VA's cadaver tissue purchases being watched
The Department of Veterans Affairs ordered $241 million of cadaver tissue and other material derived from human and animal bodies in the last three years, some of it from vendors warned by federal regulators about contamination in their supply chain.
About $4.7 million of the VA purchases were from Alachua, Fla.-based RTI Surgical Inc. and the nonprofit Musculoskeletal Transplant Foundation, of Edison, N.J., according to data obtained by Bloomberg News under a Freedom of Information Act request.
The VA ordered human tissue from the two suppliers after they were warned by the Food and Drug Administration for safety deficiencies — RTI for contaminated products and processing facilities, and Musculoskeletal Transplant for distributing tissue from tainted donor bodies, according to federal contracting data compiled by Bloomberg.
The suppliers said they have addressed the problems, which weren't tied to human harms.
Congress and veterans' advocates are pressing the VA about whether it tracks body parts and other implants used to treat veterans well enough to warn patients of potential dangers. In September 2012, the VA shelved a system it was building to help alert patients when the parts are recalled. Some of the VA's buying was made outside standardized purchasing contracts without required justifications, the Government Accountability Office said earlier this month.
“It's a big accident waiting to happen,” said Rick Weidman, executive director for government affairs with the Silver Spring, Md.-based Vietnam Veterans of America.
RTI received a warning letter from the FDA in October 2012, and Musculoskeletal Transplant received one six months later, following agency inspections.
The congressional scrutiny of the VA's medical purchasing follows a surge in patients treated in its hospitals, where grafts from cadavers are used to replace burned skin, restore broken bones or treat other wounds.
The VA has added more than 2 million veterans to its health care system since 2009. The number receiving biological implants rose 22 percent to 19,350 in the two years ended in September 2013, according to the agency.
A year earlier, the department suspended a computer project known as the Veterans Implant Tracking and Alert System — which “was developed to address shortcomings” in its ability to track surgical implants, including biologically derived ones, and help find their recipients during recalls, according to a Jan. 13 report from the GAO, the investigative arm of Congress.
The project's future is being evaluated, the VA said in a statement. The agency's safety office tracks recalls for biological products and notifies its hospitals when necessary, Thomas Lynch, the VA's assistant deputy undersecretary for health clinical operations, said in a congressional hearing last week. The VA said its safety office hasn't received any reports from its hospitals about contaminated implants.
Reports of tainted tissue in the industry are especially troubling because oversight of the suppliers isn't strong, said Chris Truitt, a former tissue procurement technician who left the industry in 2005.