RTI Biologics Warned to Correct Human Tissue Implant Safety Issues
Like us, you’ve likely seen your share of stories in the news pertaining to apparent contaminations of drugs, food, and the like. But a contamination of human tissue meant to be used in implant patients? That’s a story that’s bound to garner widespread attention.
The Food and Drug Administration is worried about this very type of contamination when it comes to human tissue supplied by the Alachua, Florida-based RTI Biologics. The safety agency alleges that the company supplied various tissues that were contaminated with Pseudomonas, Bacillus, and Serratia bacteria. Other allegations suggest that yeast and fungus could also be found in tissue samples in a variety of cases.
RTI has thus had their entire tissue processing and distribution process called into question. The FDA not only believes these practices are not sufficient so as to prevent various communicable diseases from spreading, but they also accuse the company of not correcting issues despite receiving numerous warnings in the past.
An FDA document from 2011 indicates that 758 complaints were filed with RTI over the course of a year. But in addition to those complaints, a series of lawsuits were filed for a separate incident that took place in 2005, and the media had previously taken the company to task for their methods of tissue procurement.