instrument Control System, and it's manufactured by intuitive surgical incorporated. When using the device, the surgeon sits at a console with a computer and video monitor. The surgeon uses hand grips and foot pedals on the console to control three robotic arms that perform the surgery with a variety of tools. The robotic arms, which have a wrist built into the end of the tool, give the surgeon additional manipulation ability, enabling easier and more intricate motion and better control of tools. The DaVinci system has already been cleared for several other uses. Those include laparoscopic gallbladder surgery and reflux disease surgery, non-cardiac thoracoscopic chest surgery, and certain cardiotomy procedures such as mitral valve repair. But this is the first time that this robotic-like system has received clearance for bypass surgery. Boston Scientific Corporation has recalled some of its coronary stent systems. The recall covers certain lots of both taxis expressed to drug-alluding stent systems and expressed to systems without drugs. The problem is that the balloon on the delivery catheter is used with both of these stents may fail to deflate. This can interfere with removing the balloon after placing the stent, and it can lead to serious patient complications, including emergency coronary RE bypass surgery or death. We have received reports of deaths and serious injuries associated with this problem. Hospitals that have the affected units should immediately stop using them. Patients who have either the taxis or bare-metal stents already implanted are not affected by this recall because the problem with the balloon deflation occurs when the stent is inserted. Clinicians and patients with questions can call Boston Scientific at 800-832-7822. Go to our website for more information on the production lots covered by this recall. Now we want to bring you up to date on several important changes to the labeling of antidepressant drugs. The first changes address suicide risk and clinical worsening of depression, a topic we've talked about before on this program. We told you that FDA was working with antidepressant drug manufacturers to add new warnings to their drug's labels. The drugs that are the focus of these changes are Prozac, Zoloft, Paxil, Luvox, Selexa, Lexapro, Wellbutrin, Afexer, SIRZone, and Remeron. A number of the manufacturers have already changed the labeling for their drugs and they've notified healthcare professionals about the changes. The new labeling says that both adult and pediatric patients with major depressive disorder may experience a worsening of their depression or start to have suicidal thoughts and that this can happen whether or not they're taking antidepressant drugs. Even though a causal link hasn't been established between these behaviors and the drugs, patients on antidepressant should be observed closely for clinical worsening or suicidality. This is especially important at the beginning of treatment or when the dose is either increased or decreased. Patients who develop suicidal thoughts for the first time when they take these drugs should be carefully monitored to determine whether to discontinue or modify the drug therapy. The same holds true for patients whose depression becomes persistently worse or whose suicidality is severe or abrupt in onset. The warning also points out that patients should be observed for anxiety, agitation, panic attacks, and other behavioral symptoms known to be associated with antidepressant therapy. Although FDA hasn't concluded that these symptoms are a precursor to worsening depression or suicidal impulses, patients who experience these symptoms may be at increased risk. Again, therapy should be evaluated and medications may need to be stopped if the patient has symptoms that are severe, abrupt in onset, or weren't part of the presenting symptoms. Patients and caregivers also have an important role to play in monitoring, and that includes parents of pediatric patients. They should be told to look for these kinds of symptoms or suicidal thoughts and report them immediately to health care providers. On a different note, Wyeth Pharmaceuticals, the maker of Afexer, has notified health professionals about other labeling changes. Neonates who are exposed to Afexer late in the third trimester of pregnancy have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Practitioners treating pregnant women with Afexer in their third trimester should carefully weigh the potential risks and benefits of treatment they may wish to consider tapering Afexer use during that time. These complications can also occur with other SNRIs or SSRIs. And finally, Bristol-Meyer Squibb has revised the product labeling for SIRZone to reinforce the importance of doing a thorough risk-benefit analysis when considering whether to prescribe this drug. The labeling now says that when deciding among alternative treatments for depression, the prescribers should consider the risk of hepatic failure associated with SIRZone treatment. In many cases, this would mean that drugs other than SIRZone should be tried first. Now more news about recalls of patient lifts. In a previous program, we told you about the recall of a patient lift called the FABORG person lift. In that model, the bolt securing the lift arm to the main frame could break, causing the patient to fall. And the recall advice facilities that had these lifts to stop using them. Now we want to tell you about another recall of a patient lift, this time involving Arjo's Allenty Lift Hygiene Chair, which is used to move and bathe patients. This action was taken because of tipping problems that have resulted in serious injuries to patients, including one death. Allenty Lift models, both with and without a scale, are included in this recall. Now in this case, it was not just the device, but it was the way it was being used, right? Actually, it was both the device and the way it was used. For example, castors fell off the lift while it was in use, which could have affected stability. That could have been a problem with maintaining the device properly. But use factors played a part too, as when patients leaned or shifted their weight in the seat, or when the break wasn't applied. Part of the problem was inadequate instructions