Margery Moogk Northwest Tissue Services Director

Even before the Food and Drug Administration (FDA) ordered CryoLife, Inc., a large, for-profit tissue bank, to recall all soft tissue allografts distributed since October 3, 2001, and destroy or withhold others it had not yet distributed1, the national spotlight has focused on tissue banking more than ever before. Since last November, when a Minnesota man died after receiving an osteochondral allograft contaminated with Clostridium sordellii, both safety and ethical issues have been the subject of growing scrutiny from sources as diverse as the Centers for Disease Control (CDC), The New York Times, Orthopaedics Today, The Wall Street Journal, and 60 Minutes.

Complicated by reporting that has not always been well-informed, these developments have led to mis-perceptions about tissue banking. Most coverage has not underscored the fact that even with the increase in reported infections, rates of disease transmission from tissue transplants remain very, very low. I am confident that most tissue banks still can and do remain true to their commitment to serve the community as good stewards of the gifts entrusted to them. I believe they also take seriously their responsibility to protect the safety of transplant recipients.

The Tissue Services has released more than 60,000 grafts since it began operation 14 years ago without a reported case of infection from a graft. In addition, the Tissue Services is a member of the American Association of Tissue Banks (AATB), following and sometimes exceeding AATB standards for the safe handling of human tissue.

While news coverage has not presented a balanced overview of tissue banking, it has raised legitimate concerns about whether the profit motive may influence decisions that undermine allograft safety. It also has spotlighted the very real potential that the sale of human tissue for profit will compromise tissue banks’ responsibility to provide fair and equal access to allografts, eroding public support for and confidence in donation.

Greater accountability
Clearly, anyone involved in tissue banking needs more reliable information than ever before. The coverage in both the medical and general press has reached a wide audience, from the general public and donor families to trained designated consent requesters, surgeons, and recipients. Tissue banks now must expect to provide answers to such questions as:

• How can families be sure that loved ones’ tissues are being provided to patients for medically significant surgeries and not diverted for cosmetic uses?
• How can those trained to approach grief-stricken families for consent know that they are offering the option of donation through a nonprofit agency?
• How can surgeons be confident that the tissue bank they choose has taken adequate measures to protect patients from infection?

Understanding these questions and their answers may call for a level of awareness formerly not required of the many people who participate in the long chain of events from tissue donation to transplant.

Likewise, tissue banks are going to have to be more accountable than ever before to explain everything from their federal tax status to their tissue-culturing policies.

In light of the need for a more comprehensive and knowledgeable analysis, we have devoted this issue to tissue safety. We hope it will help you make informed decisions and answer questions that concerned families, patients, or other health-care providers may ask you.