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!

 

• '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

• 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

• 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 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

Issue 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

Issue 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

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

• 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

Issue 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

Issue 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

Issue 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

• 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

Issue 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

In this issue:

• For Hurricane Season, FDA Offers Safety Tips for Medical Devices
• New Type of AAMI Resource Aims to Address Need for Rapid Guidance
• FDA Announces Two Innovation Challenges for Ethylene Oxide Sterilization Alternatives
• AAMI Nominee Wins IEC Young Professionals Competition

Focus On: HTM Education and Development