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October 13, 2016

CDC Advises Hospitals to Alert Patients at Risk from Contaminated Heater-Cooler Devices Used during Cardiac Surgery

The Centers for Disease Control and Prevention (CDC), in collaboration with National Jewish Health, has identified additional laboratory information in its ongoing investigation into heater-cooler units used during open-chest cardiac surgery.  The new laboratory findings demonstrate that the Stöckert 3T heater-cooler devices manufactured by LivaNova PLC (formerly Sorin Group Deutschland GmbH) linked to outbreaks in several states, were likely contaminated during the manufacturing process. These units represent about 60 percent of the heater-cooler devices currently in use in the United States, and may be putting patients at risk for severe infection from slow-growing bacteria known as Mycobacterium chimaera.

CDC is advising hospitals to alert clinicians and patients of this risk and advise patients to seek immediate medical care if they have had open-chest cardiac surgery and are experiencing symptoms such as night sweats, muscle aches, weight loss, fatigue, or unexplained fever.

Read more on the CDC website.

OPTN/UNOS Guidance Regarding the Zika Virus

The OPTN/UNOS Ad Hoc Disease Transmission Advisory Committee, AST, and ASTS, after careful review of information available from the Centers for Disease Control and Prevention, have issued guidance for transplant centers and OPOs in light of the recent spread of Zika virus throughout large parts of the Americas.

Zika virus may infect deceased donors prior to or during their terminal illness. Further, living donors may become infected prior to transplant. In addition, Zika virus is likely to present a concern for solid organ recipients travelling from affected regions. The risk of transmitting the disease through solid organ transplantation is unknown at this time, but based on preliminary reports, it is theoretically possible that the virus could be transmitted through blood transfusion.

The full guidance document is available here. It will be updated as more information becomes available.

CDC/FDA Health Update about the Immediate Need for Healthcare Facilities to Review Procedures for Cleaning, Disinfecting, and Sterilizing Reusable Medical Devices

On September 11, 2015, CDC issued HAN 00382 alerting healthcare providers and facilities about the public health need to properly maintain, clean, and disinfect or sterilize reusable medical devices. Recent infection control lapses due to non-compliance with recommended reprocessing procedures highlight a critical gap in patient safety. Healthcare facilities (e.g., hospitals, ambulatory surgical centers, clinics, and doctors’ offices) that utilize reusable medical devices are urged to immediately review current reprocessing practices at their facility to ensure they (1) are complying with all steps as directed by the device manufacturers, and (2) have in place appropriate policies and procedures that are consistent with current standards and guidelines.

Examples of relevant guidance include CDC’s Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 available at http://www.cdc.gov/hicpac/pdf/guidelines/Disinfection_Nov_2008.pdf; and guidance from the Association for the Advancement of Medical Instrumentation (AAMI), available at http://www.aami.org/standards/index.aspx. Health care administrators should work with their infection prevention personnel and accreditation organizations to ensure that all recommendations are properly implemented to protect patients and personnel.

Problems with medical device reprocessing should be reported to the FDA's MedWatch Adverse Event Reporting program either online at https://www.accessdata.fda.gov/scripts/medwatch/, by regular mail, or by fax. Download the form at http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm or call 1-800-332-1088 to request a reporting form, then complete and mail to address on the pre-addressed form, or submit by fax to 1-800-FDA-0178. Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements (see: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ReportingAdverseEvents/ucm2005737.htm) should follow the reporting procedures established by their facilities.

Baxter Healthcare Voluntary Recall of Irrigation Sets

UNOS was alerted through the Patient Safety portal that 17 specific lots of irrigation sets manufactured by Baxter Healthcare are subject to a voluntarily recall issued January 14, 2015. These sets are commonly used during lung recoveries but may also be used by other organ recovery teams. The reason for the recall is due to the potential for a failure of the packaging seal if shipped at high altitudes. A packaging failure may result in compromised sterility.

Baxter Healthcare recommends ceasing the distribution and/or use of these sets and removal from inventory. You may return the affected product(s) in return for credit.

Recommended Actions

  • Read the complete recall notice from Baxter Healthcare and review instructions for return of any impacted lots.
  • Do not use any product from the specific lots listed in the notice.
  • Contact Baxter Healthcare at 1-800-422-9837 or the Product Surveillance Group at 1-800-437-5176 with any questions.

