atrium/Maquet/Getinge group consent decree??

Discussion in 'Atrium Medical' started by Anonymous, Sep 7, 2014 at 8:25 PM.

Tags: Add Tags
  1. Anonymous

    Anonymous Guest

    so I have a friend who works at atrium medical and the executive VP of regulatory a tool named Ken Collins is going around telling everybody that they are going into a consent decree with FDA, he has stated that several product lines will be shut down. lots of internal chatter about the mesh product and the synthetic arteries? apparently this guy talks a lot about matters that he should not be talking about to his subordinates. from what I hear the company is a total shit show since it has been sold to getinge/maquet,
     

  2. Anonymous

    Anonymous Guest

    funny, I worked with this guy back in the late 90s at Boston sci, he is a fucking nut case! hard to believe he is still in the industry? surprised he has not been run out of med device like he was run out of practicing medicine.
     
  3. Anonymous

    Anonymous Guest

    Ken, is a true professional who has been in this industry for many years because he has a high level of integrity. Maquet is an excellent company who will turn the Atrium franchise into long term market leaders. We need more people like Ken to keep this business on the up and up!
     
  4. Anonymous

    Anonymous Guest

    I wonder why it's taken this long in particular with the iCast stent, it's been used off label for years and years and always wondered when it would attract the FDA's attention. It was only a matter of time...
     
  5. Anonymous

    Anonymous Guest

    Ken, will take the high road as always and make the right choice for the patients in need! Maquet Rocks
     
  6. Anonymous

    Anonymous Guest

    I was at a Maquet site within the last 18 months. It is the most out of control company I have ever witnessed first hand. And, as a contractor/consultant, all I work with is out of control companies (15+ years of consulting). It is unbelievable that the Agency hasn't shut them down yet. The lack of quality systems, understanding of industry, and frankly outright fraud is truly disgusting. If this guy you are talking about comes from Boston Sci (I worked with them circa 2007) all I can say is he should be barred from industry. I often feel like the Agency oversteps their bounds. In the case of Gettinge Maquet I am disappointed they have not taken swifter action. From what I saw this company is a danger to the public.
     
  7. Anonymous

    Anonymous Guest

    CONSENT DECREE FACT SHEET
    Atrium Medical Corporation and three other affiliated Maquet companies have reached an agreement concerning a Consent Decree (Decree) with the U.S. Food and Drug Administration (FDA). This voluntary agreement has been approved by a federal judge in New Hampshire and establishes a framework that provides assurances to FDA that the company will complete the improvements currently underway to strengthen its quality management system.

    The Decree provides a clear path forward for the company to complete the enhancement of its quality management system and to continue to provide products of the highest medical quality.

    There has been no indication that any of the products are unsafe. The consent decree does not require Atrium or Maquet to remove, recall or perform corrective actions on any products currently in the market or at any of our distribution facilities.

    With regard to certain products, manufacturing operations at Atrium’s facilities in Hudson, New Hampshire will be temporarily suspended while corrections are being made. These products will become temporarily unavailable, once existing inventory located at our distribution facilities has been exhausted.


    Temporarily unavailable products include: vascular grafts and surgical meshes manufactured at Atrium’s facilities in Hudson, NH. These restrictions do not apply to vascular grafts that are manufactured at other facilities and sold under the brand names of Hemashield, Intergard, Fusion and Exxcel Soft.
    In addition, Atrium has long planned to move manufacturing operations now in Hudson, NH, to a new facility in Merrimack, NH. Once production is transferred to Merrimack, these products will be available to customers inside and outside of the U.S. We expect manufacturing in Merrimack to begin in 2015.
    Certain products currently manufactured at Atrium’s Hudson facilities have been deemed medically necessary under the Decree and will continue to be made available to customers inside and outside of the U.S., provided that an authorized representative of the customer signs a Certificate of Medical Necessity form.


    Products available under a Certificate of Medical Necessity include: chest drains, local therapeutic infusion catheters, and covered stents.
    Operations at three Maquet locations that also fall under the decree – Wayne, New Jersey and Rastatt and Hechingen, Germany – will be subject to additional inspections, but will continue to produce and distribute products globally.
    All other Maquet locations and companies inside and outside of the U.S. are not part of this Decree.


