What you NEED to know about single-use instruments
After using a disposable instrument, it can be pretty tempting to put that instrument through the sterilization process and use it a second time — especially if it seems to be made well and looks like it’s strong enough to handle it. This is something many (if not most) dentists have done at least once to save a little money. Unfortunately, this can result in a variety of problems that do your practice — and your patients — more harm than good.
Reusing disposable instruments puts your patients at risk. Not only is there the potential for cross-contamination, but if single-use products are put to work more than once, they’re simply not going to be as effective as they should be, no matter how strong or well-made they look. This hurts the quality of the care you provide and could negatively impact a patient’s experience in your practice.
“I have this discussion with dentists frequently and I ask them what if that was your daughter in your chair? Would you use a new set of instruments? They don’t like to answer that question,” says John Ferone, Henry Schein’s executive director, global endodontic category management. “Then I ask why should the standard of care be any different whether it’s your daughter or any other patient? That seems to resonate. It’s a reality check.”
This isn’t an issue that’s unique to the dental industry, says Christine Santagate, director, northeast regional operations at Regulatory and Quality Solutions (R&Q). It happens in the medical field in general, with many healthcare professionals seeing reusing disposable items as a cost-saving measure. But it’s important to understand that these products are single-use for a reason. Devices have to be tested to prove they can be used in more than one procedure and provide the same results each time. If they can’t, then they’re only indicated for one-time use.
If you want to provide your patients with the best care possible, one way is to become familiar with the FDA’s single-use guidance, understand why it’s in place and then actually follow the agency’s recommendations. Single-use products can offer your practice many benefits, but only if they’re used properly.
Guidance from the FDA on single-use or disposable devices goes across the board for all medical devices that can be packaged sterile or non-sterile, depending on their end use, Santagate says. For single-use items, the guidance states products should only be used on one patient during a single procedure and then properly disposed.
“The FDA recommends that providers follow the labeling for individual products, including whether the device is single-use or multi-use. If device reprocessing instructions are not provided, it should be considered single-use,” according to the FDA. “The provision of reprocessing instructions would require a new premarket clearance (510(k), which is a type of premarket review) as reprocessing changes the intended use of the product.”
Even though the guidance is clear, many providers still opt to not follow it, mainly because they think reusing certain instruments saves them money. When a violation is reported, the manufacturer is notified and then required to contact the dentist to clarify the instructions for single-use, Santagate explains.
“Dental staff can contact the FDA and alert them about misuse. Anybody can do that,” she says. “The FDA might not be coming in and checking on you, but they are auditing manufacturers and making sure they have appropriate labeling and instructions. It’s important to remember these products aren’t made to be reused. These devices haven’t been tested to go into the autoclave or disinfectant, and putting them through the sterilization process might compromise them.”
Why you should only use single-use products once
There are quite a few single-use dental products on the market, including endodontic files, air and water syringe tips, saliva ejectors, mirrors, explorers and a variety of infection control products. While these items provide conveniences, the main reason they only can be used once is patient safety, Santagate says.
“It’s for disease prevention in general,” she explains. “While there are steam sterilizers and disinfection tools in dental offices, sometimes you lose track and instruments aren’t sterilized properly. With a single-use product, you have a guarantee it hasn’t been in anybody’s mouth. That’s the main issue.”
Studies have shown that if instruments aren’t properly cleaned ahead of the autoclave cycle, some abnormal proteins responsible for disease can potentially live through the sterilization cycle, Ferone says, putting your patients and your team members at risk.
Another problem? When you use disposable instruments more than once, they’re simply not as effective as they should be, Santagate says. They’re not made out of materials that are designed to last, so after that first use, they’re no longer as strong as they need to be to perform their job. This means procedures will take longer and your team members will have to work harder to get the results they’re after.
Single-use instruments become dull if they’re used multiple times, impacting cutting efficiency, Ferone says. Reused endodontic files are more prone to separation or breakage than they are during their first use — and that leads to big headaches for both you and your patients. How? If a file separates while it’s rotating in the root canal system, you have to notify the patient, who typically needs to go to a specialist to have the case retreated and the file removed. These patients won’t exactly be happy with the experience they had at your practice, and they might even decide not to come back.
Why dentists use disposable products more than once
The answer to this is simple: cost. Dentists want to get as much as they can out of every product they invest in, so if they think they can use a disposable product two or even three times and get the same result, then they don’t see any reason not to do it. The problem is that they’re not getting the same result and they’re also putting their patients and team members at risk.
Endodontic files represent a good example of dentists reusing instruments for cost savings. The newer NiTi (Nickel-Titanium) files cost significantly more than their stainless-steel predecessors, Ferone says, and dentists think if they can get multiple uses out of them, it will help offset that extra cost. But the amount of money saved by using instruments two or three times (which is what many dentists do, Ferone says) doesn’t really amount to much, and it certainly isn’t worth exposing patients to cross-contamination or using a product that’s been compromised.
“Endo is a profitable procedure. From the hourly standpoint, it’s probably one of the most profitable,” Ferone says. “To save an estimated $10 to $15 a case when you’re billing $700 to $1,000 for a procedure that takes 45 to 60 minutes is penny wise and pound foolish.”
The benefits of single-use products
Disposable devices are new every time, Santagate says. There’s no question about their ability to perform the job they were created for because they don’t have any wear and tear. The product is at its maximum strength and there’s no worries about cross-contamination. Team members easily and efficiently perform their jobs, which isn’t the case if they’re working with a worn-out instrument.
There’s also no need to track the devices, Ferone says. When you reuse instruments, you have to develop a good way to track them to make sure they’re not used too many times, whether it’s via color-coded labels or another method.
With endodontic files, you don’t have to worry as much about separation if you use the instruments once and then throw them away. And the fact that you don’t need to reprocess the instrument saves time, enabling you and your team to quickly move from procedure to procedure.
The bottom line is, if used properly, disposable products help to save the practice time and money while reducing the risk of cross-contamination.
Follow the guidelines
Remember, single-use products are single-use for a reason; they’re simply not meant for multiple procedures. Use products the way the manufacturer intended, and you’ll keep your patients safe while also making your team members as efficient as possible.
“These products are designed to be single-use. You might think the tip is still sharp and what a waste to throw the instrument away, but it’s not designed to be used that way,” Santagate says. “And remember, mouths are gross. Single-use products reduce the risk of cross-contamination and help prevent disease from spreading.”