Messages from the President:

FDA DONOR ELIGIBILITY (DE) WORKSHOP TO FEATURE RESULTS OF FDA OCTOBER MEETING

— Patricia Aiken-O'Neill, Esq.

The meeting with the FDA in late October produced some new opportunities to deal with several vexing issues that have plagued EBAA members since the final DE guidance was published. The EBAA is already diligently working on solutions to help members help themselves. One such help will be the DE Workshop January 14-15; banks cannot afford not to come, as the money saved as a result of the new practices introduced and decided during the meeting will more than pay for the members who attend.
Many of our members have experienced the frustration of ruling out tissue that is considered "safe" and transplantable, "but for" . . . specifically, in the areas of sepsis and dementia.
There are "best practices" that our members can integrate into their systems which may allow a broader perspective, resulting in a greater number of usuable tissue. These will be discussed and "hammered out" in the intensive two-day DE Workshop in January (14th and 15th), in Dallas which I mentioned earlier. I urge every bank to send at least one person, and ideally, two: the person on the "front line" and the "policy maker" at the bank.
When our community came together to share their practices several years ago following publication of the GTP regulation, it calmed the waters and provided practical solutions. This, we plan to recreate, with the goal of producing practical solutions to the problems that we are facing daily in a "square peg, round hole environment."

NEWS FROM THE EBAA: The Uniqueness of Eye Banking: Eye Banks Ensure the Safe Supply of Corneal Tissue for Transplantation, Research and Education