AAMI

AAMI Releases Guidance on Dilator, Ultrasound DeSterilization

Retrieved on: 
Wednesday, April 17, 2024
Rhea, Kaiser Permanente, Infection, Disinfectant, AAMI, Transport, Decontamination, Patient safety, Criterion, Patient, Classification, TIR, Sterilization

AAMI TIR99:2024; Processing Of Dilators, Transesophageal And Ultrasound Probes In Health Care Facilities provides comprehensive information for healthcare providers and sterile processing professionals on the selection, labeling, and processing of dilators and ultrasound probes.

Key Points: 
  • AAMI TIR99:2024; Processing Of Dilators, Transesophageal And Ultrasound Probes In Health Care Facilities provides comprehensive information for healthcare providers and sterile processing professionals on the selection, labeling, and processing of dilators and ultrasound probes.
  • He stated:
    This TIR addresses questions about the appropriate and acceptable way to store, transport, clean, disinfect and sterilize ultrasound probes in a healthcare setting.
  • Adoption of this TIR will give users and processing areas a more standardized process, regardless of the setting where ultrasound probes are used or processed.
  • Those interested in a full copy of the guidance document can find AAMI TIR99 here .

AAMI Announces Ralph Basile Appointed to Philanthropic Activities for the AAMI Foundation

Retrieved on: 
Wednesday, April 10, 2024
Corporation, Health, AAMI, Getinge, Research, Organization, Nursing

Arlington, Virginia, April 10, 2024 (GLOBE NEWSWIRE) -- AAMI is pleased to announce that Ralph Basile, standards corporate executive at Healthmark, will be stepping into a new philanthropic role with the AAMI Foundation.

Key Points: 
  • Arlington, Virginia, April 10, 2024 (GLOBE NEWSWIRE) -- AAMI is pleased to announce that Ralph Basile, standards corporate executive at Healthmark, will be stepping into a new philanthropic role with the AAMI Foundation.
  • Basile’s responsibilities will include raising charitable donations and assisting the Foundation in awarding scholarships, research grants, and other awards to noteworthy recipients.
  • A recognized healthcare industry leader and standards developer, Basile will also identify new areas for the AAMI Foundation to further its mission.
  • While Basile is taking on a new role with the AAMI Foundation, he will continue his role at Healthmark, a Getinge Company.

The Inner Circle acknowledges Jennifer A. Vazquez as a Pinnacle Lifetime Member

Retrieved on: 
Thursday, April 4, 2024
Kentucky Association, Biomedicine, Biomedical engineering, University, Biomedical technology, Growth, Projection, Central Florida, Learning, Knowledge, USB On-The-Go, AAMI, Biomedical equipment technician, DeVry University, Health technology, Health, Inner circle

CINCINNATI, April 4, 2024 /PRNewswire/ -- Prominently featured in The Inner Circle, Jennifer A. Vazquez is acknowledged as a Pinnacle Lifetime Member for her contributions in Medical Technology.

Key Points: 
  • CINCINNATI, April 4, 2024 /PRNewswire/ -- Prominently featured in The Inner Circle, Jennifer A. Vazquez is acknowledged as a Pinnacle Lifetime Member for her contributions in Medical Technology.
  • Jennifer A. Vazquez, a dynamic professional in the field of medical technology, has garnered recognition for her exceptional contributions and achievements in biomedical engineering.
  • With an impressive educational background and a commitment to excellence, Jennifer has established herself as a rising star in the industry.
  • Jennifer A. Vazquez attributes her success to the guidance and mentorship she has received from individuals such as Mr. Edward Reyes and Mr. Enrique Vazquez.

Electromagnetic Compatibility and Radio Compliance for Medical Devices, Upcoming Webinar Hosted by Xtalks

Retrieved on: 
Wednesday, April 3, 2024
RFID, FCC, Medicine, Knowledge, AAMI, IEC, Radio, Risk assessment, Immunity, Safety, EMC, FDA, ANSI, Federal Communications Commission, Medical device

TORONTO, April 3, 2024 /PRNewswire-PRWeb/ -- Is the team designing a medical device and seeking guidance on electromagnetic compatibility regulatory requirements? Or is there a need to integrate a radio into the device, necessitating an understanding of Federal Communications Commission (FCC) and The United States Food and Drug Administration (FDA) regulations? Would less regulatory pushback accelerate the time to market? Is there an interest in acquiring more knowledge and guidance for this process?

Key Points: 
  • In this free webinar, gain insights into electromagnetic compatibility (EMC) requirements for medical devices.
  • TORONTO, April 3, 2024 /PRNewswire-PRWeb/ -- Is the team designing a medical device and seeking guidance on electromagnetic compatibility regulatory requirements?
  • In this webinar, the expert speakers will discuss basic electromagnetic compatibility requirements under IEC 60601-1-2, the growing fields of radio frequency identification (RFID) immunity, wireless coexistence, and more.
  • Register for this webinar today to gain insights into factors that need to be considered when designing a medical device as well as obtain guidance on electromagnetic compatibility regulatory requirements.

Scutum Expands its Reach in Florida with Integration of AAMI

Retrieved on: 
Friday, March 29, 2024
Diamond, Growth, CE, AAMI, SME

NEW YORK, March 26, 2024 /PRNewswire/ -- Scutum, a global security and fire protection service provider, announced today that Affordable Alarm and Monitoring Inc. (AAMI) has joined Scutum North America.

Key Points: 
  • NEW YORK, March 26, 2024 /PRNewswire/ -- Scutum, a global security and fire protection service provider, announced today that Affordable Alarm and Monitoring Inc. (AAMI) has joined Scutum North America.
  • This new milestone expands the group's reach in Florida and consolidates its position as a leading security expert across the state.
  • Founded in 1994, AAMI serves high-end residential and small and medium enterprise clients on the Gulf side of Florida.
  • Headquartered in Naples, Florida, AAMI also has Sarasota, Tampa, and Summerfield offices.

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

Retrieved on: 
Monday, January 8, 2024
Nexus, Conference, University of Utah, Food, Johnson & Johnson, FDA, NEXUS, ISC, QSR, AAMI, ASCA, University, Omni Shoreham Hotel, Sterilization, Device, CDRH, Ethylene oxide, ISO, USB On-The-Go, Intuitive Surgical, Medical device

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
Food, Risk management, Risk, Patient, ANSI, FDA, AAMI, USB On-The-Go, Security, Hospital, Medical device

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
Organization, American Dental Association, Consumer, American Petroleum Institute, AAMI, ASTM International, USB On-The-Go, ANSI, NSF International, API, CTA, NIST, Consumer Technology Association

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
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 .

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

Retrieved on: 
Monday, October 30, 2023
Class II, AAMI, Product lifecycle, Johns Hopkins University, SS, Johnson & Johnson, Digital Solutions, Robotics, University, OTC, Johns, Organization, American Society for Microbiology, Society, Mantra, BSI, BSI Group, Partnership, Head, Stroke, Sterilization, Quality function deployment, Quality, SSI, Medtronic, Ethylene oxide, Pharmaceutical industry, Medical device, MD

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.