Donated human tissue is used in more than a half-million procedures a year in the United States, saving the sight of patients needing cornea transplants, helping burn victims, enabling others to walk again. In the 54 years since the Navy Tissue Bank in Bethesda, Md., was established the use of tissue has become an essential part of medicine. But, unregulated or underregulated, it can also be a dangerous part, which is why hearings scheduled for today before the Senate’s Governmental Affairs Committee should be followed closely by the operators of hundreds of tissue banks and countless potential patients nationwide.

Sen. Susan Collins, chairman of the committee, called the hearing because she held a similar one in 2001, in which a Food and Drug Administration official acknowledged the need for comprehensive regulations of this highly complex business, and yet today FDA appears only marginally closer to having these regulations. The first hearings were held just months before an otherwise healthy 23-year-old man named Brian Lykins, from Minnesota, had elective arthroscopic knee surgery in which bone cartilage from a cadaver would be used. Soon after the operation, he developed pain, then shock, and he died the next day. An investigation traced the lethal toxin-forming organism Clostridium sordellii to the implanted tissue. The young man’s parents are expected to testify today about their ordeal.

The larger issue, however, is what the FDA has done since 2001, or since 1997 when it laid out its plan for regulating tissue transplants, known as allografting. Mr. Lykins’ case was the most tragically dramatic, but since then an unknown number of patients have suffered infection, sometimes severe and including HIV, because the tissue they had received was improperly tested, handled or stored. The number is unknown because the FDA reporting requirements remain inadequate.

Even more than organ donation, which are transplanted quickly when the proper match is found, tissue transplant – bone, tendons, skin – can include treatments that change the nature of the tissue to reduce the chance of rejection or are altered to serve slightly different purpose. For instance, a hamstring might be used to repair a knee ligament. This requires processing and, naturally, demands a high level of care and oversight. More than that, the 2001 hearings showed that some tissue banks had shopped around for a test that its products could pass after failing initial safety screenings. They tested until they found one they could pass.

As the science of tissue transplantation progresses many more patients could be helped, but governmental oversight is essential to ensure that the donated tissue is treated with dignity and that the tissue itself is safe for use. The FDA apparently has been making barely detectable progress in this direction for years; the public today should hear why it has been so slow and what could be done to move the agency faster on this crucial medical issue.