The reuse of disposable medical devices, once a taboo subject, is drawing scrutiny as hospitals struggle to cut costs.
Generally, U.S. hospitals don't recycle a product meant for one use because they fear it might fail in the second round. One controversial exception is hemodialysis filters, which some providers use several times.
Now, prompted by industrywide belt-tightening, researchers at the Cleveland Clinic Foundation are carrying out laboratory tests to see if single-use products can be reused safely. The eight targeted products include aortic and venous cannulae, which are used to return blood to patients, and electrophysiology catheters, used for mapping and treating heart disease.
Later tests might take on balloon angioplasty catheters, more costly and complex devices that unblock patients' veins, said Fredrick Cornhill, chairman of the clinic's biomedical engineering department.
The potential savings are significant. For example, U.S. providers will spend about $420 million on such catheters in 1995, Boston-based Cowen & Co. predicts. As manufacturers continue to wage a war for customers, prices will fall to about $515 per catheter this year from about $580 in 1994, it estimates. Hospitals would spend a lot less if products could be used several times.
"What became clear to us is that we really need to look at the way we have medical devices that are single use," Cornhill said. "Our goal is to take costs out of the healthcare system."
Many hospital executives consider the reuse of disposables forbidden territory and shudder at the legal troubles that could arise if the devices don't work or infect patients. Balloon catheters, for example, might lose surface coatings that help them glide through blood vessels.
And while the Food and Drug Administration leaves the issue up to hospitals, it says providers that reuse disposable devices are liable for the products' safety and effectiveness.
Canadian and European hospitals, however, reuse many products. For example, almost 40% of Canadian hospitals performing cardiac catheterization reuse balloon catheters, according to a 1991 report.
A study, published on Nov. 15, 1994, in The Journal of the American College of Cardiology, compared the results of angioplasty at two Canadian hospitals. One reused catheters; one did not.
In a 10-month period, the hospital that reused catheters saved $110,000 in Canadian money (one Canadian dollar is equivalent to 69 U.S. cents). Both providers successfully cleared patients' veins at a comparable rate. But procedures took longer at the hospital reusing catheters and resulted in a higher rate of adverse events, such as vessel closure and deaths. It also, however, treated more patients with unstable angina.
The researchers are asking the Canadian government to fund a more thorough trial.
"There's a lot of talk about this," said David Berkowitz of ECRI, a Plymouth Meeting, Pa.-based technology assessment firm. "It sounds great to reuse a catheter or a trocar-but keep in mind some major premises, like maybe it's impossible to clean."
Sterilization could damage delicate devices, leave dangerous residuals from the process or fail to kill bacteria. ECRI tells hospitals they shouldn't reuse devices unless manufacturers provide instructions or hospitals can prove that the products still work as well. They also should make sure the reuse of devices is worth the trouble.
Right now, Cleveland Clinic doesn't reuse products labeled for single use. Its experiments don't involve patients and focus only on how products hold up to sterilization, Cornhill said. Before it goes further, it will seek help from the FDA and manufacturers. It also will analyze exactly how the reuse of devices will affect its budget, including the cost of the product, sterilization and legal liability.
"We're being extraordinarily careful," Cornhill said. "We certainly don't want to do anything that's going to harm patients or the reputation of the clinic. All the constituents have to be involved."