Association for the Advancement of Medical Instrumentation

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

Retrieved on: 
Thursday, November 9, 2023
AAMI, Cardinal Health, Education, Innovation, NYSE, CAH, Health, Research, Surgeon, USB On-The-Go, Pediatrics, Patient, Instrument, Association for the Advancement of Medical Instrumentation, Mayo Clinic, Medical device, Dentistry, Personal protective equipment

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 .

Introducing AAMI neXus, the Evolved International Standards Conference

Retrieved on: 
Monday, October 16, 2023
Omni, European, USB On-The-Go, Omni Shoreham Hotel, AAMI, FDA Center for Devices and Radiological Health, AI, CDRH, FDA, ISO, Medical device, Association for the Advancement of Medical Instrumentation, NEXUS, Device, Health equity, IEC, ISC, Cloud computing, Conference, Risk management

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.

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

Retrieved on: 
Thursday, September 7, 2023
AAMI, COVID-19, USB On-The-Go, International Clinical Research Center, Congress, Association for the Advancement of Medical Instrumentation, International Congress of Human Genetics, Knowledge, Health, Nursing

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
Health, Surgery, Cardiology, Medical Devices, Area studies, Heart, Boyd, AAMI, Latham, University, Louisiana State University, ISO, USB On-The-Go, MBA, University of North Carolina at Charlotte, Science, Acquisition, Latham & Watkins, Growth, FDA, Association for the Advancement of Medical Instrumentation, Management, Pharmaceutical industry, Silicon, Mester

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
Medical device, Association of periOperative Registered Nurses, AAMI, Water quality, Water, USB On-The-Go, ANSI, Sterilization, Organization, Perioperative, Association for the Advancement of Medical Instrumentation, AORN, PH, Nursing

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.

AAMI Foundation Awards ECRI Grant to Research Safety, Effectiveness of Isolation Gowns

Retrieved on: 
Wednesday, August 16, 2023
ECRI, AAMI, Health care, USB On-The-Go, Hartmut Haberland, Hope, Research, Doctor of Philosophy, Incidence, Patient, Association for the Advancement of Medical Instrumentation, Pharmaceutical industry, Personal protective equipment, Management, MD

PLYMOUTH MEETING, Pa., Aug. 16, 2023 /PRNewswire/ -- ECRI, the nation's largest independent patient safety organization, has been awarded a $80,000 grant from The AAMI Foundation to investigate the significance of isolation gown barrier penetration and identify ways to improve the protective features for healthcare workers and patients.

Key Points: 
  • Isolation gowns are personal protective equipment worn by healthcare workers to protect themselves and their patients by providing a barrier to fluid and particulate contamination.
  • In 2022, ECRI listed disposable gowns with insufficient barrier protection a Top 10 Health Technology Hazard.
  • Subsequent research conducted in ECRI's independent laboratory indicated that fluid can pass through the isolation gown's protective barrier, potentially contaminating the wearer.
  • Steve Campbell, executive director of the AAMI Foundation, said the Foundation is pleased to support the research, which was selected by a Research Review Committee from several applications received this year and approved by the AAMI Foundation Board of Directors.

Global Medical Plastics Market Report 2023: Sector is Expected to Reach $54.28 Billion by 2028 - ResearchAndMarkets.com

Retrieved on: 
Tuesday, July 4, 2023
Medical Supplies, Health, Heart, Plastic, Engineering, Polyvinyl chloride, Association for the Advancement of Medical Instrumentation, Polymer, Biometrics, Catheter, Sterilization, Mask, Application, PP, Implant, Growth, Digital, AI, Bandage, PVC, Syringe, Medical device, Polyethylene

During the forecasted period of 2023-2028, polypropylene is the fastest growing segment in medical plastics.

Key Points: 
  • During the forecasted period of 2023-2028, polypropylene is the fastest growing segment in medical plastics.
  • By Application: The report provides the medical plastics market analysis based on application: Medical Disposals, Drugs Packaging, Medical Instruments, Prosthetics and Implants and Others.
  • In 2022, North America dominates the global medical plastics market, driven by rise in geriatric population and the increasing demand for home healthcare services.
  • Asia Pacific is anticipated to be the fastest growing region in the medical plastics market.

