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Legacy

How the FDA's UDI Regulation Benefits the Healthcare Supply Chain, Patient Care and the Bottom Line

Supply Chain Strategies & Solutions Article
Medical device manufacturers have been working hard to comply with the new Unique Device Identification (UDI) regulations from the FDA that are aimed at bolstering the safety of medical devices.
Analytics & Research, Cost Management, Data Standards, Financial Management, Unique Device Identifier (UDI), Medical Device Technology

FDA announces digital health services pilot 

The Food and Drug Administration announced Dec. 5 that it will launch the Technology-Enabled Meaningful Patient Outcomes for Digital Health Devices Pilot, or TEMPO, an initiative aimed to promote access to certain digital health devices.
Medical Device Technology, Medical Device Technology

Guidance on Humidity Levels in the Operating Room

Advisory
Guidance on Humidity Levels in the Operating Room
Data Standards, Financial Management, Materials Management Information System (MMIS), Regulations and Regulatory Advocacy, Medical Device Technology

UDI Forum 2025: Powered by the AHRMM LUC

Discover how UDI will improve patient care, ensure traceability, streamline workflows and unlock actionable data that drives innovation and prepares your organization for future challenges and opportunities.
UDI and Data Standards, Unique Device Identifier (UDI), Medical Device Technology, Logistics, Learning UDI Community, Medical Device Technology, Data & Insights

FDA warns of potential to miss notifications on smartphone-compatible diabetes devices

The Food and Drug Administration Feb.
Leveraging Technology, Medical Device Technology
Public

AHA Responds to Commerce Department Investigation of Critical Minerals

AHA comments on the Department of Commerce’s request for public comment on its Section 232 national security investigation on processed critical minerals and derivative products.
Medical Device Purchasing, Medical Device Technology, Supply chain management, Tariffs

UDI Impacts on Recall Management Work Group Report

The UDI Impacts on Recall Management Work Group, a part of AHRMM's Learning UDI Community (LUC), has released their recommended practices reports that analyzes the barriers and highlights the benefits to patient safety and key stakeholder groups when utilizing the UDI throughout the recall process. Work group members identified recommended practices for each of these groups underscoring mutual areas for improvement in the safety and efficacy of the recall process. In addition to the two Impact Reports, there is also a comprehensive Regulatory Resource Guide and a Supporting Information document with detailed reports, resource links, surveys and summary presentations that the work group members created, as well as a Recall Time & Cost Collection Tool.
Learning UDI Community, Medical Device Technology, Regulations and Regulatory Advocacy, Unique Device Identifier (UDI)

Technology goes high-touch in the patient environment

Making up for tight budgets and reduced staffing
Health Care Facility Technology Systems, Medical Device Technology

ECRI lists top 10 medical tech hazards for 2017

The organization addresses new and old concerns that can lead to infection and other patient issues
Health Care Facility Technology Systems, Medical Device Technology

Incorporating technology into health care facilities

Robert P. Maliff of ECRI Institute discusses how to achieve rapid development of medical technology
Health Care Facility Technology Systems, Medical Device Technology