FDA Patient Safety News: Show #3, April 2002

New Wearable Defibrillator

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.

Additional Information:

LIFECOR Wearable Cardioverter Defibrillator (WCD®) 2000 System - P010030. December 18, 2001.
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm083949.htm


New Wound Dressing for Burn Patients

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.

Additional Information:

New Device Approvals: OrCel™ Bilayered Cellular Matrix - P010016. August 31, 2001.
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm085369.htm


Preventing Serious Injuries from Hemostasis Devices

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.

Additional Information:

Article: Complications Related to the Use of Vascular Hemostasis Devices (International Journal of Trauma Nursing) (see article below).
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/UCM062281


Certain Olympus Bronchoscopes Recalled

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.

Additional Information:

Olympus America Issues Voluntary Recall of Suspect Video Bronchoscopes. November 30, 2001.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm154572.htm


Recall of Ob/Gyn and Surgical Products Manufactured by A&A Medical/Rocket USA/Lifequest

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.

Additional Information:

A&A Medical, Inc., LifeQuest Medical, Inc., and Rocket USA (A&A) Recall Information.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/UCM064530


Headline: Article on Preventing Asphyxiation from Aspirated Syringe Tip Caps

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.

Additional Information:

Institute for Safe Medication Practices. Hazard Alert! Do not provide hypodermic syringes to parents for administering oral liquids to children. "ISMP Med Saf Alert";6(17):1. August 22, 2001.
http://www.ismp.org/MSAarticles/Hypodermic.html


Headline: Article on Preventing Asphyxiation from Aspirated Syringe Tip Caps

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.

Additional Information:

Institute for Safe Medication Practices. Preventing tragedies caused by syringe tip caps. "ISMP Med Saf Alert"; 4(5):1. March 10, 1999.
http://www.ismp.org/MSAarticles/Cap.html



FDA Patient Safety News is available at www.fda.gov/psn