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Human cells, tissues, or cellular or tissue-based products (HCT/Ps) are a precious resource often provided by deceased donors and/or acutely grieving family members. Living donors also provide HCT/Ps that can improve and save lives of recipients in need. Tissue banks, eye banks and cellular therapy laboratories handle these products of human origin with care and respect, understanding the special gift of donation. It is important this care and respect is followed from the time of donation and recovery to the moment of implant, transplant, infusion, or transfer to a human recipient. This guidance document, developed by a work group of the AHRMM Learning UDI Community (LUC) provides information on HCT/Ps, HCT/Ps regulation as a medical device, traceability of HCT/Ps, and the U.S. Food and Drug Administration (FDA) Unique Device Identification (UDI) Rule and its effects on HCT/Ps regulated as a medical device.
January 12, 2018 | Content Areas: Strategic Planning | Tags: Data Standards, Regulatory, UDI | Formats: Case Study
Read how FMOLHS has been working to leverage UDI barcodes and system integration for the automation of product data capture in the electronic health record (EHR). Through this work, they hope to increase the accuracy and completeness of product data in patients’ medical records, and improve workflow efficiency so that clinicians can spend less time on product documentation and more time on patient care.
December 11, 2017 | Content Areas: Support Services | Tags: Clinical Resource Management, Legislative, Regulatory, Suppliers | Formats: Webcast
Get an update on current FDA and Congressional activity on independent service for reusable medical devices and the potential impact on your costs and level of service. Learn what you can do to get ready for potential changes that could affect your organization.
AHRMM’s Senior Director, Mike Schiller, Makes the Case for UDI Adoption.
September 15, 2017 | Content Areas: Procurement | Tags: Contracting, Cost Management, CQO, Strategic Sourcing, Sustainability | Formats: On-Demand Recording | CPE Credit: 1
Even with product total cost of ownership (TCO) calculations in mind, there are additional cost savings, and environmental and human health impacts that are often missed. Learn how a new free tool has helped reduced both.
This AHRMM Fellow paper will define the regulation and explore how a supply chain department can support their organization in meeting this aspect of the regulations. Understanding the alphabet soup of acronyms that is Unique Device Identifier (UDI), their meaning, how to understand and read the standardized labeling are crucial first steps. Organizations should able to identify what defines an implant. Recognizing why is there a need to capture barcode information and have that information recorded in a patient’s record will improve continuity of care.
April 11, 2017 | Formats: On-Demand Recording
Kevin McDonald, Mayo Clinic’s director of clinical information security, discusses the proactive steps his organization takes to evaluate the security of medical devices before procurement and how such an approach may help other hospitals and health systems work with manufacturers to improve device security. A replay of this webinar is accessible from www.aha.org/cybersecurity.