FDA Patient Safety News: Show #102, September 2010

First Test to Detect Both HIV Antigen and Antibodies

FDA recently approved the first diagnostic test that simultaneously detects HIV antigen and antibodies. The test, called the ARCHITECT HIV Ag/Ab Combo assay, is made by Abbott Laboratories.

Most tests that are presently used in diagnostic settings only detect antibodies to HIV. The new test is more sensitive in detecting HIV infection, because it actually detects the p24 antigen of the virus. That means it can help diagnose HIV infection before antibodies appear in the blood. The test is approved for use with adults, including pregnant women, as well as children as young as two years old.

The test can be used in clinical and public health labs. It should not be used for routine screening of blood donors, except in urgent situations where licensed screening tests aren't available, or using them is impractical.

Additional Information:

FDA Press Release. FDA Approves First Diagnostic Assay to detect both HIV Antigen and Antibodies. June 21, 2010.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm216375.htm


First Test to Detect Both HIV Antigen and Antibodies

FDA recently approved the first diagnostic test that simultaneously detects HIV antigen and antibodies. The test, called the ARCHITECT HIV Ag/Ab Combo assay, is made by Abbott Laboratories.

Most tests that are presently used in diagnostic settings only detect antibodies to HIV. The new test is more sensitive in detecting HIV infection, because it actually detects the p24 antigen of the virus. That means it can help diagnose HIV infection before antibodies appear in the blood. The test is approved for use with adults, including pregnant women, as well as children as young as two years old.

The test can be used in clinical and public health labs. It should not be used for routine screening of blood donors, except in urgent situations where licensed screening tests aren't available, or using them is impractical.

Additional Information:

FDA/Center for Biologics Evaluation and Research. Abbott ARCHITECT HIV Ag/Ab Combo.
http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/BloodDonorScreening/InfectiousDisease/ucm216291.htm


FDA Requirements for Colleague Infusion Pump Recall

Here is information on the steps Baxter Healthcare has to take in order to carry out the recall of its Colleague volumetric infusion pumps. The recall was ordered by FDA earlier this year because of Baxter's long-term failure to correct serious problems with Colleague pumps.

Baxter is required to give Colleague pump owners a cash refund or a replacement pump at no charge. Also, facilities that lease Colleague pumps may terminate the lease without penalty. The company must also give a full refund for unused Colleague pump spare parts, batteries, and consumables.

The company's Transition Guide will give details on the refund or replacement program, provide a list of alternative pumps, and offer suggestions to help minimize disruption and patient risks during the transition period. The Guide will be issued no later than September 11, 2010.

Baxter's guide will also describe how to fill out a Certificate of Medical Necessity. It is important to submit this certificate by November 14, 2010 in order to receive a replacement or refund, and so that Baxter can continue to provide service and maintenance for existing units.

Baxter is required to complete the transition by July 14, 2012. After that, they must stop all service and support for Colleague products. Until then, clinicians and home-care users can continue to use their Colleague pumps, and Baxter will continue to provide service and maintenance. But FDA recommends replacing the pumps as soon as it is safely possible.

For people who continue to use Colleague pumps during the transition period, FDA recommends having a backup plan in case a pump fails. The plan should include how to get another pump and tubing quickly when caring for high-acuity patients, and how to handle high-risk infusions or infusions in vulnerable patient populations.

Additional Information:

FDA Press Release. FDA Issues Requirements for Baxter Healthcare Infusion Pump Recall. July 13, 2010.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm218889.htm


FDA Requirements for Colleague Infusion Pump Recall

Here is information on the steps Baxter Healthcare has to take in order to carry out the recall of its Colleague volumetric infusion pumps. The recall was ordered by FDA earlier this year because of Baxter's long-term failure to correct serious problems with Colleague pumps.

Baxter is required to give Colleague pump owners a cash refund or a replacement pump at no charge. Also, facilities that lease Colleague pumps may terminate the lease without penalty. The company must also give a full refund for unused Colleague pump spare parts, batteries, and consumables.

The company's Transition Guide will give details on the refund or replacement program, provide a list of alternative pumps, and offer suggestions to help minimize disruption and patient risks during the transition period. The Guide will be issued no later than September 11, 2010.

Baxter's guide will also describe how to fill out a Certificate of Medical Necessity. It is important to submit this certificate by November 14, 2010 in order to receive a replacement or refund, and so that Baxter can continue to provide service and maintenance for existing units.

