AAMI

AAMI and FDA Co-Sponsor Medtech Conference, ‘AAMI and FDA neXus'

Retrieved on: 
Monday, January 8, 2024

The conference will feature a wealth of FDA experts alongside industry members and will focus on the latest information on medical device regulations and standards.

Key Points: 
  • The conference will feature a wealth of FDA experts alongside industry members and will focus on the latest information on medical device regulations and standards.
  • Real-world evidence and medical device safety, presented by Daniel Caños, director of the Office of Clinical Evidence and Analysis at CDRH.
  • The FDA case for quality, delivered by Francisco Vicenty, FDA consumer safety officer.
  • Development, adoption, and now application of standards, neXus covers it all.”
    Those interested in attending can find registration for the AAMI FDA neXus here .

FDA Gives Full Recognition to AAMI Cybersecurity Guidance Document

Retrieved on: 
Tuesday, November 14, 2023

Arlington, VA, Nov. 14, 2023 (GLOBE NEWSWIRE) -- The Association for the Advancement of Medical Instrumentation (AAMI) is proud to announce that the U.S. Food and Drug Administration has officially extended complete recognition to AAMI’s groundbreaking guidance document on medical device cybersecurity, ANSI/AAMI SW96.

Key Points: 
  • Arlington, VA, Nov. 14, 2023 (GLOBE NEWSWIRE) -- The Association for the Advancement of Medical Instrumentation (AAMI) is proud to announce that the U.S. Food and Drug Administration has officially extended complete recognition to AAMI’s groundbreaking guidance document on medical device cybersecurity, ANSI/AAMI SW96.
  • Per the FDA, ANSI/AAMI SW96:2023, Standard for medical device security - Security risk management for device manufacturers , is an important resource for medical device sponsors.
  • The agency’s original announcement states, “The FDA encourages use of this new standard to enhance quality and support product performance.”
    Matt Williams, vice president of standards at AAMI, said, “FDA recognition of ANSI/AAMI SW96 is a major milestone.
  • SW96 is also the first industry guidance document that provides specific requirements for managing cybersecurity across a product’s life cycle.

ANSI Board of Directors Names Volunteer Leaders for 2024

Retrieved on: 
Wednesday, December 13, 2023

The following individuals will serve as chairs of the Institute's Policy Advisory Groups: Henry Wixon, NIST (Intellectual Property Rights Policy Advisory Group); Jeff Grove, ASTM International (National Policy Advisory Group); and Ajit Jillavenkatesa, Apple (International Policy Advisory Group).

Key Points: 
  • The following individuals will serve as chairs of the Institute's Policy Advisory Groups: Henry Wixon, NIST (Intellectual Property Rights Policy Advisory Group); Jeff Grove, ASTM International (National Policy Advisory Group); and Ajit Jillavenkatesa, Apple (International Policy Advisory Group).
  • Amanda Benedict, Association for the Advancement of Medical Instrumentation (AAMI), will chair the ANSI ISO Council.
  • Jessica Evans, NSF International, will chair ANSI's Board of Standards Review.
  • Veronica A. Lancaster, Consumer Technology Association (CTA), will serve as USNC president and chair of the USNC Council.

Cardinal Health launches SmartGown™ EDGE Breathable Surgical Gown with ASSIST™ Instrument Pockets

Retrieved on: 
Thursday, November 9, 2023

DUBLIN, Ohio, Nov. 9, 2023 /PRNewswire/ -- Cardinal Health (NYSE: CAH) announced today the U.S. launch of its SmartGown™ EDGE Breathable Surgical Gown with ASSIST™ Instrument Pockets, created to provide surgical teams safe and convenient instrument access in the operating room. Exclusively available from Cardinal Health, the gown is designed to hold one recommended instrument per pocket during surgical procedures, helping to provide handling efficiency and enabling clinical teams to focus on delivering safe patient care.

Key Points: 
  • SmartGown™ EDGE is the first pocketed surgical gown designed to help maintain instrument sterility and accessibility.
  • DUBLIN, Ohio, Nov. 9, 2023 /PRNewswire/ -- Cardinal Health (NYSE: CAH) announced today the U.S. launch of its SmartGown™ EDGE Breathable Surgical Gown with ASSIST™ Instrument Pockets, created to provide surgical teams safe and convenient instrument access in the operating room.
  • Exclusively available from Cardinal Health, the gown is designed to hold one recommended instrument per pocket during surgical procedures, helping to provide handling efficiency and enabling clinical teams to focus on delivering safe patient care.
  • For more information on SmartGown™ EDGE Breathable Surgical Gown with ASSIST™ Instrument Pockets, please visit us here .

SS Innovations Appoints Dr. Sonia Shokeen as Head of Quality and Regulatory Affairs

Retrieved on: 
Monday, October 30, 2023

FORT LAUDERDALE, FL, Oct. 30, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire -- SS Innovations International, Inc. (the “Company” or “SS Innovations”) (OTC: SSII), a developer of innovative surgical robotic technologies dedicated to making robotic surgery affordable and accessible to a global population, today announces the appointment of Dr. Sonia Shokeen as Head of Quality and Regulatory Affairs.

