FDA Patient Safety News: Show #95, February 2010

Caution on Powerheart and CardioVive Automated External Defibrillators

FDA is alerting users of certain Powerheart and CardioVive automated external defibrillators that these devices may malfunction unexpectedly. This can cause a failure to deliver the electric shocks that are needed to treat sudden cardiac arrest or arrhythmias.

The manufacturer, Cardiac Science Corporation, has received multiple complaints that these devices have malfunctioned, and that their self-test features may not show that there's anything wrong. Before each use, operators are supposed to check for a green light on the front of the AED that shows the device is rescue-ready. But the light may come on even when certain electronic components inside the device have failed.

Malfunctions could cause these AEDs to interrupt ECG analysis and thus prevent shock delivery, or fail to recognize that the pads have been placed. Malfunctions could also cause interference or background noise, which could prevent the device from accurately analyzing heart rhythm and delivering a shock.

About 300,000 Cardiac Science G3 series Powerheart and CardioVive AEDs are affected by this problem worldwide. They were manufactured between August 2003 and August 2009. FDA recommends that users contact Cardiac Science Corporation immediately to arrange for repairs or replacement.

Until the company repairs or replaces the affected devices, FDA recommends that users switch to alternate AEDs if they are available, or that they consider obtaining another AED. If an alternate AED is not available, trained responders should use manual defibrillators. If a manual defibrillator is not available, responders should use the Powerheart or CardioVive AEDs, since they may still be able to deliver the necessary shock.

In the home or in public places, FDA recommends continuing to use these devices if an alternate AED is not available. That's because the consequences of not trying to defibrillate a patient outweigh the risk that the AED may fail.

FDA is gathering more data about this situation, and as we learn more, we will share any new information that might affect the use of these AEDs.

Additional Information:

FDA MedWatch Safety Alert. Cardiac Science Corp. Powerheart and CardioVive Automated External Defibrillators: Initial Communication. November 19, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm191471.htm


Caution on Powerheart and CardioVive Automated External Defibrillators

FDA is alerting users of certain Powerheart and CardioVive automated external defibrillators that these devices may malfunction unexpectedly. This can cause a failure to deliver the electric shocks that are needed to treat sudden cardiac arrest or arrhythmias.

The manufacturer, Cardiac Science Corporation, has received multiple complaints that these devices have malfunctioned, and that their self-test features may not show that there's anything wrong. Before each use, operators are supposed to check for a green light on the front of the AED that shows the device is rescue-ready. But the light may come on even when certain electronic components inside the device have failed.

Malfunctions could cause these AEDs to interrupt ECG analysis and thus prevent shock delivery, or fail to recognize that the pads have been placed. Malfunctions could also cause interference or background noise, which could prevent the device from accurately analyzing heart rhythm and delivering a shock.

About 300,000 Cardiac Science G3 series Powerheart and CardioVive AEDs are affected by this problem worldwide. They were manufactured between August 2003 and August 2009. FDA recommends that users contact Cardiac Science Corporation immediately to arrange for repairs or replacement.

Until the company repairs or replaces the affected devices, FDA recommends that users switch to alternate AEDs if they are available, or that they consider obtaining another AED. If an alternate AED is not available, trained responders should use manual defibrillators. If a manual defibrillator is not available, responders should use the Powerheart or CardioVive AEDs, since they may still be able to deliver the necessary shock.

In the home or in public places, FDA recommends continuing to use these devices if an alternate AED is not available. That's because the consequences of not trying to defibrillate a patient outweigh the risk that the AED may fail.

FDA is gathering more data about this situation, and as we learn more, we will share any new information that might affect the use of these AEDs.

Additional Information:

Cardiac Science Corporation website. Cardiac Science Notifies AED Customers of Nationwide Voluntary Medical Device Correction. November 13, 2009.
http://ir.cardiacscience.com/releasedetail.cfm?ReleaseID=424249


Cardiovascular Problems with Lexiva

GlaxoSmithKline is notifying healthcare professionals that Lexiva (fosamprenavir calcium), a protease inhibitor, has been associated with an increased risk of myocardial infarction and dyslipidemia in HIV infected adults. The company's letter recommends that patients have their cholesterol and triglycerides tested prior to starting therapy with Lexiva and at periodic intervals during treatment with the drug. The letter also recommends treating lipid disorders as required, as well as monitoring and treating other risk factors for cardiovascular disease, such as hypertension, diabetes and smoking.

Additional Information:

FDA MedWatch Safety Alert. Lexiva (fosamprenavir calcium) - Dear Healthcare Professional Letter. December 3, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192699.htm


FDA Recommendations on STERIS SYSTEM 1 Processor

Update 02/02/10: FDA is extending to 18 months the total recommended time period for transitioning from Steris Corporation’s modified System 1 processor (SS1) to legally-marketed alternative devices. See "Additional Information" link below.