on how to secure the patient. Now if I got one of these lifts, am I supposed to stop using it? No, you don't have to stop using it, but there are several things you should be sure to do. For example, always use a safety belt to secure the patient in the lift. Also pay careful attention to safety notices and revised operating and product care instructions that Arjo recently sent to customers. Wasn't there another recall of Arjo Patient Lifts? There was another recall, but it was a different model, the Arjo Minstrel Lift. And it was recalled for two different mechanical problems. In one problem, the hanger bar could detach from the lift, causing the patient to fall. In the other problem, the foot pedal assembly could loosen and fall off, which could cause the lift to become unstable and for the patient to fall. Go to our website for more information on both of these recalls. In a recent article, the Institute for Safe Medication Practices described the dangers of mistakenly injecting long-acting penicillin intravascularly, and they highlighted some safety improvements that should help to prevent such errors. Long-acting penicillin products like Bicillin or Penicillin G. benzithine should only be administered by deep intramuscular injection. If you accidentally inject these products intravarterially, the patient could experience severe neurovascular damage, including transverse myelitis with permanent paralysis and gangrene-requiring amputation. If they're given intravenously, the result could be cardiorespiratory arrest and death due to pulmonary embolism from the insoluble matter in the injection. ISMP says that practitioners may not be aware that because of these problems, the manufacturer added safety features to pre-filled biscylence fringes and tubex cartridges. These improvements can help visualize aspirated blood if a blood vessel is entered. With this new design, blood that enters the needle can be quickly seen as a red or dark-colored spot on the barrel of the glass cartridge immediately proximal to the blue syringe hub. To find where to look for a blood spot, first locate the yellow rectangle at the base of the blue hub and draw an imaginary straight line from that rectangle to the shoulder of the glass cartridge. When the needle cover is removed, look for a second yellow rectangle which is also aligned with the spot. The old metal tubex holder, which is no longer distributed, should not be used because the metal may obstruct the view of a blood spot if improperly aligned. Enhanced warnings have also been added to the labeling and placed on the carton and syringes of all biscylent products to warn against IV injection. Still, ISMP says that important safety changes like these can easily be overlooked and they won't be effective if a practitioner still believes that the drug can be given IV. So ISMP recommends that facilities conduct education for all practitioners, including new staff who may dispense or administer these products. If biscylent products are stocked in automated dispensing cabinets, add an alert to the screen when this product is selected. Also, be sure that a copy of instructions for proper use of biscylent products accompanies all dispensed syringes. And since warnings that interfere somewhat with using a product may have a greater chance of being noticed, consider wrapping a label that says, for IM use only, around the needle cover of prefilled syringes. You can see ISMP's article and full instructions for using the tubex cartridges on our website. Here's a new example of what can happen when patient tubing is misconnected. In a previous program, we cited a case where the tubing from a portable blood pressure monitoring device was mistakenly connected to the patient's IV line and the patient died from an air embolism. In another case, an air supply hose from a pneumatic compression device was inadvertently hooked up to a needleless IV tubing port. This patient too could have died if the mistake hadn't been caught in time. In a recent safety alert, the Institute for Safe Medication Practices reported on another case in which a hospitalized child who was being treated for asthma died because of a tubing misconnection. The tubing that connected an oxygen wall outlet to the child's nebulizer became disconnected. A staff member later reattached this oxygen tubing to the Baxter clear link valve on the patient's IV set. Baxter has issued a safety alert to directors of nursing on this type of tubing misconnection hazard. Well, it's hard to understand how this connection was made in the first place since oxygen tubing generally doesn't have a lower connector. It doesn't, but ISMP says that if you exert excessive force, you can make the connection. But wouldn't the connection be likely to just pop right off? It might indeed be likely to pop off, but you have to remember that it takes just a few seconds for an air embolism to occur if you connect an air tube or an oxygen tube to the patient's IV set. ISMP says that staff training is vital in preventing these kinds of accidents. They point out that whenever tubing is connected or reconnected to a patient, staff should be required to completely trace it from the patient back to the point of origin. They also note that if IV lines were labeled, this could help alert staff if they were about to access that line accidentally. What about the issue of who's authorized to make connections or disconnect a patient? Sometimes in the rush of care, ancillary staff may be asked to make those connections. Well, ISMP says that anybody can make a mistake, but that it's more likely that untrained people, ancillary staff, students, transport workers are going to make mistakes like that. And that those people will not be allowed to connect and disconnect patient tubing. But again, back to the rush of patient care. Say there's a student or a lab tech that's standing in the room and he's asked to make this kind of connection. What then? Well, ISMP suggests that these people will be trained in how to refuse that kind of a request. You can find the complete ISMP report on our website. Well, that's all for this edition of FDA Patient Safety News. Here 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 Anita Reiner. And I'm Mark Barnett. See you next time.