IMAGE: Michael Mastomarino
AP file
This undated file photo provided by the Brooklyn District Attorney shows Michael Mastomarino who has pleaded not guilty to charges of plundering corpses for body parts.
updated 9/24/2006 2:40:31 PM ET 2006-09-24T18:40:31

The nation’s tissue bankers are considering new rules aimed at preserving public trust in their industry, following two recent scandals that made some of them appear more like body snatchers than people who help improve the lives of millions of Americans.

The leading professional association will vote next month on tighter controls over those who supply cadaver flesh and bone. Though it sounds ghoulish, body parts are used in more than a million medical procedures each year in the United States, especially knee and spine surgeries.

The government also has formed a task force to look for regulatory gaps that may be putting patients at risk. A three-month investigation by The Associated Press, published in June, detailed many such gaps.

Will the efforts succeed? Will another scandal leave relatives grieving or patients fretting about companies that supplied them tissue from donors not properly screened for diseases?

“The industry is trying really hard to weed these people out,” said John St. John of LifeNet, a longtime organ and tissue procurement agency in Virginia. LifeNet is less than 100 miles from a troubled North Carolina body parts broker “and we had no idea they existed,” he conceded. “I’d be surprised if there weren’t any more.”

At the American Association of Tissue Banks’ annual meeting in San Diego earlier this month, president Jim Forsell urged members to police their business partners and report any who do not follow the rules.

“We all know each other,” he said. “If anybody is still doing this kind of thing, they will get caught.”

It has been almost a year since Biomedical Tissue Services, a now-defunct New Jersey company, was accused of plundering corpses for body parts, including that of former “Masterpiece Theatre” host Alistair Cooke. Company owner Michael Mastromarino and three others have pleaded not guilty to charges. About 10,000 people received tissue supplied by the company.

In August, the federal Food and Drug Administration shut down Donor Referral Services of Raleigh, N.C., citing “serious deficiencies” in tissue processing, donor screening and record-keeping. Company owner Philip Guyett has denied any wrongdoing.

The FDA will not say how many people received tissue in that case because the investigation is continuing, but the association estimates that fewer than 1,500 tissues are involved. Tissues typically are distributed nationwide. Guyett previously operated his body parts business in Las Vegas, but little is known about its operation there.

After the Mastromarino case, the tissue bank association appointed a task force that inspected companies who did business with him. It also adopted a new rule allowing inspection of any business partners of association members, even if the partners themselves do not belong.

Suggested safety standards
Here are other suggestions tissue bankers and outside experts have made for both the industry and FDA to improve safety:

  • Requiring licensing and training.

“A barber has to pass a test and get licensed before a barber can cut hair. How is it that someone who can recover tissue for human transplantation doesn’t have to pass a test or get licensed? You or I could open up a tissue service tomorrow, and all we have to do is file a piece of paper with the FDA,” said Areta Kupchyk, a former FDA lawyer who now advises tissue companies.

Next year Canada will require companies to have medical or scientific directors and affirm that they will follow safety regulations. The FDA only requires tissue establishments to register each year.

  • More money and staff for FDA inspections.

Registrations of tissue businesses are at an all-time high — 2,322 as of August — but only 285 inspections were done in the first 10 months of the current fiscal year, said Dr. Ruth Solomon, head of the FDA’s tissue safety team.

Will the new FDA task force change this?

“We hope we’ll get the additional resources, but we’re not holding our breath because we’ve been disappointed in the past,” she said.

  • Requiring tissue banks to be certified by the association. The group has stricter and more specific tissue safety standards than the FDA, but membership is voluntary.
  • Limiting profits on donated tissue.

Federal law says body parts can’t be bought and sold but allows companies to earn “reasonable fees” for obtaining and supplying them.

“There is absolutely no guideline, no regulation, no definition of what that means,” Kupchyk said. “That is a huge loophole that the government has got to address.”

Reporting changes at funeral homes
Regulating or banning tissue recovery at funeral homes.

Funeral homes don’t have to report deaths that occur outside a hospital as organ procurement agencies do. This leaves them outside a formal system for donor consent and medical eligibility for transplants.

Martha Anderson, executive vice president of Musculoskeletal Transplant Foundation of Edison, N.J., the nation’s largest tissue processor, said processors should avoid small recovery businesses that deal directly with funeral homes to get body parts.

“As long as there are processors out there that will take tissue from these operations, there will be the potential for problems,” she said.

  • Reducing risk from “fresh” or “fresh frozen” tissue.

Bone can be irradiated to kill germs, but fresh tissue such as cartilage cannot without destroying its usefulness. That makes careful screening of donors and sterile removal techniques critically important.

Some tissue banks, like LifeNet in Virginia, will not supply fresh tissue. The risks it poses are unacceptably high, St. John said.

  • Requiring state-of-the-art sterilization.

Proper processing can make certain tissues safe “even if it was not screened properly or came from an infected donor,” said Dr. Marion Kainer, a Tennessee Department of Health physician formerly with the Centers for Disease Control and Prevention. “There are techniques that can sterilize tissue, Not all tissue banks use those processes.”

  • Using a bar-code system to track tissues.

There is no uniform, automated system to trace tissue from recovery to processor to supplier to doctor to patient.

Tainted tissue recipients urged to be tested
Health officials continue to investigate the Mastromarino and Guyett cases. People who received tissue supplied by their companies have been urged to seek testing for HIV and other diseases. Industry officials stress that no infections have been confirmed, but experts say that proving such a link is almost impossible unless other tissue from the donor is still available to test.

About 152 adverse events, 80 percent of them involving possible infections, have been reported since the FDA started a database to track tissue and cell problems in November 2005, Solomon said.

The companies that processed and distributed tissue supplied by Mastromarino face many lawsuits. At least 124 complaints have been filed in federal and state court against Tutogen Medical Inc., LifeCell Corp., Regeneration Technologies Inc. and Medtronic Inc., along with two of its subsidiaries.

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More than 50 federal lawsuits have been consolidated for discovery purposes in U.S. District Court in Newark, N.J. The cases will ultimately be sent back to the states in which they were filed.

The companies all deny any wrongdoing and believe there is no evidence that donors were infected.

“We do feel that the case is without merit,” Medtronic spokesman Bert Kelly said. “The tissue we distributed was cleaned and sterilized.”

David W. Field, a lawyer representing LifeCell, said: “Of all the cases filed in state and federal court, it appears less than five possibly involve LifeCell.”

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