FDA has alerted healthcare facilities about concerns with the STERIS SYSTEM 1 Processor (SS1). This device is used to reprocess medical devices in endoscopy and surgical suites.

Over time, STERIS has made a number of changes to the SS1 that could significantly affect the safety and effectiveness of this device. FDA has not approved or cleared these modifications, so it has not been determined whether the SS1 is safe or effective, or if the claims in its labeling are accurate, including claims that it sterilizes medical devices.

Improperly disinfected or sterilized instruments may transmit pathogens to patients and healthcare staff, or expose them to hazardous chemicals. Improper sterilization or disinfection may also have an adverse effect on the quality and functionality of the reprocessed instruments.

FDA has received reports of malfunctions of the SS1 that had the potential to cause or contribute to serious patient injuries, such as infections. There have also been reports of injuries to operators of the device, mostly burns from exposure to the sterilant solution.

Here's what FDA recommends. If a facility has an acceptable alternative to the SS1 to meet sterilization and disinfection needs, it should transition to that alternative as soon as possible to ensure continued patient safety. If an acceptable alternative to the SS1 is not available, the facility should promptly assess both its patient-care needs and sterilization and disinfection requirements, and take steps to obtain legally-marketed substitutes for the SS1.

Additional Information:

FDA Medical Device Safety website. Information about the STERIS System 1. Updated 02/02/10.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm194411.htm


Chondrolysis with Continuously Infused Local Anesthetics

FDA is notifying healthcare professionals about chondrolysis in patients receiving continuous intra-articular infusion of local anesthetics to treat post-surgical pain. FDA has received a number of reports of cartilage necrosis and destruction in these patients, nearly all of whom received the infusions in the shoulder. Many of the patients were otherwise-healthy adolescents and young adults. As a result of the cartilage damage, some of them required additional surgery, including joint replacement.

In these procedures, the local anesthetic was administered with an elastomeric pump over a period of 48 to 72 hours. At this point, it is not known which characteristics of the infusions may be causing the problem - whether it is the drug itself, the materials in the infusion device, or some combination of factors. It is important to note that single intra-articular injections have been used in orthopedic procedures for many years without reports of chondrolysis.

FDA is reminding healthcare professionals that local anesthetics are not approved for intra-articular infusions, or for use in infusion devices like elastomeric pumps. Because of the chondrolysis reports, FDA is requiring the manufacturers of local anesthetic drugs to specifically warn against this use in the products' labeling. A similar warning will be required for elastomeric pumps.

Additional Information:

FDA MedWatch Safety Alert. Local Anesthetics, Continuously Infused (marketed as bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine, ropivacaine) – Chondrolysis. November 13, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm190496.htm


Synex II Spinal Implant Recalled

In September, the device company Synthes USA recalled the Synex II Vertebral Body Replacement device, a titanium implant used to replace an unstable or damaged vertebral body in the T1 to L5 portion of the spine.

The devices were recalled after the company received six reports in which the device collapsed in patients who had their implants from six to 15 months. After a collapse, patients could experience neural injury, increased pain, spinal compression fracture, failure of additional fixation, and a need for revision surgery.

Surgeons and hospitals that have the Synex II devices should stop implanting them and contact the company for instructions on how to return them. The company also says that all patients with these implants should receive annual radiographic exams and pain assessment.

Patients who have already received these implants should be notified about the potential for the implant to collapse. They should be told that these failures could occur with or without a traumatic event, such as an accident or fall, and that if a failure occurs they may or may not experience pain or other symptoms. Patients should be advised to contact their doctor immediately if they do experience symptoms such as leg or back pain, muscle weakness, tingling or numbness.

Additional Information:

FDA MedWatch Safety Alert. Synthes USA, Ti Synex II Vertebral Body Replacement - Class I Recall. November 12, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm190330.htm


New Warnings on Norpramin

Sanofi-Aventis is notifying healthcare professionals about updated safety information for the antidepressant Norpramin (desipramine hydrochloride). The section on overdosage now notes that overdoses of this drug have resulted in a higher death rate than overdoses of other tricyclic antidepressants. Also, a new warning in the labeling now says to use extreme caution when giving this drug to patients with a family history of sudden death, cardiac dysrhythmias, and cardiac conduction disturbances. The warning also notes that in some patients, the cardiac dysrhythmias and death were preceded by seizures.

Additional Information:

FDA MedWatch Safety Alert. Norpramin (desipramine hydrochloride) - Dear Healthcare Professional Letter. December 2, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192655.htm


Preventing Cross-Contamination in Endoscope Processing

The FDA, the CDC and the Department of Veterans Affairs have issued a joint safety communication cautioning healthcare facilities about the risks to patients if endoscopes and their accessories are not processed properly between patients. The communication points out that if flexible endoscopes are not cleaned and then disinfected or sterilized adequately, patients can be exposed to body fluids and tissue contaminants from prior patients.

