To Reuse or Not to Reuse?

Trends favor single-use instruments, but questions remain.

BY RENÉ LUTHE, SENIOR ASSOCIATE EDITOR

In the contest between reusable and single-use equipment for the hearts and minds of US cataract surgeons, single-use instruments appear to be gaining ground. Concern about infections such as mad cow disease and toxic anterior shock syndrome have made single-use devices increasingly appealing, even to those concerned about cost. Additionally, the improvement of certain key instruments such as blades have made them more attractive to some surgeons.

On the other hand, some surgeons point out significant objections to abandoning reusable equipment. In an era of declining reimbursements, why pay more for disposable equipment when careful sterilization is a perfectly adequate deterrent to cross contamination? Why give up diamond blades for a knife made of a less sharp and durable material?

Below, industry leaders and clinicians weigh in on the reusable vs. single-use conundrum.

Weighing Blade Advantages

Long hailed as the cataract surgeons first choice due to their superior sharpness and hardness, diamond blades at last may be getting some competition. Users report that improved steel technology, and blades in new materials, such as BD Medical's Atomic Edge silicon knives, are making disposable knives a viable contender against the diamond blades.

As Randall Olson, MD, professor and chairman of ophthalmology at the University of Utah in Salt Lake City says, “You cannot get a steel blade that is going to be as sharp as a diamond blade — it's impossible.”

And while these blades are expensive, the hardness of a diamond means that the surgeon will get repeated usage without difficulty. However, Dr. Olson also says that manufacturers now offer some excellent alternatives.

“The quality of the steel really is getting better. But there's also an interesting technology, a single-use blade made out of silicon, that is almost as sharp as a diamond.”

Bradley C. Black, MD, secretary and treasurer of the Ophthalmic Outpatient Surgery Society, has long thought that the disposable steel blades have important advantages for the surgeon. For one thing, there's the greater cost of diamond blades.

“As cataract technology changes, incision size has been changing as well,” he points out. “Diamond knives are so expensive, especially if you use four, or six, or eight different sets of instruments, that every time you want to change the incision size, you would have to buy new diamond blades for each step.” The expense, Dr. Black says, is off-putting for many surgeons.

He also likes the more tactile feeling that steel blades offer. Diamond blades, he explains, can be so sharp that you hardly feel the tissue as you cut through, possibly causing the surgeon to inadvertently enlarge the incision size as the blade is being drawn out.

“I adjust the angle the blade is making through the tissue, and metal blades allow me to do that a little better than the diamond blade.”

Additionally, Dr. Black finds the sharpness of the newer steel blades so good that with proper care, they can be reused, making them an even more economical choice.

Not that diamond blades may not have some unique advantages. Limbal relaxing incisions may be one such example, according to Dr. Black. “Whenever you're making a longer incision where you're trying to maintain a specific depth of, say, 600 microns, I think you could make a case for a diamond blade,” he says. Likewise for diamond blades that offer an adjustable setting. “If you want to make it 525 microns or 573 microns, I think you would have more flexibility with a diamond along those lines with variable depth, longer incisions.”

Dr. Black also speculates that diamond blades may offer an advantage for the healing process: they allow “maybe a little bit of a finer cut through the tissue, which would maybe allow for less irritation after the incision,” he says.

As Infection Concerns Rise…

The improving quality of disposable blades is important, because it gives instrument manufacturers the means to address rising concerns about healthcare-associated infection. While proponents of reusable instruments say that following proper protocols for cleaning and sterilization of instruments reasonably addresses the possibility of cross contamination issues, others point out that this is dependent on too many variables — on technicians who won't cut corners during the cleaning/sterilization process, on solvents and detergent that completely rinse off, and on the efficacy of the sterilization process in eliminating infections.

As more than one source pointed out, European surgeons have been more enthusiastic in their embrace of single-use because of the urgent reality of “mad cow” disease (bovine spongiform encephalopathy)/Creutzfeldt-Jakob disease. “It's much more prominent on their radar screen than it is here,” says Don Mikes, Moria's vice president of global marketing. In some European countries, he reports, if there is a disposable option for a surgical component, the government will mandate its use.

The recent toxic anterior shock syndrome (TASS) outbreak in the United States led some surgeons to take another look at single-use instruments. As surgeons tried to ascertain the cause of the outbreak, Dr. Black points out that the experience led cataract surgeons to agree that cannulas, particularly cannulas on which viscoelastic had been used, should be disposable. “And possibly even tubing, which can be quite difficult as well as costly in terms of staff time and energy to properly clean, dry and re-sterilize,” he says.

The reuse of phaco tips is also a growing concern, according to Henry Mitchell, president of Crestpoint Management. He says many ASCs have reused this durable titanium tip multiple times when it is clearly marked as single-use. “The danger of reusing a phaco tip is twofold,” he explains. “The risk of contamination and the risk of this metal coming apart in the anterior chamber. During my 36 years watching thousands of cataract cases, I have seen phaco tips break at the junction of the hub and the needle.”