Key Points: 
  • Dr. Shokeen will lead SS Innovations’ Product Lifecycle Management, Quality System Management, regulatory strategy, and international submissions.
  • Dr. Sudhir Srivastava, Chairman of the Board and Chief Executive Officer of SS Innovations, said, “Dr.
  • Shokeen brings a wealth of experience to this role, and I am delighted to welcome her to the SS Innovations team.
  • Prior to joining SS Innovations, Dr. Shokeen led Quality Function in senior management roles at Johnson and Johnson (Auris Health) in its Robotics and Digital Solutions franchise in Redwood City, CA.

Introducing AAMI neXus, the Evolved International Standards Conference

Retrieved on: 
Monday, October 16, 2023

Held from February 20 to 23, 2024, at the Omni Shoreham Hotel in Washington, D.C., AAMI neXus takes the place of the International Standards Conference (ISC).

Key Points: 
  • Held from February 20 to 23, 2024, at the Omni Shoreham Hotel in Washington, D.C., AAMI neXus takes the place of the International Standards Conference (ISC).
  • Since 1991, ISC was the must attend conference for industry and regulatory leaders involved in the development and adoption of medical device standards.
  • AAMI neXus features ISC’s previous programming but includes a new focus on applying medical device standards.
  • Robert Burroughs, AAMI chief learning and development officer said, “We’re excited to bring the same focus from ISC to AAMI neXus but to add material on standards application.

Association for the Advancement of Medical Instrumentation Awards Grants to Researchers at Michigan State, Emory University, BD Medical, PAXXUS, Inc.

Retrieved on: 
Tuesday, September 19, 2023

The AAMI Foundation’s Kilmer Fund Committee awarded these grants to projects that seek to advance the science of microbiological quality and sterility assurance.

Key Points: 
  • The AAMI Foundation’s Kilmer Fund Committee awarded these grants to projects that seek to advance the science of microbiological quality and sterility assurance.
  • They include:
    $11,542 to Emory University and Emory University Hospital researchers to investigate autoclave steam effluent as a route to pathogen escape.
  • $10,000 to Michigan State University researchers to assess how healthcare workers respond to packing design features in sterility barrier packaging.
  • $13,767 to researchers at BD Medical’s Global Sterility Assurance to evaluate the effect of culture media selection and incubation conditions to recover radiation resistant microorganisms.

Join GCEA for 5th International Clinical Engineering & HTM Congress in Visakhapatnam, India

Retrieved on: 
Thursday, September 7, 2023

Arlington, Virginia, Sept. 07, 2023 (GLOBE NEWSWIRE) -- Are you interested in promoting international cooperation in clinical engineering and healthcare technology management?

Key Points: 
  • Arlington, Virginia, Sept. 07, 2023 (GLOBE NEWSWIRE) -- Are you interested in promoting international cooperation in clinical engineering and healthcare technology management?
  • The Association for the Advancement of Medical Instrumentation (AAMI) is collaborating with the Global Clinical Engineering Alliance (GCEA) to bring clinical engineering experts from around the world together to collaborate and share their knowledge.
  • The 5th International Clinical Engineering & Health Technology Management Congress (ICEHTMC) will be held in Visakhapatnam, India from November 10 - 13, 2023, and will focus on the lifecycle of medical devices and lessons learned from the COVID-19 pandemic.
  • GCEA interim president Yadin David stated, “Healthcare is a local issue, but the technology that supports the delivery of healthcare services is international.

Protaryx Medical Welcomes David Mester as New CEO to Spearhead Advancements in Transseptal Access Technology

Retrieved on: 
Tuesday, September 12, 2023

Protaryx Medical, a pioneer in medical device innovation, today announced the appointment of David Mester, MBA as its new chief executive officer (CEO).

Key Points: 
  • Protaryx Medical, a pioneer in medical device innovation, today announced the appointment of David Mester, MBA as its new chief executive officer (CEO).
  • Protaryx Medical is known for its Protaryx Transseptal Access Device, a cutting-edge technology for transseptal procedures that provides streamlined access to the left side of the heart through the fossa ovalis.
  • What sets the Protaryx device apart is its unique integration of access and transseptal crossing functions into a single device that can be used independently or integrated with another therapy device.
  • Prior to joining Protaryx Medical, Mester held pivotal senior business and technical leadership roles at Sequoia Medical, Xeltis, Gore Medical, CarboMedics, and ViVitro Labs.

New AAMI Standard on Water Quality for Medical Device Processing

Retrieved on: 
Wednesday, August 16, 2023

The first standard of its kind, ANSI/AAMI ST108:2023, Water for the processing of medical devices, revises and replaces AAMI TIR34:2014/(R)2021 , which provided information and guidance on water quality for device reprocessing.

Key Points: 
  • The first standard of its kind, ANSI/AAMI ST108:2023, Water for the processing of medical devices, revises and replaces AAMI TIR34:2014/(R)2021 , which provided information and guidance on water quality for device reprocessing.
  • AAMI’s Water Quality for Medical Device Processing Working Group developed ANSI/AAMI ST108 by reaching a consensus on research-based evidence and industry best practices.
  • Terra Kremer , co-chair of AAMI’s Water Quality for Medical Device Processing Working Group said:
    The release of this document will be a huge shift for the healthcare industry.
  • The current document AAMI TIR34 makes recommendations, but elevating its content to a standard will encourage healthcare facilities to voluntarily conform with best practices for device processing water quality.