The Latest News from AAMI

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

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Mobilizing for a 5G Future: Behind the Scenes at the FDA
In the not-too-distant future, 5G will be coming to a bevy of common and state-of-theart medical devices near you.
COVID-19–Related Trafficking of Medical Products Reported
Following the emergence of the COVID-19 pandemic, incidences of organized criminal activity related to substandard and falsified (SF) medical products represent a public health risk, according to a research brief published by the United Nations Office on Drugs and Crime (UNODC). Seizure and interception of SF products have been reported across Europe, North America, Africa, and Asia, the agency stated.
FDA Issues Draft Guidance on Considering Patient Perspectives on Medical Devices
The Food and Drug Administration (FDA) wants to listen to patients who use medical devices, as evidenced by the agency’s release of a draft guidance, Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation.
News in Brief: October 2020
Focus on Emerging Technologies: ‘Astronomical’ FDA Research on Early Biomarkers Could Stimulate Innovation
An applied research project at the Food and Drug Administration (FDA) draws inspiration from routine eye exams and from advanced astronomical technology. One day, the research could result in next-generation medical devices capable of early detection and monitoring of serious eye conditions—and, perhaps, other ailments as well.
Focus on Emerging Technologies: FDA Approves Automatic Monitoring Device for Children with Type 1 Diabetes
The Food and Drug Administration (FDA) has approved the MiniMed 770G System, a hybrid closed-loop diabetes management device.
Focus on Emerging Technologies: CMS Proposes Payment Pathway for FDA-Approved Breakthrough Medical Devices
In late August, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that could give Medicare beneficiaries faster access to new health technologies by allowing Medicare to begin reimbursing for breakthrough medical devices at the same time that the Food and Drug Administration (FDA) approves them.
Focus on Emerging Technologies: Internet-of-Things Medical Devices Increasingly Vulnerable to Hacking
The production and use of Internet-of-Things (IoT) medical devices has rapidly expanded during the previous few years. These IoT medical devices, which include hardware and sensors that gather, store, and transmit healthcare data and confidential patient information over the Internet, also have become increasingly attractive to cybercriminals.
Focus on Emerging Technologies: Telepsychiatry Holds Promise for Addressing COVID-19 Mental Health Challenges
Research indicates that mental health challenges, including anxiety, depression, and suicidal ideation, have increased during the COVID-19 pandemic. With telehealth becoming the primary method of contact between patients and providers, health professionals are addressing these mental health demands through telepsychiatry.
Focus on Emerging Technologies: Deep-Brain Stimulation Technology Uses AI to ‘Listen’ to the Brain
Whether it’s remembering where you left your keys, the precious moments of a life well lived, or the important points of a conversation, our ability to remember makes living easier— helping us define our lives and who we are.
Focus on Emerging Technologies: 3D Printing Helps Offset PPE Gap
During the COVID-19 pandemic, healthcare systems are under significant strain to address critical shortages of medical devices and personal protective equipment (PPE), creating an opportunity for on-demand solutions such as 3D printing.
AAMI Standards Monitor Digest: Highlights for the standards community
Tech World: What Brings Us All Together During These Tough Times
Danielle McGeary on what brings us all together during these tough times.
Inspector General Recommendations Seek to Reduce Fraud, Waste, and Abuse
In an effort to reduce fraud, waste, and abuse in Department of Health & Human Services programs, a new report from the Office of Inspector General (OIG) advised adhering to “unimplemented recommendations,” including adding medical device-specific information on claim forms and requiring hospitals to use certain condition codes for reporting device replacement procedures.
Google Cloud, Defense Department Team Up to Improve Cancer Diagnosis Accuracy
The U.S. Department of Defense (DoD) has tapped Google Cloud to develop a prototype for AI-enabled digital pathology testing at several DoD facilities, with plans to expand the testing to the U.S. military health system.
Career Center: Be Like Mike
Don Armstrong, CBET, CHTM, is a biomedical equipment technician in Vero Beach, FL.
Member News: ONE on ONE with Brian Barry
BRIAN BARRY is group vice president for quality, regulatory, medical safety, and scientific communications at Medtronic. Barry was elected to the AAMI Board of Directors this year.
Members on the Move: October 2020
Members on the Move: October 2020
AAMI All Star: Jennifer DeFrancesco
JENNIFER DEFRANCESCO Crothall Healthcare Technology Solutions Director at the University of Cincinnati Health
New Member Organizations: October 2020
New Member Organizations: October 2020
Novel Standards for Unregulated Health Software Consider Human Factors
In this digital age, health software is increasingly important for healthcare delivery. Unlike medical devices, unregulated software has not had the benefit of tried-and-true standards to promote patient safety and health.
Sterilization Leaders Pool Knowledge in Unprecedented Collaboration
Following a unique collaboration between medical industry leaders, AAMI has published a new, free resource showcasing the best practices and strategies for the sterilization of medical devices and packaging.