Further, when the IOL comes in contact with the ocular surface during lens insertion, it increases the risk of TASS. Single-use, preloaded lens inserters eliminate both the possibility of cross-contamination and concerns about inadequate sterilization of reusable instruments, says a representative for Hoya Surgical Optics, maker of the iSert Preloaded IOL Injection System.

Additionally, Dr. Black notes that there may be long-term viruses that the sterilization process may fail to kill. “We may not even know what they are now, but you eliminate that concern with disposables.”

Dr. Olson tells of another reason super-vigilance regarding infection may be warranted. “We just heard here at the Hawaiian Eye Meeting from Francis Mah, MD. He recommends that if you know the patient has MRSA and if they're in the high-risk category, you should culture them.”

In addition to treating the patient beforehand with antibiotics, he says Dr. Mah recommends that surgeons schedule such cases for the end of the day and use single-use instrumentation. “In some areas, that would be the majority of our patients. We just finished a study and 61% of our patients had either MRSA or MRSE. Most people don't check for that before surgery routinely.”

Unintended Consequences?

The regulations that often result from incidences such as the TASS outbreak may mean more mandates for single-use instruments in the future, Accutome's Jim O'Connor notes.

Particularly when the human element involved in the cleaning and sterilization process is sometimes less than perfectly reliable. “There are instances, I'm sure, where personnel are not following the proper techniques to clean and sterilize reusable items as well,” says Dr. Black. Disposable devices can eliminate this possibility.

Mr. Mikes concurs. “Surgical instruments that have never been used on other patients have a lower risk of transmitting contaminants than those that have — regardless of the rigor of the sterilization process. Single-use instruments offer the only guarantee of 100% cleanliness and sterility for each patient.”

And the cleaning and sterilization process may bring problems of its own. When certifying agencies tried to force ASCs to use certain enzymes and detergents when cleaning instruments, they found that the residues did not rinse off easily. “We found was that it was very difficult to get all the detergents and enzyme cleaner off the surface of the instruments, no matter how much you rinse them,” Dr. Black explains. “And the residual material on these instruments are toxic to the eye! We tried to tell these certifying agencies, you don't need these detergents and enzymes on our instruments, we used them for years without infections.”

Weighing Costs

Inevitably in the discussion of single-use vs. reusable surgical devices, the issue of cost rears its head — especially when it comes to blades. According to Carl Wortham, vice president of operations at Rhein Medical, “When our sales reps sell a box of disposable knives, they are constantly asked, ‘How many uses will I get out of it?’ We tell the customer that the disposable knives were designed as single-use, and that's what it means — single-use!”

He believes the stipulation, with the higher costs it implies, may be depressing the single-use blade market.

Dr. Olson agrees. “Surgeons are used to diamond blades, they like them and they don't want to think of their per-case cost going up because of all single-use instrumentation.”

As Mr. O'Connor notes, diamonds tend to win when it comes to costs. “The cost benefit of using one blade that costs $2,000 for two or three years as opposed to using a knife that costs $8 each time, and you're throwing it away… you can just do the math,” he says. Accutome provides a cost analysis for customers, “They tell us, here's how much we're paying for blades, here's how many cases we do per week and we can show them how much more cost-effective it would be moving to diamonds. We even factor in one repair per year with the blade.”

Most of the time, the diamond blades come out on top — but not always. “I've been in facilities where they've chipped four or five diamonds after two months of use,” Mr. O'Connor explains. “For them, it's not going to be cost-effective, because it will cost $900 to repair the diamond blade every time.”

The pricier diamond blades usually make more sense for the private surgery centers, where the cleaning protocol tends to be driven by the ophthalmologist, rather than for the larger hospitals, he says.

Moreover, Dr. Black notes that the standard cleaning and sterilization process has worked for years without incident. “Yet now we're being told that there are issues and that you cannot continue to reuse these items. Just because some may abuse reuse of disposables, or improperly clean them, we all have to pay the price?”

But Dr. Olson isn't so sure reusables are more economical across the board. He is conducting a study comparing their full costs with those of single-use instruments.

“It may not be as big a price differential as people think, if you look at everything involved,” he says. “If you do a true apples-to-apples comparison, it may be as little as a $10 per case difference.” The reasons, Dr. Olson says, are that single-use eliminates staff time spent on cleaning and sterilization, as well as time spent pulling instruments for trays, in favor of disposable trays that include blades.

Another factor in weighing the costs of reusables vs. single use is the likelihood of reusable instruments being damaged during the cleaning process.

“In the ophthalmology business, there is also a trend toward smaller instruments,” explains Mr. Mikes. “And smaller instruments are more easily damaged. That suggests that there is a greater need for disposable instruments, rather than expensive reusables that get damaged with repeated cleaning and sterilization.”

As Dr. Black summed it up, “Surgeons have to balance expense against convenience and safety issues.” So while the technology of single-use instruments have improved, there's no way around other tough questions.” OM