AAMI News, February 2020, Vol. 55, Issue 2


AAMI News, February 2020, Vol. 55, Issue 2

Soft SkillsIssue Highlights

  • What You Need to Know About the New MDS2
  •  Medical Device Community Braces for Brexit
  • First Fully Disposable Duodenoscope Receives FDA Clearance
  • Health Technology Alliance: New Energy, New Activities
Focus On: Soft Skills





  • What You Need to Know About the New MDS2
    The National Electrical Manufacturers Association recently published an updated version of its standard, HN-1 Manufacturer Disclosure Statement for Medical Device Security (MDS2). The new version provides medical device manufacturers with an expanded MDS2 form to collect and report information related to their products’ security capabilities to their customers.
  • Medical Device Community Braces for Brexit
    With the United Kingdom’s exit from the European Union moving forward, the country is planning to enter an 11-month transition beginning on Jan. 31. During this time, the region will continue to follow E.U. laws until a trade agreement—which would include medical devices and in vitro medical devices—is drawn up or until a “no-deal” Brexit is called.
  • First Fully Disposable Duodenoscope Receives FDA Clearance
    The Food and Drug Administration has granted 510(k) premarket clearance to the first fully disposable duodenoscope. The EXALT Model D duodenoscope, developed by Boston Scientific, is intended to eliminate the risk of transmitting infection-causing bacteria from one patient to another that can occur as a result of ineffective processing.
  • News in Brief - February 2020
    News in Brief, February 2020
  • Are you RICH? Characteristics of a Good Biomed Tech
    David Braeutigam, MBA, CHTM, CBET, AAMIF, ITIL, is president of Braeutigam Enterprises LLC in Arlington, TX, an AAMI Fellow, co-author of AAMI’s HTM Benchmarking Guide, and a member of the AAMI Technology Management Council. He discusses common traits of good health technology professionals.
  • Soft Skills are Essential for HTM Trainees
    HTM’s expanding reach into other departments and disciplines brings with it a growing need for soft skills training. Unlike hard skills, which are specific, measurable qualities and abilities, soft skills refer to behaviors for effective and friendly interactions with other people.
  • Checking in with AAMI Mentor–Protégé Pairs
    In 2019, AAMI revitalized its mentorship program, which pairs early-career AAMI members and seasoned healthcare technology management professionals for a year-long mentoring relationship.
  • What's New with AAMI IT?
    An effective biomedical engineering department can often go unnoticed in a hospital—that is, unless something goes wrong. AAMI’s information technology department is no different.
  • FDA Exempts Some Devices from Premarket Notification
    In a final rule titled Medical Devices; Exemptions From Premarket Notification for Class I and Class II Devices, the Food and Drug Administration identified several Class I and Class II medical devices for which 510(k) premarket notifications are no longer required.
  • Taiwan FDA Discusses Cardiac Implant Standards
    The Taiwan Food and Drug Administration held a meeting in November at its headquarters in Taipei with Dr. Jeffrey Borer, a world-renowned cardiologist, to discuss international standards for cardiovascular implants and the FDA's role in the standards development process.
  • Health Technology Alliance: New Energy, New Activities
    The Health Technology Alliance, a joint collaboration between AAMI, the American College of Clinical Engineering  and the Health Information Management Systems Society, has already lined up several projects for 2020.
  • Tech World: The Importance of Drying Flexible Endoscopes
    Several recently published studies and guidelines have highlighted the need for complete drying of flexible endoscopes to reduce the risk of microbial recontamination in reprocessed devices and to improve patient outcomes.
  • The Big Picture: Repairing Donated Equipment
    Board members of the Biomedical Engineering Society at the University of Louisville, KY, fix donated equipment for medical impoverished countries.
  • Asked and Answered: Who's Responsible for Beds?
    What department at your hospital is responsible for servicing beds and moving beds in and out of patient rooms? Is this responsibility being performed under the clinical engineering department?
  • Career Center: Keeping a Clutter-Free Work Area
    There are many reasons to keep your work space neat. An organized office visually demonstrates your organizational skills, is a better place to work, and—most importantly—projects a good professional image to all who visit your area.
  • One on One with Colleen Haugen-Ortiz
    Meet Colleen Haugen-Ortiz, CBET, a former office manager and teacher who spent three years in the U.S. Army as a biomed. Today, she’s the site lead for Reston Hospital Center in Reston, VA, and a member of AAMI’s Technology Management Council.
  • AAMI All Star: Jennifer Benolken
    Jennifer is a medical device manufacturer and regulatory specialist at DuPont in West St. Paul, MN.
  • Members on the Move: February 2020
    Members...who, what, where.
  • Standards Spotlight: International Guidance for Minimizing Risk
    AAMI has published an update to the international risk management standard. Now in its third iteration, ANSI/AAMI/ISO 14971:2019, Medical devices—Application of risk management to medical devices, provides terminology, principles, and processes for managing risks associated with medical devices, including software as medical devices and in vitro diagnostic medical products.
  • AAMI Standards Monitor Digest: February 2020
    A few nuggets from the most recent issue of AAMI Standards Monitor Online.