FDA Patient Safety News: Show #94, January 2010

Alert on Philips Avalon Fetal Monitors

Philips Healthcare is recalling the company's Avalon fetal monitors because of an increase in inaccurate readings. As a result, users may fail to identify fetal distress, fail to perform needed interventions, or perform unnecessary interventions such as cesarean delivery. All of these could result in serious injury or death to the mother and fetus.

Increased inaccuracies have included switching between the fetal and maternal heart rates, doubling or halving of the fetal heart rate, false decelerations, a mismatch between the audible and printed readings, and noisy or erratic signals.

The affected models are the FM20, FM30, FM40 and FM50. Philips is not removing them from the market at this time. While the company continues to investigate this situation, it recommends several interim steps to reduce the likelihood of inaccurate readings or their impact.

These include using the monitor's cross-channel verification feature to differentiate between the fetal and maternal heart rates, and, when in doubt, confirming the fetal heart rate with ultrasound imaging or fetal scalp electrodes.

The company also recommends that users recognize situations that can increase the likelihood of inaccurate readings. These include contractions, maternal tachycardia, fetal or maternal movement, and maternal pushing, coughing or vomiting.

Additional Information:

Philips Healthcare Field Safety Notice. Urgent Medical Device Recall - Philips Avalon Fetal Monitors FM20, FM30, FM40, FM50. November 20, 2009.
http://www.healthcare.philips.com/pwc_hc/main/shared/Assets/Documents/patient_monitoring/avalon/FSN86201075_AVALON_LETTER_FINAL.pdf.pdf


Emergency Use of Peramivir to Treat H1N1

FDA has authorized the emergency use of the investigational antiviral drug peramivir for certain adults and children hospitalized with confirmed or suspected 2009 H1N1 influenza. This includes patients who have an influenza A virus that is non-subtypeable and is suspected to be 2009 H1N1 based on cases in the community.

Peramivir, which is administered intravenously, is in the same drug class as Tamiflu and Relenza. Peramivir is authorized only under certain circumstances: when the patient is not responding to either oral or inhaled antiviral therapy, when other routes of drug administration are not expected to be dependable or feasible, or, in the case of adult patients, when the clinician judges that IV therapy is appropriate for other reasons.

Peramivir is not authorized to prevent influenza, to treat seasonal influenza, or to treat acute, uncomplicated 2009 H1N1 infection. Also, it should not be used in patients with severe allergies to Tamiflu (oseltamivir phosphate) or Relenza (zanamivir), or those who've shown resistance to Tamiflu.

Only CDC is authorized to distribute peramivir. Physicians who want to use it must apply through CDC's Peramivir IV Electronic Request System. Once the decision is made to ship the drug, it may take up to 24 hours to reach the hospital.

Because peramivir is an unapproved drug with limited safety data, health care providers or their designees are required to report certain adverse events and all medication errors associated with peramivir to FDA's MedWatch program. This must be done within 7 calendar days of the onset of the adverse event.

Additional Information:

FDA MedWatch Safety Alert. Peramivir IV. October 23, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm187814.htm


Serious Complications with Negative Pressure Wound Therapy

FDA is alerting healthcare professionals and patients about deaths and serious complications from Negative Pressure Wound Therapy (NPWT). This therapy promotes wound healing by applying negative pressure to remove fluids and infectious materials from the wound area. NPWT is used in both acute and long-term care facilities and at home.

FDA has received reports of six deaths and 77 injuries associated with NPWT systems over the past two years. Although rare, complications can occur wherever these systems are used. Most of the deaths occurred at home or in a long-term care facility. Bleeding was the most serious complication, reported in all of the six deaths and in 17 of the injury reports. Other serious effects included worsening infection of the original open wound, retention of foam dressing pieces, or foam adhering to tissues or becoming imbedded in the wound.

FDA has several recommendations to help reduce the risk of serious complications with Negative Pressure Wound Therapy. Here are some of them:

• Select patients carefully. This therapy is contraindicated in patients with exposed vasculature, nerves, organs and anastomotic sites, and also for patients with untreated osteomyelitis, non-enteric and unexplored fistulas, malignancy in the wound, and necrotic tissue with eschar present. Also, carefully consider the use of this therapy in patients with certain risk factors, including those with a high risk for bleeding and hemorrhage, and those receiving anticoagulants or platelet aggregation inhibitors.

• Assure that the patient is monitored frequently by a trained practitioner in an appropriate care setting.

• Be vigilant for potentially life-threatening complications, such as bleeding, and be prepared to take prompt action if they occur.

• Finally, if the patient is a candidate for using a Negative Pressure Wound Therapy system at home, instruct the patient and any caregivers about how to use the system and ask them to demonstrate their understanding. Make sure they know the signs and symptoms of potential complications and what to do if they occur.

