Dec. 12, 2012 at 7:52 PM ET
A Florida firm that supplies human tissue implants to the U.S. and the world is under fire for producing body parts and products contaminated with bacteria, fungi and other potentially dangerous organisms, according to federal health regulators.
Food and Drug Administration officials posted a warning Tuesday saying they’d found apparent widespread contamination throughout the Alachua, Fla., site operated by RTI Biologics Inc.
Human tendons used to heal sports injuries and “bone putty” that helps repair fractures were among contaminated products, along with sites and processes, detected at the plant that produces tissue used in all 50 U.S. states and more than 30 countries worldwide, the letter said.
FDA officials would not say Wednesday whether they had received reports of infection, illness or death linked to RTI products. Company officials said there have been no reports of disease and that no contaminated products were distributed to the public.
But an FDA inspection document from 2011 indicated that RTI had received 758 internal reports of a wide range of complaints or adverse events in a year, including four reports of infections that were sent on to FDA. Under federal law, the FDA regulates tissue, but it's up to companies to decide when to pass on complaints to the agency.
Rita Chappelle, an FDA spokeswoman, said that warning letters are aimed at getting companies to follow federal rules voluntarily.
“Failure to comply with these regulations can create conditions that could lead to potential safety risks,” she said.
RTI officials said they’re responding to the FDA’s concerns and noted that the agency has issued no recalls or restrictions on the firm’s operations.
“The issuance of the warning letter has no impact on patient safety,” the company said in a statement.
But it’s a new blow for a company that is still facing dozens of lawsuits in connection with the 2005 infamous New Jersey body-selling scheme that sent Michael Mastromarino, president of Biomedical Tissue Services, to prison. RTI Biologics was one of BTS’s biggest clients.
In addition, RTI has been the subject of media reports by NPR and the International Consortium of Investigative Journalists as well as government investigations into whether the company provided improperly obtained tissues for use in U.S. military hospitals at home and abroad.
Company records showed evidence of the Pseudomonas species of bacteria -- including a type capable of causing human disease -- 70 times in sports medicine implants produced at RTI between Jan. 1, 2011 and June 30, 2012, the FDA letter said. During that time, the company turned out some 33,000 tendons used by doctors to repair injured knees, ankles and other sites, the agency noted.
They also reported Bacillus and Serratia bacteria, fungus and yeast on multiple occasions. Records show Bacillus, Staphylococcus and fungus in samples of the bone putty produced from December through June, the letter said.
In addition, the FDA said there was contamination in the firm’s patented BioCleanse tissue sterilization process and in the company’s water supply.
The problems indicate RTI’s failure to process and distribute tissue and screen and test donors in a way that “prevents the introduction, transmission or spread of communicable diseases,” the FDA wrote. In addition, the firm has failed to correct the problem, despite repeated efforts, the agency said.
“We remain concerned about the conditions that were identified during the most recent inspection and the ongoing contamination issues that appear to be problematic throughout your facility,” said the letter from FDA Florida District Director Emma R. Singleton.
Records indicate the FDA sent inspectors to the plant in 2008, 2010 and 2011, as well as during the most recent visit from June 25 to July 11, 2012.
But the FDA stopped short of taking stronger action to limit RTI’s distribution of implants, including bones, skin, tendons, ligaments and other tissue obtained from donors in the U.S. and elsewhere.
In an earnings report conference call in October, where the firm was required to report government action that could affect profits, chief executive Brian Hutchison emphasized that there was no public health danger.
“We pride ourselves on operating in the right way, and we are dedicated to providing high quality, safe biologic implants to surgeons and their patients,” Hutchison told investors. “While this issue has no impact on patient safety, we take this matter very seriously, and are committed to fully resolve any issues.”