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U.S. Department of Health and Human Services

Show #105, December 2010

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Show #105, December 2010

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 Recalls and Safety Alerts

December2010FDA Patient Safety News Homepage
Preventing Infections When Monitoring Blood Glucose (Video, print, and e-mail functions)
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FDA and CDC are alerting healthcare professionals about the risks of transmitting hepatitis B virus (HBV) and other infectious diseases when monitoring blood glucose.

In recent years, the FDA and CDC have seen an increase in reported HBV outbreaks associated with monitoring blood glucose. That is especially the case in long-term care settings, such as nursing homes and assisted living facilities, where residents often need someone to help monitor their blood glucose levels.

But this risk exists in any setting where blood glucose monitoring equipment is shared, or where those performing the monitoring do not follow basic infection control practices. This includes acute care facilities, as well as clinics, health fairs, shelters, detention facilities, senior centers, schools, and camps.

Reusable fingerstick lancing devices should never be used for more than one person to avoid the risk of transmitting bloodborne pathogens. But the glucose meters themselves can also pose an infection risk because it is hard to ensure that blood has been completely removed from these devices. For example, a multicenter survey published in 2005 showed that 30 percent of blood glucose meters used routinely in the surveyed hospitals had detectable blood on their surfaces.

So FDA and CDC recommend that whenever possible, blood glucose meters should be used for one patient only. If that is not possible, clean and disinfect the meters after every use according to the meter's labeling to prevent carry-over of blood and infectious agents. Even when following these precautions, be sure to wash hands and change gloves between patients. It is also important to remember that these recommendations apply to other point-of-care testing devices, such as PT/INR anticoagulation meters and cholesterol testing devices.

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December2010FDA Patient Safety News Homepage
Recall of Procrit and Epogen (Video, print, and e-mail functions)
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Amgen is recalling certain lots of Procrit (epoetin alfa) and Epogen (epoetin alfa) because the vials may contain very thin flakes of glass. These glass flakes, which are barely visible, appear to come from the inner surface of the glass vials and arise over time because of the interaction of the product with the vials.

The company says there have been no reported adverse events in patients directly attributable to the glass flakes. But there is the potential for serious adverse events if patients are injected with products containing particulates.

Anyone who has Procrit or Epogen from the recalled lots should not use it or distribute it further. The company also reminds clinicians that the product labeling says to inspect Procrit and Epogen vials before using them, and not to administer the product if the liquid is discolored or contains particulates.

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December2010FDA Patient Safety News Homepage
Expanded Recall of Multi-Med Huber Needles/Sets (Video, print, and e-mail functions)
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The medical products company Multi-Med is expanding an earlier recall of the company's Huber needles. These products are being recalled because of the potential for the needles to core.

Huber needles are used to access implanted ports in patients who need repeated vascular access. The needles should be designed to penetrate a port without cutting or dislodging any silicone slivers or cores from the port. Coring could damage a port and cause leakage, possibly raising the risk of infection.
In addition, if a silicone core enters a patient's vasculature, it could lead to serious adverse events.

The expanded recall covers all Huber needles and finished products that contain the company's Huber needles, such as administration sets, which were distributed from July 12, 2005 to May 28, 2010. These products were sold under the brand names "All-Med Medical Products, Inc." and "Marquette Medical, Inc." The affected products were also provided to consignees in bulk without labeling.

Healthcare professionals and facilities that have any of the recalled products should not use them.

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December2010FDA Patient Safety News Homepage
BagEasy Resuscitation Devices Recalled (Video, print, and e-mail functions)
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WestMed, Inc., is recalling certain lots of BagEasy manual resuscitation devices, because a disconnection could occur at the retention ring of the patient port manifold. This could cause the unit not to work, delaying resuscitation while the user finds another unit or switches to a different method of resuscitation.

The recalled devices were distributed directly to medical facilities, as well as to other medical device distributors. Check the lot numbers listed on our web site against your inventory. Stop using any devices that are on the recall list, and contact WestMed customer service at 1-800-975-7987 to arrange for a return.

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December2010FDA Patient Safety News Homepage
More Patient Burns from Dental Handpieces (Video, print, and e-mail functions)
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FDA is again alerting dental professionals about the possibility of serious patient burns from electric dental handpieces that overheat. Some patients have experienced third-degree burns that required reconstructive surgery. Although FDA issued a warning about this problem in 2007, the agency continues to receive reports of patients being burned.

Burns can occur if the electric handpiece is worn or clogged. If that happens, the motor sends increased power to the handpiece head to maintain performance, which generates heat at the head or the attachment. All of this can happen very quickly. And it can happen without warning, because the patient is anesthetized and may not be able to feel the heat, and the operator is protected from the heat by the handpiece housing.

Here are some of the steps FDA recommends to prevent burns from electric handpieces:

• Maintain the handpiece according to the manufacturer's instructions. Verify how often the device should be serviced, and then stick to that schedule.

• Be sure that personnel are trained to clean and maintain the device, and that they track and record this.