Additional Information:

FDA Medical Device Safety website. Serious Complications Associated with Negative Pressure Wound Therapy Systems. November 13, 2009.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm190658.htm


Serious Complications with Negative Pressure Wound Therapy

FDA is alerting healthcare professionals and patients about deaths and serious complications from Negative Pressure Wound Therapy (NPWT). This therapy promotes wound healing by applying negative pressure to remove fluids and infectious materials from the wound area. NPWT is used in both acute and long-term care facilities and at home.

FDA has received reports of six deaths and 77 injuries associated with NPWT systems over the past two years. Although rare, complications can occur wherever these systems are used. Most of the deaths occurred at home or in a long-term care facility. Bleeding was the most serious complication, reported in all of the six deaths and in 17 of the injury reports. Other serious effects included worsening infection of the original open wound, retention of foam dressing pieces, or foam adhering to tissues or becoming imbedded in the wound.

FDA has several recommendations to help reduce the risk of serious complications with Negative Pressure Wound Therapy. Here are some of them:

• Select patients carefully. This therapy is contraindicated in patients with exposed vasculature, nerves, organs and anastomotic sites, and also for patients with untreated osteomyelitis, non-enteric and unexplored fistulas, malignancy in the wound, and necrotic tissue with eschar present. Also, carefully consider the use of this therapy in patients with certain risk factors, including those with a high risk for bleeding and hemorrhage, and those receiving anticoagulants or platelet aggregation inhibitors.

• Assure that the patient is monitored frequently by a trained practitioner in an appropriate care setting.

• Be vigilant for potentially life-threatening complications, such as bleeding, and be prepared to take prompt action if they occur.

• Finally, if the patient is a candidate for using a Negative Pressure Wound Therapy system at home, instruct the patient and any caregivers about how to use the system and ask them to demonstrate their understanding. Make sure they know the signs and symptoms of potential complications and what to do if they occur.

Additional Information:

FDA Medical Device Safety website. Advice for Patients: Serious Complications with Negative Pressure Wound Therapy Devices. November 13, 2009.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PatientAlerts/ucm190476.htm


Warning Against Nebulizing Relenza Inhalation Powder

GlaxoSmithKline is alerting healthcare professionals about the dangers of reconstituting Relenza (zanamivir) Inhalation Powder into a liquid and using it in a nebulizer or mechanical ventilator. The powder, which is used in the treatment and prophylaxis of influenza, is only intended to be inhaled using a Diskhaler.

In a recent letter, the company notes that some practitioners have dissolved Relenza Inhalation Powder in various solutions. Using a mechanical ventilator, they then delivered the drug in nebulized form to patients who could not take oral influenza medications or could not inhale the drug using a Diskhaler.

The letter describes the death of a pregnant woman with influenza who was treated with Relenza Inhalation Powder that had been solubilized and administered by mechanical ventilation. The patient's death was attributed to obstruction of the ventilator, possibly from stickiness caused by lactose in the Relenza Inhalation Powder.

The letter reminds practitioners that the safety, effectiveness and stability of Relenza Inhalation Powder have not been established for nebulization, that this use has not been approved by the FDA, and that this drug should only be administered using the Diskhaler device that comes with it.

Additional Information:

FDA MedWatch Safety Alert. Relenza (zanamivir) Inhalation Powder. October 9, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm186081.htm


Nationwide Recall of AccuSure Insulin Syringes

Qualitest Pharmaceuticals is recalling all lots of AccuSure insulin syringes because the syringe needle may detach from the syringe. If that happens, the needle could get stuck in the insulin vial, or get pushed back into the syringe, or even stay in the skin after injection.

The recalled AccuSure insulin Syringes were distributed to wholesale and retail pharmacies nationwide between January 2002 and October 2009. Anyone who has AccuSure insulin syringes should stop using them. For more information , call Qualitest at 1-800-444-4011.

Additional Information:

FDA MedWatch Safety Alert. Recall of Accusure Insulin Syringes (Qualitest Pharmaceuticals). October 27, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm188151.htm


Recall of Liquid Glucose Hexokinase Reagent

Pointe Scientific has recalled certain lots of its Liquid Glucose Hexokinase Reagent. These reagents have failed to produce accurate results at glucose values above 200 mg/dL. A list of the affected lot numbers can be found below. The company is instructing distributors and testing laboratories to destroy any of the recalled products that remain in their inventories. Laboratories should consider all test results obtained with the recalled reagents to be questionable and consult with the patient's physician about whether re-testing will be required.

Additional Information:

FDA MedWatch Safety Alert. Pointe Scientific Liquid Glucose Hexokinase Reagent. October 30, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm188562.htm


Preventing Anaphylactic-type Reactions with Dexferrum

American Regent has issued new precautionary measures for preventing anaphylactic-type reactions when administering Dexferrum (iron dextran injection).

