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  • CMS Memo: ESRD Facilities - Cleaning the Patient Station

    Tuesday, June 6, 2017

    Dialysis facilities are traditionally configured with individual treatment bays, called dialysis "stations," where patients receive their in-center dialysis treatments. Dialysis stations contain a patient chair or bed and the dialysis delivery equipment. The chair and dialysis equipment are used by multiple patients during a treatment day and it is critical that these items be thoroughly cleaned and disinfected between uses.

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  • CDC Health Advisory: Prolonged IgM Antibody Resopnse in People Infected with Zika Virus

    Monday, May 8, 2017

    In July 2016, CDC issued Interim Guidance for Health Care Providers Caring for Pregnant Women with Possible Zika Virus Exposure – United States, July 2016 (https://www.cdc.gov/mmwr/volumes/65/wr/mm6529e1.htm) that includes Zika virus immunoglobulin M (IgM) testing of pregnant women. However, some flavivirus infections can result in prolonged IgM responses (>12 weeks) that make it difficult to determine the timing of infection, especially in testing of asymptomatic people.

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  • FDA Safety Communication: RECALL - Hospira Issues a Voluntary Nationwide Recall For One Lot Of 25% Dextrose Injection, USP (Infant)

    Monday, April 24, 2017

    Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of 25% Dextrose Injection, USP, (Infant) pre-filled syringe to the hospital/user level due to the presence of particulate matter, identified as human hair, found within an internal sample syringe.

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  • CDC Health Alert: CDC Recommendations for Diagnosing and Managing Shigella Strains with Possible Reduced Susceptibility to Ciprofloxacin

    Wednesday, April 19, 2017

    This Health Advisory describes the identification of emerging Shigella strains with elevated minimum inhibitory concentration values for ciprofloxacin and outlines new recommendations for clinical diagnosis, management, and reporting, as well as new recommendations for laboratories and public health officials. Current interpretive criteria provided by the Clinical and Laboratory Standards Institute (CLSI) categorize these strains as susceptible to ciprofloxacin, which is a fluoroquinolone antibiotic and a key agent in the management of Shigella infections.

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  • FDA: Recall Phillips Healthcare HeartStart MRx Monitor/Defibrillator

    Friday, March 24, 2017

    Phillips Healthcare recalls HeartStart MRx Monitor/Defibrillator due to electrical issues that may prevent the device from operating properly. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

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  • FDA Warns of Potentially Contaminated SPS-1 Static Preservation Solution Distributed by Organ Recovery Systems, Inc.

    Thursday, March 9, 2017

    The FDA wants to heighten awareness about the potential for bacterial contamination of SPS-1, and provide recommendations to health care facilities to help mitigate potential patient exposure to infectious bacteria.

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  • FDA: Physio-Control Inc. Recalls LIFEPAK 1000 Defibrillator

    Thursday, March 9, 2017

    Physio-Control is recalling the LIFEPAK 1000 due to an electrical issue which may cause the device to shut down unexpectedly during patient treatment. Physio-Control has determined that wear and oxidation formation between the battery and device electrical contacts may cause power interruptions. This may prevent the device from delivering the electrical shock needed to revive a patient in cardiac arrest. A delay in delivering this therapy could result in serious patient injury such as permanent organ damage, brain injury, or death.

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  • FDA Class 2 Recall: Fresenius 2008 Dialysis Machines due to UF Rate Errors

    Friday, January 20, 2017

    When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate displayed on the machine.

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  • RECALL: Tego Connector No. D1000, NM1000

    Wednesday, January 18, 2017

    The FDA has announced the recall of the Tego Connector No. D1000, NM1000, a Needle Free Access Device intended for use as an accessory to an HD or infusion catheter.

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  • FDA Medical Device Recall: Nurse Assist Normal Saline Flush IV Syringes

    Wednesday, January 4, 2017

    The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

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