A piece of metal broke off a catheter and lodged inside the heart of a 32-year-old Kansas woman earlier this year -- and reignited a simmering medical controversy.
The catheter was disposable, supposed to be thrown away after its first use. Instead, critics contend it was resterilized and reused six times, a process they argue stressed the device until it broke.
Unknown to most patients, every day hospitals recycle disposable medical devices. They range from simple products like surgical clamps to complex cardiac catheters, bronchoscopes, even angioplasty balloons.
Proponents say this so-called reprocessing is a safe way for hospitals to save thousands of dollars. They argue that many devices are called disposable only so manufacturers can sell more of them, and correctly note that even brand-new catheters can break.
But critics point to the Kansas injury and laboratory discoveries of dried blood or tissue in supposedly resterilized devices. Some products, they say, simply are too fragile or have too many nooks and crannies where contamination could lodge to be safely reused.
Does that put patients at big risk?
"The honest answer is no one can tell you," says Sen. Dick Durbin, D-Ill., who contends the government doesn't have a good way to track the practice's safety, and thus is pushing the Food and Drug Administration to crack down.
The concern isn't new. In 1997, the FDA said it was investigating reports of infections and other complaints with reused medical devices -- and two years later, the agency still is investigating.
FDA's recent testing of recycled angioplasty balloons discovered they can harbor dried blood after attempted cleaning, and that repeated uses can stretch the balloons so they don't inflate properly.
Then, last spring, the FDA learned of the Kansas injury, which disposable device makers used to lobby for curbs on reprocessing.
But new catheters have been known to break, too, and companies that reprocess medical devices argue that saving hospitals from having to repurchase catheters that cost $1,000 each is important.
When a device can be safely reprocessed, "to throw it away is an unforgivable waste of scarce health care resources," Pam Furman of the Association of Medical Device Reprocessors told a recent meeting on the issue.
Reusing disposable devices is legal, although hospitals assume any liability. However, the growing fight in Washington over the issue leaves consumers in the middle wondering what to think.
Independent health experts say consumers shouldn't panic, because reports of patient problems are so rare that there's no evidence recycled devices are a big risk.
"I would just be absolutely amazed if this is a major public health problem and the (leading hospitals) have failed to realize it," says Dr. William Jarvis of the Centers for Disease Control and Prevention.
The CDC, he notes, has had to investigate very few outbreaks linked to reused devics in the past decade. But it is about to study the issue in Brazil, where poverty means devices are reused hundreds of times more often than here, to better understand of how much reuse products can stand.
Durbin, in contrast, has asked Congress' General Accounting Office to investigate reused devices here, and last week won Senate approval for $1 million for FDA to better monitor the practice.
The FDA suggests the issue, like much in medicine, may boil down to evaluating reused devices on a case-by-case basis: Some may be fine to reuse 10 or 12 times as long as they're reprocessed under certain standards, while other devices might be too risky.
"We're not saying it's safe...We're not saying it's unsafe. We don't know. We're still looking at this," said Larry Spears, FDA's director of medical device enforcement.
In October, the FDA will announce how it plans to further address the practice.
Written By Lauran Neergaard