FDA Acts to Ensure Safety of Transplant Tissue : Health: The agency issues first-ever rules after finding some ‘brokers’ may be dealing in infectious body parts. There is no evidence of a widespread problem.

The Food and Drug Administration, reacting to concern in Congress, moved Friday to guarantee the safety of human tissue and bones used in 450,000 transplant operations in the United States each year.

FDA Commissioner David A. Kessler said that the agency was issuing interim rules on an emergency basis after finding evidence that some “tissue brokers” may be dealing in infectious body parts, principally cadavers from Eastern Europe and Russia.

Congressional hearings over the past three years have shown that human tissues, bones and tendons used in transplants have gone unregulated--unlike organ transplants. Officials said the new rules would attempt to close that gap.

But Kessler and congressional advocates of the new rules stressed that no widespread health problem has been discovered because most tissue and bones come from accredited tissue banks that follow their own strict screening procedures. Although tissue transplants rarely have been the cause of infectious diseases, officials said the potential exists for infections such as AIDS and hepatitis to be spread through unsafe tissues.

Human tissues, tendons and bone parts are commonly used in such surgical procedures as skin grafts for burn victims, heart valve operations, some eye surgery and many arm, leg and lower back operations.

FDA officials said they believed that their action marked the first time a country has regulated these human materials. The interim rules will take effect Tuesday when they are published in the Federal Register, with more comprehensive regulations to be issued later.

Sen. Paul Simon (D-Ill.) and Rep. Ron Wyden (D-Ore.), who last month introduced legislation to regulate tissue transplants permanently, commended Kessler on the new rules. Simon said the FDA’s move will “avert a risk to public health” but that “it does not eliminate the ability of the Congress to move on more comprehensive regulation” of tissue and tissue banks.

Officials told a news briefing that FDA investigators, working undercover, recently determined that two tissue brokers were selling imported body parts obtained from foreign cadavers without proper screening of the tissues or documentation of the donors’ intent. Some of the corpses were believed to be homeless people who died on the street, and one blood sample tested positive for hepatitis B.

The officials said the brokers were the subject of an ongoing investigation, but that no criminal wrongdoing has been alleged.

The Simon-Wyden legislation, which Congress will consider when it reconvenes next month, would establish industry-wide standards for the treatment and preservation of tissues, would set up record-keeping procedures for tracking both tissues and patients and would defray costs of the new system with small “user fees” to be paid by tissue banks.

Kessler said that the new safeguards would apply immediately under emergency powers granted to him by Public Health Service legislation. “Tissues may only be used after tissue banks have ensured that donors have been adequately tested and screened for infectious diseases,” he said.

Kessler said the regulations “state FDA’s authority to inspect any such facilities and to detain, recall or destroy tissue that lacks that appropriate documentation.