You may also find this information in the Patient Safety section of Transplant Pro.  

U.S. Multi-state Measles Outbreak, December 2014–January 2015

The Centers for Disease Control and Prevention (CDC) and State Health Departments are investigating a multi-state outbreak of measles associated with travel to Disneyland Resort Theme Parks (which includes Disneyland and Disney California Adventure). The purpose of this HAN Advisory is to notify public health departments and healthcare facilities about this measles outbreak and to provide guidance to healthcare providers. Healthcare providers should ensure that all of their patients are current on MMR (measles, mumps, and rubella) vaccine. They should consider measles in the differential diagnosis of patients with fever and rash and ask patients about recent international travel or travel to domestic venues frequented by international travelers. They should also ask patients about their history of measles exposures in their community.

Recommendations for Health Care Providers

  • Ensure all patients are up to date on MMR vaccine* and other vaccines.
  • For those who travel abroad, CDC recommends that all U.S. residents older than 6 months be protected from measles and receive MMR vaccine, if needed, prior to departure.
    • Infants 6 through 11 months old should receive 1 dose of MMR vaccine before departure.†
    • Children 12 months of age or older should have documentation of 2 doses of MMR vaccine (separated by at least 28 days).
    • Teenagers and adults without evidence of measles immunity** should have documentation of 2 appropriately spaced doses of MMR vaccine.
  • Consider measles as a diagnosis in anyone with a febrile rash illness and clinically compatible symptoms (cough, coryza, and/or conjunctivitis) who has recently traveled abroad or who has had contact with someone with a febrile rash illness. Immunocompromised patients may not exhibit rash or may exhibit an atypical rash. The incubation period for measles from exposure to fever is usually about 10 days (range, 7 to 12 days) and from exposure to rash onset is usually 14 days (range, 7 to 21 days).
  • Isolate suspect measles case-patients and immediately report cases to local health departments to ensure a prompt public health response.
  • Obtain specimens for testing, including viral specimens for confirmation and genotyping.  Contact the local health department for assistance with submitting specimens for testing.

* Children 1 through 12 years of age may receive MMRV vaccine for protection against measles, mumps, rubella, and varicella.

† Infants who receive a dose of MMR vaccine before their first birthday should receive 2 more doses of MMR vaccine, the first of which should be administered when the child is 12 through 15 months of age and the second at least 28 days later.

** One of the following is considered evidence of measles immunity for international travelers: 1) birth before 1957, 2) documented administration of 2 doses of live measles virus vaccine (MMR, MMRV, or measles vaccines), 3) laboratory (serologic) proof of immunity or laboratory confirmation of disease.

For more information:

FDA warns health care professionals not to inject patients with IV solutions from Wallcur, of San Diego

The U.S. Food and Drug Administration is alerting health care professionals not to use Wallcur, LLC, simulated intravenous (IV) products in human or animal patients. These products are for training purposes only.

Before administering IV solutions to patients, health care professionals should carefully check the labels to ensure that the products are not training products, such as Practi IV Solution Bags marketed by Wallcur. Wallcur’s training products, which may bear the words “for clinical simulation,” are not to be administered to patients.

FDA is aware that some Wallcur training IV products have been distributed to health care facilities and administered to patients. There have been reports of serious adverse events associated with the use of certain products, i.e., Practi IV Solution Bags.

If you suspect that any Wallcur training IV products may have been administered to a patient, whether or not the incident has resulted in an adverse event, please report the incident to FDA’s MedWatch Adverse Event Reporting program by:

FDA will continue to investigate and monitor this issue. The agency is also working with the Centers for Disease Control and Prevention to inform health care professionals and state health departments.

To view the FDA alert: http://www.fda.gov/Drugs/DrugSafety/ucm428431.htm

Key Messages on Ebola

The Centers for Disease Control and Prevention (CDC) is working with other U.S. government agencies, the World Health Organization (WHO), and other domestic and international partners in an international response to the current Ebola outbreak in West Africa. This document summarizes key messages about the outbreak and the response. It will be updated as new information becomes available and will be distributed regularly.

Other Ebola information from the CDC can be found here.

