For the first time in its more than 40-year history, the University of Miami Tissue Bank has announced a tissue recall, citing past problems with its hepatitis testing procedures.
UM officials stress that there is no evidence that patients who received tissue during surgeries are at risk of contracting hepatitis — UM always tested its tissue for the disease. The problem boils down to how UM tested for hepatitis: When the U.S. Food and Drug Administration implemented new testing requirements in 2008, UM’s tissue bank kept on doing its tests the old-fashioned way.
“It’s a compliance issue, it’s not a safety issue,” said Dr. Thomas Temple, CEO and medical director for the 105-employee tissue bank, a key tenant within the UM Life Science and Technology Park. Had there been safety concerns, Temple said, “I would have probably jumped off a bridge ... I’m an orthopedic surgeon, I use this tissue every day.”
The recall involves 210 tissue donors, but because one donor can supply bone, skin and other tissue to multiple patients, the total number of affected patients is much larger: about 36,000.
The FDA declined to comment on the matter.
During the past few days, UM has been mailing recall notices across the country and, in some cases, internationally — notifying any hospital or surgery center that received the tissue. Any unused tissue will be returned to UM, but most has been used in surgeries, so there’s not much else that can be done at this point.
Worried patients who received the tissue might choose to get screened for hepatitis, but UM says such tests are unnecessary. The older “diagnostic” method of testing that UM was using is very effective, Temple said. He believes the old test might even be more accurate than the newer FDA-approved version.
Temple stressed that UM launched the recall voluntarily. A UM internal audit discovered the testing problem in either late 2008 or early 2009, Temple said, and UM quickly did an after-the-fact round of testing using the FDA-approved test and blood serum samples that the tissue bank kept on file for its donors. All those tests came back negative.
In a handful of organ donor cases for which UM didn’t have blood serum, the organ recipients are also hepatitis-free. In the long history of UM’s tissue center, the university says it is not aware of a single reported case of a patient contracting a disease because of a mistake by the tissue bank.
Nationwide, the tissue bank industry has experienced explosive growth in the past decade, but some have called for increased safety protections. Much of the concern has focused on the growing number of for-profit companies in the tissue bank business. In some instances, a donated corpse has been disrespectfully mutilated in an attempt to harvest as much human issue as possible. A California family sued last year after the extreme damage to their loved one’s corpse shocked those who attended the funeral home viewing.
As a small, nonprofit tissue bank — one that pioneered the whole concept of tissue banking — UM has generally enjoyed an impeccable reputation.
Chris Truitt, a tissue bank expert who advocates for increased oversight, said UM’s tissue recall doesn’t appear to cause any danger to patients and is “more like just an embarrassment.”
Still, Truitt said it is telling that UM itself caught the error, as opposed to FDA regulators.
“Right now, the tissue banking industry, it really is kind of like the Wild West. Each company kind of polices itself,” Truitt said. “There’s no real sheriff in town when it comes to this.”
Incidents of disease being spread through transplanted tissue are extremely rare, but it can happen.
In 2001, a 23-year-old Minnesota man died after routine knee surgery because the tissue he received was infected with a dangerous bacteria.
A year later, The Miami Herald reported that a Gainesville-area tissue bank, then known as Regeneration Technologies, had been scolded by the Centers for Disease Control and Prevention for infecting patients with diseased tissue. A Central Florida medical examiner once testified before Congress that RTI accepted corpses infected with cancer and other serious diseases, The Herald reported.
"We have provided more than four million implants with zero incidence of implant-associated infection," the company, now known as RTI Biologics, said in a statement Thursday.
At UM, Temple said the tissue bank is treating the recall as a learning experience. The UM tissue bank has severed ties with the on-campus lab that mishandled the hepatitis testing, and the university has invested additional resources to strengthen employee training and compliance safeguards.
Temple said the tissue bank’s guiding mission continues to be community service and research, not profits — adding that the facility posted a net loss for the last two years.
Dr. Theodore Malinin, who ran the UM tissue bank for decades and is still employed as a researcher, said UM typically rejects about 12 percent of its tissue donors — using a disease-screening process that goes far beyond the FDA minimum requirements.
“That’s a fairly large percentage, but for safety’s sake, we have to do it,” Malinin said.