Single-Use Vs. Sterilizable Dental Products

The concept of a “throwaway society” is one in which consumerism has led to overconsumption and wasteful disposal of products that could – and should – be reused. To an extent, items in the dental office should be reused, but when infection prevention is concerned, there are very good reasons why some items can be reprocessed and why some items are single-use.

Knowing whether products or tools are single-use or reusable is a fairly straightforward issue, but too often, clinicians make the mistake of reprocessing single-use items or, in some cases, reprocessing equipment beyond the manufacturer’s recommendations.

Read the instructions

Some violations may just be chalked up to an honest mistake and simply not knowing any better. But other cases are downright shocking.

“This topic can drive me bonkers,” Karen Daw, “The OSHA Lady”, speaker and consultant, says. “I’ve conducted dental practice consults where disposable prophy cups, suction tips, water syringes, impression trays-and even dental floss-has been found in cold sterile solution. The reason for this? The practice intends to reuse these items.”

It shouldn’t be difficult to figure out which items can be reprocessed and which are intended only for a one-time use. Single-use items are designated as such and there is a standardized symbol on those items’ packages.

“To determine single-use vs. sterilizable items, the user should reference the MIFU (manufacturers’ instructions for use),” Daw says. “For example, the manufacturer might indicate single-use only by placing a number ‘2’ in a circle with a line through it to indicate that using anything more than once is prohibited. Or, it might plainly state on the box ‘disposable’. Other times, it takes due diligence to figure out whether the items can or should be reprocessed.”

In cases where single-use items are mistakenly reused, settling into bad habits seems to be the predominant cause.

“It’s something that you would think everybody should know, but it gets overlooked, and then we develop bad habits,” Jackie Dorst, RDH, BS observes. Dorst is an infection prevention consultant and speaker. “One of the most frequent breaches that I see is not understanding that the face mask that the clinical team wears is a single-use item. Very often you’ll see photos where they pull that mask off of their face and just pull it down under their chin. And then they dismiss that patient and see the next patient, use that same mask again for the next patient, pulling it up from their neck or chin area and put it right over their face. If they look at the box, that the face mask comes in, it has that ‘2’ with a line through it. designating that that mask is a single=use item.”

Why?

So why are clinicians reusing these items? It can be blamed on saving some money and repeating bad habits.

“It’s something that they’ve been doing for a number of years,” Dorst observes. “As research has been done, CDC has published more information, new guidelines. Maybe the dental team has not learned that information. It’s something that they may not have reviewed and implemented in their practice. The manufacturers of burs and endo files must submit to the Food and Drug Administration the cleaning and sterilization methods they recommend, and show research that they have gone to the laboratory, and have documentation that the instructions that they’re providing in their IFUs will sterilize that particular item. And if the manufacturer cannot produce those laboratory results, then the manufacturer cannot get what’s called a 510(k) clearance from the Food and Drug Administration for reprocessing that item.”

Items such as protective masks aren’t especially expensive. Pulling down one’s protective mask beneath the chin, and even using the same mask with multiple patients, is a worrisome trend Dorst has noticed.

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“I think the rationale behind that is that once that mask is used, obviously it’s soiled on the exterior. It has splatters and splashes that could have come out of the patient’s mouth,” Dorst says. “It could have bacteria, viruses, fungus, microorganisms. And once the clinician touches it with their hand, or even their gloved hand, they’ve transferred the germs from the mask to their hand. Then, if they had any aerosol splatters during patient care on their neck area, and they pull that mask down under the chin, contamination is on the inside of the mask. We constantly see, in the media, inaccurate photos showing dental personnel with a mask pulled underneath their chin. So after they do that procedure and then they replace that mask over their nose and their mouth, all of the microorganisms that were on their neck are now transferred to their nose and their mouth. They could acquire an infection through exposure to the mucous membranes from any of those microorganisms.”

While the majority of violations, in this regard, seem to be from reusing single-use items, risks exist on the other end of the spectrum: Not properly processing equipment requiring special attention.

“There is the possibility that when the manufacturer received the FDA clearance that the instructions for use state that this device can only be cleaned and sterilized, say, 100 times,” Dorst says. “And then after that, it should be sent back to the manufacturer, either for a retrofitting or for an engineering update. Maybe there are items that need to be replaced in it – gaskets, seals, whatever – and then it’s valid for another 100 sterilization cycles, for example. Again, that’s going to be specified in the manufacturer’s instructions for use. So, it is important for the dental team members to have those instructions for use for all of their items.

