• COVID-19 vaccine vials stored in a freezer. 5 Ways to Keep Vaccine Cold Storage Equipment Safe from Hackers
    Gabe Cherry, Senior Writer, Michigan Engineering
    Oct 26, 2021
    A study published in BI&T found that an attacker located near freezers for storing vaccines could use electromagnetic interference to fool temperature sensors into giving false readings. The FDA's Acting Director of Medical Device Cybersecurity recommends five preventative steps.
  • A sterilization specialist works on equipment New Sterility Assurance Strategies for Products Sensitive to Sterilization Processes
    Sopheak Srun and Molly Swanson
    Oct 26, 2021
    Medical device sterilization specialists describe how the combination of aseptic processing and terminal sterilization results in a lower risk to the patient compared with aseptic processing alone. A STERILIZATION CENTRAL feature.
  • FDA_logo_high_quality_sq_200-1 FDA Issues Final Guidance for De Novo Requests and Classification
    Randolph Fillmore
    Oct 20, 2021
    The FDA’s Center for Devices and Radiological Health (CDRH) has issued an updated and final guidance on the medical device De Novo request and classification process.
  • ElisabethGeorge2021_sq Standards Leader Elisabeth George to Receive Röntgen Award
    Jennifer Peters
    Oct 20, 2021
    Head of Global Regulations & Standards for Philips Elisabeth George was recently announced as the 2021 recipient of the National Electrical Manufacturers Association (NEMA) Röntgen Award.
  • A man wearing 3D headset interacts with a computer generated model of a heart FDA Advancing Regulatory Science to Accelerate Medical Extended Reality (MXR)
    Martha Vockley
    Oct 20, 2021
    The U.S. FDA  has approved almost a dozen medical extended reality (MXR) technologies such as 3D virtual scenes for use in rehabilitation, visualization and planning, and surgical applications. Take a look "behind the scenes" at the Administration's plans for this unique tool.
  • A nurse holding a clipboard checks a dialysis machine Just Published! Acute Dialysis Survey Readiness Handbook: Second Edition
    Martha Vockley
    Oct 20, 2021
    The latest edition of the Acute Dialysis: Survey Readiness Handbook is now available as an indispensable source of guidance for dialysis professionals. According to the authors, the document has underdone a "tremendous amount of updating" to keep up with the field.
  • A ventilator operates next to a patient in a hospital. Improved Inventory Tracking Plays Vital Role in Battle Against COVID-19 at Banner Health
    Chris Hayhurst
    Oct 19, 2021
    Using a visual dashboard and a four-step process, HTM leaders at Banner Health improved their ability to track when and where devices are being used. The result aided in their response during a surge in COVID-19 patients. One of 2021's Bright Ideas.
  • Sam A - sq Get to Know the AAMI Standards Team: Sam Alameda, Program Manager
    Gavin Stern
    Oct 19, 2021
    A fun Q and A with Sam Alameda, program manager, shared services on AAMI's standards team.
  • Chenai sq Get to Know the AAMI Standards Team: Chenai Maguwah, Senior Manager
    Gavin Stern
    Oct 19, 2021
    A fun Q and A with Chenai Maguwah, senior manager, shared services on AAMI's standards team.
  • Eye Tracking Study - sq Study: How Virtual Reality Makes MRI Imaging an Easier Experience
    Fran Kritz
    Oct 13, 2021
    A study published in the journal Scientific Reports describes a virtual reality (VR) device intended to make MRI imaging easier for those who have difficulty tolerating the closed, noisy spaces of an MRI machine, as well as enable radiologists to capture more precise and useable images.
  • Medical devices and the outline of Australia Australia Cadetship Program Brings New Professionals to HTM
    Chris Hayhurst
    Oct 13, 2021
    A highly successful cadetship program in Queensland, Australia has striking similarities to AAMI's new U.S. national BMET Apprenticeship Program. A co-founder of the Australian program explored what makes such a program successful with AAMI.
  • Photo portrait of Philip Schneider In Memoriam: Philip Schneider
    Oct 13, 2021
    AAMI mourns the passing of Philip Schneider, a leader, mentor, and friend to many within the sterilization community.
  • ingredient list Comments from the ‘No Peanut’ Gallery: SBOM Usefulness and Limits
    Christopher Gates
    Oct 12, 2021
    Director of Product Security Christopher Gates shares his insights on how the software bill of materials (SBOM) can help reduce preplanted cybersecurity vulnerabilities in medical devices. A CYBERINSIGHTS feature.
  • A technician preforms equipment maintenance. The Ground has Shifted in the ‘Right to Repair’ Debate. What’s Next?
    Chris Hayhurst
    Oct 7, 2021
    In just the past few months, the ground has shifted in the debate over medical device servicing, often referred to as "right to repair." The big question now is: What’s next?
  • An infant lays next to an ECG monitor in the neonatal room. Reflecting on Cybersecurity and Patient Safety
    Axel Wirth
    Oct 5, 2021
    Warning signs of a baby’s distress during birth were allegedly missed due to an ongoing ransomware attack, resulting in the death of the baby. Axel Wirth describes how this painfully tragic event serves as an important reminder that reactive cybersecurity practices are simply not enough. A CYBERINSIGHTS feature.
  • Madeline Rozsa Voices of HTM: Madeline Rozsa
    Gavin Stern
    Oct 4, 2021
    "I take pride in everything I work on from simple to challenging—and as much as a challenge frustrates me, it thrills me!" says Madeline Rozsa, biomedical technologist at Kingston Health Sciences Centre in Ontario, Canada.
  • Heidi Horn sq Voices of HTM: Heidi Horn
    Gavin Stern
    Oct 4, 2021
    No matter what role you have in HTM, to be successful, you have to have "good communication and project management skills, patience, and a commitment to ensuring the medical equipment is safe and reliable," says Heidi Horn vice president of healthcare product marketing at Nuvolo.
  • Voices of HTM - Renee Gordon sq Voices of HTM: Renee Gordon
    Gavin Stern
    Oct 4, 2021
    Renee Gordon is an intern at Baystate Health in the UConn Clinical Engineering Program. "Being curious about and willing to learn about new technology and also being adaptable are characteristics that a successful HTM professional should have," she says.
  • Don Armstrong sq Voices of HTM: Don Armstrong
    Gavin Stern
    Oct 4, 2021
    Don Armstrong has been an HTM professional for nearly four decades, after falling into the field. Literally. 
  • Colleen H sq Voices of HTM: Colleen Haugen-Ortiz
    Gavin Stern
    Oct 4, 2021
    What does every HTM professional need? According to Colleen Haugen-Ortiz, HTM quality specialist at GE, that's "a good multi-head screwdriver."