Show #31, September 2004
Show #31, September 2004
|Robotic-like Device Cleared for Coronary Bypass Surgery|
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 mini-thoracotomy or sternotomy. It's called the da Vinci Endoscopic Instrument Control System, and it's manufactured by Intuitive Surgical, Inc.
In 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 da Vinci system has already been cleared for several other uses. These include laparoscopic gall bladder 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 this robotic-like system has received clearance for bypass surgery.
|Recall of Certain Boston Scientific Coronary Stents|
Boston Scientific Corporation has recalled some of its coronary stent systems. The recall covers certain lots of both TAXUS Express2 drug-eluting stent systems and Express2 systems without drugs.
The problem is that the balloon on the delivery catheters used with both of these stents may fail to deflate. This can interfere with removing the balloon after placing the stent, and lead to serious patient complications, including emergency coronary artery 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 TAXUS or bare metal stents already implanted are not affected by this recall, because the problem with 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.
|Important Warnings in Antidepressant Drug Labeling|
Now an update 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 drugs' labels. The drugs that are the focus of these changes are: Prozac (fluoxetine), Zoloft (sertraline), Paxil (paroxetine), Luvox (fluvoxamine), Celexa (citalopram), Lexapro (escitalopram), Wellbutrin (bupropion), Effexor (venlafaxine), Serzone (nefazodone), and Remeron (mirtazapine).
A number of the manufacturers have already changed the labeling for their drugs, and have notified health care 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 antidepressants 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 the 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 Effexor, has notified health professionals about other labeling changes. Neonates who were exposed to Effexor late in the third trimester of pregnancy have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Practitioners treating pregnant women with Effexor in their third trimester should carefully weigh the potential risks and benefits of treatment, and may wish to consider tapering Effexor use during that time. These complications can also occur with other Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs) or Selective Serotonin Reuptake Inhibitors (SSRIs).
And finally, Bristol-Meyers Squibb has revised the product labeling for Serzone 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 prescriber should consider the risk of hepatic failure associated with Serzone treatment. In many cases, this would mean that drugs other than Serzone should be tried first.
- FDA Center for Drug Evaluation and Research: Antidepressant Use in Children, Adolescents and Adults.
- MedWatch Safety Alert - Effexor and Effexor XR (venlafaxine HCl).
- MedWatch Safety Alert - Serzone (nefazadone hydrochloride).
- MedWatch Safety Alert - Wellbutrin (buproprion HCl).
- MedWatch Safety Alert - Paxil (paroxetine HCl).
|Recall of Arjo ALENTI Patient Lifts|
Now, more news about recalls of patient lifts. In a previous program, we told you about the recall of a patient lift called the Faaborg Person Lift. In that model, the bolt securing the hanger bar to the lift arm could break, causing the patient to fall. The recall advised 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 ALENTI 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. ALENTI lift models both with and without a scale are included in this recall.
In the case of the ALENTI lift, the problem was both with the device and the way it was used. For example, casters fell off the lift while it was in use, which could have affected stability. That could have been related to maintenance of the device. But use factors played a part too, as when patients leaned or shifted their weight in the seat, or when the brake wasn't applied. Part of the problem was inadequate instructions on how to secure the patient.
Institutions with these ALENTI lifts can continue to use them, but there are several things they should be sure to do. For example, always use a safety belt to secure patients in the lift. Also, pay careful attention to safety notices and revised operating and product care instructions that Arjo recently sent to customers.
Another model Arjo lift, called the MINSTREL, was previously 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 the patient to fall. Go to our website for more information on both of these recalls.
- Medical Device Recalls - Class 1 Recall: Arjo ALENTI Lift Hygiene Chair.
- Medical Device Recalls - Class 1 Recall: Arjo MINSTREL Patient Lifts.
|Reducing the Danger of Injecting Long-Acting Penicillin IV|
In a recent article, the Institute for Safe Medication Practices described the dangers of mistakenly injecting long-acting penicillin intravascularly, and highlighted some safety improvements that should help prevent such errors.
Long-acting penicillin products, like Bicillin or penicillin G benzathine, should only be administered by deep intramuscular injection. If you accidentally inject these products intra-arterially, 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 Bicillin syringes 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 strut 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 Bicillin 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 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 Bicillin 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 Bicillin 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.
- ISMP Medication Safety Alert - May 6, 2004 (Volume 9, Issue 9): Bicillin Products: Syringe enhancements may help to prevent IV administration.
- Full Prescribing Information – Bicillin LA.
|Preventing Fatal Tubing Misconnections|
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 of tubing misconnection, this time involving a hospitalized child being treated for asthma. 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 Clearlink valve on the patient's IV set, and the child died. Baxter has issued a safety alert to directors of nursing on this type of tubing misconnection hazard.
ISMP notes that oxygen tubing generally doesn’t have a Luer connector, but they point out that it’s still possible to make a connection between the tube and a Clearlink valve if you use excessive force. Although this kind of connection might not hold for very long, it only takes seconds for an air embolism to occur and kill the patient if you connect an oxygen or air tube to an IV port.
ISMP says that staff training is vital in preventing these kinds of accidents. They suggest that whenever tubing is connected or reconnected to a patient, staff should be required to completely trace it from the patient 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.
ISMP points out that it's possible for anyone, even a trained professional, to misconnect patient lines, but that untrained people, like ancillary staff, students and transport personnel, are more likely to commit errors. And so ISMP recommends that these people not be allowed to connect and disconnect patient tubing.
ISMP notes that in the rush of patient care, sometimes a student or a transport worker or a lab technician will be asked to connect or disconnect a tube. ISMP suggests that these people be taught how to refuse if someone asks them to connect or disconnect medical tubing.
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