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3D Printing Helps VA Patient Who Was ‘Grasping at Straws’
Brian Stallard
Jul 15, 2021
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.
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First Direct-to-Consumer Hearing Aid Receives FDA Clearance
Fran Kritz
Jul 15, 2021
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.
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IAHCSMM to Change Its Name
Gavin Stern
Jul 14, 2021
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.
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FDA Issues Final Guidance on UDI Form and Content
Randolph Fillmore
Jul 14, 2021
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.”
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FDA Updates Recommendations for Reprocessing Reusable Flexible Bronchoscopes
Randolph Fillmore
Jul 14, 2021
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.
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Improving AI-Enabled Medical Devices with Data Consortiums and Encryption Technology
Gabrielle Hirneise
Jul 14, 2021
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.
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VA New York Harbor HTM Response to COVID-19
Martha Vockley
Jul 14, 2021
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.
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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.
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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.
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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.”
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
Health Equity: The Common Denominator in FDA Initiatives for Pediatric Device Innovation
Martha VockleyJul 28, 2021The U.S. FDA is contributing to a new public-private initiative to create a strategic framework aimed at transforming the pediatric medical device ecosystem. The agency is also expanding efforts to collect crucial, real-world data.
Tips to Identify and Avoid Burnout
Jennifer PetersJul 28, 2021“Burnout” has been a buzzword for several years, even more so during the COVID-19 pandemic, when the health technology community was challenged by new stresses both at work and at home. A recent survey by The Hartford found that 61 percent of those questioned identified as being burned out.
Two Key Research Projects Win AAMI Foundation Grants
Erin ClancyJul 27, 2021The AAMI Foundation has named the 2021 recipients of the Mary K. Logan Research Award Program. Two grants, totaling $80,000, were awarded to research initiatives that focus on improving patient outcomes by advancing the landscape of clinical alarms and enhancing radiation effects on breast cancer patients.
AAMI Standards Debuts New Cloud-Based Committee Central Platform
Jul 26, 2021AAMI’s standards committees and working groups are transitioning to a new information management platform for an optimized workflow and voting process.
