The Latest News from AAMI
AAMI News, January 2020, Vol. 55, Issue 1
Issue Highlights
- Navigating E.U. Regulatory Reorganization under MDR
- Recruiting the Next Generation with 'HTM in a Box'
- A Call for More Detailed Metal Implant Labeling
- More Innovators Enter the Robotic Space
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Navigating E.U. Regulatory Reorganization under MDR
The E.U.’s MDR replaces the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive and provides a new set of regulations to improve transparency and administer the production and distribution of medical devices
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Recruiting the Next Generation with ‘HTM in a Box’
With fewer qualified candidates in the hiring pool and an aging workforce, recruiting new healthcare technology management professionals is more important than ever.
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A Call for More Detailed Metal Implant Labeling
The FDA's Immunology Devices Panel is pushing for more stringent labeling requirements for manufacturers of metal-containing medical implants.
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More Innovators Enter the Robotic Surgery Space
Medical robots can make minimally invasive surgeries easier with robot-assisted surgery.
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News in Brief - January 2020
News from the field.
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Surgical Robots: A Biomedical Engineering Challenge
The integration and maintenance of surgical robots present unique challenges to healthcare technology management professionals.
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Siemens Healthineers Acquires Precision Robotics Innovator
Siemens Healthineers has acquired Corindus Vascular Robotics for $1.1 billion in a cash deal that gives the Munich, Germany-based company a precision robotics system aimed at endovascular coronary and peripheral vascular interventions.
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Chinese Regulatory Authority Meets with AAMI, ANSI
Delegates from the Chinese National Medical Products Administration (NMPA) met with AAMI and the American National Standards Institute (ANSI) standards staff in Washington, D.C.
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CDRH Pilot, Innovation Challenges Address Ethylene Oxide Hurdles
The FDA Center for Devices and Radiological Health has launched a voluntary pilot project for industry to help facilitate new sterilization methods that use less ethylene oxide and hasten approvals for sterilization site relocations.
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Remembering Fenil Sutaria
Clark W. Houghtling, vice president of business development and technical affairs at the Cosmed Group headquartered in Jamestown, RI, shared his tribute to Fenil Sutari.
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Tech World: Laser Safety Is a Big Deal
Laser safety can be thought of as safeguarding against worst-case scenarios—those times when the safety mechanism on the laser fails or a staff member forgets to perform a task.
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The Big Picture: AAMI Standards Meeting
A joint meeting of the AAMI Committee on Standards Strategy and the AAMI Standards Board.
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Asked & Answered: Medical Device Sterilization Validation
Is it possible to do medical device sterilization validation at your healthcare facility? If so, is there a good resource for how to do it?
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Career Center: A ‘Starter Kit’ for HTM Compliance Programs
The “starter kit” auditing workbook is nearly completely customizable to fit the needs of any HTM department of any size.
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One on One with Stéfan Robert
STÉFAN ROBERT is senior staff, systems design engineer at Dexcom in San Diego, CA.
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AAMI All Star: Larry Talapa
Larry Talapa is a technical service specialist and microbiologist at 3M in St. Paul, MN.
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Members on the Move: January 2020
Members who, what, and where.
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Standards Spotlight: U.S. Adopts Two Medical Robotics Standards
Two international standards for medical robots are being adopted as American National Standards.