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September 30, 2016

Manufacturer News

  • DePuy Synthes initiates Class I recall of medical power tool battery packs over explosion risk
  • BD receives FDA clearance for next-gen blood collection and separation technology
  • GE Healthcare’s Biosafe announces Sefia platform to address multiple steps in cell therapy production process
  • FDA classifies two field actions related to HeartWare HVAD System as Class I recalls
  • Sanofi names Alan Main as EVP consumer healthcare
  • Hospital and IDN News

  • U.S. healthcare system ranks 50th out of 55 countries for efficiency
  • Kosair Children's Hospital renamed as Norton Children's Hospital
  • GPO News

  • Premier awards agreement to Key Surgical
  • Vizient Inc launches Ediom, a cognitive computing and data science company
  • Tips for Greater Success

  • 5 Tips for Getting That Promotion
  • News of the Weird

  • Crows knocked out power to 100,000 in 3 states
  • Bear at Polish zoo finds WWII mortar grenade
  • Stock Watch

  • Health Stocks
  • Manufacturer News
    DePuy Synthes initiates Class I recall of medical power tool battery packs over explosion risk

    Johnson & Johnson (New Brunswick, NJ) subsidiary DePuy Synthes (West Chester, PA) initiated a select recall of power tool system battery adaptors due to possible explosion risks. The FDA labeled the recall as a Class I, the most serious type of recall issued, indicating “a reasonable probability that use of these products will cause serious adverse health consequences or death.” The company said it is recalling the Adaptor and Light Adaptor for their SBD and SBD II due to a potential for the adaptors “to produce extreme internal pressure, which may cause the device to explode.” Such a failure could cause serious adverse health consequences, including death. The recall affects a total of 451 units with manufacturing dates between October 6, 2005 and April 5, 2016 and distribution dates between January 2006 and June 2016.

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    BD receives FDA clearance for next-gen blood collection and separation technology

    BD (Becton, Dickinson and Company) (Franklin Lakes, NJ) received FDA 510(k) clearance for the BD Vacutainer Barricor plasma blood collection tube (BD Barricor), the next-generation blood collection and separation technology designed to improve sample quality, help clinicians receive test results faster, and ultimately improve patient care and clinical efficiency. BD Barricor is a single-use, plastic, evacuated tube used to efficiently obtain high-quality plasma for in vitro diagnostic use. The BD Barricor tube uses a novel mechanical separation technology to obtain plasma from whole blood samples, replacing the need for gel tubes. The BD Barricor tube is the first to leverage this technology in a clinical setting. The mechanical separator technology reduces centrifugation time from 10 minutes to three minutes, compared to leading gel tubes, and reduces cellular contamination by 50 to 65 percent compared to leading plasma gel tubes, according to the company. The BD Barricor tube is now commercially available. For more information, visit barricor.bd.com/.

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    GE Healthcare’s Biosafe announces Sefia platform to address multiple steps in cell therapy production process

    GE Healthcare’s (Waukesha, WI) recently acquired Biosafe Group introduced Sefia, a state-of-the-art, multi-function platform which uses a combination of continuous-flow centrifugation, temperature control and fluidic management to enable purification, concentration, washing and final formulation during cell processing. Sefia further advances access to a single-solution manufacturing platform to enable turnkey, scalable manufacturing of cell therapies. Sefia is a functionally closed laboratory instrument designed for use in good automated manufacturing practice (GAMP)-compliant environments. Harnessing two new technologies along with smart process control, temperature regulation and eight separate fluid pathways, Sefia performs simple and complex manipulation of large volumes of cells at a fast processing speed. For more information, visit www.genewsroom.com/press-releases/ge-healthcare%E2%80%99s-biosafe-announces-sefia-platform-address-multiple-steps-cell-therapy.

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    FDA classifies two field actions related to HeartWare HVAD System as Class I recalls

    Medtronic plc (Dublin, Ireland) announced that two previously communicated global voluntary recalls related to the HeartWare International HVAD System have been classified as Class I by the FDA. In a safety notification letter distributed globally in May and June 2016, HeartWare notified physicians regarding potential damage to controllers from exposure to moisture through loose power and data connectors. In August 2016, HeartWare issued a global voluntary recall of certain models of unimplanted, sterile HVAD Pump Implant Kits (pumps) in hospital inventory. The HVAD pumps contained in these sterile implant kits may be susceptible to electrical faults and connection failures if fluid enters the driveline-to-controller connector during or after the implant procedure. Electrical faults or connection failures could interrupt circulatory support due to a pump stop, potentially resulting in serious injury or death.

