Just as the medical device reprocessing industry was starting to get a little heady about its renaissance, it is stumbling on an unexpected trip wire hidden in a federal bioterrorism bill that could send it reeling back to the Dark Ages.
Some ominous language has been floating around Capitol Hill in recent months, and it may land in the conference report on the Bioterrorism Preparedness Act of 2001, a post-Sept. 11 bill that could be on President Bush's desk as early as Memorial Day, reprocessing industry insiders said. The bill primarily is meant to secure bioengineering facilities and the nation's food and water supply, but three or four paragraphs proposed by Senate Health, Education, Labor and Pensions Committee Chairman Edward Kennedy (D-Mass.) take dead aim at the reprocessing industry.
On one side of this classic healthcare feud are the reprocessors, who maintain they are saving precious hospital dollars when they clean, sterilize and recondition devices designed for one use only to make them as good and safe as brand new-but at roughly half their original cost. On the other side are the original equipment manufacturers that insist their disposable items were designed for single use only and would be unsafe otherwise.
The reprocessing industry is wringing its hands over the latest proposals that would for the first time require reprocessors to file complicated applications with the Food and Drug Administration to recondition so-called Class I devices, deemed the least risky, least invasive devices used in hospitals. Surgical bits, blades and burrs typically fall into this category.
Although hospitals never broadcast it, it's safe to assume that they cleaned such devices themselves for years until the FDA stepped in two years ago and insisted that hospitals register the same way third-party reprocessors do if they wanted to continue to pursue the cost-saving endeavor. In addition the FDA required hospitals and third-party reprocessors to undergo the same stringent application procedures for the single-use devices they recondition as the original manufacturers.
The draft proposals also would require reprocessors to label devices they reconditioned with a name and logo at least as large as the original equipment manufacturer's. In many cases that is a physical impossibility for lack of space on the product, reprocessors argue, not to mention that it would give the manufacturers an incentive to blow up their labels even larger.
"It's really an anticompetitive requirement that has no public health benefit," said Susan Grymes, an associate with the Association of Medical Device Reprocessors, a Washington-based trade group of three companies that corner an estimated 80% of the nation's reprocessing market.
The language, as written in a Senate proposal purportedly authored by Kennedy and Sen. Judd Gregg (R-N.H.), essentially would scrap whatever inroads to legitimacy that the industry has made in the past two years, Grymes said. The third-party reprocessing industry has blossomed since August 2000, when the FDA began its heightened enforcement (Jan. 28, p. 44).
The proposals mark the furthest point the debate has gone in legislative circles in Washington. A panoply of healthcare organizations, including the American Hospital Association, the Cleveland Clinic Foundation and Henry Ford Health System, sent a letter May 1 to the House and Senate conferees strongly objecting to the Senate proposal for the bioterrorism bill. Calling the language "unnecessary and burdensome," they said it would increase costs without improving safety or efficiency.
"We believe the language is intended to be so burdensome and costly that it puts an end to reprocessing," they said in the letter. Meanwhile, the device manufacturers "have a financial incentive to label devices single use," yet there are no standards that make the single-use label meaningful, they said.
"This would be somewhat of a disaster for the Cleveland Clinic," said John Clough, M.D., director of health affairs at the 1,003-bed hospital. "It essentially would make it necessary to make a lot of things single use that have never been single use . ... This is looking to solve a problem that does not exist."
James Connelly, senior vice president and chief financial officer of Henry Ford, said reprocessing saves the five-hospital system as much as $4 million per year.
He added, "The people who are best to make the judgments are the healthcare professionals and the clinicians who work every day in the clinical environment. We don't think it ought to rest with lawmakers in any form," Connelly said.
Grymes said the draft language was put forward by the disposable- device manufacturers, a charge the manufacturers deny.
"I don't know the genesis of the language, but I definitely support it," said Josephine Torrente, president of the Association of Disposable Device Manufacturers, a Washington trade group made up of six of the largest manufacturers, including Johnson & Johnson, Becton Dickinson and Boston Scientific Corp.
Torrente said the association has been "educating senators" in recent months "on where the FDA has fallen short of its promises." For example, the FDA promised two years ago to issue guidance on allowing reprocessors to leave the original manufacturer's name on items they recondition, she said. Manufacturers would prefer not to see their names on the reconditioned items. But no guidance has come yet, Torrente said.
At deadline, with the conference due to start its first consideration of the bill, it was unclear what the fate of the proposed language would be.
Torrente noted that the bioterrorism bill might move quickly-too quickly to accommodate the reprocessing language. If so, it could very well "wait for its own vehicle later this year," she said.