• Examine the handpiece before use, and be sure a worn drill or burr is not being used.

• Do not use a handpiece that has not been properly maintained.

• And finally, report overheating to the manufacturer.

FDA is also asking the manufacturers of electric dental handpieces to help identify the root causes of overheating, determine whether their required maintenance procedures are feasible and whether users understand them, and consider steps to reduce the risk of overheating.

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 Preventing Medical Errors

December2010FDA Patient Safety News Homepage
Preventing Fires in the Operating Room (Video, print, and e-mail functions)
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An estimated 600 surgical fires occur each year in the U.S. Although most are minor, some result in serious injury, disfigurement, or even death.
The Anesthesia Patient Safety Foundation (APSF) says the vast majority of these fires are preventable. With the assistance of ECRI Institute, APSF recently produced a video about why operating room fires occur and the "best practices" to keep them from happening. The video describes the "Surgical Fire Triangle", when an ignition source, a fuel, and oxygen come together.

APSF says that the majority of OR fires occur when high oxygen concentrations are present, particularly in procedures involving the head, neck and upper chest.
An enriched oxygen environment occurs when the concentration of oxygen exceeds that of ordinary room air. APSF says that it is vital for OR personnel to consider whether supplemental oxygen is really necessary for each patient, and describes precautions to take if it is. For example, avoid using an open delivery source such as a nasal cannula.

Ignition sources, like electrosurgical pencils and lasers, form another leg of the "Surgical Fire Triangle". Fuel sources, such as drapes and alcohol-based prep solutions, complete the triangle.

To help OR team members learn how to prevent operating room fires, APSF is distributing complementary copies of the video on DVD. Request the DVD or watch it online at: apsf.org.

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December2010FDA Patient Safety News Homepage
Sterility Issues with AVM Clips (Video, print, and e-mail functions)
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Microneurosurgical clips are used to occlude small vessels during surgery for intracranial arteriovenous malformations (AVM). Some AVM clips are supplied sterile and some are not, and this can cause confusion. For example, FDA received a report about a patient who was accidentally implanted with three non-sterile AVM clips that had not been sterilized. The patient was placed on prophylactic IV antibiotics and was to be scheduled for an imaging study to rule out infection.
In this case, the surgeon chose an Aesculap AVM Micro Clip because its style and size was compatible with the very small vessel being clipped. The confusion may have arisen because the clip typically used by this facility, which is also made by Aesculap, is supplied sterile. Although AVM Micro Clips have a symbol and text and noting that they are non-sterile, the packaging for the sterile and non-sterile clips is similar.

Here are two ways to help avoid mix-ups between non-sterile and sterile clips:
• First, be aware that some devices within the same manufacturer's product line may be sold sterile, while others may not be. For example, Aesculap's Yasargil Aneurysm clips are sold sterile, whereas Aesculap AVM Micro Clips come non-sterile and must be sterilized before use.

• Second, consider placing non-sterile products in a separate location from sterile ones to help tell them apart. For non-sterile devices, be sure to follow the sterilization methods in the product labeling.

As a reminder, FDA encourages people to report any problem with a medical device through MedWatch, the FDA's adverse event reporting program.

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 FDA Consumer Corner

December2010FDA Patient Safety News Homepage
Don’t Use Infant Sleep Positioners (Video, print, and e-mail functions)
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FDA and the Consumer Product Safety Commission (CPSC) are warning people not to use sleep positioners for their babies, because there is a chance they could suffocate. In the last 13 years, at least 12 babies between the ages of one and four months have died when they suffocated in positioners, or when they became trapped between a sleep positioner and the side of their crib or bassinet.

People have been using positioners to keep their babies in certain positions when they sleep. Some positioners are flat pads with side bolsters. Others are inclined like a wedge, or have some other design. These products may be promoted to reduce acid reflux, minimize "flat head" syndrome, or even to prevent sudden infant death syndrome (SIDS). But there is no scientific evidence to support any of these claims.

Many parents and other people who care for babies know that babies should be placed on their backs to sleep. This reduces the chance of SIDS by nearly half. They may worry about how to make sure their babies stay on their backs. But once babies are able to roll over onto their tummies, it is okay to leave them there, because babies who can flip over can also turn their heads, which reduces their chance of suffocation. However, if babies flip over or scoot around while in a sleep positioner, they can have a hard time freeing their faces from the device or they can become trapped between the positioner and the side of their crib or bassinet.

So do not use infant sleep positioners. They are not necessary, and they can be dangerous. Put your baby to sleep on his or her back, and keep the crib free of pillows, comforters, quilts and toys. That way, your baby has room to safely move or turn while sleeping. Here is an easy way to remember - follow the ABCs of safe sleep - Alone on the Back in a bare Crib.

And if you have any questions, contact your child's healthcare provider.

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FDA Patient Safety News is a product of the US Federal Government, and as such is NOT copyrighted or restricted in any way. We encourage the further use and distribution of the video or text of the program by anyone – either in its entirety or as individual stories.

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