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U.S. Department of Health and Human Services

Show #9, October 2002

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Show #9, October 2002

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 New Medical Products

October2002FDA Patient Safety News Homepage
FDA Approved Glucose Test for Children with Diabetes (Video, print, and e-mail functions)
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Let's start with our new products bulletin board, and tell you about some devices FDA recently approved for marketing. You can find information on all FDA-cleared medical products on FDA's web site.

In a previous program, we talked about a new glucose monitoring device for adult diabetics that's worn on the wrist like a watch. Now this device is also approved for adolescents, and for children age 7 and older. It's called the "Glucowatch G2 Biographer," and it's made by a California company named Cygnus.

This device is different from the usual glucose monitor because it doesn't use blood drawn through a finger-stick. Instead, a small electrical current from the device extracts a tiny amount of fluid through the skin. Then a sensor on the back of the watch measures the glucose level in this fluid every 10 minutes, for up to 13 hours. These glucose measurements are stored in the device and can be read by the patient. A built-in alarm can be programmed to go off if the patient's glucose level reaches dangerously high or low levels.

By supplementing regular finger-stick measurements, this device provides information on glucose trends that may help patients and their healthcare providers better manage their disease. But remember. This device isn't intended to replace the regular blood glucose meter. Finger-stick tests will still be needed to calibrate the device, to cross-check a patient's glucose levels, and to make treatment decisions like changing insulin doses.

Additional Information:

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October2002FDA Patient Safety News Homepage
New Use for Genetically Engineered Protein in Spine Surgery (Video, print, and e-mail functions)
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In a recent Talk Paper, FDA announced the approval of a device that treats degenerative disc disease by helping to fuse vertebrae in the lower spine. What's different about this device is that it uses a genetically engineered protein to help build bone tissue during the fusion process. Conventional devices generally use a bone autograft taken from the patient's own hip.

This device is made by Medtronic Sofamor Danek of Memphis, Tennessee, and it's made up of several components. One component, called the LT-Cage, maintains the spacing between the vertebrae and temporarily stabilizes the diseased area of the spine. The other component called the InFUSE bone graft, contains the genetically engineered protein that will eventually form bone and grow into the vertebral space, permanently fusing that area of the spine. It also contains a scaffold made of bovine collagen for the protein to grow on.

The decision to approve this device was based on a clinical study that showed that the device is as safe and effective as the same fusion cage component filled with autograft bone. Both methods produced successful fusion in approximately 90 percent of patients at 24 months. The manufacturer will continue to investigate the product to check for possible long-term side-effects, including those on the immune system.

The study was performed at multiple sites and consisted of a randomized arm which included 143 patients who were given the InFUSE Bone Graft/LT-CAGE device and 136 patients who were given the same cage and the standard bone graft.

This device should not be used on patients who have an allergy to titanium, titanium alloy, or bovine Type I collagen; patients who have had a tumor removed from the area of the implantation site; and patients who are still growing. And, since the effects of the genetically engineered human protein on a developing fetus are not well understood, the device should not be used on patients who are or may be pregnant.

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 Recalls and Safety Alerts

October2002FDA Patient Safety News Homepage
Certain Gonorrhea Test Kits Recalled by Abbott Laboratories (Video, print, and e-mail functions)
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Here's news about a product recall. Abbott Laboratories has initiated a worldwide recall of some of its laboratory kits used to diagnose gonorrhea. The kits are unreliable because they may give false negative results. The recall includes 32 lots of gonorrhea test kits that were distributed to hospitals and laboratories in the first six months of 2002 - from January 11 to June 24. About 750,000 tests are affected.

Abbott has notified clinical labs to stop using the affected test kits and to destroy any remaining product. These labs were also advised to contact the health care providers they serve and have them determine if their patients need to be retested. A retest should be offered to patients whose test results were negative and who were not already treated. Repeat testing should be performed on fresh specimens, and not on retained specimens. Abbott Labs will reimburse expenses associated with repeat testing.

Physicians with questions can reach Abbott Labs at 1-866-233-0471. Consumers or laboratories with questions can contact the company at 1-800-527-1869.

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October2002FDA Patient Safety News Homepage
Update on CryoLife tissue recall (Video, print, and e-mail functions)
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In our last broadcast, we told you about a recall of certain human allograft tissues processed by CryoLife, Incorporated. FDA ordered this recall because CryoLife had not validated procedures to prevent infectious disease contamination during processing.