Baxter is required to complete the transition by July 14, 2012. After that, they must stop all service and support for Colleague products. Until then, clinicians and home-care users can continue to use their Colleague pumps, and Baxter will continue to provide service and maintenance. But FDA recommends replacing the pumps as soon as it is safely possible.

For people who continue to use Colleague pumps during the transition period, FDA recommends having a backup plan in case a pump fails. The plan should include how to get another pump and tubing quickly when caring for high-acuity patients, and how to handle high-risk infusions or infusions in vulnerable patient populations.

Additional Information:

FDA MedWatch Safety Alert. Baxter Colleague Infusion Pumps: FDA Ordering Recall. May 4, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm210695.htm


Air/Gas Embolisms with Pressurized Spray Devices

FDA is advising operating room personnel about the importance of using gas or air-pressurized sprayers properly. These products are used to deliver hemostatic agents, including fibrin and non-fibrin sealants.

FDA has reports in which gas and air embolisms occurred during or immediately after using the sprayers to apply a hemostatic agent. The adverse events appear to be associated with not using the devices according to their labeling and instructions. In some reports, the device was used at higher than the recommended pressure, or too close to the bleeding site.

Given the life-threatening consequences of a gas or air embolism, FDA recommends that clinicians using these sprayers take certain precautions. Use the sprayer device that is recommended by the manufacturer of the hemostatic agent. Select an air or gas pressure setting that is within the range recommended by the manufacturer of the sprayer, and keep the distance between the spray head and the tissue surface above the minimum recommended by the manufacturer.

Clinicians should also monitor patients for signs of an air or gas embolism, and be sure that the regulators are maintained properly and checked regularly for safe performance.

Additional Information:

FDA MedWatch Alert. Air- or Gas-Pressurized Spray Devices: Risk of Air or Gas Embolism. July 9, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm218530.htm


Expanded Recall of Hospira Liposyn and Propofol

Hospira is expanding a recall of several of the company's injectable products because some of the containers may contain particulate matter, which consists mainly of inert stainless steel particles that are not visible. Because these particulates do not dissolve in blood, they could potentially act as emboli and impede blood flow or cause mechanical damage to the body.

This recall, which broadens the company's first action on March 31, 2010, affects a number of lots of Hospira's propofol injectable emulsion 1%. It also affects Liposyn products, including Liposyn II in 10 and 20 percent, and Liposyn III in 10, 20 and 30 percent.

Anyone who has propofol or Liposyn from the recalled lots should not use or distribute it further. Quarantine the products immediately and arrange for a return by calling 1-877-884-7835. The company is working with FDA to address the issues that led to the recall, and will distribute new product as it becomes available.

Additional Information:

FDA MedWatch Alert. Hospira Brand Liposyn and Propofol: Recall. June 10, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm215033.htm


Recall of Certain LIFEPAK Defibrillators

Physio-Control has alerted users of LIFEPAK 20 and LIFEPAK 20e defibrillators about possible failures in AC or DC power that could delay or prevent these devices from delivering therapy. If a failure occurs while the device is being used in the AC or line-power mode, the unit should automatically switch to the DC, or battery mode. But after the battery is depleted, the AC failure will prevent the battery from recharging and all power will be lost. All power could also be lost if a failure occurs in the DC, or battery mode and the user cannot plug the unit into an AC source.

The company says that it will update the power supplies on the affected devices. In the meantime, users should keep the units in service if they are functioning normally. It is important to inspect and test the devices every day according to the company's operating instructions, because that can help identify potential power failures. If possible, the units should be kept connected to an AC source with the batteries charged. For more information, contact Physio-Control Technical Support at 1-800-442-1142.

Additional Information:

FDA MedWatch Alert. LIFEPAK 20 and LIFEPAK 20e External Defibrillator/Monitors by Physio-Control Inc.: Class I Recall Due To Power Supply Failure. July 2, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm217980.htm


Recall of Certain LIFEPAK Defibrillators

Physio-Control has alerted users of LIFEPAK 20 and LIFEPAK 20e defibrillators about possible failures in AC or DC power that could delay or prevent these devices from delivering therapy. If a failure occurs while the device is being used in the AC or line-power mode, the unit should automatically switch to the DC, or battery mode. But after the battery is depleted, the AC failure will prevent the battery from recharging and all power will be lost. All power could also be lost if a failure occurs in the DC, or battery mode and the user cannot plug the unit into an AC source.

The company says that it will update the power supplies on the affected devices. In the meantime, users should keep the units in service if they are functioning normally. It is important to inspect and test the devices every day according to the company's operating instructions, because that can help identify potential power failures. If possible, the units should be kept connected to an AC source with the batteries charged. For more information, contact Physio-Control Technical Support at 1-800-442-1142.

