Legal wranglings on SUD reprocessing mostly aid reprocessors - News

While science and economics are at the core of the now-widespread hospital practice of reusing single-use medical devices, a set of far-reaching government edicts make up the backbone of an activity that has gained in popularity in the face of some powerful manufacturing adversaries joined by doubters in hospitals across the country. By most estimates, at least four out of every five U.S. hospitals today either reprocess a selected number of medical devices in-house or send those devices to a commercial third-party reprocessor, then reuse the item in a strategy that has both saved money and sparked controversy in many hospital circles. What's more, the vast majority of hospitals that reprocess SUDs enlist support of a small number of for-profit reprocessing concerns.

The hotly contested marketing component of the issue has been explored in detail before, most recently as part of a description of a recent continuing education session on the subject that reprocessing supporters insist was little more than an unfairly constructed cautionary ale warning against reusing SUDs (see "Panel delivers mostly one-sided snub of reprocessed SUDs," Healthcare Purchasing News, July 2003, pg. 28). The complex science behind reprocessing is probably better left for more scholarly pages. But the legal and regulatory decisions that have led to the current sate of the reprocessing market are still evolving. The bedrock determinations on reprocessing have been dispensed not just by the FDA, but by Congress as well.

After lengthy deliberations that can be traced back as far as 1987, the basic rulings that essentially sanctioned and regulated reprocessing were handed down by the FDA in August 2000. More recently, the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) signed into law by President Bush last October has spelled out in more elegant detail what hospitals and commercial reprocessors can and cannot do regarding the many devices that can now be reprocessed for a second use and more. Other rulings have dealt with gray area matters such as the reprocessing and reuse of open, but unused medical devices. Naturally, there's more. A so-called Guidance Document was issued by the FDA in June, stirring the pot further.

It's enough to keep regulators as busy as the scientists who work for both the FDA and the companies that reprocess SUDs for U.S. hospitals. But in general, whether a ruling was sought by hospitals, the commercial reprocessors or the original equipment manufacturers, it has mostly been the reprocessors that have come out on top with most of the verdicts.

Much of the power of the FDA and the MDUFMA is derived from the labeling of medical products (just as it is with pharmaceuticals), and many of the rules address the labels on a medical device. "Congress has tried to make sure that clinicians know when they are using SUDs and that the data behind the reprocessing of those devices ensures they are as safe and effective as the original devices," says Don Selvey, vice president of regulatory affairs and quality assurance for Phoenix-based Alliance Medical, one of the three largest national reprocessing operations.

Another matter of contention is the means of identifying a reprocessed medical device. The MDUFMA compels reprocessors to affix their brand or logo of some kind on a reprocessed device. While reprocessors favor that notion in principle, they also point out that due to the size and shape of certain devices, surgical drill bits, for example, branding them with a logo or other insignia may be technically difficult, if not impossible. "That ruling is clearly in tended for all manufacturers, including reprocessors," says Selvey. The industry was initially given 18 months to come up with a means of compliance, though that time frame has recently been set back through a June 23 Guidance Document which concedes that 18 months may not be enough time to develop a labeling strategy that complies with the law while not damaging the very device that is being reprocessed. In the meantime, various other technical questions surrounding the reprocessing of SUDs are gradually being answered. One involves the type and quality of data that an OEM must submit to the FDA in its 510(k), particularly for riskier, more invasive Class III devices, nearly all of which still cannot be legally reprocessed. An FDA ruling issued on April 26, for instance, allows OEMs to simply submit data regarding reprocessing to the agency, shielding from public scrutiny proprietary product development data that could easily be used by competitors in a "me-too" crazy manufacturing world.

According to Selvey, reprocessors are not opposed to anything in the MDUFMA. "Our focus was on time frames, making sure they were reasonable," he says. "We're very pleased with how the law turned out." That's mostly because the fledgling reprocessing industry has 'happily gained legal recognition for tough, self-imposed scientific standards and has been eager to reassure hospitals that reprocessed products are not just good investments, but contribute safely to positive outcomes as well.

Says Selvey, "Hospitals that had reprocessed in-house, and then conclude that they want to turn to a third-party reprocessor can do so and find a reprocessor with a clean inspection record and the FDA backing that makes those hospitals more comfortable with the idea of reuse. It's a practice that is here to say."

Materials managers, with a well-deserved reputation as a cynical group to begin with, have been riled by allegations that some OEMs were intentionally selling certain noninvasive products with structural weaknesses that rendered those devices suitable for a single use, but generally unfit for reprocessing. In part to help ease that sensitivity, companies like Alliance have begun joining with a few OEMs in co-marketing agreements intended to help assuage those fears. In one, Alliance and Nellcor, the Pleasanton, CA-based Tyco unit that manufactures pulse oximeters, items that are prime candidates for reprocessing, announced in April the formation of "Reprocessing Plus," a program designed to promote Nellcor's pulse oximetry sensor remanufacturing to Alliance customers who had not yet chosen to participate in Nellcor's own sensor recycling plan. The collaboration agreement also appears to be a concession not just to the validity of SUD reprocessing, but a nod to its cost-savings potential, an argument reprocessors have made for years.

In a release, Dan Roth, Nellcor's director of marketing, said, "Cost-conscious customers will benefit from Nellcor's high-quality, market-leading remanufactured pulse oximetry sensors, combined with Alliance Medical's dedication to placing patient safety first in the cost-control equation. Alliance's commitment to quality, service and cost-savings makes them the ideal partner. As the original equipment manufacturer, only Nellcor can offer a remanufactured Nellcor oximetry sensor."

Watch for more such arrangements in the future.

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