Explore an array of research tissues—from umbilical cord blood to skin, cartilage, liver, and lung—as we delve into the nuances of their usage in medicine and clinical trials. Gain insights into the disparities between research and transplant criteria, delve into the process of isolating primary cells, and discover how researchers harness various cell types to propel advancements in healthcare and pharmaceutical innovation. Join us for an illuminating session that promises to broaden your understanding of the vital role research tissues play in driving scientific progress.

Join us on April 3 for "Celebrating Generosity: Exploring Diverse Approaches to Honoring Donors," where we'll explore the myriad ways organizations honor and celebrate the selfless act of tissue donation. This captivating webinar brings together three speakers from different organizations to share their unique perspectives and experiences in commemorating tissue donors. Don't miss out—reserve your spot today and join us in honoring those who have given the gift of life.

This webinar will provide an overview of two important sterilization methods used for Human cells, tissues, and cellular and tissue-based products (HCT/Ps). This includes an introduction to the technology, feasibility and applications, and considerations for their use and adoption.

This webinar will provide overview of the auto-referral interface between MDI Log and several OPO call centers; its development and success.

This webinar will be the debut universal MS recovery packs! This webinar will cover the process of how the universal MS packs came to be as well as how you and your teams can access them for a more efficient and streamline recovery process!

Seven million Americans are living with a chronic wound from diabetes, heart disease or vascular disorders. Amnion grafts are used as an advanced treatments to improve healing of these wounds. Dr. Frazer will discuss how amnion grafts are used in his practice to restore movement and mobility with lower limb wounds.

The use of Normothermic Regional Perfusion (NRP) in DCD donation, while common in Europe, is recently becoming a strategy to increase organ utilization and transplant outcomes in the US. NRP enables an in situ functional assessment of organs following donor circulatory death to give transplant centers to confidence to accept those organs for their patients. Experience with NRP also shows recipient outcomes are improved compared to organs from DCD donors by the standard rapid recovery procedures.

Join us on April 17, for the second installment of AATB's webinar mini-series, "Back to Basics: From Referral to Recipient." Delve into the essential steps of the tissue donation continuum as we explore the critical processes of approaching families, facilitating authorization discussions, and completing the Donor Risk Assessment. Led by industry experts, this webinar provides an informative overview of key concepts, including AATB standards and practical examples, while offering insights into the rationale behind the UDRAI. Don't miss this opportunity to gain valuable knowledge and enhance your understanding of the tissue donation process.

This webinar will offer insights into the profound impact of tissue donation on the lives of both donor families and recipients.

In this webinar, members of AATB Quality Council and staff will introduce the newly released Educational Resource Tool on Quality Agreements. Join them to hear how and why this tool was developed, how to use it, and how it can help your organization improve relationships with your suppliers and other partners.

AATB is thrilled to offer a new and exciting webinar mini-series entitled ‘Back to Basics: From Referral to Recipient.’ This webinar mini-series is an informative overview of key concepts throughout the tissue donation continuum with a focus on answering the question, ‘Why do we do what we do?’ Our first webinar in this series will cover the start of the continuum: the referral and screening process. Speakers will cover what to ask based on the referral source, rationale behind the questions, and algorithmic screening.

Multilingual families speak a language other than English and discussing tissue donation with family members can be difficult for both, the family, and the healthcare professional. Because of this, it is important to learn more about the family’s culture, gender roles, cultural beliefs/customs etc. This educational activity will discuss how professionals working with multilingual families can make sure they are getting accurate information and the best care possible. Speakers will share best practices when it comes to translators, interpreters, resources, and other important considerations to create meaningful relationships based on trust and respect.

This webinar will highlight the many ways that non-transplant anatomical donations can also be lifesaving. We will delve into how they train future clinicians to prevent surgical error and medical complications and how they are used to train transplant recovery teams as well as transplant physicians performing lifesaving operations. We will also discuss research using these tissues results in earlier disease detection and improved treatments, and immediate application for emergency medicine professionals to save persons suffering from life-threatening injuries. The presentation includes videos and testimonials from the clinicians using these amazing gifts.

Hear about the Standards Rebuild Project from the coordinators of the program. Following the posting of the draft 15th edition in December 2023, learn about how it was designed, how you will be able to participate in this stage, and what resources AATB plans to provide to assist with the transition from the 14th edition. Bring your questions for the open Q&A that will follow the presentations.

The tissue banking industry is undergoing an “era of opportunity” as the need for supplying the medical field with a variety of regenerative medicine solutions increases. As the regulatory paradigm has evolved, so have days of tissue banks marketing products exclusively regulated as Section 361 Human Cells, Tissues, and Cellular and Tissue-Based Products. In a regulatory world where tissue may be regulated as a Section 361 HCT/P, as a Section 351 HCT/P, or even as a medical device, the requirements for reporting adverse outcomes have never been more confusing to new and existing players in this emerging regulatory space for industry. Join John Mayhall, the Mayor of Regulationville, and Kip Hanks, AATB Director of Regulatory and Governmental Affairs, as we navigate the many regulatory pathways and requirements for human tissue product adverse outcomes reporting.

This presentation will review the use of costal cartilage allografts in reconstructive ear procedures. We will discuss conditions and scenarios requiring reconstruction, surgical reconstruction options, costal graft preparation, and examples of reconstructive ear procedures.

