At a growing number of hospitals the controversial practice of reprocessing disposable medical devices for reuse is stepping out of the shadows and into the bright light of clinical respectability.
In a clear sign of the changing times, several hospital purchasing groups have started contracting with vendors of reprocessing services, showing that the practice is quickly going mainstream.
Safety and cost lay at the heart of the debate over whether hospitals should clean, sterilize and reuse products, such as orthopedic drill bits and catheters, sold by manufacturers for one-time use.
Proponents argue that manufacturers often label their products unnecessarily as single-use, seeking to spur sales at considerable cost to hospitals. When properly cleaned and sterilized, many devices can be used several times, saving money-from 25% to 50% of the cost of buying new products-and posing no additional risk to patients, reprocessors argue.
Opponents, including devicemakers and some sterilization experts, argue that certain products, such as endoscopes and angioplasty catheters, either can't be cleaned and sterilized properly or may be damaged in the process. They argue that reprocessing poses too many risks to justify the savings, however attractive the savings might appear.
Last year the Food and Drug Administration, which had been virtually silent on the matter, gave an important boost to reprocessors and their customers. By rejecting a petition from devicemakers that asked the FDA to regulate reprocessors as stringently as it does original equipment manufacturers, the FDA spared reprocessors from obtaining marketing approval for each device they intended to clean, sterilize and repackage.
Shortly afterward, group purchasing organizations, those consolidators of hospital buying power for goods and services, got serious about the possibility of discount contracting.
Without explicitly endorsing reprocessing, Health Services Corporation of America, Cape Girardeau, Mo., has added the practice to its roster of discounted member services.
In November 1998, HSCA launched a three-year agreement with Vanguard Medical Concepts, Lakeland, Fla., one of the largest reprocessors in the $40 million industry. More than 101 hospitals have signed on so far, according to HSCA, and the pace of sign-ups is holding steady. "Pretty exceptional for a contract that's only three months old," says Mark Miriani, vice president for materials management at HSCA.
At 334-bed Columbia Hospital in Milwaukee, Mary Jo Wentzel, director of cardiovascular services, is a recent reprocessing convert. In 1997 when a committee from Columbia and two affiliated hospitals started looking at reprocessing, Wentzel opposed the idea, she says. But after nearly two years of study, Wentzel decided that for certain products, such as electrophysiology catheters, reprocessing was clinically and fiscally sensible.
Columbia, which belongs to HSCA, tapped Vanguard for reprocessing last spring and now uses a mixture of independent and HSCA contracts to cover the service for various products. Although savings are hard to gauge this early, Wentzel says, Columbia probably saved $30,000 during the first six months of reprocessing sequential compression devices.
St. Louis-based AmeriNet is another group that has gotten into the reprocessing act through a contract with
Alliance Medical Corp., Phoenix.
Arthur Goodrich, a marketing vice president at Alliance, says AmeriNet and other groups have gone beyond earlier deals to resterilize and repackage open but unused products, such as sutures. They now embrace full-blown reprocessing, or "recycling," as he prefers to call it.
Not all groups have added reprocessing to the contracting menu, however.
"For now, Novation does not have a national reprocessing contract in place," says Kathy Harlan, director of Novation's surgical products business unit. Rather, the Irving, Texas-based buying group for more than 1,800 hospitals of VHA and University HealthSystem Consortium, is sticking to a mix of purchasing contracts for products that are specifically labeled as reusable or another category called reposable, meaning limited reuse, to supplement disposable items.
Nevertheless, several of VHA's offices around the country, including the Northeast and the West Coast, have entered into various reprocessing agreements for their member institutions, confirms Lynn Gentry, a Novation spokesman.
At San Diego-based Premier, an alliance of about 1,700 not-for-profit hospitals, spokeswoman Laura Yandell says the group has no reprocessing contracts but is researching the idea.
Just because a purchasing group has a reprocessing contract doesn't mean hospitals should necessarily use it. Reprocessing must be a "device to device decision" that each hospital makes, says Janet Schultz, a consultant and vice president at MedAscend in Atlanta. Even a well-negotiated national purchasing contract, Schultz says, "doesn't lessen the responsibility for the institution to make sure that what they're getting is what they want . . . a safe and efficacious process that results in a safe and efficacious device."