AAMI News, September 2021, Vol.56, No.9


AAMI News September 2021

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





  • GlobalNetworking_ISC_217569173_sq Key MedTech Subjects Highlighted at 2021 International Standards Conference
    The AAMI/FDA/BSI 2021 ISC will be a dynamic review of recent changes and a look to what’s ahead in medtech standards and regulation. The three-day virtual conference will focus on three major subjects and two keynotes that you won't want to miss.
  • Nurses work with a training dummy in a hospital room. New VA Center Aims to Partner with Industry on Risk Assessment
    The Veterans Health Administration is creating a new Clinical Systems Performance Evaluation Center (C-SPEC) that will support companies in systematically assessing and mitigating healthcare technology risk.
  • Matt Neil hold his son Isaiah while standing in front of a machine for radiation treatment ‘Daddy’s Machine’: HTM Professional Services Son’s Radiation Therapy Device
    Matt Neil, a radiotherapy service engineer at BJC Healthcare in Springfield, MO, has been servicing the device that delivers his son's radiation therapy treatments, experiencing firsthand how HTM professionals ensure that every family gets the best possible care.
  • MedicalDeviceMonitor_278890190_sq AAMI Responds to FDA Discussion Paper on Cybersecurity and Servicing
    The Center for Devices and Radiological Health at the FDA sought input on the crucial topic of protecting medical devices from cyberattacks. Now, AAMI and our wealth of knowledgeable members have weighed in on how HTM professionals can help.
  • Heidi Horn sq Voices of HTM: Heidi Horn
    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.
  • Mike Powers sq1 Voices of HTM: Mike Powers
    <p>Mike Powers used to run a nuclear reactor in the U.S. Navy. "The neat thing about that job was getting to work with radiation and electronics daily. The other best place to work with those two things is medical imaging equipment, and so a transition into a different-but-similar field was a natural step," said Powers, who's now director of clinical engineering at Intermountain Healthcare.</p>
  • Priyanka Upendra sq Voices of HTM: Priyanka Upendra
    As the senior director of customer success at Asimily, Priyanka Upendra's mission is “healing the devices that heal.”
  • Voices of HTM - Renee Gordon sq Voices of HTM: Renee Gordon
    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.
  • Codi Nelson sq Voices of HTM: Codi Nelson
    Codi Nelson initially heard about the HTM field through a high school teacher. "He said his son worked on anesthesia machines, and I thought, 'Man, that sounds awesome!'"
  • Colleen H sq Voices of HTM: Colleen Haugen-Ortiz
    What does every HTM professional need? According to Colleen Haugen-Ortiz, HTM quality specialist at GE, that's "a good multi-head screwdriver."
  • Madeline Rozsa Voices of HTM: Madeline Rozsa
    "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.
  • Don Armstrong sq Voices of HTM: Don Armstrong
    Don Armstrong has been an HTM professional for nearly four decades, after falling into the field. Literally.&nbsp;
  • Fluke Biomedical logo BMET Apprenticeship Program Earns Industry Training Support
    AAMI's U.S. national BMET Apprenticeship Program&nbsp;has gained valuable new support from Fluke Biomedical. A manufacturer of biomedical test equipment and training software, Fluke is offering free Advanced Training Courses to participating apprentices.
  • Fernanda Zamudio poses while backpacking. Voices of HTM: Fernanda Zamudio
    BMET Fernanda Zamudio works at Tenet Health at The Hospitals of Providence in El Paso, TX. While working on a variety of medical equipment, she specializes in respiratory equipment.
  • JoJo Gonzalez IamHTM Sq Voices of HTM: JoJo Gonzales
    "We strive for and keep aloha in our hearts." Managing Kaiser Permanente's island-wide maintenance service program in Hawaii can be quite challenging. Thankfully, Clinical Technology Manager JoJo Gonzalez has "an outstanding team that is up to the challenge."
  • Ethylene-Oxide-Sterilization_Swabs_292265983_sq September 2021 Sterilization Standards Week Highlights: Progress and New Guidance
    A look at AAMI’s Fall 2021 Sterilization Standards Week, including updates regarding radiation sterilization, ethylene oxide, and in-person standards meetings at AAM's offices in Arlington, Virginia.
  • Man stands dwarfed by a technological cloud When Is Cloud Technology Appropriate? Best Practices for Medical Devices
