The Food and Drug Administration (FDA) began regulating medical dental devices in 1994. For example, laboratories that manufacture sleep devices now need to be registered with the FDA. Also, outsourcing must be executed with full and proper disclosure. Materials must be registered with and accepted by the FDA as well. Yet other devices and restorations such as crowns and bridges go largely unregulated, says the National Association of Dental Laboratories (NADL).
“The dental laboratory technician who manufactures sleep devices and dental restorations is rarely seen by the patient, yet always is in the foreground of a successful device,” said Laura Sheppard, CDT, TE, owner of Device Masters Dental Laboratory in Michigan and a board member of the NADL. Sheppard adds that unlike their colleagues in the European Union, dental lab technicians in the United States aren’t required to have a formal education or specific training, nor must they demonstrate core competency.
“Some labs are unaware or misinformed, do not have quality systems in place, are not registered, or do not follow regulatory requirements,” said Sheppard. “Oral healthcare compliance is required and guaranteed by law. Understanding existing laws is imperative to patient safety. It is the joint responsibility of labs and dentists to ensure regulatory compliance for the safety of the patient.”
The NADL has launched its “What’s In Your Mouth?” campaign to raise public awareness of regulations, standards, transparency, safety issues, and the role that the dental laboratory and its technicians play as part of the oral healthcare team. To ensure their patients are getting quality restorations, the NADL suggests that dentists find out if their state requires minimum dental lab standards, stay informed of legislative updates, and find out if the lab they work with and the technician that fabricates their restorations are certified.
“We all know that oral healthcare should be offered with the best and safest services possible,” said Sheppard. “Dentists and laboratories alike must do their best to become informed and act accordingly to provide the highest level of medical device service for their patients.”