Search Results
The default setting for search results displays All Content. If you prefer to see recent content only, please adjust the date filter.
Filter your results:
Types
Topics
77 Results Found
Report offers ways to address cybersecurity challenges posed by legacy medical devices
The Food and Drug Administration on Nov. 16 announced a new report from government contractor MITRE, Next Steps Toward Managing Legacy Medical Device Cybersecurity Risks.
LUC Resources and Deliverables
Toolkits/Methodology
AHRMM’s Learning UDI Community (LUC) is a health care collaborative effort, in collaboration with the U.S.
Announcement of GUDID Release 2.2 Deployment and Document Updates
Advisory
An announcement of GUDID Release 2.2 deployment and document updates.
Business Case for the UDI Presentation
Toolkits/Methodology
With significant pressures on hospitals and healthcare systems, it is incumbent upon those who recognize the benefits of UDI to build the business case for UDI adoption in the healthcare delivery e
FDA webinar Oct. 31 on proposed rule for laboratory developed tests
On Oct. 31 at 1 p.m. ET, the Food and Drug Administration will host a webinar to review its recent proposed rule for laboratory developed tests, which would amend the agency’s regulations to require most laboratory developed tests to meet the same medical device requirements as other in vitro diagnostic products.
Business Case for the UDI Work Group Report
Guides/Reports
Overview:
The Business Case for the UDI work group, a formal work group of the Association for Healthcare Resource & Materials Management’s (AHRMM) Learning UDI Community (LUC) is com
FDA approves first sterilization system for 3D-printed medical devices
The Food and Drug Administration the week of Aug. 7 cleared for marketing the first sterilization system for 3D-printed devices in health care facilities.
EPA proposes new standards for ethylene oxide sterilizing facilities
The Environmental Protection Agency today proposed requiring commercial sterilization facilities to comply within 18 months with stricter emission and control standards for ethylene oxide (EtO), a type of gas used to sterilize certain medical devices that cannot be sterilized using alternative methods.
FDA releases FAQs on new requirements for medical devices vulnerable to cybersecurity threats
Effective today under the Consolidated Appropriations Act of 2023, medical devices seeking approval from the Food and Drug Administration must meet certain cybersecurity requirements if they connect to the internet and contain software and technological characteristics vulnerable to cybersecurity threats.
FDA reports issues with certain reworked Philips ventilators
Philips has reported two potential issues with Respironics Trilogy ventilators that were recalled in June 2021 and reworked, the Food and Drug Administration announced last week. The silicone sound abatement foam used to replace the polyester-based polyurethane foam may separate from the plastic backing, potentially blocking the air inlet and lowering inspiratory pressure, FDA said.