The Latest News from AAMI

 


AAMI News November

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





  • Innovation Challenges Explore Ethylene Oxide Alternatives, Emissions Control
  • A portrait of Steve Campbell, AAMI ONE on ONE with Steve Campbell
    STEVE CAMPBELL is the chief operating officer of AAMI and executive director of the AAMI Foundation. He became acting president of AAMI in November. We had a one-on-one with Steve to learn more about him.
  • Cybersecurity Risks Accelerate During COVID-19
    Failing to install software patches or other cybersecurity-critical upgrades continues to make the healthcare system vulnerable to attack, according to at least two reports.
  • A human face made up of binary code faces an assortment of dental instruments. AAMI Explores Artificial Intelligence and Dentistry with New Standards Initiatives
    AAMI is exploring two new directions for AAMI guidance and standardization: A joint effort with the American Dental Association aimed at designing a sterilization standard for dental facilities and a commitment to defining safe and effective practices for the use of artificial intelligence for medical care.
  • ‘Warrior Watch Study’ Uses Wearable Devices to Examines COVID Stress
    Researchers at Mount Sinai in New York are looking for volunteers to participate in the Warrior Watch Study, which is the first of its kind. The study is the latest to leverage wearables into the ongoing conversation about COVID-19. The study aims to understand the impact the pandemic has on the psychological wellbeing of healthcare workers, while also looking to predict infection before symptoms appear.
  • Device Industry Examines Ways to Satisfy Need for Rapid Regulatory Response
    In the modern age of technological advancement, it’s important to understand that critical situations similar to COVID-19—where rapid change will be needed from medical device regulators—will continue to emerge. Almost a year since COVID-19 swept the globe, the human population is still reeling. One aspect of healthcare that often gets overlooked—the standardization of medical device use—likely will never be the same in the wake of the pandemic.
  • Experts Address Roadblocks to Harmonization of EU Medical Device Standards
    The BSI/AAMI International Medical Device Standards & Regulation Conference, held virtually on Nov. 3–4, featured a session on standards harmonization and the processes leading toward harmonization. Tony Wilkes, a harmonization consultant, spoke on efforts to achieve uniformity on standards within the European community. He noted that complying with standards has been voluntary and there has been a “presumption to conform.
  • The Future of Virtual Reality in HTM Training
    Using virtual reality to train HTM professionals could help offset expensive training costs to fly teams to training facilities and allows professionals to work on new skills without purchasing new equipment. VR offers a low-risk environment for HTM professionals to learn or relearn critical skills. 
  • Brexit May Present ‘Huge Opportunity’ for Device Makers
    Although medical device makers will face challenges following Brexit, the UK’s withdrawal from the European Union also offers potential opportunities for the industry, according to Graeme Tunbridge, director of the Medicines and Healthcare products Regulatory Agency (MHRA).
  • fda-logo FDA, Stakeholders Continue Quest to Build Trust in the Use of AI in Medical Devices
    Artificial intelligence (AI) and machine learning (ML) are at the intersection of a multitude of fields. However, very few stakeholders are taken into account when promoting engagement with these technologies. The Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH), which is at the forefront of advancing these technologies for the healthcare industry, is attempting to bridge the gap between the interests of different stakeholders by assembling the Patient Engagement Advisory Committee (PEAC), which consists of patients, healthcare experts, caregivers, and more.
  • New Law Expands Telehealth for Veteran’s Mental Health Treatment
    A recently signed U.S. law offers a variety of new and expanded measures to help prevent suicides among veterans, with services including an expansion of telemedicine-delivered mental health services, particularly for veterans in rural areas. 
  • Study: Many De Novo Classified Devices Short on Effectiveness Data
    A study reviewing 63 moderate-risk medical devices that received FDA clearance via the agency’s De Novo classification pathway found that one in six lacked sufficient end-point effectiveness data.
  • FDA Outlines 2021 Guidance Priorities
    <p>The Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has released its final and draft guidance publication priorities for the 2021 fiscal year.<br /> </p>
  • AAMI All Star: Joyce Hansen
    JOYCE HANSEN Vice President, Sterility Assurance at Johnson and Johnson