Case Series of Self-Inflicted Sodium Nitrite Toxicity in Three Michigan Counties: A Comparison of Scene Investigations, Toxicology, and Autopsy Findings. Sodium nitrite toxicity has become increasingly popular as a means for suicide due to its ease of access within the United States. It is commercially available and used as a food additive, antifreeze admixture, and medically utilized as an antidote for cyanide poisoning. Ingestion of a large amount of sodium nitrite, an odorless, white, and water-soluble crystalline powder, can induce severe methemoglobinemia; a metabolic disorder characterized by the inability of hemoglobin to bind and carry oxygen throughout the body. The presentation highlights eight cases from three different southeast Michigan counties of suicide by sodium nitrite ingestion. The presentation also explores the social aspect in the alarming increase rate of suicide by sodium nitrite ingestion, and the careful considerations forensic pathologists need to be aware of when encountering these cases

Supporting families before, during, and after donation is a process of continuous and compassionate education. As research becomes a larger part of the donation landscape, it is critical that the professionals who work with donor families be able to fully explain how a gift could be used for research. Rather than letting a donor family envision a vague and perhaps frightening use of their loved one’s gifts, donation professionals can demystify what research is. Knowing the extensive touch to the lives of many and potential discoveries further strengthens a family’s support of donation and pride in the legacy of their loved one.

The session will be focused on removing stigma from the trans community by helping people understand the trans experience (ie, what is a trans person, and what are their unique lived experiences/health needs). If people don’t know and understand “transness” how can they work on being aware of what to take into consideration.

From updating policies to allocation and forecasting, and variation in processor-specific criteria, working with multiple processors can be challenging. This presentation will discuss challenges, processes, and improvement opportunities undertaken between donor services, quality, and recovery departments to ensure the gift is maximized through collaborative partnerships.

Supply chains and inventory management have become hot topics through COVID and the post-pandemic world. During this session, we will review lessons learned in inventory and supply management, documentation processes, instrument sterilization, and much more. Join us as representatives from three organizations compare and contrast their practices and experiences in inventory and sterile supply management.

Find out ways your Tissue Bank can support the funeral providers and make sure the donor and their family are always first. We have heard from many successful funeral provider liaisons on what their secret is to working side by side with funeral providers when it comes to donation.

Join AATB and representatives from several tissue recovery organizations for another interactive case study session. This program will review challenging and complex cases, how issues presented themselves, follow-up actions, and case outcomes. For each case, the audience will respond to the live polls to vote for how they would handle each scenario.

This session provides a review of antemortem toxicology data demonstrating substance levels beyond what is commonly deemed lethal. Increased tolerance may influence how possible overdose deaths are evaluated and impacts how we evaluate donor eligibility.

This session will have a look behind the scenes of a tissue bank microbiology laboratory. Why do lab samples have to meet certain criteria for processing? Why are collection devices laboratory specific? Why is a specific size tissue sample required for testing? Why is lab sample shipping important? Why is there a time limit on the lab samples? During this presentation, we will discuss microbiology test method validation regarding donor-related lab samples and environmental-type cultures. We will also do an overview of common microorganisms and methods for identification.

Every year, more than 9,000 people who look for a bone marrow transplant don’t find a match in time. Ossium Health is a bioengineering company that uses bone marrow from vertebral body donation to address patients’ unmet needs in hematologic malignancies, inflammatory disease and transplant rejection. As the first organization to build a bank of deceased donor bone marrow, Ossium is working to bridge the bone marrow transplant gap and ensure everyone gets the transplant they need. In this presentation, we’ll discuss how the gift of bone marrow from deceased donors can be used to save lives and share information about other therapies made possible through cells found in bone marrow.

During this presentation, we will discuss the process of merging donation organizations. Changes in the donation landscape, regulatory oversight, and metric criteria have led to mergers and shifts in donation service area lines. First, New England Donor Services will discuss the growing pains from the combination of New England Organ Bank and LifeChoice. Then, we will review the ongoing merger of The Living Legacy Foundation and Washington Regional Transplant Community.

Do you ever find yourself sharing a common bond with a provider on the phone who reports a rare diagnosis that you’re both unfamiliar with? As donation professionals, we are tasked with not only understanding a wide variety of medical conditions, but also investigating how they impact an individual’s ability to donate certain tissues. Join us for a deep dive into four rare diseases, where we will explore how they do – or do not – impact tissue donation and how processors view these rare diagnoses and their impact on processing the tissue gifts.

This session will discuss the unique developmental and regulatory considerations of tissue products regulated as biologics and, therefore subject to Section 351 of the Public Health Service Act (PHS). The speakers will discuss the many clinical, regulatory, and legal requirements demanded of these products that distinguish them from other products. In addition to complying with 21 CFR 1271 as an HCT/P, tissue products regulated as biologics also meet the Food, Drug, and Cosmetic Act’s definition of a drug. Therefore, not only must these products comply with the donor eligibility requirements and current Good Tissue Practices (cGTPs) outlined in 1271, but they must also comply with current Good Manufacturing Practices (cGMPs) in 21 CFR 210 and 211 and the Quality System Regulations in 21 CFR 820. These products must also demonstrate identity, purity, potency, and safety as per 21 CFR 600. Safety and efficacy must be proven in the clinical setting. Before being introduced into the clinical setting, a successful Investigational New Drug (IND) application must be in effect. The many requirements of 21 CFR 312 must be followed as the product moves from Phase I through Phase 3 clinical trials. If a sponsor believes their product has demonstrated both safety and efficacy in the clinical trials, they will submit a Biological License Application (BLA) to the FDA. As part of the BLA application, a pre-market approval inspection is conducted. If a BLA is granted, a sponsor may begin to lawfully market their product. The sponsor may be required to launch a Phase 4 post-marketing study to gather additional efficacy data in specific populations, examine side effects associated with long-term use, and/or additional safety information.

This presentation will provide an overview of the critical elements to consider to ensure that a process being implemented can produce allografts that are processed consistently while meeting predetermined specifications.