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    Sanofi names Alan Main as EVP consumer healthcare

    Sanofi (Paris, France) appointed Alan Main as EVP consumer healthcare effective October 1, 2016. Main will be a member of the executive committee and lead a newly created consumer healthcare global business unit. In this role, he will be responsible for building and maintaining Sanofi’s leading position in consumer healthcare (CHC). This includes the expected integration of Boehringer Ingelheim business into Sanofi, given that the combined business will have a wider portfolio of brands to serve Sanofi’s consumers on a more global basis. Main most recently worked as global president for Bayer Medical Care.

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    Hospital and IDN News
    U.S. healthcare system ranks 50th out of 55 countries for efficiency

    According to the Bloomberg Health-Care Efficiency Index, the U.S. healthcare system is one of the least efficient in the world, ranking 50th out of 55 countries in 2014. The index, which was created in 2012, assesses life expectancy, healthcare spending per capita, and relative spending as share of gross domestic product. Hong Kong was ranked the most efficient country, with Singapore, Spain, South Korea and Japan rounding out the top five. Among these countries, average spending per capita was $2,638 and average life expectancy was about 83 years, according to Bloomberg. Russia's healthcare system was ranked the least efficient. Brazil, Azerbaijan, Columbia and Jordan were also at the bottom of the list. Among these countries, spending per capita was $2,525 on average and average life expectancy was about 73 years. The U.S. barely escaped the bottom five, with average spending per capita of $9,403, slightly more than 17 percent of GDP. Average life expectancy in the U.S. was 78.9 years.

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    Kosair Children's Hospital renamed as Norton Children's Hospital

    Kosair Children's Hospital (Louisville, KY) was renamed Norton Children's Hospital. The name change, which will take effect November 10, 2016 comes after a legal battle between Kosair Charities and Norton Healthcare (Louisville, KY). In 2014, Kosair Charities claimed funds it gave to the children's hospital were misused by Norton. In its suit, Kosair Charities alleged Norton boosted its bottom line and lined the pockets of executives using a portion of the more than $6 million Kosair Charities donated to the hospital each year. Norton filed a counterclaim accusing Kosair Charities of fraud, claiming the organization had stopped making contractually required contributions to the children's hospital but was still soliciting donations from the public to support the hospital. The parties settled their dispute earlier this year. The settlement called for the Kosair name to be removed from the children's hospital.

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    GPO News
    Premier awards agreement to Key Surgical

    Premier Inc (Charlotte, NC) awarded a group purchasing agreement to Key Surgical (Minneapolis, MN) for instrument cleaners and enzymatics, effective October 1, 2016. The new agreement allows Premier members to take advantage of special pricing and terms pre-negotiated by Premier for instrument-cleaning brushes and enzymatics. The complete line of surgical instrument-cleaning brushes from Key Surgical includes everything from brushes designed for cleaning inner channels/lumens of surgical instruments to external cleaning of box locks and hinges to brushes intended specifically for endoscope cleaning. Key Surgical brushes feature several bristle materials and handle types/styles to keep up with various/changing needs. Bristles composed of antimicrobial nylon, rigid polypropylene, brass, or stainless steel are available to help ensure proper removal of bioburden can be achieved. Key Surgical also carries brushes that can be sterilized and used in the OR to keep instruments, such as rasps and saws, free of debris during a procedure. Additionally, Key Surgical’s brush cleaning line also includes products designed for clean verification such as pipe cleaners.

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    Vizient Inc launches Ediom, a cognitive computing and data science company

    Vizient Inc (Irving, TX) announced the formation of Ediom LLC, a cognitive computing and data science company solely focused on the needs of healthcare. Vizient formed the new company with Anita Pramoda, founder of Owned Outcomes Inc and former CFO at Epic Systems. Ediom will use its proprietary cognitive computing platform to provide software and analytic solutions for big health data challenges across the provider, supplier, and payor end markets. Ediom’s capabilities will further boost the company’s ability to analyze increasingly critical work closer to the point of care and to patients.

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    Tips for Greater Success
    5 Tips for Getting That Promotion

    In this week’s Tips for Greater Success, Dan Nielsen, founder of AmericasHealthcareLeaders.com and NIHCL.com, writes, "If you are looking to move forward in your organization, then pay attention to these 'Five Ways to Fast-Track Your Promotion' by Jack & Suzy Welch, featured on LinkedIn. This article focuses on the things you have control of as an employee while acknowledging there are sometimes outside factors determining advancement opportunities. While there is nothing you can do about the outside factors, be mindful of the things you can do. They point out that while the best way to move up is to consistently “deliver great results and deliver them the right way,” there are some additional things you can do..." To read the five things and the rest of this week's Tips, visit http://dannielsen.com/2016/09/29/5-tips-for-getting-that-promotion/.

