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U.S. Department of Health and Human Services

Show #3, April 2002

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Show #3, April 2002

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 New Medical Products

April2002FDA Patient Safety News Homepage
New Wearable Defibrillator (Video, print, and e-mail functions)
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FDA recently approved an unusual cardioverter/defibrillator that's worn like a vest instead of being implanted. This non-invasive device is called the LIFECOR Wearable Cardioverter Defibrillator 2000, and it's manufactured by Lifecore, Inc., of Pittsburgh, Pennsylvania. It's intended for patients who need a defibrillator, but can't or won't have an implanted one.

The device is made up of an electrode belt that's worn around the chest beneath the patient's clothing. It connects to a monitor with an alarm module that's worn around the waist. The entire device is worn continuously 24 hours a day, except when the patient is bathing. About once a week, the patient connects the monitor to a modem that will relay data by telephone to the physician's computer.

The device can detect ventricular tachycardia and ventricular fibrillation by sensing the heart's electrical activity on the surface of the chest, in much the same way as an electrocardiogram. If an abnormal heart rhythm is detected, the device displays a message instructing the patient to press and hold two response buttons to prevent the electrical shock from occurring. If the abnormal heart rhythm persists and the patient becomes unconscious, the patient will involuntarily release the buttons. Once the buttons are released, the device delivers an electrical shock to restore the heart rhythm to normal.

In clinical trials, the Wearable Cardioverter Defibrillator was 71% successful in the treatment of sudden cardiac arrest compared to a 25% success rate for patients who called 911. The device effectively detected and treated five incidents of sudden cardiac arrest, and detected two other incidents that were untreatable. The two failures to treat occurred because the patients incorrectly assembled the electrodes in the vest. As a result, Lifecor made some modifications to the vest in order to make it more user-friendly.

The Wearable Cardioverter Defibrillator should not be used on certain patients, including those who must have an implantable defibrillator or who already have one implanted. In addition, it shouldn't be used by patients who are exposed to high levels of electromagnetic interference such as they might get from powerful electric motors, radio transmitters, power lines, or electronic security scanners. This interference can prevent the device from detecting an abnormal heart rhythm.

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April2002FDA Patient Safety News Homepage
New Wound Dressing for Burn Patients (Video, print, and e-mail functions)
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In another recent action, FDA approved a new dressing used in burn patients. The dressing, called OrCel, is manufactured by Ortec International, Inc., of New York City. It's not used on the burn itself, but rather on the site where some of the patient's healthy skin was removed for grafting to the burn site.

In this technique, called split thickness skin grafting, healthy skin is removed from a non-burned area of the patient's body and grafted to the burn site. This leaves an open wound where the healthy skin was removed. This area can be treated with several products, including gauze dressings and biological dressings. With the advent of OrCel, physicians now have another modality to choose from.

OrCel is an absorbable cellular matrix, made of collagen, in which human skin cells have been cultured. When this dressing is applied to the open wound created where the patient's healthy skin was removed, the patient's own skin cells migrate into the dressing and take hold, along with the cultured cells, as healing commences. The dressing is gradually absorbed during the healing process.

This product is not a skin substitute. Rather, it serves as a favorable environment in which the patient's own skin can grow over the wound. It should not be used on wounds that are infected, or in patients who are allergic to bovine products, since the collagen is derived from cows. And it shouldn't be used in patients allergic to certain antibiotics, since these are used when the skin cells are processed.

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 Recalls and Safety Alerts

April2002FDA Patient Safety News Homepage
Preventing Serious Injuries from Hemostasis Devices (Video, print, and e-mail functions)
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Since 1996, FDA has received over three thousand reports of adverse events associated with the use of vascular hemostasis devices. These are also known as arteriotomy closure devices, and they're used to seal off the femoral artery puncture site in patients undergoing cardiac catheterization procedures. They provide an alternative to manual compression, which is the traditional method of closing the puncture site.

Reported complications with these devices include hematoma, retroperitoneal bleeding, pseudoaneurysm, and infection. In fact, surgical intervention was needed to repair the femoral artery in almost a third of the reports we received. And some of the reported complications have even resulted in patient deaths.

In one report, continued oozing was observed at the insertion site after a cardiac catheterization procedure, and the patient was diagnosed with retroperitoneal bleeding. A large hematoma caused urethral obstruction, which led to kidney damage and eventually the patient had to undergo hemodialysis. In another case, a patient was discharged following closure with a vascular hemostasis device, only to return days later with bleeding from the groin. This patient then required surgery to repair a ruptured pseudoaneurysm.

In 1999, FDA issued a notification to practitioners about how to minimize these kinds of complications. Because we're continuing to receive many complication reports, we want to re-emphasize those recommendations.

In general, the FDA notification stressed the importance of recognizing that there are several different types of hemostasis devices approved by FDA, so manufacturers' instructions and recommendations for individual devices will vary. It's important to carefully follow the manufacturer's warnings, precautions and instructions on how to select patients and use the particular device you've chosen.