    About Atrium and Maquet
    Atrium, part of Maquet, specializes in manufacturing medical devices for the treatment of coronary and vascular disease, tracheal bronchial management, chest trauma, hernia and soft tissue injury.

    Maquet offers innovative therapy solutions and infrastructure capabilities for high-acuity areas within the hospital — including the operating room (OR), hybrid OR/cath lab, and intensive care unit (ICU) — as well as intra- and inter-hospital patient transport. Additionally, Maquet develops intelligent and sustainable room concepts that exceed the expectations of modern hospitals, working in close cooperation with customers, production engineers and architects to integrate high quality products and services.

    Headquartered in Rastatt, Germany, Maquet is the largest subsidiary of the publicly listed GETINGE Group AB of Sweden. Maquet has 6,550 employees and provides 40 international sales and service organizations, as well as a network of more than 300 sales partners.

    For more information about Maquet, please visit www.maquet.com.



    About Getinge Group
    Getinge Group is a leading global provider of products and systems that contribute to quality enhancement and cost efficiency within healthcare and life sciences. We operate under the three brands of ArjoHuntleigh, Getinge and Maquet. ArjoHuntleigh focuses on patient mobility and wound management solutions. Getinge provides solutions for infection control within healthcare and contamination prevention within life sciences. Maquet specializes in solutions, therapies and products for surgical interventions, interventional cardiology and intensive care.

    For more information about Getinge Group, please visit www.getingegroup.com.

    PRODUCT STATUS
    With regard to some products, manufacturing operations at Atrium’s facilities in Hudson, New Hampshire will be temporarily suspended while corrections are being made. These products will become temporarily unavailable, once existing inventory located at our distribution facilities has been exhausted.

    For more details, please see the list of Restricted Products below

    Certain products currently manufactured at Atrium’s Hudson facilities have been deemed medically necessary under the Decree and will continue to be made available to customers inside and outside of the U.S., provided that an authorized representative of the customer signs a Certificate of Medical Necessity form.

    For more details, please see the list of Restricted Products Available with Certificate of Medical Necessity below

    Operations at three Maquet locations that also fall under the decree – Wayne, New Jersey and Rastatt and Hechingen, Germany – will be subject to additional inspections, but will continue to produce and distribute products globally.

    All other Maquet locations and companies inside and outside of the U.S. are not part of this Decree.



    Restricted Products

    Under the terms of the Decree, the following products manufactured at Atrium’s Hudson, New Hampshire facilities will be unavailable until further notice, except to the extent that these products are in current inventory at our distribution facility.

    We regret the inconvenience caused by the temporary unavailability of these products. We are committed to helping you serve your patients, and our sales representatives will work with you to identify other products that can provide the same or a similar service until the products below are available again.



    Restricted products include:

    Product Area Product Name
    BioSurgery Prolite
    Prolite Self-Forming Plug
    Prolite Ultra
    Prolite Ultra Self-Forming Plug
    ProLoop
    C-QUR
    C-CUR V-Patch
    C-QUR Tacshield
    C-QUR FX
    C-QUR CentriFX
    C-CUR Mosaic
    C-QUR Film
    Vascular Grafts FLIXENE
    FLIXENE with IFG
    Advanta VXT
    Advanta VS
    Advanta SuperSoft
    Advanta SST
    Advanta SST Large Diameter
    Vascular Graft Accessories Tunneler
    Vein Graft Tunnleing System
    Vascular Patch Ivena Vascular Patch


    Restricted Products Available with Certificate of Medical Necessity

    Certain products manufactured at Atrium’s Hudson facilities have been deemed medically necessary under the Decree and will continue to be made available to customers inside and outside of the U.S, provided that the authorized representatives of U.S. and International customers have signed the attached CMN form certifying that, after learning from this Notification Guide of the FDA findings at the Atrium Hudson manufacturing facility, and evaluating the relevant risks and benefits, there is an immediate medical need for the continued use and purchase of these products.