Additional Information:

Physio Control. Urgent Medical Device Correction – LIFEPAK 20 and LIFEPAK 20e Defibrillators/Monitors. May 2010.
http://www.physio-control-notices.com/(S(fnmiysq5bi1tkcmwnfmmgy55))/ResourcePdfs/Domestic%20LP20_20e%20customer%20letter.pdf


Recall of Certain LIFEPAK Defibrillators

Physio-Control has alerted users of LIFEPAK 20 and LIFEPAK 20e defibrillators about possible failures in AC or DC power that could delay or prevent these devices from delivering therapy. If a failure occurs while the device is being used in the AC or line-power mode, the unit should automatically switch to the DC, or battery mode. But after the battery is depleted, the AC failure will prevent the battery from recharging and all power will be lost. All power could also be lost if a failure occurs in the DC, or battery mode and the user cannot plug the unit into an AC source.

The company says that it will update the power supplies on the affected devices. In the meantime, users should keep the units in service if they are functioning normally. It is important to inspect and test the devices every day according to the company's operating instructions, because that can help identify potential power failures. If possible, the units should be kept connected to an AC source with the batteries charged. For more information, contact Physio-Control Technical Support at 1-800-442-1142.

Additional Information:

Physio Control. Field Correction on LIFEPAK 20/20e Defibrillator/Monitor. May 2010.
http://www.physio-control-notices.com/ResourcePdfs/LP20%20Field%20Action%20Explanation%20-%20May%2027%202010.pdf


Mylotarg Withdrawn from U.S. Market

Pfizer is withdrawing the cancer drug Mylotarg (gemtuzumab ozogamicin) from the U.S. market because a recent clinical trial failed to show clinical benefit for the drug, and also raised safety concerns. Mylotarg was approved in 2000 under FDA's accelerated drug approval program to treat acute myeloid leukemia in patients aged 60 and older who were not considered candidates for other chemotherapy.

Accelerated approval requires the company to conduct additional clinical trials after the drug is approved to confirm its benefit. The confirmatory trial was stopped when no clinical benefit was apparent in patients who were treated with Mylotarg in combination with standard chemotherapy. These patients also experienced a higher death rate --- 5.7% in patients treated with Mylotarg plus chemotherapy versus 1.4% in patients treated with chemotherapy alone.

Because of this market withdrawal, Mylotarg will not be commercially available to new patients. Patients currently receiving the drug may complete their therapy after consulting with their healthcare professionals. Providers should tell patients about the product's potential safety risks.

Additional Information:

FDA MedWatch Alert. Mylotarg (gemtuzumab ozogamicin): Market Withdrawal. June 21, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm216458.htm


Suicide Risk with Tramadol

Ortho-McNeil-Janssen is notifying healthcare professionals about strengthened warnings for Ultram (tramadol hydrochloride) and Ultracet (tramadol hydrochloride/acetaminophen). These drugs contain tramadol, which is a synthetic opioid analgesic used to manage chronic pain.

The new warnings emphasize that certain patients have a higher risk of suicide if they are treated with tramadol. Because of this, tramadol should not be prescribed for patients who are suicidal or addiction-prone. In addition, tramadol should be prescribed with caution for patients who are taking tranquilizers or antidepressants, who use alcohol excessively, or who suffer from emotional disturbances.

The labeling changes also emphasize the additive effects and risk of overdose if tramadol is used with alcohol or other CNS depressants, including sedatives, tranquilizers, muscle relaxants, and tricyclic anti-depressants. The revised warnings also highlight the possibility that the drug could be diverted, misused and abused.

Additional Information:

FDA MedWatch Safety Alert. Ultram (tramadol hydrochloride), Ultracet (tramadol hydrochloride/acetaminophen): Label Change. May 25, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm213264.htm


Velcade and Hepatic Impairment

FDA is notifying healthcare professionals that patients with moderate to severe hepatic impairment who are beginning therapy with Velcade (bortezomib) should be started at reduced doses and closely monitored for toxicity. This recommendation does not apply to those with mild hepatic impairment. Velcade is used to treat patients with multiple myeloma and those with mantle cell lymphoma who have received at least one prior therapy.