Users should also be sure to complete the training recommended by the specific device manufacturer, since training on how to properly use these devices also varies from device to device.

In addition, the notification listed several specific recommendations.

First, do not use vascular hemostasis devices to treat patients with suspected double wall vessel punctures. Punctures of the posterior wall are not closed with these devices.

Second, when treating patients with bleeding disorders or those medicated with platelet glycoprotein iib/iiia receptor inhibitors, carefully weigh the benefits of using a vascular hemostasis device against the risk of bleeding at the puncture site.

Third, pay special attention to any post-procedure patient-management instructions or ambulation recommendations for the specific device being used.

And most importantly, carefully monitor the groin puncture site to minimize the chance of complications. Instruct patients to contact their care provider if they experience any signs or symptoms of late bleeding like hematoma or swelling.

Of course it's important to recognize that complications can also occur when manual compression is used to close the puncture site. An important question is whether these complications occur more frequently with one method of closure than with another. FDA hopes to help answer that question with some research over the next year or two.

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April2002FDA Patient Safety News Homepage
Certain Olympus Bronchoscopes Recalled (Video, print, and e-mail functions)
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If you use bronchoscopes in your facility, you should be aware that Olympus America, Inc., is recalling certain bronchoscopes because of looseness in the biopsy channel port housing. This can lead to microbial contamination of the port. You can find the model numbers for the affected bronchoscopes on our FDA Patient Safety News web site.

Olympus has asked that all bronchoscopes of the affected models be returned, whether or not the biopsy port housing is loose.

Here's the address where you can send the affected bronchoscopes:

Olympus National Service Center
Attention: Bronchoscope Modification
2400 Ringwood Avenue
San Jose, California, 95131.

If you have any questions about this recall, you can phone the company directly. Call Laura Storms-Tyler, Director of Regulatory Affairs and Quality Assurance at Olympus. Her number is 631-844-5688.

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April2002FDA Patient Safety News Homepage
Recall of Ob/Gyn and Surgical Products Manufactured by A&A Medical/Rocket USA/Lifequest (Video, print, and e-mail functions)
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Now for an alert about another recall, this one of certain medical devices manufactured by A&A Medical, Inc. of Alpharetta, GA. This company manufactures many types of Ob/Gyn 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.

The firm does business under the names A&A Medical, Rocket USA, and Lifequest. This recall includes all products manufactured under any of these names that are labeled as sterile or EtO processed. And it covers products shipped since 1999, both here in the U.S. and internationally. The recall includes, but is not limited to, devices 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 web site.

These devices may also be sold by distributors other than the manufacturer. FDA is working to identify all distributors of these products and as we receive this information, we'll post it on our web site. These distributors are being asked to contact their customers who received the affected products.

Here's how to handle this recall in your facility: First, do not use A&A Medical, Rocket USA, or Lifequest products that are labeled as sterile or EtO processed. Second, periodically consult our web site for a listing of distributors of these products. Third, if you have products from these distributors, contact the distributor for further instructions. And remember, not all of a particular distributor's products may be affected by this recall.

If you need additional information you should call the manufacturer at 1-800-424-1234 or contact FDA's Center for Devices and Radiological Health at 1-800-638-2041.

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 Preventing Medical Errors

April2002FDA Patient Safety News Homepage
Headline: Article on Preventing Asphyxiation from Aspirated Syringe Tip Caps (Video, print, and e-mail functions)
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We want to talk about an August 2001 alert from the Institute for Safe Medication Practices on choking hazards when hypodermic syringes are used to administer liquid medications by mouth. This report describes the asphyxiation of a 5-month-old child when a cap from a hypodermic syringe was ejected into his throat during oral drug administration.
Syringes are often used to deliver oral medication, particularly to infants, young children and ailing older adults. They're easy to use and come in various sizes. But there are two types: an oral syringe that's specially designed for this purpose, and the standard hypodermic syringe, used without the needle. It's the hypodermic syringes that have been involved in the accidents.

The Institute of Safe Medication Practices article warns that choking can occur if the small, translucent caps on hypodermic syringes are inadvertently left on the syringe during use. It's easy for that to happen because the cap appears to be a part of the syringe. In fact, with some hypodermic syringes, medications can actually be drawn up and administered without removing the cap. The problem is that during the administration of the drug, the pressure from the plunger can cause the cap to be ejected directly into the child's trachea. And unfortunately, that's what happened in this latest case.

The Institute of Safe Medication Practices warns that hypodermic syringes should never be used to administer oral medications. Practitioners should tell parents to use either a measuring cup or a syringe that's specially designed for administering oral medications. On these oral syringes, the caps are usually colored and shaped for easy visibility, and they don't dislodge easily when the plunger is depressed. But even with these syringes, you should warn parents to remove the cap before administering the drug.

