When you see the "single-use only" label on your trocar packaging, do you do you heed it, disposing of each trocar after use? Or are you among the many facilities ? including some of the nation's finest ? that sends them off to a reprocessor and buys the re-sterilized devices for a fraction of the price of new?

Whether and how trocars are reprocessed is the center of much debate and, most recently, legislation (see "States Debate Letting Patients OK Reprocessed Devices" on page 25). Despite the fact that the reprocessing of single-use devices is a multi-million-dollar industry regulated by the FDA, there are lingering fears it may present a risk to patients ? either because the devices aren't actually as good as new or because they haven't been properly sterilized. Here's what experts on both side of this issue have to say.

Legitimizing practice
Reprocessing medical equipment has gained popularity since the early 1990s, says Greg Wenthe, chief marketing officer of SterilMed, Inc., in Maple Grove, Minn. He says hospitals began by reusing small, non-invasive devices such as compression sleeves after they were cleaned and disinfected. As the costs of practicing medicine went up and reimbursement rates went down, many began looking at other high-volume items for reprocessing potential.

As reprocessing became more common, the government began studying its safety. In 2000, the Government Accountability Office (then the General Accounting Office) issued a report stating there was "little available evidence of harm from reuse" of medical devices, but added that the process required oversight. Soon afterward, the FDA developed regulations for the practice: Third-party reprocessors must demonstrate that their devices are substantially equivalent ? meaning sterile and fully functional ? through pre-market notification submissions, or 510(k)s, submitted to and approved by the agency. The result, says Mr. Wenthe is that "third-party processing became a recognized industry."

Within the regulations
Brand new trocars and many other devices used in invasive procedures often sport single-use-only labels, but Mr. Wenthe says this designation is selected by the manufacturers for labeling purposes.

"The manufacturers use it as a marketing claim, because they want people to throw out the devices so they'll buy more new devices that could have been reprocessed under FDA regulations," he says. "If we go through the same stringent parameters as the original equipment manufacturers, why should we be singled out? There's no proof that reprocessed devices are not as safe as devices used for the first time."

When a reprocessing facility receives trocars, it cleans, sterilizes, sharpens and inspects them thoroughly for cracks or other damage that could compromise integrity. Further, "unlike the original equipment manufacturers, we test every device instead of just looking at a few samples from each lot," says Mr. Wenthe. His company has clearance under the FDA 510(k) requirements that says its devices can be reprocessed for a maximum of five uses.

Other processing companies report that they undertake the same stringent quality measures and that, as a result, "we really don't have many concerns for our devices from a clinical standpoint," says Rick Ferreira, the COO of Ascent Healthcare Solutions in Phoenix, Ariz., which has been reprocessing trocars for eight years.

"Every device has to go through cleaning and testing before it is returned to use," he says. "Reprocessors are regulated as stringently, if not more, than the original equipment manufacturers."

He notes that Ascent reuses trocars three times at most: "We typically see them discarded after the second or third use because of cracks developing in the sheath or damage caused from shipping," says Mr. Ferreira.

Which brings up the matter of tracking: How do you know whether you're getting a device that's been reprocessed an approved number of times? It's quite easy, actually, says Dan Vukelich, JD, the executive director of the Association of Medical Device Reprocessors, which represents 95 percent of U.S. third-party reprocessors. He says each device and each package carry matching ID numbers specific to the device so that the reprocessor can see who used it last and how many times it's been reused.

"These are all patient safety measures that aren't done by the original equipment manufacturers," says Mr. Vukelich. He notes that the AMDR's members serve hospitals that are consistently listed by national media such as U.S. News & World Report as being the best in the country. "The very best hospitals in the country would not risk their good names to save $40 on a trocar," if they didn't feel reprocessing the devices was safe, he says.

Moving into the gray area
Although reprocessed devices have their supporters, there are still those who'd rather see the devices used once and then discarded. The Advanced Medical Technology Association (AdvaMed for short) testified in September to the House Committee on Government Reform Hearing on the FDA's oversight and regulation of reprocessed devices that medical devices are designed for their optimal performance and safety under the intended condition of use, not after cleaning.

"They typically have characteristics that make them extremely difficult to effectively clean and resterilize," says Stephen J. Ubl, president and CEO of AdvaMed, in his testimony. "Single-use devices are not designed to ? and may fail to ? withstand the harsh conditions encountered during reprocessing."

Product manufacturers also insist that they can't vouch for the quality of any device after its first use. Trocar manufacturer Ethicon Endo-Surgery insists that its devices are designed for only one application.

"Under the law and FDA regulations, reprocessors are considered the manufacturers of the devices they reprocess and distribute, [but] reprocessors do not have access to Ethicon Endo-Surgery design specifications and, therefore, any claims they make about the benefits of a reprocessed device should be validated by the reprocessor's own testing data," says spokeswoman Bridgett Golden. "Ethicon Endo-Surgery does not have sufficient data to support the practice of reprocessing nor to warrant the performance of a single-use device beyond the intended use on a single patient."