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    News of the Weird
    Crows knocked out power to 100,000 in 3 states

    A utility company says two crows triggered a power outage in mid-July that knocked out service to about 100,000 customers in three Western states. Spokesman David Eskelsen told local news that an investigation shows the crows touched a capacitor bank — a device that controls voltage — at a substation in southwest Idaho. Eskelsen says the capacitor bank caught fire, and a separate device that should have rerouted electricity malfunctioned, sending the entire substation offline. Customers in eastern Idaho, western Wyoming, and southern Montana lost power for about three hours. Rocky Mountain Power says upgrades have been made to the damaged substation.

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    Bear at Polish zoo finds WWII mortar grenade

    Taking a toy from a bear can be dangerous, especially when the toy is a mortar grenade. Malgorzata Chodyla, spokeswoman for a zoo in Poznan, in western Poland, said that a visiting Border Guard officer noticed that a female bear named Ewka was playing with something odd. On closer look, it proved to be a rusty mortar grenade from World War II. The bear was swiftly locked up following the discovery on Saturday, the public was barred from the area and army sappers took the explosive to a test range to detonate it safely.

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    Stock Watch
    Health Stocks

    Quotes last updated at 9/30/2016 10:30:29 AM EST

    Company Price Change Trends
    S&P 500 Index 2159.22 +8.09 Analyze
    NASDAQ Composite 5278.96 +9.81 Analyze
    ABBVIE INC 62.545 -0.275 Analyze
    AMERISOURCEBERGN 79.915 -1.335 Analyze
    ABBOTT LABS 41.83 +0.39 Analyze
    ALERE INC 42.625 -0.165 Analyze
    BAXTER INTL INC 47.191 +0.271 Analyze
    CR BARD INC 222.755 -0.985 Analyze
    BECTON DICKINSON 177.69 +1.25 Analyze
    BRISTOL MYERS SQ 54.11 +0.24 Analyze
    BOSTON SCIENTIFIC 23.34 +0.04 Analyze
    BOVIE MEDICAL CORP 4.75 +0.06 Analyze
    CARDINAL HEALTH 76.98 +0.08 Analyze
    CERNER CORP 61.53 +0.00 Analyze
    CLOROX 125.4029 +0.7429 Analyze
    CANTEL MEDICAL 77.60 +0.40 Analyze
    CONMED CORP 39.73 +0.22 Analyze
    CEPHEID 52.70 -0.03 Analyze
    CRYOLIFE 17.24 -0.17 Analyze
    DANAHER 77.74 +0.61 Analyze
    DIVERSICARE HEALTHCARE SERVICES 9.7595 +0.0095 Analyze
    DYNACQ HEALTHCARE 0.07 +0.00 Analyze
    EXPRESS SCRIPTS 69.30 -0.54 Analyze
    GENERAL ELECTRIC COMPANY 29.63 +0.10 Analyze
    HCA 74.88 -0.38 Analyze
    HMS HOLDINGS 21.92 -0.03 Analyze
    HOLOGIC INC 38.32 +0.18 Analyze
    HILL-ROM HOLDINGS INC 61.34 +0.38 Analyze
    HENRY SCHEIN 161.9625 +0.8125 Analyze
    HEALTHSTREAM INC 26.51 +0.20 Analyze
    INTEGRA LIFESCIENCES HOLDINGS CORP 82.56 -0.19 Analyze
    ICU MEDICAL 124.88 -0.11 Analyze
    JOHNSON & JOHNSON 118.38 +1.11 Analyze
    MASIMO CORP 58.76 +0.18 Analyze
    MCKESSON CORP 163.82 -0.60 Analyze
    MEDASSETS 31.35 +0.00 Analyze
    MEDTRONIC INC 85.78 +0.38 Analyze
    MIMEDX GROUP INC 8.43 +0.08 Analyze
    3M COMPANY 176.79 +1.42 Analyze
    MERIT MEDICAL SYSTEMS 23.83 +0.07 Analyze
    MICROSOFT 57.41 +0.01 Analyze
    MYLAN LABS 37.97 -0.50 Analyze
    OMNICELL 37.42 -0.01 Analyze
    OWENS & MINOR 34.58 +0.23 Analyze
    PHILIPS 29.38 +0.00 Analyze
    PREMIER INC 31.61 -0.11 Analyze
    QUIDEL CORP 21.40 +0.51 Analyze
    SUPERIOR UNIFORM GROUP 19.31 +0.09 Analyze
    SMITH & NEPHEW 32.66 +0.29 Analyze
    STERIS CORP 72.71 +0.08 Analyze
    STANLEY BLACK & DECKER INC 122.38 +0.65 Analyze
    STRYKER CORP 116.64 +0.94 Analyze
    TELEFLEX MEDICAL 164.42 -0.09 Analyze
    THERMO FISHER SCI 157.32 +1.26 Analyze
    ZIMMER HOLDINGS 113.56 +0.00 Analyze
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