• Portrait photo of Simon Mejia An “American Dream” in Healthcare Technology Management
    Jennifer Peters
    Nov 18, 2021
    The “American Dream” is alive and well in the HTM field, at least if you’re Simon Mejia. Originally from Hidalgo, Mexico, Mejia moved to the United States in 2010 to find a job and help support his family. Soon after, he unexpectedly found himself exploring an even brighter future — a career in HTM.
  • Herman McKenzie Ask Herman: The Joint Commission Answers Your Questions
    Nov 17, 2021
    Questions and responses from a presentation given by Herman McKenzie, MBA, CHSP, director of the Department of Engineering at The Joint Commission during AAMI eXchange REWIRED.
  • MedicalDevice_Network_Hospital_sq Connected Health and Cybersecurity: Advice about the Device
    Greg Garcia
    Nov 17, 2021

    We rarely think about the potential vulnerability to cyberattacks of the network-connected devices that are enabling our care. However, the benefits from rapid advances in the use and capabilities of “connected health” also come with potential risks. A CYBERINSIGHTS feature.

  • silhouetted professionals sit around a table in front of the AAMI logo. Nominees Sought for AAMI Board of Directors
    Nov 17, 2021
    AAMI has launched a search to fill several positions on its Board of Directors and Nominating Committee in 2022. Interested individuals should be able to demonstrate a depth of experience and dedication to AAMI, and all nominations must be received by Dec. 31, 2021.
  • Emergency room medical device Effective Maintenance Plans Save Lives, and BMETs Are a Vital Component for Success
    Richard L. “Monty” Gonzales, EdD
    Nov 17, 2021
    Monty Gonzales, president of the College of Biomedical Equipment Technology, describes how overlooking the role of the BMET in accurately documenting preventive maintenance, checks, and services can lead to devastating consequences. A TROUBLESHOOT IT feature.
  • A TRIMEDX employee services medical devices TRIMEDX Joins AAMI BMET Apprenticeship Program as Employer Partner
    Brian Stallard
    Nov 15, 2021
    A U.S. national BMET Apprenticeship Program recently launched by AAMI has gained a valuable new employer partner. TRIMEDX, an industry-leader in clinical asset management for healthcare systems, will be offering apprenticeship opportunities through the AAMI registered apprenticeship program as soon as early 2022.
  • 10k AAMI Members AAMI Exceeds 10,000 Members, a Milestone for Health Technology
    Brian Stallard
    Nov 9, 2021
    The active membership of AAMI now exceeds 10,000 thanks to the commitment of the organization’s many professionals and leaders—all united in their dedication to the development, management, and use of safe and effective health technology.
  • Blue clouds sit in front of a serve computer room. ISC21: Responding to Regulatory Challenges of Cloud Computing, Artificial Intelligence
    Martha Vockley
    Nov 5, 2021
    The acceleration of cloud computing and AI has created new challenges that affect all kinds of cutting-edge medical devices. The burning question is, how can quality and performance be evaluated, managed, and regulated when platforms and software change frequently, rapidly, and unpredictably?
  • FDA_logo_high_quality_sq_200-1 CDRH’s “Digital Transformation Initiative” Moves Forward
    Randolph Fillmore
    Nov 4, 2021
    The FDA's CDRH has made notable progress in its Digital Transformation initiative to offer more online platforms to support virtual work, especially regarding the FDA's medical device premarket submissions review program.
  • A group of people applaud an accomplishment. AAMI Seeks 2022 Nominations for Awards Programs
    Gavin Stern
    Nov 3, 2021
    Do you know a health technology innovator, safety advocate, or revolutionary? How about a standards leader or humanitarian? You can make sure that your deserving peers are recognized for their achievements by nominating them for an AAMI or AAMI Foundation award.
  • FDA_logo_high_quality_sq_200-1 Medical Device Machine Learning Principles Published Jointly by FDA, MHRA, and Health Canada
    Randolph Fillmore
    Nov 3, 2021

    The U.S. FDA and its counterparts Health Canada and the UK’s Medicines and Healthcare products Regulatory Agency have jointly issued 10 guiding principles to inform the development of Good Machine Learning Practices in medical device development.

  • PTGrade_KiaHealth_sq Study: Physical Therapy App Rivals In-Person Exercise Corrections
    Fran Kritz
    Nov 3, 2021
    A recent study published in the Journal of Medical Internet Research found that a health app was as effective as a physical therapist in suggesting exercise corrections for people undergoing physical therapy.
  • MedCrypt Logo AAMI and MedCrypt Establish Cybersecurity Visionary Award
    Nov 2, 2021
    AAMI and proactive medical device cybersecurity innovator MedCrypt are establishing a new award focused on recognizing and encouraging leaders in the emerging medical device cybersecurity space: the AAMI & MedCrypt Cybersecurity Visionary Award.
  • A young patient lies in bed next to an intravenous infusion pump. New TIR on Infusion Pump Testing Focuses on Clinically Relevant Metrics
    Martha Vockley
    Nov 1, 2021
    A new AAMI technical information report, TIR101:2021, aims to help product designers and developers apply a more robust testing regime to infusion devices—and, ultimately, improve device, medication, and patient safety. 
  • ISC_Weiner_sq ISC21: International Standards Conference Details Combination Product Challenges
    Jennifer Peters
    Oct 28, 2021
    Combination products add a new level of risk through the way the products interact, as detailed at the 2021 International Conference on Medical Device Standards and Regulation (International Standards Conference, or ISC).
  • A rusty hook on a red email envelope to represent a phishing attack. ISC21: Standards and Regulations Meet Increasingly Complex Cyberthreats
    Jennifer Peters
    Oct 28, 2021
    In a year that saw the first direct patient death attributed to a cyberattack, as well as a ransomware attack that led to a widespread gas shortage, cybersecurity issues were front and center at the 2021 AAMI/FDA/BSI International Conference on Medical Device Standards and Regulation (International Standards Conference, or ISC).
  • The wrist of patient earing the nuralert monitoring device. FDA Grants Breakthrough Device Designation to Neuralert’s Stroke Detection System
    Fran Kritz
    Oct 27, 2021
    The Food and Drug Administration (FDA) recently granted a Breakthrough Device Designation to the Neuralert Monitor, bands that continually monitor for signs stroke in at-risk patients.
  • A surgeon puts on gloves in a surgery room next to an air traffic controller A Smooth Flight Toward Success: Redefining Sterile Processing for Surgical Centers
    W. Zeh Wellington
    Oct 27, 2021
    What can sterile processing professionals learn from air traffic control? The director of procedural care–surgical services at the Ann and Robert H. Lurie Children’s Hospital of Chicago explains how they effectively addressed a surgical sites supply dilemma.
  • 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.