The Latest News from AAMI
AAMI News, December 2019, Vol. 54, No. 12
Issue Highlights
- 2019—The Year in Review
- FDA to Focus on Lowering Ethylene Oxide Emissions
- CDRH Quality Pilot Expands to Noncompliant Manufacturers
- AAMI's Healthcare Technology Collection Puts Innovation on Display
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2019—The Year in Review
Take a look back at the people and events that defined 2019.
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FDA to Focus on Lowering Ethylene Oxide Emissions
The FDA recently convened a public advisory committee to comment on the feasibility of potential strategies to reduce or eliminate environmental ethylene oxide emissions from industrial medical device sterilization.
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CDRH Quality Pilot Expands to Noncompliant Manufacturers
The FDA has awarded the nonprofit Medical Device Innovation Consortium $2.8 million to expand their Case for Quality Voluntary Improvement Program pilot to include medical device manufacturers not compliant with the agency’s quality system regulations.
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AAMI’s Health Technology Collection Puts Innovation on Display
AAMI has unveiled its Health Technology Collection, a museum like exhibit housed at the AAMI Center for Excellence in Arlington, VA. The Collection displays the breadth and depth of medical devices designed to treat disease and improve the quality of life of patients.
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News in Brief: December 2019
News from the healthcare technology field.
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FDA Guidance Describes Process for Requesting Review of Denied Export Certificates
The Food and Drug Administration has issued final guidance describing the process an establishment must undertake if seeking review of a denied request for a Certificate to Foreign Government for a medical device.
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HTM Hits the Road in 2019!
AAMI staff members traveled to several cities and states in 2019 to meet with healthcare technology management professionals and spread the word about careers in HTM.
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New Members Appointed to AAMI Foundation Board
The AAMI Board of Directors appointed two new AAMI Foundation Board members in November to build on the Foundation’s newly focused mission and strategic plan.
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Mary K. Logan Research Grant Supports Continuous Monitoring Research
Last year, a team at Cincinnati Children’s Hospital Medical Center in Ohio was awarded the $40,000 Mary K. Logan Research Grant in order to fund a project aimed at studying effective pediatric continuous monitoring.
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AAMI Foundation Offers 10 Scholarships in 10th Year of Program
To celebrate the 10th anniversary of the Michael J. Miller Scholarship Program, the AAMI Foundation will award 10 scholarships to students pursuing a career in a healthcare technology management field.
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AAMI Resources to Add to Your Holiday Wish List
From ST79 to the CHTM Study Guide, there are plenty of AAMI resources that make good gifts.
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Tech World: Environmental Challenges in Sterile Processing
Despite the environmental challenges of sterile processing being some of the most difficult aspects for our SPDs to control, they are critical to our ability to prevent contamination of our devices and infection in our patients.
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Career Center: The Secret of Success? It's Enthusiasm
Paul Kelly, CBET, is the director of biomedical engineering, the Green Initiative, and asset redeployment at Washington Hospital in Freemont, CA; an AAMI Fellow; and a member of the AAMI Board of Directors.
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Asked & Answered: Routine Equipment Cleaning and Maintenance Processes
What routine medical equipment cleaning and maintenance processes do you follow, and how does your facility document this work for surveyors from The Joint Commission?
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One on One with Travis Lindahl
TRAVIS LINDAHL is a staff engineer for product safety at Stryker Instruments in Kalamazoo and represented the U.S. as a young professional at the 83rd IEC General Meeting in Shanghai, China, Oct. 21–25, 2019.
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AAMI All Star: Louis 'Lou' W. Schonder, Jr., CBET
Lou Schonder is the Director of earthMed in Upper Darby, PA; secretary and treasurer of the Philadelphia Area Medical Instrumentation Association.
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Members on the Move: December 2019
Who, what, and where in December 2019.
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Standards Spotlight: New Projects for Sterilization and HTM Education
The AAMI Standards Board approved three new work item proposals in November—two projects in the sterilization area and one in the medical equipment management area.