While Mr. Wenthe acknowledges he does not have the specific schematics for Ethicon's devices, he says his company works closely with the FDA to show SterilMed's reprocessed trocars are as effective and safe as new ones and has submitted validation testing data to support that claim.

"Even without having the drawings or designs on how they originally put their product together, we can still show the FDA that our reprocessed devices have substantial equivalence," he says. "The same regulatory body that clears Ethicon to market their original product is the same one that clears SterilMed to reprocess the same device."

Ultimately, the FDA sided with the reprocessors. In a statement delivered on Sept. 26, the agency said it believed reprocessed devices met the requirements to be considered safe and effective.

"The laws and regulations in place are designed to protect the public health by assuring that the practice of reprocessing and reusing [single-use devices] is based on sound science," says Daniel Schultz, MD, director of the Center for Devices and Radiological Health at the FDA, in a statement.

Reprocessed in practice
Mr. Vukelich says some physicians prefer using reprocessed trocars because they've already proved functional in at least one instance. But will a reprocessed trocar perform like a new one?

Yes, says Beth Nicoll, RN, the supply chain director of projects and contracting at Fairview Health Services in Minneapolis. After careful consideration, her facility began reusing trocars and other devices through an FDA-approved third-party reprocessor in 2001 ? and it hasn't looked back. "We reprocess?single-use devices, as they're quality products that meet clinical criteria at a better price, about half the cost of a new device," says Ms. Nicoll. "Our experience has been that these devices don't have a higher failure rate than a new device."

Still, some surgical facilities prefer not to use reprocessed devices due to bad experiences with an in-house reprocessing system or a lack of noticeable benefit. Reading Hospital Surgicenter at Spring Ridge in Wyomissing, Pa., used to reprocess trocars in-house, but now relies exclusively on first-use disposable devices.

"Our staff found they were difficult to clean, and when you reassemble them you could put them back together backward, so there was a large margin for error," says administrative director Pam Ertel, RN, BSN, CNOR, RNFA, FABC, CASC. "And in some of them the rubber gaskets were degraded, which could have lead to CO2 [insufflation] leaks."

Another issue was that blades sent out for sharpening often came back too sharp.

"When you're going through someone's peritoneum, you have to put force behind the trocar, and if the blade's too sharp there's a fear that you could rupture the patient's aorta," says Ms. Ertel. "The new disposable trocars have a safety blade so that can't happen."

Making financial sense
Although Ms. Ertel says the practice was cost-effective, she stopped it soon after several new physicians and residents who preferred one-use disposable trocars began performing procedures at her facility.

"If surgeons have something that they're used to using, it's difficult for them to change, but surgeons only want the instruments ? they don't care about the costs or savings," says Mehnet Kocakulah, PhD, professor of accounting at the University of Southern Indiana in Evansville, Ind. "Administrators, however, are more interested in this area."

A new trocar can cost anywhere from $40 to $90, with $55 being about average; Mr. Wenthe says a reprocessed one sells for half that. Ms. Ertel says she's found that trocars are now inexpensive enough to make disposing of them more feasible.

"The price has come down so much, it's not even an issue," she says. "We won't consider using a third-party processor because we're happy using single-use devices."

But that's not the case for everyone
"It's imperative to think about savings in the climate we're in," says Mr. Wenthe. "With reimbursement rates and managed care payments going down and costs going up, you need to find ways to conserve resources. This is a way to reduce costs without changing the way you do business."

Dr. Kocakulah saw how effective reprocessed devices could be when he helped implement them in a hospital, a process he described in "Cutting Costs in Surgery" in the January-February 2001 issue of Heath Progress. His case study describes how one hospital saved tens of thousands of dollars by using reprocessed trocars ? once it had educated everyone involved in the supply chain about the far-reaching benefits of the reduced healthcare costs.

"The administration has to work with the physician and show how it makes it easier for everyone concerned, even the patients," says Dr. Kocakulah.

Doing your duty
If your facility decides to start using reprocessed trocars, it may be your job to educate the staff about these devices ? and that may come down to your having faith in the product. A facility administrator who asked not to be named says her facility has saved about $8,000 from using reprocessed trocars over the past four years, but she says there is still some reluctance to use them. "The devices have been fine," she says. "It's the struggle with the staff that has been very hard."

It becomes clear that someone is reluctant to use these devices when they're left sitting on the shelf, she says. When this happens, she finds who among the staff is not taking the trocars and talks to them about how safe the devices are. "Physicians are usually willing to use them once they know the reasons," they're being asked to use them, she says.

But don't base your faith in reprocessed devices on clinical data or industry chatter. This administrator toured the reprocessor's site and was convinced of the efficacy after having seen how thoroughly devices are cleaned and inspected. If you want to judge for yourself on whether you're compromising patient safety to save money you might want to do the same if you want to be sure.