AAMI News, July 2021, Vol.56, No.7


AAMI News July 2021

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





  • Ethernet cables neatly plugged into network hardware. HTM Lessons Learned from a Communication Loss Crisis
    In a special “lessons learned” session during AAMI eXchange REWIRED, HTM consultant Rehman Syed joined Victor Boyd, Sr Director of Service Technical Operations at Nihon Kohden, to revisit a healthcare technology communication loss crisis and what other HTM departments can learn from the duo’s experience.
  • FDA_logo_high_quality_sq_200-1 FDA Publishes Draft Guidance on Remanufacturing Medical Devices
    Because many medical devices are reusable and need periodic preventive maintenance, on June 18, the U.S. Food and Drug Administration (FDA) has published draft guidance, Remanufacturing of Medical Devices to clarify the statutory and regulatory requirements of either “servicing” a medical device or “remanufacturing” a medical device.
  • A ventilator operates next to a patient in a hospital. VA New York Harbor HTM Response to COVID-19
    When NYC became the epicenter of the COVID-19 pandemic last year, the VA NY Harbor Healthcare System operationalized the U.S. VA’s “fourth mission”—responding to national emergencies and supporting not just veterans, but also public health. HTM staff share how they helped the system respond to this unprecedented crisis.
  • A blindfolded woman stand before a stream of data Improving AI-Enabled Medical Devices with Data Consortiums and Encryption Technology
    Riddhiman Das, cofounder and CEO of TripleBlind talks with AAMI about the pitfalls and inherent biases of AI design for the clinical setting and how the secure sharing of "blind" data can help.
  • FDA_logo_high_quality_sq_200-1 FDA Updates Recommendations for Reprocessing Reusable Flexible Bronchoscopes
    Due to an increasing number of Medical Device Reports regarding infections caused by—or contamination of—reusable flexible bronchoscopes, the FDA has released updated device recommendations as a supplement to its 2015 safety communication regarding reprocessing these devices.
  • FDA_logo_high_quality_sq_200-1 FDA Issues Final Guidance on UDI Form and Content
    The FDA has issued final guidance, Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI) to assist labelers and FDA-accredited issuing agencies in complying with unique device identifier (UDI) labeling requirements, including by clarifying FDA’s interpretation of certain requirements under 21 CFR 801.40.”
  • A blank "Hello my name is" nametag IAHCSMM to Change Its Name
    Members of the International Association of Healthcare Central Service Materiel Management (IAHCSMM) have voted to change the name of the organization, which consists of members from the sterile processing community.
  • Bose Hearing Aid First Direct-to-Consumer Hearing Aid Receives FDA Clearance
    Bose may be on customers' shopping lists when looking for smart speakers and headphones. But the Framingham, MA, company has now entered a new area—by offering a direct-to-consumer, “self-fitting” hearing aid that’s received premarket clearance from the FDA.
  • Veteran Michael Nicoletti holds up the Gio Ear Canal Stent 3D Printing Helps VA Patient Who Was ‘Grasping at Straws’
    During the worst of the COVID-19 pandemic, the Additive Manufacturing team at the Ralph H. Johnson Veterans Affairs Medical Center in Charleston, SC, became a hub for 3D-printing. Now, they've 3D-printed a new kind of medical device: the Gio Ear Canal Stent. A 2021 Bright Idea feature story.
  • A patient monitoring system in a hospital. Sound Troubleshooting Steps and a Solid Relationship with IT: Essential Components in Solving Telemetry Issues
    BMET specialist Becky Crossley, CBET, explains how effective communication with a hospital's IT department is vital for troubleshooting hospital telemetry, such as patient monitoring systems, A TROUBLESHOOT IT feature.
  • AAMI eXchange 2022 logo and the San Antonio Riverwalk Call for Proposals now OPEN for eXchange 2022 in San Antonio
    AAMI is now accepting session proposals AAMI eXchange 2022, taking place on June 3-6, 2022 in San Antonio, Texas. Presenters are eligible to earn CEUs toward maintaining certification. The priority deadline for submissions is August 27 at 11:59 p.m. ET.
  • A man holds a mirror in front of his face. The image is reflected into the mirror repeatedly, creating an optical illusion. We Have Met the Enemy, and He Is Us
    Cybersecurity expert Axel Wirth shares his thoughts on the recent U.S. Executive Order and an urgent need to strengthen cybersecurity in healthcare sectors. Learn how the key to improvement will be turning the right culture into action. A CYBERINSIGHTS feature.
  • A little girl watches a woman present through video chat. Innovators Sought for Technologies to Improve Pediatric Mental Health
    The Center for Advancing Innovation (CAI) and Children’s National Hospital are seeking submissions for the upcoming “Innovate Children’s Health Challenge,” an event to encourage the commercialization of technology to improve children’s healthcare—in particular, advances in diagnostics, therapeutics, and digital health tools that address pediatric mental health.
  • A doctor works on a tablet with medical devices in the background. AAMI Health IT Committee Embraces Life Cycle Approach in Developing HIT1000 Series of Standards
    Experts involved in the development of the AAMI HIT1000 series for health IT explain what it took to design a series of standards with a total lifecycle approach. A SETTING STANDARDS feature.
  • Sterile packaging lab staff Surveying the Field: KiiP Team Gains Deeper Insight into Sterile Packaging and Its Use
    The processes involved in delivering a sterile medical device to the sterile field involves a complex web of activities and stakeholders. The Kilmer innovations in Packaging project group surveyed these stakeholders to discover important trends and perspectives. A STERILIZATION CENTRAL feature.
  • HospSterilization_Sq_247618456 Joint Commission Checklist Proves ‘Instrument-al’ for Sterile Processing Department
    The management team at the Ann & Robert H. Lurie Children’s Hospital of Chicago share how to best prepare your sterile processing department for an unexpected visit from The Joint Commission.