Reprocessing Trend Steams Ahead; OEMs Just Steam

Originally Published MDDI June 2004

NEWSTRENDS

John Conroy

Reprocessing of single-use medical devices by third-party firms continues to grow, even as the war of words between reprocessors and device manufacturers continues unabated.

In a new market research report, Frost & Sullivan calls the 20-year-old practice a “significantly growing trend” fueled by hospital administrators looking to pare costs. “The results speak for themselves in terms of economic appeal,” says Charlie Whelan, the author of the report. “Hospitals are increasingly sold on the idea.”
OEMs, generally speaking, are not. AdvaMed (Washington, DC), the 1100-member trade association of medical device manufacturers, cites a recent survey by the Center for Patient Advocacy in which 75% of surgeons believe the use of reprocessed single-use devices (SUDs) poses “a health and safety risk to patients,” asserts Jeff Ezell, the association's media director. 

Citing AdvaMed's own statistics, the Frost & Sullivan report says that medical device producers in the United States took in approximately $79 billion in 2002. SUDs made up approximately $7 billion of that market. Revenues from reprocessed devices are approximately 2% of that total, according to the report. One of the three major reprocessing firms, Vanguard Medical Concepts (Lakeland, FL), projects a $2.3-billion market for reprocessed devices, or nearly 20 times larger than the market size in 2003. 

Approximately 250 different types of SUDs are being reprocessed. “I would say the market easily almost doubled from 2002 to 2003. In my estimates, it's growing very significantly,” Whelan says. While the market has expanded rapidly in the last three years, it is unlikely to reach the multibillion-dollar level “any time soon,” he notes.

Both sides point to conflicting studies or data to support their respective points of view. 

Whelan says that OEMs have examined reprocessed products taken from clients after replacing the devices with new ones. Back at their labs, OEMs “pore over reprocessed devices looking for problems with them and publish studies or get other clinicians to say that these things are no good. There hasn't been any kind of unbiased critical large-scale study as to whether these devices are just as effective [as new ones].”

OEMs “should have embraced this a long time ago,” insists Dan Vukelich, deputy executive director of the Association of Medical Device Reprocessors (AMDR). “They must see this as an economic threat. Frost & Sullivan says we're growing, and we know we're growing.”
The closest thing to a neutral study is a June 2002 report from the United States General Accounting Office that AMDR has posted on its Web site. The report's title may be a fair summation of the differences over the practice: Single-Use Devices—Little Available Evidence of Harm from Reuse, but Oversight Warranted.

“We're held to the exact same standards as the original medical device manufacturer,” Vukelich points out. AMDR also points to support for its position from groups such as the American College of Cardiologists. The college's official position is that reprocessed electrophysiology (EP) catheters are safe. He also singles out one small step toward cooperation by small OEMs noted in the Frost & Sullivan report as a potential trend. Last year Nellcor and Alliance Medical, a major device reprocessor based in Phoenix, signed a comarketing agreement for Nellcor's pulse oximetry sensors.

Ezell, who hadn't yet read the Frost & Sullivan report, says, “Single-use devices are designed for optimal performance and safety—not ease of cleaning and sharpening. They typically have characteristics that make them extremely difficult, if not impossible, to effectively clean and resterilize.” These characteristics include “small, difficult-to-access areas, such as long, narrow lumens; acute angles; crevices; coils and joints; reinforcing meshes; and rough, porous, or occluded surfaces.”

Ezell says the manufacturer's trade association is “closely monitoring” how FDA follows the provisions of the 2002 Medical Device User Fee and Modernization Act (MDUFMA). The association backed Section 302 of the act, which permits SUD reprocessing for FDA-approved devices that have validation data for cleaning, sterilization, and functionality.

In a letter sent in March to FDA's Center for Devices and Radiological Health, AdvaMed claims that two of three third-party firms responsible for reprocessing the majority of SUDs in the United States have violated the law by not submitting timely validation data as required by Section 302 of MDUFMA.

“AdvaMed believes that reprocessed devices should be regulated in the same way as devices designed to be reused. The idea that a device can be reused over and over and still be considered a single-use device is counterintuitive,” Ezell insists.

The problem with this self-definition, of course, has always been that reprocessors believe SUDs are mislabeled. “We like to joke that if OEMs could label an x-ray machine a single-use device, they would,” Vukelich remarks.

The controversy is likely to continue. “It goes to a lot of people's vested interests,” says Whelan.


Copyright ©2004 Medical Device & Diagnostic Industry