    Restricted products available with a Certificate of Medical Necessity include:

    Product Area Product Name Accessories
    Oasis Dry Suction Water Seal Drains, including accessories Oasis Chest Drains Pneumostat
    PVC Catheters
    PVC Firm Catheters
    Silicone Catheters
    ATS Blood Bags
    Pleuraguide Kit
    Ocean Wet Suction Water Seal Drains, including accessories Ocean Chest Drains
    Express Dry Suction dry Seal Drains, including accessories Express Chest Drains
    Express Mini-500 Chest Drains
    Local Therapeutic Infusion Catheters
    ClearWay RX Catheter
    ClearWay OTW Catheter
    Covered Stents iCAST Covered Stent (US)
    Advanta V12 Covered Stent (OUS)
     
  8. Anonymous

    Anonymous Guest

    Wow! I'm sure the spin is on and every single Rep is out making damn sure those drains and stents get sold. The device industry is not a healthy place to be anymore, very sad.
     
  9. Anonymous

    Anonymous Guest

    Agree, between calls to recruiters to try and get out before they can be associated with this Maquet/Getinge mess.
     
  10. Anonymous

    Anonymous Guest

    This will trigger the battle cry for IDN stent consignment there's no way Atrium flys under the radar any longer with this current fiasco. Hospitals will not be willing to purchase large quantities of stents only to be told by the FDA that issues are present, too risky. The glory days for Atrium are long gone.
     
  11. Anonymous

    Anonymous Guest

    So what's the latest news these days? Just a former Atrium employee here following as a interested spectator.
     
  12. Anonymous

    Anonymous Guest

    Atrium is doing just fine and will come out of the decree a better company with even bigger market share. It is always better to research and learn facts rather than speculate the state of a company like Atrium.
    For those of you who have something negative to say about Ken, you are true Cowards to be anonymously posting completely asinine and unnecessary comments about a former colleague.

    Dr. Collins (Ken) definitely has an unorthodox and very unique approach to dealing with colleagues and subordinates which will drive the weak ones away. However, when it comes to caring about patient health (MUM), he is one of the best in the business and that company and its employees are lucky to have his services.
     
  13. Anonymous

    Anonymous Guest

    Time will tell, I can say with complete honestly MANY are looking aggressively to leave. As with any Corp adverse events will impact the bottom line and bottom line impacts incomes. This also gives competition a chance to impact business. Ask the Cortis folks in about one year if Cardinal has impacted there pay checks, I'm sure it's business as usual there as well TODAY. We aren't dumbasses people, please.
     
  14. Anonymous

    Anonymous Guest

    MAQUET is a garbage company. Pretty soon Trevor Carlton will be out and Frank Kozar the fool who got the Warning letter in Wayne NJ will replace him. Atrium will slowly be dismantled and destroyed. The Kozar will destroy MAQUET Atrium just like he destroys everything else. Heinz Jacqui is out of his league! AGAIN this company is run by idiots.
     
  15. Anonymous

    Anonymous Guest

    New Boss = Bright future!
     
  16. Anonymous

    Anonymous Guest

    Beware what you wish for, the "new" Mgmt model in the device industry is anything but "bright". The new montra....new Boss worse than the old Boss!
     
  17. Anonymous

    Anonymous Guest

    New boss after a traumatic event means change in management. They will bring in there own team. This needs to happen at Atrium as senior management is why the company is in the situation with the FDA. Employees should support the new boss in cleaning house of the senior management problem.
     
  18. Anonymous

    Anonymous Guest

    Maquet totally messed up a good company and great product. How does Raul still have a job
     
  19. Anonymous

    Anonymous Guest

    Any of these issues resolved with product back on the streets? What does an entire divison do during the intrim? JH still running the show? Just wondering
     
  20. anonymous

    anonymous Guest

    These people at Atrium have destroyed peoples lives.
    Thousands upon thousands of people have a 0 quality of life due to their incompetence and ignorance and greed.
    They are not here to help anyone but their own bank accounts.
    There will be a day soon when all of you scum bags will be locked up for fraud and attempted murder along with criminal assault.
    Karma has a way of getting you back from what you took from us, our livelihoods.
    Your hernia mesh has caused thousands upon thousands of people to experience 0 quality of life which means they no longer can enjoy their lives due to your life threatening products.
    In the United States there are laws in place for people like you who destroy human life....tick tock the clock is ticking.....