The dilemma: Should you tell patients when you reuse single-use devices?

Ethical issues, including billing, move to forefront in same-day surgery

You know you can safely reuse medical devices labeled for single use. And you have your protocols in place. But a new ethical question is coming up: How do you handle patients, specifically in terms of informed consent and billing?

"Health care providers are so focused on 1) cost issues — saving money — and 2) technically, can we do it?" says Jan Schultz, MSN, RN, president of Jan Schultz and Associates, a consulting service in Allison Park, PA, that focuses on the reprocessing continuum. "The ethical issues are just beginning to surface."

In several meetings at which Schultz discussed reusing devices, she’s asked the audience of health care professionals if they would be willing to have a single-use device reused on themselves. "Very few, maybe 1%, raised their hands and said they were comfortable," she says. "That tells me right there that there’s an ethical dilemma."

While most consumers may not be aware that some medical devices labeled for single-use are being reused, those who do find out are furious. Consider the results from a recent survey by Wilson and Associates, a Los Angeles research firm. When consumers were asked if they would make any new decisions based on what they had learned in the survey about the reuse of medical devices, 90% said they would choose a facility with a policy against re-use. (See more survey results, p. 35.)

Should you tell patients a device labeled as single-use is being reused? Consider these points:

The issue of informed consent revolves around the device that’s being reused and the risks associated with that reuse, sources say.

Patients have a right to know any significant risks associated with their treatment, Schultz points out. Consider what device you’re reusing, she suggests. For example, basins reused in the post-anesthesia care unit may carry no significant risks. Reused biopsy forceps in endoscopy might be difficulty to clean, however, and could carry increased risk of infectious complications above and beyond that of a single-use device.

"Whether or not infectious complications materialized, if the risk is there, some ethicists would say the patient has a right to know that and give consent," she says.

Make a formal assessment of the risks associated with the device you’re reusing and include your ethics committee if your facility has one, suggests Sherron C. Kurtz, RN, MSA, CNOR, CNAA, director of perioperative services at Henry Medical Center in Stockbridge, GA. (For information on how to determine risks, see Same-Day Surgery, June 1997, p. 69.)

Henry Medical Center reuses laparoscopic scissors, tracking the number of times they’re reused; four is the maximum. After each reprocessing, the scissors are examined. "With our informed consent, nothing is different," Kurtz says. "We think we’re giving the patient a comparable product."

Reprocessors claim that when reuse of single-use medical devices has a scientific basis supporting it, reuse doesn’t constitute a "new methodology" or "off-label use." Thus, it isn’t necessary to tell patients a single-use device is being reused.

It’s critical for clinicians to tell patients if a new methodology or new products are being tested, says Arthur Goodrich, vice president of Sterile Reprocessing Services in Houston. Whether reuse of medical devices is a new methodology is "not a black and white issue," Goodrich concedes, explaining that proper reuse of single-use medi-cal devices is product-specific.

He has heard this analogy to explain overuse of the term "off-label": If reused single-use devices are "off-label," so are orthopedic implants that don’t get the manufacturer-recommended quarantine when they arrive at a facility.

Goodrich’s stance is that reprocessors are not changing the "single-use" designation from the manufacturer."It’s just one more single use before it has to be tested again" for functionality, he says, adding that reprocessors stand behind the integrity of the products they reprocess.

"My personal thought is that the patient probably ought to know [that a single-use device is being reused]. But that’s my personal opinion, not the AORN position," says Dorothy Fogg, RN, BSN, MA, perioperative nursing specialist at the Center for Nursing Practice, Health Policy, and Research at the Association of Operating Room Nurses in Denver. She advises that the reprocessed device should be reused only if it meets the initial form and function criteria as established by the manufacturer, and that the patient should be told that information. (For AORN’s position, see Same-Day Surgery, September 1997, p. 118.)

Nurses often call the center and ask about reusing devices. They usually don’t ask about billing, Fogg says. "More often, we raise questions about how charges are done," she says. "For instance, we ask, ‘Are you charging each patient the same amount?’"

Most callers say they are charging patients the same original price, regardless of whether the device is new or being reused, she says.

Since AORN hasn’t taken a position on the billing issue, she doesn’t tell nurses what to do. "We say, ‘You realize that’s an ethical issue that your facility needs to address.’"

Freestanding facilities might be able to bring up such issues in joint meetings between the owners of the facility and the health care providers.

"But if nurses are told ‘This is what you’ll do’ when they have questions about a practice, get a designated ethics group to help you sort it out," Fogg says. If you are a hospital or hospital-affiliated facility, use the ethics committee, she advises.

To avoid problems when reusing a single-use device, bill the patient for the actual cost of reuse, not the cost of the original device, Goodrich advises. A product that’s reprocessed three times, for instance, would have four uses. "You could add the original cost, plus three reprocessings, divide it by four, and that’s your charge. If you think you’re saving 50%, then the device price to the patient should be reduced by that amount. Or if that’s what you’re billing line item in fee for service, in quarterly reporting for cost, those costs have to be reported accurately as well."

With the move to managed care, that scenario may become less common, Kurtz says. "With procedure-based fees, if a patient needs two of something, you don’t charge extra if you need four."

In the meantime, the issue is a thorn in the side of many same-day surgery managers. Consider that additional costs are incurred with reusing devices, Kurtz says. For example, staff must separate items for packaging, and there are shipping costs. She struggles with how billing could be handled if a different price were used.

"If we determine, or HCFA determines for us, that we should be charging differently for these, then we have to determine what systems we have to build to do that," she says. If additional costs are incurred in redesigning the billing systems, there may not be enough cost savings to justify reusing the devices, she maintains. "It’s definitely an ethical issue that I haven’t resolved."