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Table of Contents

Table of Contents

Editorial

Letter From the Editor

Original Research

Improving Eye Bank Tissue Donations in a Hospice Population

Factors associated with thickness of eye bank-prepared DSAEK graft tissue

A Nomogram for Producing Consistently Thin Posterior Lamellar Microkeratome Cuts for DSAEK

Practice-Related Material

Donor Eligibility/Suitability

Tissue Donor Eligibility Trends and Challenges

Communicable Disease Testing — 11th Annual FDA and the Changing Paradigm for HCT/P Regulation

HCTP Case Presentations: Adverse Reactions and Product Deviations

FDA & the Changing Paradigm for HCT/P Regulation

Donor Eligibility/Suitability

Authors

David Glasser, MD

Abstract

Donor eligibility and suitability determinations are key to maintaining a safe and effective donor pool. A careful reading and understanding of FDA regulations and guidance documents and Eye Bank Association of America (EBAA) Medical Standards are usually sufficient to make eligibility and suitability decisions. This commentary explores some of the more ambiguous situations that may be encountered. When regulations and standards do not provide clear guidance, consultation with the eye bank’s Medical Director is warranted.

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