The three agencies are concerned about this problem because of continuing reports to FDA of processing errors. These include the use of improper accessories for endoscopy irrigation setups, improper reprocessing intervals for reusable endoscopy accessories, failure to discard single-use accessories, and failure to follow the manufacturer's instructions for endoscope processing.

The safety communication stresses that the only way facilities can assure that their patients are adequately protected against cross contamination is to set up a quality system program covering all aspects of endoscopy processing, and then to rigorously comply with it. The communication provides several general recommendations for a quality system program, plus a more detailed set of recommended policies and procedures.

Here's a summary of the general recommendations:

• Establish an institutional program with written procedures for endoscope processing, and ensure that those responsible for processing understand the importance of this job.

• Train and re-train employees to process endoscopy equipment properly, periodically assess their competence, and be sure they follow the endoscope manufacturer's processing instructions.

• Be sure staff members understand that endoscopes cannot be properly disinfected or sterilized without first cleaning them thoroughly in order to remove gross contamination and debris.

• Be sure your automatic endoscope reprocessor or sterilizer is compatible with the endoscope, and that the connecting parts of these devices fit properly.

• Finally, be sure that endoscopes or accessories that will come in contact with sterile tissue are sterilized before each use, and that endoscopes that will come in contact with intact mucous membranes -- in the respiratory and GI tracts, for example -- undergo at least high level disinfection before each use.

The safety communication also lists the responsibilities of manufacturers in helping to assure that endoscopes and their accessories are properly processed.

Additional Information:

FDA Medical Device Safety website. Preventing Cross-Contamination in Endoscope Processing - Safety Communication from FDA, CDC, and the VA. November 19, 2009.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm190273.htm


Mixups between Kapidex and Casodex

The Institute for Safe Medication Practices (ISMP) has reported medication errors due to name confusion between Kapidex (dexlansoprazole) and Casodex (bicalutamide). Kapidex is used to treat erosive esophagitis and gastroesophageal reflux disease. Casodex is used in combination therapy to treat metastatic prostate carcinoma, and is contraindicated in women. Patients who receive either drug because of a name mixup could experience unintended drug effects or adverse events.

ISMP suggests several ways to avoid these name mixups:

• First, take the time to verify written or verbal orders.

• Also, build an alert into your computer system, and consider adding this pair of drugs to your list of confusing drug names.

• Finally, ISMP recommends that prescribers include the drug's purpose when writing prescriptions.

Additional Information:

ISMP Medication Safety Alert! Kapidex-Casodex confusion. August 13, 2009.
http://www.ismp.org/newsletters/acutecare/articles/20090813-1.asp


Ear Candles: Ineffective and Risky

FDA is warning people not to use ear candles because they can cause serious injury. An ear candle is a hollow cone about 10 inches long made from a fabric tube soaked in beeswax or paraffin. They are promoted and sold in health food stores, health spas and salons, flea markets and on the Internet.

In use, the candle is placed in the outer ear and lit while the person lies on his or her side or sits upright. The burning candle supposedly creates a vacuum that draws ear wax and "toxins" out of the ear canal. Claims for these devices include relief from headaches and ear infections, improved hearing, and even "blood purification."

But studies have shown that ear candles produce no vacuum in the ear, and they don't remove ear wax. In fact, FDA has found no scientific evidence that ear candles are effective for any medical purpose, and has taken action against manufacturers of these products.

Most importantly, ear candles can be dangerous. In addition to being a fire hazard, they can cause burns to the face and ears, perforate the eardrum, and plug the ear canal with candle wax. FDA is particularly concerned that these products are being advertised for use in children, who may be especially prone to injuries and complications.

So the bottom line is simple -- don't use ear candles.

Additional Information:

FDA Medical Device Safety website. Advice for Patients: Ear Candles. February 18, 2010.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PatientAlerts/ucm200896.htm


Ear Candles: Ineffective and Risky

FDA is warning people not to use ear candles because they can cause serious injury. An ear candle is a hollow cone about 10 inches long made from a fabric tube soaked in beeswax or paraffin. They are promoted and sold in health food stores, health spas and salons, flea markets and on the Internet.

In use, the candle is placed in the outer ear and lit while the person lies on his or her side or sits upright. The burning candle supposedly creates a vacuum that draws ear wax and "toxins" out of the ear canal. Claims for these devices include relief from headaches and ear infections, improved hearing, and even "blood purification."

But studies have shown that ear candles produce no vacuum in the ear, and they don't remove ear wax. In fact, FDA has found no scientific evidence that ear candles are effective for any medical purpose, and has taken action against manufacturers of these products.

Most importantly, ear candles can be dangerous. In addition to being a fire hazard, they can cause burns to the face and ears, perforate the eardrum, and plug the ear canal with candle wax. FDA is particularly concerned that these products are being advertised for use in children, who may be especially prone to injuries and complications.

So the bottom line is simple -- don't use ear candles.

Additional Information:

FDA Consumer Update. Don't Get Burned: Stay Away from Ear Candles. February 18, 2010.
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm200277.htm



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