The Latest News from AAMI

 

  • AAMI News, April 2021, Vol.56, No.4

    Be on the lookout for the IN FOCUS tag, indicating a story ties into the focus of this issue: Sterilization.

  • AAMI News, March 2021, Vol.56, No.3

    Be on the lookout for the IN FOCUS tag, indicating a story ties into the focus of this issue: Education.

    Issue Highlights
    • How health technology education is adapting to COVID-19
    • AAMI apprenticeship program for BMETs gets a green light
    • The AAMI Exchange announces a fully virtual event
    • Find out all of the AAMI Award and AAMI Foundation Scholarship winners
    • Practical tools to improve patient safety
    • How aviation industry advances can improve hospital alarm design
    • The value of competency assessments for paving a clear career path
    • Troubleshooting problems with admitting, discharging and transferring patient information

    Focus on Education

  • AAMI News, February 2021, Vol.56, No.2

    Be on the lookout for the IN FOCUS tag, indicating a story ties into the focus of this issue: Healthcare at Home.

    Issue Highlights
    • How the FDA is speeding up device innovation
    • A look at PPE challenges on the front lines of COVID-19
    • An HTM team's creative plan to replace defibrillators
    • Meet the AAMI Standards Team's new senior directors
    • New guidance to help 'clean up' confusing IFUs

    Focus on Healthcare at Home

  • AAMI News, January 2021, Vol.56, No.1
    Issue Highlights
    • FDA Examines When 'Microneedles' Are Medical Devices
    • CDRH Looks Forward to a ‘Reset’ for COVID-Delayed Work
    • In Memoriam: Louis Leibow
    • COVID-19 Compels Health System to Devise Creative Defibrillator Replacement Strategy
    • Steam Sterilization Standard ST79 Receives Community Driven Update
    Focus on Artificial Intelligence
  • AAMI News, December 2020, Vol.55, No.12
    Issue Highlights
    • CMS Finalizes New Rules on Coverage for Artificial Hearts and VADs
    • 3D Printing Helps Solve Ventilator Shortage During COVID-19
    • FDA Issues New Draft Rules on Electromagnetic Compatibility for Devices Seeking Premarket Approval
    • Emergency-Use Options for Decontaminating Masks, PPE
    The Year in Review
  • AAMI News Special Standards Issue
    Learn what's going on in the world of standards, and get introduced to AAMI's new and longtime standards staff in this special edition of AAMI News!
  • AAMI News, November 2020, Vol.55, No.11
    Issue Highlights
    • New Law Expands Telehealth for Veteran’s Mental Health Treatment
    • Study: Many De Novo Classified Devices Short on Effectiveness Data
    • Industry Examines Ways to Satisfy Need for Rapid Regulatory Response
    • Experts Address Roadblocks to Harmonization of EU Medical Device Standards
    Focus on Sterilization
  • AAMI News, October 2020, Vol.55, No.10

    Issue Highlights

    • 'Astronomical' FDA Research on Early Biomarkers
    • CMS Proposes Payment Pathway for Breakthrough
    • IoT Medical Devices Increasingly Vulnerable to Hacking
    • Telepsychiatry Holds Promise for COVID-19 Challenges
    • Deep-Brain Simulation Technology Uses AI
    • 3D Printing Helps Offset PPE Gap
    • Novel Standards for Unregulated Health Software
    • Sterilization Leaders Pool Knowledge in Unprecedented Collaboration

    Focus on Emerging Technologies

  • AAMI News, September 2020, Vol.55, No.9
    emergency equipment

    Issue Highlights

    • FDA Issues Second EUA for Heart Pump
    • A Full Slate of HTM Learning Events this Fall
    • Behind the Scenes at the FDA: MRI Safety Guidance
    • Just Published! AAMI HTM Succession Guide
    • Pediatric Device Competition Highlights COVID-19 Innovations
    • FDA Increases User Fees for 2021
    • In Memoriam: Zachary Collins
    • COVID-19 Medical Device Shortage List Posted by FDA

