AHRMM LUC Comments to the FDA’s Communications About the Safety of Medical Devices

By AHRMM

On November 17, 2020, the FDA held a virtual public meeting to discuss it’s communication process related to medical device safety. 

The purpose of the meeting was to discuss the development, content and format of the FDA's safety communications about medical devices. The goal of this public meeting was to share the FDA's current practices for medical device safety communications, and to hear from stakeholders (including patients and caregivers, health care providers, regulated industry, and media) about ways to improve the FDA’s safety communications to ensure stakeholders receive the information they need in a timely, clear, and consistent manner.

The AHRMM Learning Unique Device Identifier (UDI) Community (LUC) members submitted public comments and recommendations at the November 2020 meeting related to the need to include the UDI in the recall process. They highlighted the prototype recall database and electronic submission form, as well as survey data supporting its creation.

AHRMM sponsors the Learning UDI Community (LUC). The LUC is comprised of physicians, clinicians, hospital supply chain professionals, manufacturers, distributors, software application providers, health care consultants and representatives from Group Purchasing Organizations (GPOs), GS1, HIBCC, HIDA and the FDA. The mission of the LUC is to enhance patient safety and improve supply chain efficiency by developing recommended practices that speed the adoption and maximize the utilization of the UDI. 

To date, there have been 13 LUC workgroups involving over 600 individuals that have addressed a wide range of issues from making the business case for UDI to incorporating the UDI throughout the recall process.

 

Download the LUC Comments

 

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