Today in Boot Camp - Interesting Fact

"All donors are recovered in the United States and meet FDA, AATB, and applicable state requirements. Potential donors are screened for risk factors associated with infectious diseases and medical conditions that might rule out donation. Historically, fewer than seven percent of donors referred make it through the screening process and are accepted as eligible donors."

Here’s a breakdown:

1. Donor Recovery & Compliance:

   • All amniotic membrane donors in the U.S. must meet strict regulatory standards set by the FDA (Food and Drug Administration), AATB (American Association of Tissue Banks), and applicable state requirements.

   • The FDA oversees human tissue donation under 21 CFR Part 1271, which ensures donor eligibility, tissue handling, and processing standards to prevent disease transmission.

   • The AATB provides additional guidelines that many tissue banks voluntarily follow to maintain best practices.

2. Screening Process:

   • Potential donors undergo comprehensive screening for medical and social history risk factors, including:

     • Infectious diseases (HIV, Hepatitis B & C, syphilis, etc.)

     • High-risk medical conditions

     • Drug use and other lifestyle factors that may impact tissue safety

   • This process is similar to screening for organ and blood donations.

3. Acceptance Rate (~7%):

   • Due to the stringent criteria, fewer than 7% of referred donors typically make it through the entire screening process and are accepted as eligible donors.

   
   

   KEY TAKEAWAY

   • This low acceptance rate ensures the highest level of safety and quality for amniotic tissue used in medical applications.