American Association of Tissue Banks Risk Report

⚖️ Legal & Regulatory

The tissue banking industry faces significant legal challenges with recurring legal and compliance issues. There have been frequent reports of legal compliance risks which could potentially impact operations and reputation. These challenges underline the need for stringent oversight and regulatory adherence in tissue handling and distribution.

• Former eye bank workers have reported on 🗓 November 20, 2024, that pressures and lax oversight led to multiple errors, highlighting ongoing compliance challenges.
• On 🗓 August 11, 2023, a report linked a tuberculosis outbreak to bone grafts, exposing oversights in testing procedures.
• An FBI probe on 🗓 August 8, 2018, revealed potential legal compliance risks around the operations of a Portland tissue bank.
• Legal issues around tissue donation, highlighted on 🗓 October 9, 2012, included charges against a Ukraine morgue official, raising questions about international compliance.
• A 2005 report on 🗓 July 21 exposed financial and health threats in the industry, with MBA students investing in solutions.

🏗️ Operational & Business Continuity

Operational risks have been brought to the forefront in the tissue banking sector due to incidents suggesting lapses in handling procedures and oversight. These risks could threaten the continuity of operations and require urgent mitigation to maintain service reliability and public trust.

• A second deadly tuberculosis outbreak was linked to tainted bone grafts on 🗓 August 4, 2023, revealing critical operational lapses.
• On 🗓 September 7, 2012, RTI Biologics suspended imports of human tissue from Ukraine due to operational risks, highlighting vulnerabilities in supply chain management.

📜 Innovation & R&D

Innovation remains a focus within the tissue banking sector, indicated by advancements and investments aimed at improving procedures and addressing health threats. Continued emphasis in this area drives growth and enhances capabilities, which are crucial for sustaining industry leadership.

• On 🗓 May 28, 2025, BioStem announced revolutionary wound care patents expected to transform diabetic foot ulcer treatment.
• Cornell MBA students on 🗓 July 21, 2005, invested in a biomedical start-up to help address serious health threats within tissue banks.
• Genesee County Medical Examiner was the first to harvest heart valves for transplants during autopsies on 🗓 April 5, 2013, representing a forward step in medical procedures.

🏅 Awards & Recognition

The American Association of Tissue Banks has received recognition for its association with notable achievements in the sector. These acknowledgments enhance the organization's profile and underscore its role in setting high standards in tissue banking.

• LifeCell received accreditation from the AATB, confirmed on 🗓 January 17, 2020, showcasing their adherence to best practices.
• On 🗓 October 3, 2024, Dr. Hannis Thompson was recognized for exceptional contributions to tissue banking at the AATB annual meeting.