Don't miss the PDF edition of this issue of AAMI News, which includes a special Year in Review section.

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

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

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

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

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

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

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

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

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

• 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

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

• 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

• 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

• 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

• 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

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

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

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

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

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