AAMI News, April Vol.57, No.4


AAMI News April 2022

The latest from AAMI News in April, including a Focus on Standards.





  • Cartoon of a robot doctor examining a surprised man New AAMI Consensus Report: Guidance on Risk Management for AI, ML
    Is artificial intelligence in medical devices safe? A new consensus report from AI experts and regulatory specialists responds to an urgent need to address the potential risks of emerging machine learning applications in health technology.
  • Amy-Alexander-holding-Swabs_sq 3D Printing COVID Testing Swabs to Close a Supply Chain Gap
    How did the Mayo Clinic handle a shortage of testing supplies while COVID-19 and supply chain problems rocked the globe? This this BRIGHT IDEA feature, one 3D Anatomic Modeling Lab describe how they changed gears to produce 485,000 testing swabs in a mere four months!
  • Child_MedicalTechnology_124990765_sq Pediatric Medical Device Pitch Competition Offers $150K in Grants to Spur Innovation
    Calling all innovators! “While great advances are made in adult medical devices, children are often left behind because the pediatric market is small and there are not incentives to develop for pediatrics"  An annual competition helps address this problem, but it needs applicants today!
  • Tablet_reading_academic_happy_423948206_sq AAMI Recognizes Authors in Cloud Computing, Cybersecurity, and Smart Pumps
    A team exploring the frontier of medical device cloud computing, a cybersecurity duo capturing best practices for frontline personnel, and a nurse/pharmacist research team have all made outstanding contributions to AAMI’s publications in the past year. Congratulations to the 2022 recipients of our AAMI Publications Awards recipients!
  • fda-logo FDA Budget Request for 2023 Contains Increase for Medical Device Program
    Is the U.S. FDA taking cybersecurity in medical devices and device supply chains seriously? Well... according to a new budget request from the agency to Congress, they're eight billion dollars serious.
  • A line of formally dressed people applaud. ACCE Awards Recognize HTM Advocates, 2022
    The 2022 winners of ACCE Advocacy Awards have been announced, celebrating individuals who have championed the varied corners of healthcare technology management (HTM) throughout their careers. AAMI joins our vibrant HTM community in congratulating the  recipients!
  • Bakul-bio-pic-2019-1_sq Bakul Patel Prioritizes Global Strategy, Health Equity in New FDA Role
    In this interview with AAMI News, the CDRH's first Chief Digital Health Officer of Global Strategy and Innovation, Bakul Patel, reflects on the work of the Digital Health Center of Excellence as its first director and shares his priorities for his new role. 
  • A sampling of panels from Health First's digital HTM dashboard. Digital Dashboard Project Wins 2021 Bright Ideas Award
    It sounds like a simple strategy, but it has reduced the number of devices that took 30 days or longer to repair by a whopping 30% while simultaneously increasing the number of repairs completed within 24 hours! 
  • MedicalDevice_Hallway_Hospital_240996735_sq HSCC’s Model Contract Language Template Represents a Win-Win Cybersecurity Solution for HDOs and MDMs
    To ease the burden in establishing cybersecurity requirements between HDOs and MDMs, the Health Sector Coordinating Council has created the Model Contract Language template. Working as a “prenegotiated” contract between HDOs and MDMs, the template helps to improve clarity, reduce the time burden, and enhance the implemented level of security mitigations.
  • FDA_logo_high_quality_sq_200-1 More Than 100 Novel Devices Received FDA Marketing Authorization in 2021
    The 2021 annual report of the FDA's Center for Devices and Radiological Health (CDRH) reported that more than 100 novel devices received FDA marketing authorization last year, as the agency works to spur innovation of new medical devices that are safer, more effective, and address unmet medical needs. 
  • Two engineering students. One works on a 3D printer while the other studies HTM Education Program Focuses on Device Design
    What happens when a student of HTM professional wants to leverage their repair skills to design medical devices? At the University of Windsor in Ontario, Canada, a newly launched stream of courses is designed to do just that—to teach HTM students how to design new, innovative biomedical equipment.
  • WG84-co-chairs_sq AAMI Awards Honor Standards Developers, Technical Committees
    Who are some of the hardest working folks in health standards development? This year's AAMI Awards in standards were defined by the passionate (and productive!) sterility assurance community who ensure the safety of patients and staff everywhere.
  • A technition inserts dental instruments into an autoclave for steam sterilization. What’s on the Horizon for HDO Sterilization Guidance? WG 40 Co-chairs Weigh In
    AAMI's Sterilization Hospital Practices Working Group (WG 40) is known for developing the state-of-the-art standard for steam sterilization and sterility assurance in healthcare facilities, ANSI/AAMI ST79. But that's not all they've worked on! The WG 40 co-chairs provide a glimpse of what's on the horizon in this SETTING STANDARDS column.