Wednesday, August 21, 2002 - A Colorado company may have shipped tainted human tissue to hospitals this spring, according to a federal inspection report that found numerous violations of the company's own safety rules.

U.S. Food and Drug Administration officials issued a seven-page warning letter to Englewood company AlloSource Inc. in early July for failing to follow the company's own policies in handling cadaver skeletal and muscular tissue. The company ships to hospitals in five states.

One patient who received donated human tissue from AlloSource contracted a severe post-operative E. coli infection, according to the letter from the FDA. AlloSource president Thomas Cycyota said Tuesday that it was not clear whether the patient got the infection from the tissue or something else.

But he said the company did violate its own safety procedures and said there was no excuse for that. About 85,000 patients a year get tissue transplants from AlloSource, he said.

Five patients could have received contaminated tissue from a donated piece of right tibia muscle, the FDA letter said. Cycyota said the company has been working with those tissue recipients' surgeons - none of whom work in Colorado - and none has noticed any medical problems with their patients.

Despite the incidents of contaminated tissue listed in the FDA warning letter mailed July 2 to AlloSource, Cycyota said the company has no reason to believe any bad tissue left the building.

AlloSource cleans and readies tissues for transplants and surgeries at Colorado's biggest hospitals as well as those in Missouri, Southern California, Illinois and Wyoming.

In a seven-week investigation between Feb. 11 and April 3, FDA officials discovered that the company "failed to prepare, validate and follow written procedures for prevention of infectious disease contamination and cross contamination" during processing at the Englewood building.

Doctors at hospitals that received the tissue for transplant are tracking where the tissue went and monitoring their patients for infections. So far in Colorado, hospitals and company officials say, no one has gotten sick.

"The physicians monitor appropriately for infections," said Keri Goerke, director of surgical services at the hospital.

State health officials couldn't say Tuesday how many hospital infections had been reported or they were investigating.

This is the second piece of bad publicity for the tissue transplantation industry in a week.

On Aug. 14, the FDA shut down part of CryoLife Corp., a Georgia-based donated human tissue processor that ships human tissue and heart valves to hospitals nationwide, including Colorado. FDA officials said 27 people developed serious infections after receiving tissue implants processed by the company. One of them had died, according to the FDA.

University of Colorado Hospital doctors performed "thorough patient reviews" after discovering they received tissue from both CryoLife and AlloSource. No one has detected an infection because of implanted cadaver tissue at the hospital in recent history, said spokeswoman Sarah Ellis.

Children's Hospital receives heart valves from CryoLife, but so far FDA officials haven't found the heart valves to pose contamination risk, officials at Children's said.

Tissue processing plants have little guidance from federal safety officials on how to go about cleaning and prepping donated human soft muscular and skeletal tissue for transplant, Cycyota said.

Federal guidelines in place address removing tissue infected with HIV or AIDS from the donor transplant pool, he said.

When FDA inspectors visit the facilities, they look at the company's self-made rules and make sure workers are following them, which wasn't happening at AlloSource, Cycyota said.

"We just didn't follow our own procedures, which isn't acceptable," he said. "We have not really been regulated with that level of scrutiny. . . . Tissue banking as a whole is under a lot more scrutiny, and we welcome that."

More than half the tissue harvested from cadavers has some sort of infection, Cycyota said. Through rigorous cleaning and preparing with alcohol, hydrogen peroxide and antibiotics the tissues are safe before they go into a transplant patient.

But company procedure dictates that workers process uninfected organs before infected ones, and AlloSource broke those rules, the FDA said.

Cycyota said the company's 125 employees met with lawyers Tuesday to learn about the new rules.

The company has about three months to fix the problems, Cycyota said.

"We take this very seriously," he said. "But we can say with some level of assurity that our tissues are safe."