Medical Device Daily Washington Editor

WASHINGTON – The surge of device recalls seems to have ebbed, the Vioxx story has faded from the front pages, and Andrew von Eschenbach seems poised to take the helm at the FDA, leading one to think that all might be well with the agency.

But the agency finds that it has no time to rest. A pair of tissue bank scandals earlier this year has pushed it further into an unwelcoming spotlight, and, in response, on Wednesday it reported plans to assemble a multidisciplinary task force to look into its regulatory approach to the tissue harvesting industry.

Jesse Goodman, MD, director of the Center for Biologics Evaluation and Review (CBER), said that the task force's main goal “is to identify whether any additional steps are needed to further protect the public health while assuring the availability of safe products.” It will focus specifically on whether last year's revamp of tissue regulations, coded as 21 CFR Part 1271, is adequate to keep track of non-organ donations.

The most recent report of illicit tissue sales names Philip Joe Guyett Jr., of Raleigh, North Carolina, as the object of an investigation concerning violation of screening and record-keeping regs (Medical Device Daily, Aug. 28, 2006). The agency reported the closure of his operation, Donor Referral Services (also Raleigh) Aug. 18.

Over a two-year period, Guyett purportedly harvested hundreds of specimens from an unsterile room within a funeral home that he sold to the Cooperative Human Tissue Network, part of the National Cancer Institute.

Much of the hand-wringing over Guyett stems from his previous brushes with the law, a habit of exaggerating his expertise to pull in customers and the failure of organizations to recognize his deception. His resume was said to have indicated he did a stint as an anatomy instructor at Mount San Antonio College (Walnut, California) between 1997 and 1999, but the school's records do not confirm that claim.

He also described himself as a “forensic specialist” at the Clark County, Nevada, coroner's office, but the office indicated that his position there was part-time and voluntary. Guyett was charged in 2000 with pocketing $1,100 after selling a cadaver that had been willed to Western University (Pomona, California) the deceased's next of kin to another school. The Los Angeles District Attorney's office dropped the charges in exchange for community service, including highway clean-up work and three years of probation, but this experience apparently did not blunt his interest in the tissue donation industry.

The agency forced Biomedical Tissue Services (BTS; Fort Lee, New Jersey) to close operations in February after the Kings County, New York, district attorney's office filed charges that the company had engaged in unauthorized harvesting of body parts. The company's founder, Michael Mastromarino, and three others were charged with enterprise corruption, grand larceny and unlawful dissection.

Part 1271, which was effective May 25, 2005, is designed to clamp down on disease transmission and covers establishment registration, donor eligibility, current good tissue practices, labeling, adverse-event reporting, and inspection and enforcement.

Under 1271, inspections of tissue establishments are still based on risk, which can leave an entity operating under the radar screen for a number of years. According to the September/October 2001 edition of Orthopedic Technology Review, the agency had not inspected “at least 36” of the 154 tissue banks in operation at that time.

The author made the case that tissue bank regulatory functions are an unfunded mandate, forcing the agency to “borrow resources from other programs” to keep up inspections.

In 2003 Goodman, as CBER chief, testified before Congress that in fiscal 2001, 51 of the 132 inspected tissue establishment received a Form 483, an official report of regulatory violations to which recipients must respond within 30 days. The following fiscal year, the number of inspections rose to 165, 48 of which generated 483s.

Goodman noted that these inspections “resulted in 10 regulatory actions, including a mandatory recall” for CryoLife (Kennesaw, Georgia). Cryolife tissues were implicated in several problems, including a tissue donee testing positive for Staphylococcus epidermis after receiving a heart valve provided by the company.

A search of the CBER warning letter database indicates that the center issued no warning letter to a tissue bank after August 2005. Cryolife snared a warning letter in connection with the events described, but it was issued by the agency's Atlanta district office, and all but one of the citations in this warning letter referenced 21 CFR Part 820, the text describing the quality systems regulations applied to medical device production.

At present, the states of New York and Florida have regulations calling for registrations and inspections of facilities, and the American Association of Tissue Banks (AATB; McLean, Virginia) published a set of accreditation standards in 1986.

Bob Rigney, president of AATB, told Medical Device Daily that members must be accredited and that the FDA drew on the association's standards in devising its regulatory scheme.

Rigney also told MDD that the association would “like to see tighter enforcement activity with banks not accredited by AATB,” but that he is under the impression that the agency's resources have not always been up to the task. However, he said that the budget for fiscal 2007 includes sufficient funds to hire 18 full-time equivalents dedicated to enforcement of tissue regulations.

Rigney insisted, however, that “other than the two [cases cited above], the record has been pretty clean” for the tissue industry. He noted that most tissues are “pretty heavily processed, reducing the risk that diseases will be transmitted.”

He said that LifeCell (Branchburg, New Jersey) was perhaps the first entity to catch on to the chicanery at BTS when a LifeCell employee noticed a data discrepancy in some files and sought clarification. When the employee looked up the name of the physician on file for a donation, the employee discovered that the physician did not exist. The information was forwarded to the FDA and the state attorney's office.

Only time will tell whether the recent problems are a trend or a mere blip on the screen, but on paper at least, the agency seems determined to sew up any holes in this part of its regulatory safety net.