FDA Warnings to Body-Parts Vendors Overlooked by VA
A U.S. Department of Veterans Affairs safety office isn’t tracking a health agency’s warnings on the potential for contaminated body tissue, a federal auditor’s review found.
The VA office doesn’t keep tabs on the Food and Drug Administration’s warning letters to suppliers of human and animal tissue, according to a U.S. Government Accountability Office report released for a congressional hearing today.
Lawmakers are asking questions about the VA’s ability to identify recalled products and notify affected patients, and possible conflicts of interest from agency doctors serving on a board of a vendor that received an FDA warning.
“I am alarmed at the great risk of harm our veterans face when they receive biological implants,” Representative Mike Coffman, a Colorado Republican and chairman of a House Veterans’ Affairs subcommittee, said during the hearing.
The veterans agency ordered $241 million in cadaver tissue and other material derived from human and animal bodies in the past three years, some of which came from vendors warned by federal regulators about contamination in their supply chain, according to data compiled by Bloomberg. The tissue is used to replace burned skin, restore broken bones and treat other conditions.
The GAO, Congress’s investigative arm, reported in January that employees of one VA hospital system weren’t always recording serial numbers for implants, a lapse that might make it difficult to notify veterans of recalls.
The veterans agency can “significantly improve” tracking and inventory of tissue and other biological implants, Philip Matkovsky, a VA assistant deputy undersecretary for health, said in remarks prepared for the hearing.
It plans to automate tracking for implants, much like it does for blood products, he said.
VA officials told GAO auditors in today’s report that they found no evidence of patients being harmed by contaminated tissue products. They also told the auditor that they don’t track FDA warning letters because the notices are intended to give suppliers an opportunity to take voluntary corrective action, according to the report.
The letters typically precede enforcement actions and recalls. The VA’s patient-safety office does monitor tissue recalls, according to the GAO report.
The safety office has notified the agency’s hospitals of 13 tissue recalls from November 2008 through September 2013, according to the auditor’s review.
Most of those recalls were due to the possibility of contamination, “for reasons such as compromise of product sterility, tissue recovered from donors with risk factors for communicable diseases, incomplete donor records, or manufacturers suspected to have deviated” from FDA manufacturing regulations, it said.
In two cases, VA officials continued ordering tissue from suppliers after federal regulators admonished the vendors for safety deficiencies in FDA warning letters, Bloomberg News reported in January.
One vendor, RTI Surgical Inc. (RTIX), was cited for contaminated products and processing facilities. Musculoskeletal Transplant Foundation, a nonprofit organization, was faulted for distributing tissue from tainted donor bodies.
Both Alachua, Florida-based RTI Surgical and the Edison, New Jersey-based foundation have said they addressed the FDA’s concerns. The deficiencies haven’t been tied to any patient injuries.
The FDA letter at least temporarily hurt RTI’s relationship with some customers, Brian Hutchison, the company’s chief executive officer, said in an August 2013 call with analysts.
Several VA doctors have served on a board of the Musculoskeletal Transplant Foundation, Coffman said during the hearing. He questioned whether that violated federal conflict-of-interest statutes.
VA employees are required to disclose conflicts of interest, the agency’s Matkovsky said during the hearing. Of the doctors who have served on a foundation board, none were found to have been involved in procurement decisions, he said.
Cindy Gordon, of Issues Management/Insight Communication in Princeton, New Jersey, didn’t immediately provide comment. She is designated to speak for the foundation.
The American Association of Tissue Banks, a McLean, Virginia-based nonprofit group that accredits tissue banks, would support new legislation directing the VA to develop a standard identification system for tissue and other biological implants.
It would ensure products can be “appropriately tracked from a human tissue donor all the way to recipient,” Frank Wilton, the group’s chief executive officer, said in written remarks prepared for the hearing.
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