    Focus on Risk Management

  • AAMI News, August 2020, Vol.55, No.8
    hospital device with monitor

    Issue Highlights

    • FDA Delays UDI Enforcement
    • AAMI Foundation Establishes Kilmer Scholarship Fund Committee
    • AAMI Partners with Amplifire to Bring Cognitive Science, Analytics to Training
    • Looking for a Job or a Candidate? AAMI Career Center Can Help
    • “Must-Have” TIR24971 Complements Risk Management Standard

    Focus on: Service and Repair

  • AAMI News, July 2020, Vol.55, No.7
    human factors abstract

    Issue Highlights

    • AAMI Statement Against Racism and Intolerance
    • With Human Factors, Words Matter
    • AAMI’s Human Factors Webinar Series
    • Classifying Human Factors Issues for MAUDE and Recall Databases
    • AAMI Mourns Loss of Noted Clinical Engineer George Panagiotopoulos
    • What Can Amazon Teach Us About Defibrillators?
    • Understanding the Stages of ACI Certification
    • Demystifying Standards: A Journey into New Sterilization Standards

    Focus on: Human Factors

  • AAMI News, June 2020, Vol. 55, No. 6

    ANews_Home_June2020Issue Highlights

    • Manufacturers Reinvent Playbook for COVID-19
    • The Pros and Cons of N95 Mask Decontamination Methods
    • FDA Issues Final Guidance on Requesting Nonbinding Feedback 
    • Sterile Processing Department Takes on Vital New Role in COVID-19 Hot Spot
    Focus On: Healthcare Technology Appreciation
  • AAMI News, May 2020, Vol. 55, No. 5

    ANews_Home_MayIssue Highlights

    • Collaborative COVID-19 Response Brings Out the Best in HTM
    • AAMI, BSI Recommendations for Machine Learning
    • Potential Implications of the MDR Delay 
    • Upcoming Efforts to Improve Healthcare Cybersecurity
    Focus On: Cybersecurity
  • AAMI News, April 2020, Vol. 55, Issue 4
    COVID-19

    Issue Highlights

    • AAMI Coronavirus Resources
    • FDA Pilots eSTART Program for Premarket Submissions
    • AAMI Education Rethinks the Education Experience
    • Olympus and Amplifire Team Up for Endoscope Processing
    Focus On: Sterilization
  • AAMI News, March 2020, Vol. 55, Issue 3
    Virtual Reality

    Issue Highlights

    • HTM Professionals Build and Implement VR Training Programs
    • FDA Reclassifies Medical Image Analyzers
    • AAMI Nominates Members for Board of Directors
    • Tech World: The Potential of Wearable Health Technology Devices

    Focus On: Medical Alarms

  • 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
  • AAMI News, January 2020, Vol. 55, Issue 1
    Robotic Assisted SurgeryIssue Highlights
    • Navigating E.U. Regulatory Reorganization under MDR
    • Recruiting the Next Generation with 'HTM in a Box'
    • A Call for More Detailed Metal Implant Labeling
    • More Innovators Enter the Robotic Space
    Focus On: Robotics
  • AAMI News, December 2019, Vol. 54, No. 12
    2019 in ReviewIssue Highlights
    • 2019—The Year in Review
    • FDA to Focus on Lowering Ethylene Oxide Emissions
    • CDRH Quality Pilot Expands to Noncompliant Manufacturers
    • AAMI's Healthcare Technology Collection Puts Innovation on Display
    Focus on: The Year in Review
  • AAMI News, November 2019, Vol. 54, No. 11

    Issue HighlightsAugmented Reality

    • FDA Outlines Details of Proposed ASCA Pilot Program
    • Ambulatory Surgery Centers: A Growing Medical Device Market
    • FDA Encourages Patient Engagement in Device Development
    • New Augmented Reality Imaging Tool Helps Guide Surgeons

    Focus On: Imaging

  • AAMI News, October 2019, Volume 54, Issue 10
    SterilizationIssue Highlights
    • What Does It Mean to Design for Failure?
    • AAMI Foundation Embarks on New Direction
    • FDA Guidance Considers Uncertainty in Benefit-Risk Determination
    • AAMI, ISO Publish Sterilization Standards for Packaging

    Focus On: Sterilization