    Experts from industry, medical device software development, and regulatory consulting recently pooled their knowledge to develop a new guidance document for the appropriate use of public cloud computing both as a component of medical devices and in support of quality systems.
  • An audio waveform flows in and out of an ear Updated IEC 60601-1-8 Breaks New Ground in Development of Alarm Sounds
    The International Electrotechnical Commission’s (IEC’s) 60601 series of technical standards is concerned with the safety of medical electrical equipment and represents a benchmark for the commercialization of medical equipment in many countries. A SETTING STANDARDS feature.
  • Pic New Technology Uses AI and Machine Learning to Identify Pediatric Genetic Disorders
    For children with certain rare genetic disorders, the difference between life and death too often depends on their diagnosis. If they’re lucky enough to be identified early, the interventions they have available can be more effective, and developmental support can be provided when it’s needed most.&nbsp;
  • FDA Launches Progress Tracking Program for 510(k) Premarket Applications
    The U.S. FDA has just launched an&nbsp;application progress tracking program&nbsp;that takes the guesswork out of determining the status of a 510(k) premarket application.
  • Photo portrait of Kurt Finke Finke, Healthcare Technology Management Leader, Retires from VA
    After 37 years of distinguished service, Kurt Finke, director of the Office of Healthcare Technology Management (HTM) with the U.S. Department of Veterans Affairs (VA), has retired. AAMI leadership, colleagues, and friends, celebrate the impact of his career.
  • A row of unlit lightbulbs and a single lit one. Call for Healthcare Technology’s ‘Bright Ideas,’ 2022
    AAMI is now accepting nominations for its annual “Bright Ideas” program, which recognizes innovative HTM departments that are implementing creative solutions to challenges.
  • PPE_EmergencyRoom_Hospital_421551927_sq Safety Is a Must when Repairing or Replacing Equipment in an Isolation or COVID-19 Room
    <p>What safety measures should HTM professionals follow when repairing or replacing equipment in an isolation room or COVID-19 room? BMET Specialist&nbsp;Becky Crossley explains in this TROUBLESHOOT IT feature.<br /> </p>
  • CBET-LOGO-1500_sq AAMI BMET Apprenticeship Program Gains Valuable College Support
    Will the next generation be ready to repair your medical devices? AAMI's national BMET Apprenticeship Program has gained valuable new support through the College of Biomedical Equipment Technology. The online college is offering Apprentice Program participants access to A&amp;P and mathematics courses at a reduced rate.<strong></strong>
  • Indian flag over a medical device Does India’s ICMED Plus Scheme Defy Standards Harmonization?
    Significant adjustments have recently been made India’s quality management Certification for Medical Devices (ICMED) scheme. The new scheme now has experts worried that India is stepping further away from the international harmonization of medical device standards.
  • The symbol of a lock and fingerprint float above a computer motherboard. Reflecting on CyberInsights with Axel Wirth
    Cybersecurity expert Axel Wirth has been penning CyberInsights for five years. He takes a moment to reflect on the article series and answer five questions that have been essential to medical device cybersecurity discussions. A CYBERINSIGHTS feature.
  • Joe Deater dressed as Jon Snow from Game of Thrones for Halloween. Voices of HTM: Joe Deater
    Joe Deater is a&nbsp;BMET III at Munson Healthcare in northern Michigan and&nbsp;adjunct instructor at Northwestern Michigan College for the Biomed I and II classes for their associate degree program.
  • Karen W - Sq Voices of HTM: Karen Waninger
    Karen Waninger&nbsp;serves as corporate administrative director of healthcare technology management (HTM) for Franciscan Health, a job where "no two days are ever the same."
  • A hospital cleanroom. ISO 14698 or EN 17141: Is There a Choice for Cleanroom Compliance?
    The Chairperson of ISO/TC 209 attempts to resolve the perplexity that a new standard for controlling microorganism in clean rooms has caused for the international medical sterilization community. A&nbsp;STERILIZATION CENTRAL&nbsp;feature.
  • Herman McKenzie Ask Herman: The Joint Commission Answers Your Questions
    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.