Therefore, it could not ensure that its processed human tissue was free from fungal and bacterial contamination.

You'll find the newest information on the specific products affected by this recall and on product availability by going to our web site.

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 Preventing Medical Errors

October2002FDA Patient Safety News Homepage
Burns from Misuse of Forced-Air Warming Devices (Video, print, and e-mail functions)
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Forced-air warming systems are often used to maintain normal body temperatures in patients before, during and after surgery. They're an effective way to keep patients warm and prevent complications from hypothermia. These systems deliver heated air through a hose to an inflatable blanket that covers the patient. With the blanket attached, the heated air is evenly distributed across the patient's body.

But serious burns can occur when the hose isn't attached to the blanket. Without the blanket, the heated air can be extremely hot and concentrated at the hose nozzle, and blow directly onto the patient's skin. Burns can also occur if the patient's skin comes in direct contact with the hose surface.

This practice, where forced-air warming is applied without a blanket, is called "hosing" or "free hosing". Hosing has caused first, second and even third degree burns. The most serious report we've received to date describes a burn that resulted in muscle necrosis so severe that that the patient's leg had to be amputated above the knee.

This kind of injury can occur with any forced-air warming system that's supposed to be used with a blanket - but isn't. There are plenty of warnings about the risks of hosing - in manuals, in printed instructions, and on device labels. ECRI has published a Hazard Report specifically warning about this problem. Yet, despite all these warnings, hosing still occurs.

One manufacturer, Augustine Medical, has begun a campaign to help spread the word about the dangers of hosing. The company has developed a web site called "stophosing.com" where you can get more information on hosing and request educational materials like pamphlets, posters and warning labels for hoses. The web site also gives tips to help prevent hosing, such as storing blankets in a location that's close to where they're going to be used.

But the primary message is clear and simple: always use a blanket with forced-air warming.

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 Recalls and Safety Alerts

October2002FDA Patient Safety News Homepage
Electromagnetic Interference with Medical Devices (Video, print, and e-mail functions)
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These days, most health professionals have heard about the problem of electromagnetic interference, or EMI. That is, the hazard that's created when electronic devices like cell phones interfere with certain electrically powered medical devices, like infusion pumps. Most hospitals already have signs warning patients and staff about using electronic devices in certain areas. Yet interference continues to occur and, although it's rare, patients can be injured.

One interference incident is described in an FDA article entitled "Don't Answer That Cell Phone!" It appeared in the June edition of the journal Nursing 2002. It explains how a patient in the ICU was receiving epinephrine through an infusion pump when a visitor received a call on her cell phone. When the call was answered, the pump increased the rate of the drip. This gave the patient an unintended bolus of medication that led to epinephrine toxicity.

But cell phones aren't the only source of electromagnetic energy that can cause interference, and infusion pumps aren't the only medical devices that can be affected. For example, interference has been reported with powered wheel chairs, monitoring equipment, hemodialysis devices and cardiac devices.

The article in Nursing 2002 summarizes the precautions you can take to avoid EMI related problems. First, educate yourself about the potential for electromagnetic interference with medical devices, and learn how to recognize problems when they occur.

Urge your facility to use standard procedures to prevent EMI, particularly in areas where critical care devices are used.
Be sure to supervise the use of radio transmitters near electrically powered medical devices.
Place signs prohibiting cell phone use in areas where there are many critical devices in use.
And when you do see an incident of EMI, be sure to report it.

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 Advice for Patients

October2002FDA Patient Safety News Homepage
New Liposuction Website (Video, print, and e-mail functions)
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Now for the part of the program called "Patients are Asking," that helps you answer questions about medical products and procedures that are on people's minds. Today we want to let you know about a new FDA website for consumers on liposuction.

This website gives an overview of what patients can expect before, during and after the surgery, as well as information they should have before making a final decision to have the procedure.

The site explains what liposuction is, what type of doctor performs the procedure, ideas on how to choose the right doctor, the risks involved in the procedure, and FDA's role in regulating liposuction devices. There's also a Liposuction Surgery Checklist, intended to help a person determine if they're a good candidate for the procedure. The web site encourages patients to educate themselves by knowing the potential risks involved, and to ask their doctor questions if something isn't clear.

