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FDA issues import alert, additional recommendations against using plastic syringes made in China 

The Food and Drug Administration yesterday announced an import alert for plastic syringes manufactured by two China-based manufacturers, in addition to recommendations against using any other Chinese-manufactured plastic syringes.

FDA clarifies definition of 'remanufacturing' for medical devices needing maintenance

The Food and Drug Administration May 9 released final guidance clarifying the definition of “remanufacturing” for reusable medical devic

AHRMM Supply Chain Fundamentals

The Supply Chain Fundamentals eLearning series provides foundational skills for supply chain professionals. Participants will learn how to develop and apply tools, approaches, and techniques used in the design and operation of health care systems and the integrated supply chain.

UDI: A How-To Guide for Implementation with Your Organization

On-Demand Educational Webinars
This session explains the benefits of implementing the UDI such as immediate device status updates through collaboration with manufacturers and suppliers, increased patient care satisfaction, and how the data you collect can turn your analytics into strategic and critical business decisions. Learn the step by step process that FMOLHS used to implement UDI.

The UDI Rule: Are You Ready?

On-Demand Educational Webinars
Hospitals need a tool to leverage the use of UDI within their health care organizations to empower the Cost, Quality, Outcomes Movement. This webinar explains the many benefits the UDI system can bring both to a hospital’s bottom line and to patients. With proper tools implemented by healthcare providers, UDI will help to lower cost and increase quality, thereby improving patient outcomes.

AHRMM LUC Comments to the FDA’s Draft Guidance for Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices

The AHRMM LUC members submitted comments and recommendations to the FDA's Draft Guidance for Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices. They recommend that information related to all Class I Medical Devices be included in the GUDID without exception.

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.

Unique Device Identifier (UDI-DI) Communication Change Process Report

The UDI-DI Change Communication Process Work Group, a part of AHRMM's Learning UDI Community (LUC), recently released a report analyzing current communication processes and their implications on all stakeholders related to changes to the UDI-DI. Gain a clear understanding of how these changes are documented in affected software systems, identify gaps between current and desired states, and develop recommended practices to improve the process for all stakeholders.

Assuring Patient Safety through Capture and Management of Product Attributes

Supply chain attributes inform critical supply availability and alignment with internal and external needs, integral to meeting pressures to deliver safe care.

Minimizing Medical Tubing Misconnections - The ENFit® Patient Safety Initiative

A panel of provider thought leaders as discusses the ISO 80369-3 (ENFit) small bore connector conversion successes, lessons learned and implementation processes.