American Hospital Association Information on Ebola

The American Hospital Association is offering information on Ebola it believes would be useful to health care providers and institutions right now. The package is available on the ACCME website at http://www.accme.org/cme-addresses-ebola.

DEA Rescheduling of Hydrocodone Combination Products

On October 6, 2014, the Drug Enforcement Administration (DEA) final rule rescheduling hydrocodone combination products (HCPs) into Controlled Substance Schedule II took effect. Please see the AMA fact sheet describing the new requirements.

The DEA rule states that prescriptions for HCPs that are issued before October 6, 2014, that have authorized refills may be dispensed in accordance with DEA rules for refilling, partial filling, transferring, and central filling Schedule III-V controlled substances until April 8, 2015.  Some pharmacies have indicated, however, that once HCPs are in Schedule II on October 6, certain pharmacy systems, state laws and other factors will not allow remaining refills to be dispensed.

Baxter Recall of Sodium Chloride Irrigation Solution

UNOS was alerted through its Patient Safety Portal that Baxter International, Inc., has issued a voluntary recall for one lot of 0.9% sodium chloride irrigation solution in a 1000 mL plastic bottle. The recall is dated April 21, 2014. The containers in this specific lot may contain particulate matter that might contribute to potential wound irritation, local infection or sepsis.  

Baxter recommends that you locate and remove from your facility any product from the lot specified in the recall. You may return the affected product(s) in return for credit.

Recommended Actions

  • Read the complete recall notice from Baxter and review instructions for return of any affected product.
  • Do not use any product from the specific lot listed in the notice.
  • Contact The Center for One Baxter at 1-800-422-9837 if you have any questions.

Hospira Recall of Irrigation/Drainage Sets

UNOS was alerted through its Patient Safety Portal that specific lots of products manufactured by Hospira Inc.are subject to a voluntary recall issued March 28, 2014. The products are commonly used for bladder irrigation and urinary drainage, but they can also be used for perfusion and/or flushing during organ recovery. The sets listed may not have been completely sealed during the manufacturing process and thus may be at risk of compromised sterility.

At least two distributors have provided these products to OPTN/UNOS member institutions. Hospira, the manufacturer, recommends that you immediately quarantine any product from the affected lots. You may return the affected product(s) in return for credit.

Recommended Actions

  • Read the complete recall notice from Hospira and review instructions for return of any affected lots.
  • Do not use any product from the specific lots listed in the notice.
  • Contact Hospira Customer Care at 1-877-946-7747.

Kidney Allocation System Educational Opportunities

In preparation for the new Kidney Allocation System (KAS), UNOS is offering professional education materials, events, and presentations. Resources include tools to educate patients, staff, and transplant providers on the new system. On-demand presentations include:

  • Introduction to the New Kidney Allocation System
  • The New Kidney Allocation System: What referring physicians need to know
  • The New Kidney Allocation System: Basic preparations

A live town hall-style question and answer session is planned for March 25, and webinars will be held in April and May. Please check http://transplantpro.org/kidney-allocation-system/ for details.

DiaSorin EBV Testing Kit has Potential to Produce False Negatives

As the OPTN contractor, UNOS was alerted through its Patient Safety Portal that specific lots of LIAISON EBV testing kits have the potential to produce false negative results. DiaSorin, the manufacturer of these kits, recommends that as a precaution, you destroy any remaining inventory. DiaSorin states that they will replace, free of charge, any kits you have to destroy.

Recommended Actions

ASTAGRAF XLTM (tacrolimus extended-release capsules), Prophylaxis of Organ Rejection in Adult Kidney Transplant Recipients, Receives Unique HCPCS Code

CMS has assigned a unique HCPCS Code, or J Code, to ASTAGRAF XL one year earlier than expected. Effective January 1, 2014, the new ASTAGRAF XL HCPCS code is J7508 (tacrolimus, extended release, oral, 0.1 mg). Please see the Medication Guide for ASTAGRAF XL and full Prescribing Information, including Boxed Warning at www.astagrafxl.com.

