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  • FDA Med Watch: Clindamycin Injection ADD - Vantage Vials by Alvogen - Recall: Lack of Sterility Assurance

    Monday, June 19, 2017

    Alvogen is voluntarily recalling seven lots of Clindamycin Injection USP ADD-Vantage Vials to the hospital/retail level due to microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the product. Clindamycin Injection is manufactured for Alvogen by Hospira Inc., a Pfizer Company.

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  • CMS Memo: REVISED ESRD Facilities - Filling Saline Syringes at the Patient Treatment Station

    Tuesday, June 6, 2017

    The 2008 ESRD Conditions for Coverage at 42 CFR 494.30(b)(2) state that the facility must "ensure that the clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications…"

    Dialysis procedures for initiation and discontinuation of hemodialysis treatments require the use of sterile normal saline in syringes to aid in the care of a patient’s vascular access. During survey observations, ESRD facilities have been noted to fill syringes with saline for vascular access care or to flush medications by drawing saline from the single dose saline bag or the IV tubing connected to the patient at the dialysis station.

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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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  • New CDC Report: Spread of Resistant Fungus, C. auris

    Thursday, May 25, 2017

    CDC has just released an MMWR update on Candida auris (C. auris) cases identified in U.S. health care facilities through May 2017. In June 2016, CDC released the first clinical alert about C. auris. Soon after, CDC began reporting on the first U.S. cases. Although C. auris is still rare in the United States, we are seeing an increasing number of cases. The MMWR provides information on the 77 C. auris cases reported to CDC through May 12, 2017.

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  • 2017 Large Scale Cyber Attack: Update

    Wednesday, May 17, 2017

    CMS EPRO, along with CMS cyber security personnel, continues to support the HHS Emergency Management Group and the collective response to the 2017 Large-Scale Cyber Attack, we wanted to provide you an update as of 8:45 AM EDT, Monday May 15, 2017.

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  • FDA MedWatch: Canagliflozin (Invokana, Invokamet): Drug Safety Communication - Increased Risk of Leg and Foot Amputations

    Tuesday, May 16, 2017

    Based on new data from two large clinical trials, the FDA has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations. FDA is requiring new warnings, including the most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe this risk.

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  • CDC Health Alert: Prolonged IgM Antibody Response 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: 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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