As a result of a December 2005 Washington Post series examining the safety of the practice, the reprocessing of medical devices labeled for single use is again being debated.
According to the December 17 article by Alec Klein, the concerns expressed in the series were enough to convince Congressman Tom Davis (R-VA) to send a letter to the Food and Drug Administration (FDA) asking for a detailed explanation of its regulation of the reprocessing industry and the specific measures the agency is taking to "ensure that reprocessed single-use medical devices are safe and efficacious." The letter was cosigned by Henry Waxman (D-CA).
The reprocessing of single-use devices is a complex issue. The manufacturers of medical devices, and their trade groups, say that reprocessing single-use devices is not in the best interest of patient safety. A position paper from the Advanced Medical Technology Association (AdvaMed), the largest association representing manufacturers of medical devices, states that "single-use devices are designed and manufactured for use in a single patient and are intended by the original manufacturer to be disposed of permanently after use."
"These items were not intended to be reused," says Mark Brager, a spokesperson for AdvaMed. "Some of them are very difficult to reprocess, and it exposes patients to an unnecessary risk."
"I don't want to draw any conclusions, but infection rates in hospitals are going up, and that is a serious concern," he adds. "So anything that can be done to keep down infection rates should be implemented," like using disposable products, he says, as they were designed to be used.
Medical facilities and the reprocessing industry disagree with this position and contend that reprocessed items are as safe as-or even safer than-new devices. Of the 14 hospitals that earned Honor Roll status in 2004, a mark of particular distinction from the U.S. News and World Report ratings, 13 used reprocessed devices, says Dan Vukelich, deputy executive director of the Association of Medical Device Reprocessors (AMDR), a trade group representing the three national single-use device reprocessors. According to Vukelich, AMDR members reprocess medical devices for 87% of America's top medical facilities.
"The FDA requirements are very stringent," he explains, "and every single reprocessed item is inspected and sterilized."
In the middle of the debate are nursing and medical organizations, such as the Association of periOperative Registered Nurses (AORN) and the American College of Cardiology (ACC).
"We don't take a real stand; instead, we attempt to provide information," says Byron Burlingame, MS, RN, CNOR, a perioperative nursing specialist at the AORN's Center for Nursing Practice. The AORN Web site offers a guidance statement on the topic, available at http://www.aorn.org/about/positions/pdf/Reuse.pdf. The statement notes that providers "are required to report deaths or serious injuries to the FDA if it can be reasonably determined that a medical device may have caused or contributed to the incident." This is true whether the medical device in question is reused or new. For a list of frequently reprocessed devices, visit http://www.fda.gov/OHRMS/DOCKETS/98fr/03-10413.html. (For more information from the FDA on this topic, visit http://www.fda.gov/cdrh/reuse.)
A position paper from the ACC states that "for more than 20 years, cardiovascular specialists have been safely using reprocessed electrophysiology . . . catheters to treat their patients." It points out that neither the FDA nor the Centers for Disease Control and Prevention has found reprocessing to be unsafe.
Between August 1996 and December 1999, the FDA's Medical Device Reporting system documented 245 adverse events associated with the reuse of single-use devices. These included seven deaths, 72 injuries, 147 malfunctions, and 19 unclassified incidents. However, the FDA was unable to find a pattern of product failures with single-use devices that differed from those that occurred with an item's initial use.
In June 2000, the Government Accountability Office (GAO, then called the Government Accounting Office) compiled a report entitled Single-Use Medical Devices: Little Available Evidence of Harm from Reuse, but Oversight Warranted. The report revealed that 20% to 30% of U.S. hospitals reused at least one type of single-use device, a figure that has increased substantially since the GAO report. They reported that "although [single-use device] reprocessing does pose theoretical health risks, clinical evidence shows that certain devices can be reprocessed safely." Careful reprocessing of appropriate single-use devices had not been demonstrated to be a public health risk, according to testimony from several public health experts. Further, according to the report, several reports of adverse events, allegedly related to single-use device reprocessing, "were inaccurate or not relevant to the debate." While the GAO didn't find any inherent danger in the process, it also concluded that single-use device reprocessing may not always be safe and should be subject to oversight.
In response to such concerns, the FDA in 2000 provided guidelines that subjected reprocessors to the same regulatory requirements applied to original equipment manufacturers, while the Medical Device User Fee and Modernization Act of 2002 added additional regulatory requirements for reprocessors.
On average, reprocessed medical devices offer a 50% cost savings, and they cut down dramatically on medical waste. But the scientific data to either support or disprove the safety of reprocessing of single-use devices are scant.
"The problem is that it is very difficult to know whether or not a device has been reused," says Brager. "Up until recently, there hasn't been a law requiring items to be marked that they had been reprocessed. Now we will be able to better assess whether infections or adverse events are being caused by these items. And hopefully, reporting by providers will increase as well."
As a result of the Washington Post series, the GAO is also planning to revisit the issue.
"Following the publication of stories in the Washington Post, the GAO received a bipartisan request from the House Government Reform Committee to look at the issue," says Paul Anderson, managing director of the office of public affairs at the GAO. "We have agreed to update our June 2000 report on reuse of single-use medical devices, focusing on government oversight of reprocessing."
Vukelich, however, asserts that the Washington Post articles lacked concrete information and alarmed readers by exaggerating the risks associated with reprocessed devices.
The articles did not mention that the FDA has put stringent regulations into place, he says, and were inaccurate in saying that reprocessing had little federal oversight before the year 2000. They also failed to mention that hundreds of adverse event reports are filed every year, resulting from procedures performed using devices during their initial use. Also omitted, says Vukelich, are any hard numbers showing that patients are injured as a consequence of using reprocessed single-use devices.
"We never did find out why the author of the series decided to write on this topic," says Vukelich. "We cooperated with him fully, but there was nothing for him to uncover." Whether or not that is so, as the reprocessing industry continues its rapid growth, oversight will be needed, and nurses will need to be vigilant in reporting problems with medical devices, whether they are reused or new.