The liposuction website also links to other sources of information. For example, patients can link to professional organizations, such as the American Academy of Dermatology, the American Society of Plastic Surgeons, and the American Society for Aesthetic Plastic Surgery. Another link is to an article in the magazine FDA Consumer, in which the American Society for Aesthetic Plastic Surgery offers some additional guidelines for people considering liposuction.

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 Recalls and Safety Alerts

October2002FDA Patient Safety News Homepage
Updated CDC Guidelines on Prevention of Catheter-Related Infections (Video, print, and e-mail functions)
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Now for the part of the broadcast where we let you know about recent publications on patient safety or medical error. This time we want to tell you about recently updated guidelines on how to prevent infections when using intravascular catheters. The guidelines were published on August 9, 2002 by the Centers for Disease Control and Prevention, as part of CDC's MMWR Recommendations and Reports. If you insert intravascular catheters or if you're responsible for surveillance or infection control, you’ll probably find this comprehensive report useful.

The guidelines point out that intravascular catheters are indispensable in modern-day medical practice, particularly in ICUs. Although these catheters provide necessary vascular access, their use does put patients at risk for local and systemic infections, including local site infections, bloodstream infections, septic thrombophlebitis, endocarditis, and other metastatic infections, such as lung or brain abscess, osteomyelitis, and endophthalmitis.

These guidelines provide background information and specific recommendations on reducing the incidence of bloodstream infections from intravascular catheters. Here are some of those recommendations.

* Train health-care providers who insert and maintain catheters.
* Use maximal sterile barrier precautions during central venous catheter insertion.
* Use a 2% chlorhexidine preparation for skin antisepsis.
* Avoid routine replacement of CVCs in order to prevent infection.
* And, if the infection rate is still high despite these strategies, use short term catheters that are impregnated with antiseptics or antibiotics.

These guidelines also identify performance indicators that can be used by health-care institutions to monitor success in implementing these recommendations.

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 Related Article

October2002FDA Patient Safety News Homepage
Nursing 2002 (June issue) article: Don't answer that cell phone! (Video, print, and e-mail functions)
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BY JULIA MARDERS, RN, MS, AND DONALD WITTERS, MS

A PATIENT IN THE ICU was receiving epinephrine via infusion pump when a visitor received a call on his cell phone. When he answered, the pump increased the rate of the drip. The patient received an unintended bolus of medication and subsequently developed epinephrine toxicity.

What went wrong?

Under certain conditions, cell phone radio transmissions can cause electromagnetic interference (EMI) and disrupt the function of electrically powered medical devices -- in this case, the infusion pump. Although EMI-related patient injuries are relatively rare, sources of electromagnetic energy such as radio signals, AC power line disruptions, and electrostatic discharge can disrupt medical device performance.

Although many medical devices are tested for EMI and meet applicable performance standards, some may still be susceptible to potentially serious problems in certain situations.

What precautions can you take?

* Educate yourself and your colleagues about the potential for EMI with medical devices and learn how to recognize and report problems.

* Develop and follow policies and procedures to ensure electromagnetic compatibility, especially in areas where critical care devices are used. For more information, refer to the Food and Drug Administration’s Web site at http://www.fda.gov/cdrh/emc/index.html.

* Manage the use of radio transmitters near electrically powered medical devices. Post signs prohibiting cell phone use where necessary. Make sure all patients, visitors, and staff members understand and adhere to these policies.

* If a death, injury, or device malfunction occurs because of actual or suspected EMI, notify the person responsible for reporting such problems or submit an adverse event report to MedWatch (at the numbers below or report on-line at http://www.fda.gov/medwatch).

Although you need to support the adverse event–reporting policy of your health care facility, you may voluntarily report a medical device that doesn’t perform as intended by calling MedWatch at 1-800-FDA-1088 (fax: 1-800-FDA-0178). The opinions and statements in this report are those of the authors and may not reflect the views of the Department of Health and Human Services. Beverly Albrecht Gallauresi, RN, BS, MPH, coordinates Device Safety.

Julia Marders is a nurse-consultant and Donald Witters is chairman of the electromagnetic compatibility group center for Devices and Radiological Health, Food and Drug Administration in Rockville, Md.

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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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