An updated boxed warning for Dexferrum now says that a test dose should be administered before giving the first therapeutic dose. A test dose of 0.5 mL should be given gradually, over at least five minutes. Although reactions are usually seen within a few minutes, patients should be observed for at least an hour after the test dose.

The boxed warning also points out that some patients have experienced fatal reactions after receiving the test dose. Others have died after tolerating the test dose and then receiving a therapeutic dose. Because of this, patients should be observed for signs and symptoms of anaphylactic-type reactions every time Dexferrum is administered, and resuscitation equipment and trained personnel should be readily available.

The company's letter says that patients with a history of drug allergy or multiple drug allergies, and patients receiving ACE inhibitors, may have a higher risk of anaphylactic-type reactions. It also reminds clinicians that Dexferrum should only be used for patients whose iron deficiency isn't amenable to oral iron therapy.

Additional Information:

FDA MedWatch Safety Alert. Dexferrum (iron dextran injection) - Labeling Change. October 16, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm186899.htm


Energy Levels in External Biphasic Defibrillators

FDA is looking into the safety and effectiveness of biphasic defibrillators used for cardioversion and defibrillation in order to understand the conditions that affect their performance.

Over the past three years, FDA has received reports of 14 events in which a 200 joule biphasic defibrillator was ineffective in terminating an arrhythmia, whereas a subsequent shock from a 360 joule device resulted in immediate defibrillation or cardioversion. The majority of these events occurred during attempts at cardioversion of atrial fibrillation, but there was at least one instance of attempted defibrillation of a ventricular arrhythmia.

It is important to emphasize that FDA's analysis of these cases does not suggest the need for any change in current clinical practice. Clinicians and first responders should continue to use the defibrillators they already have. But to help us better understand this issue, FDA is asking healthcare professionals to report instances where it took shocks from two different devices to defibrillate or cardiovert a patient.

Additional Information:

FDA MedWatch Safety Alert. External Biphasic Defibrillators: Initial Communication. November 10, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm189839.htm


Energy Levels in External Biphasic Defibrillators

FDA is looking into the safety and effectiveness of biphasic defibrillators used for cardioversion and defibrillation in order to understand the conditions that affect their performance.

Over the past three years, FDA has received reports of 14 events in which a 200 joule biphasic defibrillator was ineffective in terminating an arrhythmia, whereas a subsequent shock from a 360 joule device resulted in immediate defibrillation or cardioversion. The majority of these events occurred during attempts at cardioversion of atrial fibrillation, but there was at least one instance of attempted defibrillation of a ventricular arrhythmia.

It is important to emphasize that FDA's analysis of these cases does not suggest the need for any change in current clinical practice. Clinicians and first responders should continue to use the defibrillators they already have. But to help us better understand this issue, FDA is asking healthcare professionals to report instances where it took shocks from two different devices to defibrillate or cardiovert a patient.

Additional Information:

Report Serious Adverse Events/Problems to FDA
http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm


Never Use Parenteral Syringes for Oral Medications

A recent report by the Institute for Safe Medication Practices says that despite past warnings, serious medical errors continue to occur when parenteral syringes are used to administer oral medications. The underlying problem is that once a parenteral syringe is filled with a liquid intended for oral use, it can be accidentally connected to an intravenous line. That's why oral syringes should always be used for oral medications because they can't readily be connected to an IV line and can't accommodate a needle.

ISMP describes several cases in which oral medications were prepared in a parenteral syringe and accidentally given intravenously. In one case, a week-old infant died after an intermittent feeding was prepared in a parenteral syringe and administered intravenously instead of through a nasogastric tube. In another case, a nurse prepared yogurt in a parenteral syringe, intending to give it through an enteral tube to treat diarrhea. The patient had both an enteral and PICC line, both of them unlabled, and the nurse accidentally administered the yogurt through the PICC line.

In still another case, Versed and Tylenol liquids were withdrawn into a parenteral syringe, to be given orally to a child being prepared for surgery. When the nurse in charge was called away, a student nurse gave the drugs intravenously. The child was unconscious for nearly an hour and required several days of antibiotics. In these cases and others, it took only a momentary mental lapse to connect a parenteral syringe containing an oral liquid to the wrong line - sometimes with fatal results.

ISMP points out that it is not enough to have the pharmacy dispense oral liquids in a unit-dose cup. In some cases, nurses have withdrawn the liquid from the cup into a parenteral syringe and then administered the dose intravenously.

ISMP stresses that all patient care and procedure units should be supplied with oral syringes, even if they are used infrequently, and nurses need to understand the importance of using them. They should carry an auxiliary label that prominently says, "for oral use only."

ISMP's alert features a ten-point strategy for promoting the use of oral syringes in healthcare facilities.

Additional Information:

ISMP Medication Safety Alert! Oral syringes: A crucial and economical risk-reduction strategy that has not been fully utilized. October 22, 2009.
http://www.ismp.org/Newsletters/acutecare/articles/20091022.asp



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