• CMS Logo Sq CMS Delays Breakthrough Devices Reimbursement Rule
    Fran Kritz
    Apr 14, 2021
    The Centers for Medicare and Medicaid Services (CMS) put a hold on implementing a final rule that would have provided immediate Medicare reimbursement for devices authorized through the Food and Drug Administration’s (FDA's) Breakthrough Devices Program.
  • Industrial Sterilization Supplement 2 - sq Freely Available Sterilization Supplement to Get Second Installment
    Brian Stallard
    Apr 14, 2021
    AAMI will soon launch the latest installment in a growing collection of best practices and strategies for the sterilization of medical devices and tools. The new document, titled Industrial Sterilization: Challenging the Status Quo, Driving for Continuous Improvement, will a freely available and peer-reviewed supplement to AAMI’s journal, BI&T. The series represents a unique collaboration between medical industry leaders,
  • FDA_logo_high_quality_sq_200-1 FDA Alert Cites Possible Infections from Processed Urological Endoscopes
    Randolph Fillmore
    Apr 12, 2021
    In an April 1 letter to health care providers, the U.S. Food and Drug Administration warned of possible patient infections from reprocessed urological endoscopes.
  • European Union flag fades into a photo of an operating room A Clouded Future for European Medical Device Harmonization
    Brian Stallard
    Apr 12, 2021
    Changes to how the European Commission will use standards to support medical device regulation are leaving standards developers with concerns, questions, and uncertainty about the future of international standards harmonization.
  • A small piece of white lint. Lint Fiber–Associated Medical Compilations Following Invasive Procedures
    Wava Truscott, PhD, MBA
    Apr 8, 2021
    Pieces of lint are thought of as fluffy, soft, flexible little things. What harm could they possibly do if left in a wound after an invasive procedure? The truth is that they can seriously affect patient quality of life and even threaten their mortality. A STERILIZATION CENTRAL feature.
  • CDRH RWD - sq FDA CDRH Promotes Value of Real-World Evidence for Medical Device Submissions
    Randolph Fillmore
    Apr 8, 2021
    The FDA’s Center for Devices and Radiological Health (CDRH) has affirmed the value of using Real World Evidence (RWE) in FDA regulatory decision making, offering a detailed series of examples in a report of RWE usage in premarket and postmarket decisions.
  • Ask the Joint Commission: A Q&A with Herman McKenzie Ask Herman: The Joint Commission Answers Your Questions
    Apr 8, 2021
    Herman McKenzie, MBA, CHSP, director of the Department of Engineering, Standards Interpretation Group, at The Joint Commission answers questions posed by AAMI members.
  • A man studies learning materials on his laptop. Learn More in 2021: AAMI’s Biggest Education Offerings for the Year
    Chris Hayhurst
    Apr 8, 2021
    The good news for AAMI members with an eye toward education in 2021 is that despite the limitations imposed by the pandemic, the list of courses you can choose from is growing by the day.
  • A white N95 mask lies on a table. Study: Most Methods for Sterilizing Single-Use N95 Masks Adequate
    Fran Kritz
    Apr 8, 2021
    A review by researchers at UCLA found that most methods used by healthcare systems to process N95 masks, intended for single use, are likely to do an adequate job of preparing the equipment for reuse.
  • A key made up of 1s and 0s Reflecting on Recent Trends in Cybersecurity
    Axel Wirth
    Apr 8, 2021
    A Cyber Insights post: Chief security strategist Axel Wirth analyzes how healthcare cybersecurity fared in 2020.
  • Pediatric Device Heart - sq Medical Device Pitch Competition Seeks Pediatric Heart Innovations
    Apr 8, 2021
    The National Capital Consortium for Pediatric Device Innovation (NCC-PDI) is accepting applications through April 12, 2021, for its annual “Make Your Medical Device Pitch for Kids!” competition. This year’s competition focuses on innovations in pediatric devices that treat congenital heart disease.
  • AAMI Exchange Rewired, Jan 7-11. Registration now open. AAMI eXchange Has Been REWIRED! Here’s What’s Coming
    Apr 7, 2021
    AAMI recently announced that the annual AAMI eXchange is being redeveloped into a fully virtual event for 2021. Now, we are ready to share what’s in store for June 7 to 11 at the AAMI eXchange REWIRED.
  • BasileNozawa AAMI Welcomes New Additions to AAMI Board and Nominating Committee
    Apr 6, 2021
    The AAMI Board of Directors and Nominating Committee are welcoming two seasoned professionals: Ralph Basile, vice president of marketing and regulatory affairs for Healthmark; and Susumu Nozawa, head of regulatory affairs, North America, for Siemens Healthineers.
  • Photo portrait of Jo-Ann Maltais In Memoriam: Jo-Ann Maltais
    Apr 2, 2021
    The AAMI standards community is mourning the passing of Jo-Ann Barbara Maltais, Ph.D., an experienced executive and advisor for medical device and drug development who led the design and implementation of several crucial AAMI standards.
  • Crowdsource-sq Innovators Showcase Digital Tools for COVID-19 Diagnostics
    Martha Vockley
    Mar 31, 2021
    Innovators in the health technology industry are powering through these issues to come up with crowdsourced, future-oriented solutions. Last fall, the U.S. Department of Human Services (HHS) challenged industry with a 10-day COVID-19 At-Anywhere Diagnostics Design-a-Thon to develop innovative health tools.
  • fred Get to Know the AAMI Education Team: Fred Moxley
    Mar 31, 2021
    A fun Q and A with Fred Moxley, senior meetings manager at AAMI.
  • Sherrie Get to Know the AAMI Education Team: Sherrie Schulte
    Mar 31, 2021
    A fun Q and A with Sherrie Schulte, vice president of education at AAMI.
  • A woman participates in online learning. Health Technology Education Adapts to COVID-19
    Chris Hayhurst
    Mar 30, 2021
    More than a year after COVID first hit, educators and education-program leaders all say the same thing: Nothing about the pandemic has been routine or expected, but the courses and the teaching and the learning all continue—health tech training has hardly missed a beat.
  • Photo portrait of Joyce Hansen Johnson & Johnson’s Joyce Hansen Joins AAMI Foundation Board
    Brian Stallard
    Mar 30, 2021
    The AAMI Foundation is pleased to announce that Joyce Hansen, VP, Johnson & Johnson Microbiological Quality and Sterility Assurance, has been appointed to the AAMI Foundation board of directors.
  • Kasey Get to Know the AAMI Education Team: Kasey Fuelling
    Mar 24, 2021
    A fun Q and A with Kasey Fuelling, director of training solutions at AAMI.