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“One of the big challenges that I see now is with technology coming into the dental operatory, like intraoral scanners,” she continues. “Many of the intraoral scanners have a protective sleeve that goes over the scanner tip, and that can either be disposable, or – if the manufacturer has submitted their process for cleaning and sterilization – then it will have specific instructions. One particular scanner sleeve that I reviewed, the manufacturer stated that it could be cleaned and autoclaved up to 10 times. And the manufacturer stated that the scanner sleeve must be sterilized in a Class B autoclave. If office didn’t have a Class B, then it was going to have to purchase a new autoclave to sterilize this tip. Sterilizing the sleeve, in a traditional gravity autoclave, would be reprocessing that product off-label.”

The rules

The manufacturer’s instructions for use provide necessary guidance for which items are reusable and which are not, but they get those rules from an even higher authority.

“The Centers for Disease Control and Prevention (CDC) reference the Food and Drug Administration on disposable devices,” Daw observes. “These are items to be used for one patient during a single procedure and will not be reprocessed for use on any other individual. On this they are very clear: If the device does not have validated reprocessing instructions, it should be considered single-use and disposed of accordingly, regardless of the labeling. If in doubt, contact the manufacturer directly.”

The biggest issue involving whether an item should be reused or not is if the manufacturer indicates that it can be properly sterilized.

“Most of the diamond burs and endo files are not validated by the manufacturer for sterilization,” Dorst adds. “What has been determined by CDC is that diamond burs cannot be effectively cleaned. The physical structure of a diamond bur is such that there’s too big of a risk for retention of microorganisms and debris. Unless a surface is clean, it will not be completely sterilized. It will not be sterilized in an autoclave, because an autoclave sterilizes by steam touching the surface of the instrument. So retained debris on a diamond bur or an endo file could result in failure of sterilization of that item.”

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“The CDC and FDA go so far as to recommend classifying burs, endo files and broaches as single-use, because of how difficult they are to clean,” Daw adds. “Plus, repeated sterilization cycles can dull the cutting surface and increase the likelihood it might break during a procedure. In fact, the FDA considers all diamond-coated burs and scaler tips single-use, unless the manufacturer has a 510k clearance on file. I believe as of the time of this publication, there still aren’t any that have been cleared a such. I think this surprises people the most. But it makes sense. Have you ever tried cleaning sandpaper? It’s the same thing.”

Best practices

Not every category of item is, definitively, single-use or sterilizable. There may be items the practice can buy that can be reprocessed, rather than thrown out. However, finding the right item for the practice requires balancing costs and the staff’s time.

“Opting for disposable alternatives prevent the need to use labor and resources to clean and sterilize items and eliminates human error in reprocessing,” Daw says. “When considering what is best for the practice, I recommend conducting a cost-comparison. Factors to include for the calculation would be cost of the item, time and hourly pay to reprocess, cost of materials and energy needed to clean and reprocess, cost in labor if a process is halted due to broken bur or file, and the cost of an infection control breach. Disposable items can potentially improve patient safety, when you consider that there is no possible patient-to-patient contamination. The flip side to this is that, environmentally, more items may end up in the trash.”

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Some issues seem so obvious that they’re not worth mentioning, however, some shocking practices persist.

“Another big no-no: Reusing single-dosage medication vials, needles, syringes and IV bags,” Daw says. “Part of what the CDC advises would benefit us all, not just as healthcare providers, but as patients, as well. You’d be absolutely shocked by how often the following occurs in medical and dental practices. This list is straight from the CDC site:

• Never administer medications from the same syringe to more than one patient, even if the needle is changed

• After a syringe or needle has been used to enter or connect to a patient’s IV it is contaminated and should not be used on another patient or to enter a medication vial

• Never enter a vial with a used syringe or needle

• Never use medications packaged as single dose vials for more than one patient

• Assign medications packaged as multi-dose vials to a single patient whenever possible

• Do not use bags or bottles of intravenous solution as a common source of supply for more than one patient

• Follow proper infection control practices during the preparation and administration of injected medications

“Per the CDC,” she continues, “‘Syringe reuse and misuse of medication vials have resulted in dozens of outbreaks and the need to alert over 100,000 patients to seek testing for bloodborne pathogens such as Hepatitis B virus, Hepatitis C virus, and HIV.’ This is just in the past decade. More information on the CDC’s One and Only safe injection campaign, including checklists for the office, can be found at: https://www.cdc.gov/injectionsafety/1anonly.html

Clear distinctions exist explaining why some items can be reused and why others should only be used just once. Manufacturers should give clear guidance on which items can be reprocessed and the methodology to do so.