CDC Health Advisory: Acute Hepatitis and Liver Failure Following the Use of a Dietary Supplement Intended for Weight Loss or Muscle Building

Recently, a number of previously healthy individuals developed acute hepatitis and sudden liver failure of unknown cause after using a dietary supplement for weight loss or muscle building. CDC recommends increased vigilance by public health agencies, emergency departments, and healthcare providers for patients who develop acute hepatitis or liver failure following use of a weight loss or muscle building nutritional supplement. CDC requests that state health departments report such occurrences to the CDC. CDC also recommends that, as part of a comprehensive evaluation, clinicians evaluating patients with acute hepatitis should ask about consumption of dietary supplements. To learn more, visit http://emergency.cdc.gov/HAN/han00356.asp.

Educational Materials Available for Health Insurance Marketplace

The Health Insurance Marketplace will open October 1. About 90% of the currently uninsured will get some health insurance premium assistance in the new Marketplaces. It will be especially important for the organ transplant community to know where to direct individuals and families for the most current and accurate resources. What you can do to help:

  1. Visit Marketplace.cms.gov, where you’ll find brochures to share with colleagues and distribute to patients and at community venues; posters, application checklists, fact sheets, and more.
  2. Encourage your family, patients, students, and other community members to visit HealthCare.gov to set up an account and explore enrollment options. Assistance is available in more than 150 languages 24/7 toll-free at 1-800-318-2596.  It is important to get the word out to and enroll people age 18-35.

Open enrollment begins October 1, 2013. Coverage begins January 1, 2014.

Nationwide Voluntary Recall of All Products for Sterile Use from Compounding Pharmacy Located in Cedar Park, Texas

The U.S. Food and Drug Administration (FDA) is alerting health care providers and patients of a voluntary nationwide recall of all products produced and distributed for sterile use by Specialty Compounding, LLC, Cedar Park, Texas. There have been recent reports of bacterial bloodstream infections potentially related to the company's calcium gluconate infusions.

CDC and the FDA are working with Texas state officials to determine the scope of the contamination.

According to the FDA, information provided by the firm stated that the recalled products (i.e., all products produced and distributed for sterile use by Specialty Compounding) were distributed directly to patients nationwide, with the exception of North Carolina, which received no products. The full text of the recall is available on the FDA website at http://www.fda.gov/Safety/Recalls/ucm364643.htm?source=govdelivery. Also according to the FDA, information provided by the firm stated that recalled products were also distributed to hospitals and physician offices in Texas.

Use of PCV13 in Immunocompromised Adults

The CDC ACIP has released recommendations for the use of 13-Valent Pneumococcal Conjugate Vaccine and 23-Valent Pneumococcal Polysaccharide Vaccine in adults with immunocompromising conditions.See the recommendations in the MMWR and the indications and data for PCV13 in healthy adults aged 50 and above.

Astellas Announces FDA Approval of ASTAGRAF XLTM (tacrolimus extended-release capsules) for the Prophylaxis of Organ Rejection in Adult Kidney Transplant Recipient

Astellas Pharma US, Inc. (“Astellas”), a U.S. subsidiary of Tokyo-based Astellas Pharma Inc. (Tokyo: 4503), has announced that the U.S. Food and Drug Administration (FDA) has approved ASTAGRAF XLTM (tacrolimus extended-release capsules) for the prophylaxis of organ rejection in patients receiving a kidney transplant with mycophenolate mofetil (MMF) and corticosteroids, with or without basiliximab induction.

ASTAGRAF XL is the first once-daily oral tacrolimus formulation available in the U.S. for kidney transplant recipients. ASTAGRAF XL offers a potentially promising treatment option for appropriate kidney transplant recipients as a core component of an immunosuppressive regimen for the prophylaxis of organ rejection.

The two primary, randomized, comparative phase 3 clinical studies to support FDA approval enrolled 1,093 patients (545 on tacrolimus extended-release) in the U.S., Europe, Canada, South America, Australia and South Africa. Astellas was granted marketing approval for tacrolimus extended-release capsules under the trade name Advagraf® in Europe in 2007 and under the trade name Graceptor® in Japan in 2008. In total, tacrolimus extended-release capsules have been approved for use in 73 countries.

ASTAGRAF XL is not for use with medicines called cyclosporine (Neoral®, Sandimmune®, Gengraf®). It is not known if ASTAGRAF XL is safe and effective when used with sirolimus (Rapamune®) in people who have had kidney transplants. It is not known if ASTAGRAF XL is safe and effective in children under 16 years of age who have had kidney transplants.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For full prescribing information, please visit www.astagrafxl.com.