For the operating room staff, opening a packet of disposable instruments before performing ophthalmic surgery is as routine as scrubbing in. Yet have you ever wondered if these instruments are “reprocessed” single-use devices—and, if so, whether they have been reprocessed correctly, according to government standards?

Odds are, unless you’ve had reason to investigate the issue, you haven’t given much thought to the question of reprocessing. Yet if you step foot in Washington, D.C., you’ll find trade associations and government regulatory bodies focused on whether single-use devices should be reprocessed, and how they should be regulated. The debate is likely to heat up again this fall, with Congress expected to turn its attention to the issue.

The Issues
The uproar started when the FDA moved to regulate the reuse of single-use devices—especially within the hospital setting—by introducing new guidelines for those companies in the business of reprocessing the devices.

It’s an issue mired in economics and politics—and patient safety. And while the focus thus far has been primarily on disciplines like cardiology and interventional radiology, ophthalmology has not escaped scrutiny.

For instance, several years ago, Northern California–based LaserVue Eye Center was involved in a widely publicized lawsuit alleging it reused microkeratome blades that could have potentially exposed patients to infectious diseases or uneven flaps. The lawsuit stemmed from an investigation by the California Department of Health, which found that the center’s surgeons had rinsed and reused microkeratome blades and hand pieces instead of sterilizing them.

The health department’s investigation revealed that microkeratome blades were rinsed with sterile water and reused on a second patient provided that 1) with the first patient, the blade worked properly and there was no visible bleeding and 2) less than 30 minutes elapsed between patients. The microkeratome assembly was rinsed and reused for up to four consecutive patients. While no actual infections were reported, the department required the eye center to notify some 2,700 LASIK patients that their surgeons had rinsed and reused the blades.

While this is a rare and extreme case of misuse, it does raise the question of whether the reuse and reprocessing of single-use devices should be more tightly regulated. At this time, the Academy does not have a formal policy on the issue. Several aspects of single-use devices and the practice of ophthalmology should be considered before any guidelines are developed, noted Richard L. Abbott, MD.

“First of all, this is an issue where there are no absolutes,” he said. “What may be applicable for one type of single-use device, for example a microkeratome blade, may not be relevant for another device, for instance a phacoemulsification tip. Second, we need to take into consideration several issues, including whether the design of the instrument or device is amenable to reuse, whether it can be appropriately sterilized, whether reuse will compromise its function in any way—potentially altering outcomes—and whether the device will perform at the same level with the same quality for multiple uses given proper sterilization techniques. But again, this needs to be determined on a case-by-case basis.”

The Economics
Thomas A. Weingeist, PhD, MD, sees the reprocessing issue as one of economics, especially in terms of physician costs. “In an effort to reduce health care costs while maintaining safety for the public, it seems over-burdensome for physicians and hospitals to be prohibited from reusing certain devices,” he said.

To illustrate his point, Dr. Weingeist noted that diode probes used for cyclophotodestruction cost in excess of $200 each. “We [at the University of Iowa] and third party commercial outfits have developed safe and reliable methods of sterilizing these and many other instruments, yet they are now designated for one-time use.” He added, “When the first endolaser photocoagulators were commercially available, they were reusable. Now, each is a single-use device costing more than $100, whether it is used for five laser spots or thousands.”

Dr. Weingeist acknowledged that medical device companies are “entitled to a return on their investment.” But by making single-use devices, these companies benefit financially while the cost of providing health care continues to skyrocket.

A Tale of Two Techniques
While the economic impact is falling primarily on university medical centers like Dr. Weingeist’s, the potential is there for individual practices—especially high-volume practices—to be directly affected.

In ophthalmology, that means high-volume refractive and cataract surgeons. A quick look at these two subspecialties vividly illustrates the complexity of creating a blanket policy on the subject:

Refractive surgery. For refractive surgeons like Robert K. Maloney, MD, the reprocessing debate centers on microkeratome blades. Reusing microkeratome blades without sterilizing them “is an appalling violation of the standard of care,” Dr. Maloney said. “However, what about the physician who properly sterilizes these blades? Are they safe to reuse?”

Dr. Maloney cited a research study out of Saudi Arabia, which used a scanning electron microscope to determine whether any deterioration could be found in the quality of the blade after up to four consecutive uses. The researchers found none. “This suggests that perhaps physicians could safely use them in patient after patient if they could properly sterilize them.”

However, it’s difficult to properly sterilize microkeratome blades. They would have to be gas sterilized because heat or autoclaving causes them to rust, Dr. Maloney said. “Very few ophthalmologists have the capacity to gas sterilize instruments. Plus, the blades must be handled carefully, as any nicks or dings could result in bad flaps.”

For most refractive surgeons, then, reuse may not be worth the hassle. The price for a microkeratome blade is $40 to $65. Dr. Maloney uses one blade per patient. “To me, it’s not worth the price to take the risk of reusing blades.” And he has the luxury of figuring the costs of these disposable blades into his overall costs because refractive surgery practice is generally a “cash” business, with patients paying the full fee of the procedure.