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 Related Article

April2002FDA Patient Safety News Homepage
Complications Related to the Use of Vascular Hemostasis Devices (Video, print, and e-mail functions)
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By Beverly Albrecht-Gallauresi, RN, BS MPH
International Journal of Trauma Nursing
April-June 2000, Vol. 6, Number 2 pgs 64-65


The Food and Drug Administration (FDA) receives reports of adverse events involving medical devices that may have caused or contributed to a death or serious injury. Since 1996, the FDA has received more than 1400 serious injury and 26 death reports involving the use of vascular hemostasis devices (Table).

Hemostasis devices are used percutaneously to seal off the femoral artery puncture site that is accessed during diagnostic and interventional cardiac catheterization. Three types of hemostasis devices that are currently marketed have been approved by the FDA: (1) a collagen plug placed at the femoral artery puncture site; (2) an extravascular collagen plug in combination with a biodegradable anchor placed inside the femoral artery; and (3) devices that use surgical sutures deployed around the arterial entry site.

The FDA has received adverse event reports involving significant injury from each of these device types. A major problem reported to the FDA is bleeding from the femoral artery. Potential contributing factors for bleeding include patient selection, user training, and insertion technique.

The following 2 case studies are excerpted from reports received by the FDA.

Case Report 1
A 69 year old man underwent a diagnostic cardiac catheterization. After the procedure a hemostasis device was used at the femoral artery site to prevent bleeding. When continued oozing was observed at the insertion site, the physician assessed the patient and diagnosed retroperitoneal bleeding. A large hematoma caused urethral obstruction and subsequent kidney damage. The patient subsequently underwent hemodialysis.

Case Report 2
A 39 year old man underwent a diagnostic cardiac catheterization. During the procedure the cardiologist used multiple needle sticks to locate the femoral artery. It is believed that the backwall of the femoral artery was punctured. The patient became very restless during the procedure and additional sedation was needed to continue. After the procedure, a hemostasis device was used to control bleeding at the femoral puncture site. Continuous oozing was noted from the site, the patient remained restless, and within 15 minutes of the procedure his blood pressure dropped significantly. Medications and medical internventions did not improve the patient's condition. He continued to deteriorate, experienced cardiac arrest, and died. The patient's reported cause of death was exsanguination as a result of retroperitoneal bleeding.

The FDA convened a committee to evalute the etiology of the reported complications associated with the use of these devices. Their deliberations, in an effort to reduce the number of complications related to hemostasis devices, led the FDA to issue the following recommendations in an FDA "Dear Colleague Letter" to health care practitioners:

Manufacturers' instructions and recommendations vary for individual vascular hemostasis devices. In general, to avoid complications when using vascular hemostasis devices, we recommend that you carefully follow the device manufacturer's warnings, precautions, and instructions regarding patient selection and device use.



In addition, we offer the following specific recommendations:

*Do not use vascular hemostasis devices to treat patients with suspected double wall punctures, as punctures of the posterior wall are not closed with these devices.
*Carefully weigh the risk of bleeding at the puncture site against the benefits of using a vascular hemostasis device.
*Carefully monitor the groin puncture site to minimize the occurrence of complications with vascular hemostasis devices.
*Special attention should be paid to any post-procedure-management instructions or ambulation recommendations for the specific vascular hemostasis device used.

IMPLICATIONS FOR TRAUMA NURSING

Case reports 1 and 2 are related to iatrogenic trauma. Whenever treatment modalities, such as vascular hemostasis devices, are used, there is still a need for careful nursing observation to determine if the device is effective. Nurses should observe the patient for vital sign changes, signs and symptoms of blood loss, including the presence of a hematoma or ecchymosis, or the loss of arterial perfusion distal to the puncture site.

Table. Adverse events reported to the FDA Regarding hemostasis devices, 1996-1999

Type of Event VS Number of Reports
Death = 26
Injury = 1454
Malfunction = 353
Other = 73
Total = 1906

REPORTING ADVERSE EVENTS

The FDA is interested in additional data on adverse events involving the use of hemostasis devices or other medical and radiation-emitting devices. Health care providers employed by facilities (e.g., hospitals, nursing homes) that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facility. All other providers may submit their reports to MedWatch, FDA's voluntary reporting program. The reports can be submitted by telephone at 1-800-FDA-1088; fax: 1-800-FDA-0178; via the MedWatch Web site at http://www.fda.gov/medwatch; or by mail to MedWatch, FDA, HF-002, 5600 Fishers Lane, Rockville, MD 20852-9787.

References


1. Gallauresi BA, Collagen hemostasis devices. Nursing 1999 Jan: 29:31.
2. Feigal DW. FDA Dear colleague letter: complications related to the use of vascular hemostasis devices. Rockville (MD): US Department of Health and Human Services, 1999.

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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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