Manufacturer instructions play vital role in guiding purchase, use of dental products
July 09, 2021
Dentists have a lot to consider when making purchases for their practices, and being aware of the manufacturer instructions that accompany products can help ensure they buy what is right for them and use the items correctly too.
"Practitioners should consider if the product will work under their practice setting, is not incompatible with other materials and will fulfill the specific intent of use," said Ana Bedran-Russo, D.D.S., Ph.D., chair of the American Dental Association Council on Scientific Affairs. "The manufacturer instructions describe the best technique and handling needed to maximize performance of a product."
Instructions can guide the purchase and use of products in many different ways, from helping dentists find the light-curing unit that meets the specifications needed to cure the light-activated, resin-based composites they use in their practices to making sure they know how to safely reprocess an instrument that is intended for multiple uses.
Light-cured, resin-based restorations will function only as the manufacturer intends when they receive the required amount of light energy at the wavelength that matches the photoinitiator within the composite, according to an ADA Professional Product Review
that looked at the effective use of dental curing lights.
In an ADA Clinical Evaluators Panel report
on light-curing units, written by the ACE Panel Oversight Subcommittee of the Council on Scientific Affairs and ADA Science & Research Institute staff, 4 out of 5 dentists said they read the manufacturer instructions for information on how to effectively use and maintain their curing units. They also said their top four considerations when selecting a unit were portability, power, durability and cost.
"When looking to purchase a new curing unit, you want to make sure it has the wavelength and energy to polymerize the resin composite you have in your practice," Dr. Bedran-Russo said. "This information will be in the manufacturer instructions. The curing unit manufacturer will specify the energy output of the curing unit and the wavelength range of the light source, and the dental composite manufacturer will specify the energy requirement of the material, along with the absorption wavelength of the photoinitiator. This information can be combined to ensure a successful light-curing procedure."
Another Professional Product Review evaluated high-speed air-turbine dental handpieces based on weight and balance, dimensions, light profiles, speed, noise and more — factors dentists may want to consider when picking out the handpiece that matches their practice needs and personal preferences.
Manufacturer instructions play an important role in the reprocessing of dental instruments, including handpieces.
Since 2014, the Food and Drug Administration has shared concerns with the dental standards community that reprocessing instructions are unclear or inadequate for devices such as diamond rotary instruments and carbide burs. Reusable dental instruments that are designed and labeled for multiple uses must be reprocessed by thorough cleaning followed by sterilization or high-level disinfection between patients, according to a technical report from the ADA Standards Committee on Dental Products
. If a dental instrument manufacturer does not provide validated, clear and feasible cleaning instructions, then the FDA says the company needs to label its device as single use.
When an instrument is not thoroughly cleaned, the downstream process of sterilization or high-level disinfection may be rendered ineffective, leading to potential cross-contamination or improper functioning of the instrument because of the presence of residual debris, the technical report states.
The committee published the report in January to help manufacturers of reusable dental instruments develop and validate reprocessing instructions that follow FDA guidelines
. The report uses the cleaning process for dental burs as an example to illustrate the variables that need to be considered when cleaning a dental instrument. By validating its cleaning process, a manufacturer can provide documented evidence that its instructions are effective in rendering a dental instrument safe for use in more than one patient.
The ADA Standards Program, founded in 1928, involves active participation by scientists at the ADA Science & Research Institute and the work of more than 600 volunteers from the dental profession, dental industry, government and academia to establish baseline standards and technical recommendations for almost every tool used in modern dentistry.
During the COVID-19 pandemic, manufacturer instructions have been vital in laying out how specific cleaners and disinfectants work.
According to the Centers for Disease Control and Prevention's infection control recommendations for dentistry
, cleaning should always precede disinfection, and a disinfectant should not be used as a cleaner unless the product label indicates it is suitable for such use. For disinfection, the CDC recommends dentists use Environmental Protection Agency-registered hospital disinfectants or detergents/disinfectants that state on their label they are appropriate for use in health care settings.
The CDC also states dentists should follow manufacturer instructions related to amount, dilution, contact time, safe use and disposal when using products for cleaning and disinfection.
For any product or equipment dentists use in their practices, they cannot assume they know exactly how to use it because they used something similar in the past.
"Often you will see that products under a similar category of materials will have distinct instruction," Dr. Bedran-Russo said. "There are no universal instructions for a category of material. It's important for dentists not to assume they know how a product is supposed to work simply because they used something like it before. Products and techniques are constantly changing, so recognizing your limitations will also play a key role in practice success."
How does the work of the ADASRI impact the products you use?: This example of manufacturer instructions for a polymer-based restorative material shows how American National Standards Institute/ADA Standard No. 27 helps to form instructions for restorative materials.