Additional Information:

FDA MedWatch Safety Alert. Velcade (bortezomib): Starting Dose Adjustments for Patients with Hepatic Impairment. January 26, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm198424.htm


Shortage of EPINEPHrine Syringes Can Cause Errors

The American Society of Health-System Pharmacists (ASHP) and the Institute for Safe Medication Practices (ISMP) are warning that the current shortage of pre-filled EPINEPHrine emergency syringes could result in serious medication errors. Problems can occur when users attempt to replace the 1 mg/10 mL syringes by diluting a more concentrated form of the drug from an ampul or vial.

ASHP and ISMP give several recommendations to help avoid errors during the shortage:

• Reserve current supplies of EPINEPHrine emergency syringes for code boxes and situations where pharmacists will not be present to dilute solutions during a code situation.

• If using 1 mg/1 mL ampuls or vials instead of emergency syringes, package the vial, the diluent, and the syringe label in a clear plastic bag that's labeled with the drug name and strength. Include instructions on preparing a dilution that is equivalent to a prefilled 1 mg/10 mL emergency syringe.

• Do not stock multiple-dose 30 mL vials of injectable EPINEPHrine 1 mg/mL in code boxes. These vials look similar to the 30 mL vials of topical EPINEPHrine that may also be stocked in code boxes or used in the OR.

• Place auxiliary labels on EPINEPHrine emergency syringes that have an intracardiac syringe, warning against intravenous and endotracheal use. Caution practitioners about possible injury if they try to remove the fixed needle.

• Finally pharmacists should let practitioners know about the shortage and recommend appropriate substitute products.

Additional Information:

National Alert Network Message from the American Society of Health-System Pharmacists (ASHP) and the Institute for Safe Medication Practices (ISMP). EPIHEPHrine pre-filled syringe shortage. June 16, 2010.
http://www.ashp.org/DocLibrary/Policy/PatientSafety/NAN-alert-epinephrine-06-16-2010.aspx


Avoiding Patient Injuries with Dermatome Instruments

FDA has received several reports of lacerations in patients undergoing skin graft procedures using dermatome surgical instruments made by Zimmer Inc. In one case, the device cut to the bone and the donor site had to be sutured.

The patient injuries occurred with both air- and electric- powered dermatome instruments. The reports stated that the injuries resulted from improper maintenance.

Proper maintenance is important for all medical devices. According to Zimmer, dermatome instruments should be returned every 12 months for inspection, preventative maintenance, and factory calibrations.

As a reminder, FDA encourages people to report any problem with a medical device through MedWatch, the FDA's adverse event reporting program.

Additional Information:

FDA Medical Device Safety Tip. Air or Electric Dermatome Instruments. July 20, 2010.
http://wcms.fda.gov/FDAgov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm219563.htm


Avoiding Patient Injuries with Dermatome Instruments

FDA has received several reports of lacerations in patients undergoing skin graft procedures using dermatome surgical instruments made by Zimmer Inc. In one case, the device cut to the bone and the donor site had to be sutured.

The patient injuries occurred with both air- and electric- powered dermatome instruments. The reports stated that the injuries resulted from improper maintenance.

Proper maintenance is important for all medical devices. According to Zimmer, dermatome instruments should be returned every 12 months for inspection, preventative maintenance, and factory calibrations.

As a reminder, FDA encourages people to report any problem with a medical device through MedWatch, the FDA's adverse event reporting program.

Additional Information:

MedWatch – The FDA Safety Information and Adverse Event Reporting System
http://www.fda.gov/Safety/MedWatch/default.htm


Phase-Out of Epinephrine CFC Metered-Dose Inhalers

Epinephrine inhalers that use chlorofluorocarbons (CFCs) as a propellant will no longer be sold in the U.S. after December 31, 2011. CFCs released into the environment damage the ozone layer in the atmosphere.

Epinephrine inhalers, which are used to treat asthma, are sold over-the-counter as Primatene Mist or epinephrine mist. Because these products will not be available after the end of 2011, people who now use them will need to switch to a different way to treat their asthma. And because there presently are not any FDA-approved epinephrine inhalers that are made without CFCs or sold without a prescription, people will need to talk to their doctors.

There are other inhalers that contain a different asthma medication, such as albuterol, but they are only available by prescription. Albuterol inhalers use propellants called hydrofluoroalkanes (HFAs) that do not harm the environment. They are metered dose inhalers like the epinephrine inhalers, so they are used the same way, but people should understand that albuterol inhalers may taste or feel different from the epinephrine inhalers they are used to, and they may need instruction on how to use them properly.

Additional Information:

FDA Center for Drug Evaluation and Research. Phase-Out of Epinephrine CFC Metered-Dose Inhalers. April 19, 2010.
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm193304.htm



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