AAMI Releases Special Report on Artificial Intelligence

Retrieved on: 
Thursday, April 13, 2023
Intelligence, Learning, AAMI, Health, Intermountain Health, HTM, Medical college, Equipment manager, Policy, Health equity, Big data, USB On-The-Go, Risk management, Black box, Minerva Surgical, Inc. v. Hologic, Inc., MS, American Medical Association, Organization, Publication, Medical College of Wisconsin, Artificial intelligence, Knowledge, Growth, AI, Bias, MPH, Association for the Advancement of Medical Instrumentation, Anesthesiology, Safety, Computer security, Medical device

AAMI has recently released an in-depth report, “ Artificial Intelligence, the Trust Issue ,” that provides expert insights for product developers, regulators, standards developers, hospital systems, healthcare technology management (HTM) professionals, risk managers, and clinicians.

Key Points: 
  • AAMI has recently released an in-depth report, “ Artificial Intelligence, the Trust Issue ,” that provides expert insights for product developers, regulators, standards developers, hospital systems, healthcare technology management (HTM) professionals, risk managers, and clinicians.
  • The report is the first of an ambitious new AAMI series of Medical Device Safety in Focus reports that will explore hot topics in healthcare technology.
  • “Communication buys grace,” added Mike Powers, system director of healthcare technology management, Intermountain Healthcare, and a member of AAMI’s Artificial Intelligence Committee.
  • The first edition of MDSIF puts you in the room with the foremost experts working at the confluence of artificial intelligence and healthcare, from multiple fields and viewpoints.

Vivera Welcomes Former FDA Investigator Dennis Moore as Regulatory and Compliance Advisor

Retrieved on: 
Tuesday, February 14, 2023
RAPS, Food and Drug Administration, Life, Compliance Advisor/Ombudsman, AAMI, Safety, Patient, Association for the Advancement of Medical Instrumentation, FDA, Pharmaceutical industry, Medical device

NEWPORT BEACH, Calif., Feb. 14, 2023 /PRNewswire/ -- Vivera welcomes Mr. Dennis Moore as its Regulatory and Compliance Advisor.

Key Points: 
  • NEWPORT BEACH, Calif., Feb. 14, 2023 /PRNewswire/ -- Vivera welcomes Mr. Dennis Moore as its Regulatory and Compliance Advisor.
  • Mr. Moore will guide Vivera through the regulatory pathway for ZICOH , the Company's intelligent, dose-controlled prescription medication delivery system.
  • Mr. Moore is a former United States Food and Drug Administration (FDA) Investigator and California Medical Device Senior Investigator with more than twenty years of experience.
  • "As a former FDA Investigator, Mr. Moore knows the ins and outs of the FDA regulatory process.

Standard for PPE Updated for Additional Equipment Types and Safety Guidance

Retrieved on: 
Wednesday, January 18, 2023
Infection, Beartown Wilderness Addition A, Classification, Blood, COVID-19, PPE, PB, Committee, Device file, Knowledge, AAMI, Emory University Hospital Midtown, ANSI, American National Standards Institute, Fluid mechanics, Personal protective equipment, Association for the Advancement of Medical Instrumentation, Medical device

That performance is based on the ability of these protective barriers to prevent exposure to blood, body fluids, and other potentially infectious materials.

Key Points: 
  • That performance is based on the ability of these protective barriers to prevent exposure to blood, body fluids, and other potentially infectious materials.
  • It also establishes an industry-wide classification system and associated labeling requirements for these various gowns and drapes.
  • Holdsworth currently co-chairs the AAMI Protective Barriers (PB) Committee, which is responsible for the standard and developed the revised new edition.
  • The PB Committee’s pandemic preparedness task group is seeking additional members, data, and materials relevant to PPE practices during a time of emergency.