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Case Studies
FMOL Health System UDI Capture Work Group Case Study
WORK GROUP TITLE: UDI Capture Work Group CASE STUDY PARTICIPANTS: James Phillips, Consulting Manager, DSI, the Office of Data Standards and Interoperability, Franciscan Missionaries of Our Lady Health System (FMOLHS) CASE STUDY ORGANIZATION:
Data Standards, Regulations and Regulatory Advocacy, Unique Device Identifier (UDI), Strategic Planning
Issue Brief
AHRMM Awareness Brief: Draft Guidance for UDI Convenience Kits
This Awareness Brief provides a quick reference to the Draft Guidance for UDI Convenience Kits, released by the FDA in January 2016. The draft guidance defines the term “convenience kit” for purposes of compliance with UDI labeling and data submission requirements only.
Data Standards, Regulations and Regulatory Advocacy, Unique Device Identifier (UDI), Procurement
Advisory
Guidance on Humidity Levels in the Operating Room
New Guidance on Humidity Levels in the Operating Room
Data Standards, Financial Management, Materials Management Information System (MMIS), Regulations and Regulatory Advocacy, Medical Device Technology
Letter/Comment
The Official Comment of AHRMM to the United States Department of Health and Human Services Food and Drug Administration (FDA) regarding Unique Device Identification for Medical Devices Docket No. FDA-2011-N-0090
AHRMM comments to the FDA regarding an amendment to the UDI proposed rule to address the UDI implementation time frame required by the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA).
Cost, Quality and Outcomes (CQO) Movement, Data Standards, Materials Management Information System (MMIS), Regulations and Regulatory Advocacy, Suppliers, Leadership
Advisory
FDA Releases Proposed Rule on Unique Device System for Medical Devices
The FDA UDI ruling has finally arrived - the proposed rule has published. Please see the FDA website (www.fda.gov/udi) for a link to the proposed regulation. Highlights include a 120 day comment period to begin shortly, 6 months later a final ruling that will begin with Class III devices within 2 years, possibly sooner. Below is the FDA press release:
Products and Services Contracting, Data Standards, Distribution, Regulations and Regulatory Advocacy, Unique Device Identifier (UDI), Logistics
Magazine & Journal Articles
A Broader Focus for Tomorrow's MMs
AHRMM's Cost, Quality, and Outcomes (CQO) Movement will provide training and education to help supply chain professionals make the correlation between cost, quality, and outcomes.
Data Standards, Financial Management, Materials Management Information System (MMIS), Regulations and Regulatory Advocacy, Strategic Planning
Letter/Comment
AHRMM Comment Letter to FDA Regarding the Draft Guidance for Industry on the Global Unique Device Identification Database (GUDID)
On November 21, 2013, AHRMM submitted electronically
Asset Management, Data Standards, Unique Device Identifier (UDI), Leadership