• FDA_logo_high_quality_sq_200-1 FDA Publishes Draft Guidance on Remanufacturing Medical Devices
    Randolph Fillmore
    Jul 8, 2021
    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and need periodic preventive maintenance, on June 18, the U.S. Food and Drug Administration (FDA) has published draft guidance, Remanufacturing of Medical Devices to clarify the statutory and regulatory requirements of either “servicing” a medical device or “remanufacturing” a medical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.
  • Ethernet cables neatly plugged into network hardware. HTM Lessons Learned from a Communication Loss Crisis
    Brian Stallard
    Jul 8, 2021
    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.
  • Good Morning HTM co-hosts AAMI eXchange REWIRED Success Promises ‘Bright Future’ Ahead
    Brian Stallard
    Jul 6, 2021
    AAMI’s eXchange REWIRED online conference wrapped up on June 11, proving to be a rousing success with well over 1,000 real-time participants. Attendees praised the event for delivering on the promise AAMI made to create an online event that was more than “just another virtual event.”
  • FDA_logo_high_quality_sq_200-1 UPDATED: FDA Releases Cybersecurity Discussion Paper, Seeks Feedback
    Gavin Stern
    Jul 1, 2021
    The FDA’s Center for Devices and Radiological Health (CDRH) has developed a discussion paper intended to consider cybersecurity issues that are unique to the servicing of medical devices. The agency is seeking feedback on the paper from the health technology community.
  • Photo credit: Natfirmino (CC BY-SA) Clinical Engineering’s Role at Sírio-Libanês Hospital (Brazil) during COVID-19
    Martha Vockley
    Jun 30, 2021
    For a clinical engineering department in Brazil, battling on the front lines of COVID-19 began as a struggle to reduce damage and improve the effectiveness of the hospital’s response to the pandemic. Now, the department is emerging from its most challenging days with unexpected benefits that will outlive the pandemic.
  • A technician types at a keyboard while getting live video support Efficiency in Field Repair with Live Video Support
    Martha Vockley
    Jun 30, 2021
    In an AAMI Exchange REWIRED education session, attendees learned how Draeger field technicians who are stumped by a problem can get help on the spot via live video with more experienced technicians.
  • A patient uses a digital tablet to speak with her doctor. The Gains and Pains of Digital Health
    Jennifer Peters
    Jun 30, 2021
    During the COVID-19 pandemic, many patients and healthcare providers embraced telehealth options for the first time. During AAMI eXchange REWIRED, health technology experts explored the numerous benefits and challenges posed by remote digital health options.
  • Paper faces become increasingly colorful to represent diversity. Survey: Open Positions and Untapped Diversity for HTM
    Brian Stallard
    Jun 29, 2021
    A survey of 71 healthcare organizations and more than 7,000 HTM professionals has validated ongoing concerns while making some promising revelations. The first-of-its kind survey conducted by AAMI also clearly outlines areas where the HTM field may improve.
  • HospSterilization_Sq_247618456 Joint Commission Checklist Proves ‘Instrument-al’ for Sterile Processing Department
    W. Zeh Wellington, John Olmstead, Christine Pytel
    Jun 23, 2021
    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.
  • Sterile packaging lab staff Surveying the Field: KiiP Team Gains Deeper Insight into Sterile Packaging and Its Use
    Ralph J. Basile, Malinda Elammari, Erin Kyle, Jane Severin, Katherine Olson, and Teri Meadow
    Jun 23, 2021
    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.
  • 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
    D. Classen and M. Segal
    Jun 23, 2021
    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.
  • silhouetted professionals sit around a table in front of the AAMI logo. Announcing 2021 Members to AAMI HTM Leadership Groups
    Jun 22, 2021
    Seven AAMI members and leaders in the healthcare technology management space have accepted roles on the Technology Management Council and the Healthcare Technology Leadership Committee for a three-year term.
  • FDA_logo_high_quality_sq_200-1 FDA Updates Premarket Notification Submissions Guidance for Peripheral Atherectomy Devices
    Randolph Fillmore
    Jun 21, 2021
    The U.S. FDA updated its Premarket Notification Guidance for peripheral vascular atherectomy devices aimed at removing atherosclerotic plaque from diseased arteries by cutting, shaving, sanding, or vaporizing.
  • Hospital Connectivity What HTM Professionals Need to Know about Wireless Technology
    Chris Hayhurst
    Jun 21, 2021
    HTM professionals in need of tough questions answered or CEU credits have a new resource, a just-released webinar (free to AAMI members) on medical device connectivity featuring insight from four wireless technology experts.
  • neurolutions ipsihand Device to Improve Post-Stroke Hand Grasping Gets De Novo Authorization
    Fran Kritz
    Jun 21, 2021
    The US FDA has granted De Novo authorization for a new device that combines a brain-computer-interface and exoskeleton to help stroke patients regain the use of their hand, arm, or wrist - Neurolutions, the IpsiHand Upper Extremity Rehabilitation System.
  • Medical Device Patient New View: HTM from the Patient Perspective
    Chris Hayhurst
    Jun 21, 2021
    Three people from different areas of the country with different work histories and areas of expertise. Three patients facing medical emergencies and unplanned journeys through their local healthcare systems. And finally, three stories with a common theme: They were all shared by leaders within the HTM community.
  • Industrial Sterilization Supplement 2 - sq Freely Available Sterilization Supplement Gets Second Installment
    Brian Stallard
    Jun 21, 2021
    AAMI has launched the latest installment in a growing collection of best practices and strategies for the sterilization of medical devices and tools. The series represents a unique collaboration between medical industry leaders.
  • An airplane taking off. United Airlines Introduces Telehealth-Observed COVID Self Testing
    Fran Kritz
    Jun 16, 2021
    One of the largest airlines in the United States, United Airlines, announced that a telehealth-based collaboration to help travelers returning to the U.S. comply with CDC requirements for a negative COVID-19 test taken within three days of travel.
  • FDA_logo_high_quality_sq_200-1 FDA Advises on Cybersecurity Concerns in Annual Forum
    Gabrielle Hirneise
    Jun 16, 2021
    Kevin Fu, acting director for medical device cybersecurity and program director for the DHCoE at the FDA, spoke of growing security concerns at the 2021 FDA Science Forum, addressing recent headway the FDA has made in guiding cybersecurity regulations and overcoming recent challenges within the medical device landscape.
  • A face made up of 1s and 0s represents artificial intelligence. AAMI Roundtable on AI in Healthcare
    Chris Hayhurst
    Jun 16, 2021
    For years, artificial intelligence promised to transform healthcare. So, how is AI being used in medical settings today, and what still needs to happen to make this vision a reality?