Debate over Reprocessed SUDs Continues

Conflicts over reprocessing single-use devices (SUDs) have persisted for many years, and 2005 was no different. From a major merger to a Massachusetts bill that would require informed consent when using reprocessed SUDs on patients, the reprocessing industry stirred up quite a bit of debate during the past year.

Alliance Medical Corp. and Vanguard Medical Concepts merged to create the largest reprocessor of single-use devices. Since the merger was only approved in December, its direct effect has yet to be seen. However, the growth of third-party reprocessors could push OEMs to participate in SUD reprocessing.

Millstone Medical Outsourcing Inc. (Fall River, MA) started a reprocessing program with an orthopedic OEM last year. A manufacturer that had already contracted Millstone Medical for other services brought up the idea after becoming concerned over third-party reprocessor growth, according to Shannon Tillman, president of Millstone Medical.

The company doesn't consider itself a third-party reprocessor; instead, Millstone is a subcontractor. The firm is not registered with FDA as a reprocessor. “We would never take a device that a company made, do reverse engineering, and then offer it back to a hospital,” says Tillman. With regard to reprocessing, Millstone Medical works for the OEM, who is the product owner.

There are three manufacturers that are reprocessing either in-house or subcontracting it through Millstone or a similar company, says Tillman. “From my perspective, it's their way of dealing with major hospital accounts that are demanding a reprocessing option. Rather than lose those accounts, they're providing the service that a third-party reprocessor would provide.”

Although this option allows manufacturers to provide direct knowledge of a device to the reprocessor, not everyone sees the logic in the idea. “If that's possible, then the OEM should be selling a reusable device,” says Larry Pilot, partner at McKenna, Long and Aldridge LLP (Washington, DC). “Why would a company that makes an SUD want to cooperate with a reprocessor and expose itself to the liability that comes with that? Years ago, I predicted that this is a fertile environment for the trial attorneys, because eventually, there will be an [adverse] incident, and maybe more incidents.”

John Grotting, CEO of Alliance Medical Corp. (Phoenix) and the newly merged reprocessing firm, predicts that more OEMs will want to explore reprocessing. “It's clear that the failure to offer a reprocessing alternative is hurting the OEMs. I'm quite confident that during 2006 you'll see some additional OEMs begin to work directly with companies like ours, and we welcome that.” A cooperative relationship between OEMs and reprocessors may also help manufacturers gain customer trust. OEMs could be seen as critical of reprocessed devices only because they want to sell new ones. Grotting suggests that hospitals will be more trusting of a supplier that works with a reprocessor.

A more-concrete change occurred in August, in the form of labeling reprocessed SUDs. When the Medical Device User Fee and Modernization Act of 2002 went into effect, it required any device to display the name of its manufacturer. The Medical Device User Fee Stabilization Act of 2005 amended section 502(u) of the Federal Food, Drug, and Cosmetic Act to apply only to reprocessors of SUDs.

FDA issued a draft guidance last October on how to implement the new law. It stated that a reprocessed SUD must “prominently and conspicuously” display the name of its reprocessor. In cases in which a device or “an attachment” doesn't clearly show this name, the reprocessor can put a detachable label on its packaging. The label is ultimately placed on the patient's medical record. The requirement will become effective August 1, 2006.

Grotting has no problem with the provision, because it's something that his company has been doing all along. “We've always marked our devices on the packaging, and each individual device has a mark on it that identifies how many times it's been reprocessed and that it's done by [Alliance or Vanguard].”

Another development that happened during the summer still hasn't been resolved. Senators in Massachusetts introduced a bill that would require patient consent before using a reprocessed SUD that pierces the skin or enters the body or bloodstream. The bill, praised by AdvaMed, MDMA, and MassMEDIC, would be the first of its kind. Supporters say that patients have a right to know where their devices came from. Pilot suggests that the device's history should also be disclosed. Reprocessors are against the bill, because it implies that there's a higher level of risk involved in using reprocessed SUDs.

“These are devices that have been demonstrated to be substantially equivalent to brand-new devices. They're fully regulated by FDA,” says Grotting. “If you're going to get into the risk associated with devices, then you should do it with new devices in the same way.”

Tillman says if the bill is passed, it could snowball to other states, but it wouldn't make reprocessing go away. “I think there are plenty of hospitals that have reprocessed their own devices. Whether they're doing it themselves or using a third party, it's a real issue for them on the financial side.”

The year ended on a controversial note with the publication of a series of negative Washington Post articles about the reprocessing industry. “That painted a pretty grim picture of third-party reprocessing,” says Tillman.

No matter which side prevails, last year's events in the reprocessing industry proved that emotions on both sides of this issue will remain passionate. Opponents will continue to fight against the practice, and supporters will continue to be optimistic about the growth of the industry.—Maria Fontanazza

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