Nevertheless, the costs do add up—just multiply the price of the blades by 3,000 surgeries a year. Even so, he said, “the benefits of a new blade outweigh the costs, so I am happy to replace the blade every time, and I believe the majority of my colleagues performing refractive surgery feel the same way.”

Cataract surgery. If you ask cataract specialist Samuel Masket, MD, the same question about reusing phacoemulsification tips, you will receive a remarkably different answer.

Three aspects of the phaco tip are in sharp contrast to a microkeratome blade, Dr. Masket said. First, unlike microkeratome blades, the phaco tip is amenable to sterilization through autoclaving. “Second,” he added, “the way we use ultrasound today, these tips can be used many times without developing metal fatigue.” Third, while both the microkeratome blade and the phaco tip cost $40 to $60, government reimbursement for cataract surgery (usually performed on an older population than LASIK surgery) is historically low—thus making cost a more significant issue.

For these reasons, many cataract surgeons have reused phaco tips despite the fact that they are designed for single use. Fortunately, the vast majority of cases have proceeded without any problems. However, “There has been a patient injury—blindness—linked to reprocessed phaco tips,” reported Josephine M. Torrente, JD, a Washington, D.C., attorney.

Once again, economics plays a role, and Dr. Masket puts responsibility for the conundrum cataract surgeons face right on the shoulders of the government. “On one hand,” he said, “the FDA mandates that the phaco tip be disposed of because it is designated as a single-use device. Yet on the other, another government agency continues to reduce reimbursement rates,” forcing physicians into a corner.

How We Got Here
Before the late 1970s, most medical products were considered to be “reusable,” defined as equipment that is used and reprocessed multiple times. This included equipment that could be soaked in solutions of glutaraldehyde, hydrogen peroxide or peracetic acid and used again.

Several factors led to the introduction of single-use devices, including a demand for disposable equipment, the development of new plastics and the availability of ethylene oxide sterilization.

The FDA maintains that the practice of reprocessing single-use devices expanded when an increasing number of hospitals decided that reuse was a cost-saving measure and an answer to the concerns of medical waste. When reprocessing became too complicated for hospitals and physicians, an industry of third party reprocessors evolved to help hospitals in their quest to lower costs by reusing equipment designed for single use.

On Aug. 14, 2000, the FDA released a guidance document announcing that it would enforce premarket requirements on reprocessors of single-use devices. After a substantial phase-in period, reprocessors would be required to provide data to the FDA in a 510 (k) or premarket approval application before distributing their products for use in American patients. The FDA said that this approach equitably applies existing regulations to original equipment manufacturers, third parties and hospitals to minimize risks associated with reprocessed single-use devices.

What’s Next?
In mid-August, Congress Daily reported that the single-use device issue will almost certainly be addressed this fall, possibly in a proposed FDA bill.

As this issue of EyeNet went to press, the FDA’s “reuse” Web site carried the following statement: “Despite a lack of clear data that directly link injuries to reuse, the practice of reprocessing single-use devices merits increased regulatory oversight. We are concerned because we do not have enough information to be certain that single-use devices are being reprocessed properly. The FDA recognizes that our medical device–problem reporting systems cannot adequately capture information about potential clinical problems related to reuse. Our plan is to phase in additional oversight based on assessment of current practice and potential risk.”

“The FDA has indicated that they would be receptive to receiving data to support the resterilization and reuse of expensive ophthalmic equipment,” said Walter J. Stark, MD. “But there’s no incentive for industry to do this.”

In discussions at last year’s Annual Meeting, the Academy’s Committee for Research, Regulatory and External Scientific Relations reviewed the FDA’s 2000 guidelines. It focused its discussion on ophthalmic devices that are commonly reprocessed—but recommended that the Academy not submit formal comments to the FDA, as the guidelines do not apply to ambulatory surgical centers or individual practices. Moreover, committee members pointed out that some devices reprocessed by hospitals could be exempt from this requirement. Accordingly, the committee voted to take no position on the issue while instructing Academy staff to continue to track this issue with the FDA.

“Several committee members noted that we physicians must band together to encourage manufacturers to demonstrate that their devices are effective for multiple uses when sterilized in the appropriate way,” Dr. Stark said.

The greatest fear of those watching the issue is that the FDA or Congress might move to require ophthalmologists to strictly adhere to using covered devices only once in ambulatory care centers or private practices. “Any legislation that increases the cost to doctors will eventually lead to increased costs for the patient and/or decreased access to the latest medical care and devices,” Dr. Stark said. “Anything that can be done to reduce costs to the patient, third parties and the government will permit us to continue to provide the best possible medical care for our patients.”

And patient care is the bottom line. In this turbulent regulatory environment, individual ophthalmologists must fall back on common sense. “Always do what is in the best interest of the patient,” Dr. Abbott recommended. “This should dictate if and when reusing single-use devices is, in fact, appropriate.”