On 11-6-23, FDA issued a Safety Communication, recommending to not use certain lots of sodium chloride and sterile water products manufactured by Nurse Assist, LLC and sold under multiple brands. These products may not be sterile and bear expiration dates of 11-1-23 to 9-18-28. HCT/P Deviation reporting to FDA is required when there is potential HCT/P contamination, core CGTP requirements are deviated from, and affected product is distributed. 21 CFR 1271.210(a) and (b) are core CGTPs and require “reagents used in processing and preservation of HCT/Ps must be sterile, where appropriate.” If you encounter any supply chain disruption issues, please contact delk-brooksk@aatb.org.

AATB is committed to improving the Standards for Tissue Banking. Explore our volunteer-driven initiative, the 'Standards Rebuild Project,' which aims to simplify and enhance our requirements.

AATB emailed a Member Satisfaction Survey through Survey Monkey to all AATB Members on Wednesday, November 1. If you did not receive the survey, please check your spam. The results of this brief survey will help us identify the needs and preferences of our members and the changes we could implement to remain adaptive and enhance the member experience. Individuals who complete the survey and leave their name and email address will be entered into a drawing to win one (1) of five (5) gift cards. The survey closes Wednesday, November 22. If you have questions or problems accessing the survey, please email davisa@aatb.org.

Stanford News
Stanford researchers discovered breast cancer cells work together to break out of the membrane and become invasive.

Cureus
A 66-year-old patient received subepithelial connective tissue graft (SCTG) in guided bone regeneration (GBR) and still had well-maintained tissue contour in a follow-up examination at 14 months.

Medical Device Network
Tissue repair implants are a key area for innovation in medical devices according to a report from GlobalData.

NYU Langone Health
According to new research, studying healthy tissue surrounding areas of lung cancer may be a better predictor of if the cancer is likely to return.

Phys.org
A new technique allows tissue cells to regenerate muscle outside of the body to be implanted back into the body, reducing the risk of rejection or extended healing time.

Curious about the rise in Sodium Nitrite suicides? Join us for an exploration of self-inflicted Sodium Nitrite Toxicity in three Michigan counties on November 15, titled 'The "Suicide by Salt" Epidemic.' Discover the alarming trend of sodium nitrite as a method of suicide, driven by its easy accessibility in the United States. Delve into the dark world of sodium nitrite ingestion, an odorless, white, water-soluble crystalline powder capable of inducing severe methemoglobinemia – a condition where hemoglobin loses its ability to transport vital oxygen throughout the body.  Register now and secure your virtual seat.

In “Deviations, Devices, and Drugs: A Regulatory Roadmap for Human Tissue Reporting,” we'll explore the evolving landscape of tissue banking, and where opportunity meets innovation in regenerative medicine. The tissue banking industry is experiencing a transformative 'era of opportunity,' and understanding the regulatory framework is crucial. Join us on December 6 as we navigate the complex regulatory pathways and requirements for adverse outcomes reporting for human tissue products. Whether it's Section 361 HCT/P, Section 351 HCT/P, or medical devices, this webinar will clarify the path ahead. Don't miss out on this essential regulatory roadmap.  Register now and secure your virtual seat.

Join us on December 8 for “Pediatric Death: SUIDS, Trauma, and Accidents,” the final webinar in the FREE Donation & Death Investigation Webinar Series. Curious about the unique considerations for organ and tissue donation in pediatric cases? Delve into the intricacies of pediatric and sudden unexpected infant deaths (SUIDS) from a medicolegal perspective. Discover the factors that determine suitability for donation and gain valuable insights into potential limitations and how to address them effectively. Join us for this essential discussion! Register now and secure your virtual seat. The 2023 Donation & Death Investigation Webinar Series includes seven webinar presentations, all FREE and designed to enhance your understanding of the complex relationship between these two fields. Register now for our upcoming webinar or the entire series.

Florida: Responds to referrals for the purpose of evaluating for potential tissue donation and successfully completes the authorization or donor disclosure process with the next of kin. Performs activities associated with screening for medical suitability, family approach, authorization, or donor designation, and coordinates the tissue donation process following established LifeLink policies and procedures.

Norcross, Georgia: Directs, delivers and monitors tissue recovery staff training.  Primary technical contact for tissue procurement. Ensures the performance of all recovery personnel relating to the proper procurement, storage, and shipment of tissue for transplantation. Provides support for in-services, Public Affairs activities, and professional development seminars.

Tampa, Florida: Primary responsibility is to work in conjunction with Hospitals in our service area to respond to referrals and evaluate for the purpose of determining a potential organ/tissue donor.  Applying LifeLink Organ Recovery policies and procedures in performing and documenting, donor evaluation, family approach, authorization/donor designation, and the medical/social behavior interview with appropriate family members/associates for the purpose of transplantation.