Reuse of medical tools raises safety questions

FDA weighs risks, costs as single-use devices are cleaned and used again


When patients come to the University of Virginia Health System to have an abnormal heart rhythm diagnosed or treated, they are told that doctors will be threading thin wires through their veins directly into their heart. They learn that they face a slight risk of infection, or of damage to the heart, lungs or blood vessels from the invasive procedure.

But there is one thing they are not told: Although the catheters and wires are labeled "single use only," they might have been used before. They have been cleaned and sterilized, but they have spent time in someone else's blood vessels and heart.

In hospitals and clinics around the nation, these devices and others -- biopsy needles used to extract tissue, tiny scissors used to cut out tissue in patients' gastrointestinal tracts, wires or balloons that go into the coronary arteries or the heart -- are being reused more and more often despite their labeling.

The practice of reusing devices that are approved only for one-time use is not necessarily dangerous, experts say, but it generally violates federal regulations. So far, the government has declined to ask the companies that reprocess the devices to submit evidence that they are safe and effective, but is reconsidering its approach.

"We have used what we call `enforcement discretion' not to go after them," said Dr. Larry Kessler, director of the office of surveillance and biometrics at the Food and Drug Administration.

One reason is that the FDA has little evidence of a safety problem, Kessler said, although it is widely acknowledged that research is urgently needed.

"There's a big `yuck' factor to reusing devices," Kessler said. But, he added, "there are no products where we have significant evidence that there is immediate harm to public health."

Some doctors and federal officials say the issue is more about economics than safety. Manufacturers make less money when single-use devices are cleaned, sterilized and reused. Hospitals and medical centers save money, in some cases tens of thousands of dollars a year, when they reuse the devices.

Doctors say manufacturers charge so much that they often cannot afford to use devices just once; nor can they pass the cost along to patients, because in many cases the rates have been set in advance by insurance companies or Medicare. And, they say, many expensive devices that are labeled "single use only" can safely be used repeatedly.

Manufacturers say hospitals are putting patients at grave risk to save money. "The real issue is patient safety," said Josephine Torrente, president of the Association of Disposable Device Manufacturers. "Until you prove otherwise, these devices are safe and effective for one use. After that, they're garbage."

The FDA, caught in the middle, is considering regulating those who reprocess devices in the same way it regulates the original makers. They would have to get approval -- showing that the reprocessed devices are safe and effective -- before they could sell them. The only exception would be devices, such as surgical saw blades, that are considered to pose a very low risk after being cleaned and sterilized. The agency is also suggesting that manufacturers explain on labels the risks of reprocessing the devices.

The agency will conduct a satellite teleconference today in which manufacturers, companies that reprocess the devices, doctors, hospitals and ethicists can comment. On Dec. 14, the FDA will hold a public meeting on its proposal.

Are reprocessed devices really as good as new?

One way to keep track of problems is through the FDA's device surveillance system. When medical devices fail or injure patients, manufacturers, hospitals and doctors are supposed to notify the agency. Of the 100,000 such reports to the agency each year, virtually all are from devices that were used just once, Kessler said.

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