It is the joint responsibility of labs and dentists to ensure regulatory compliance for the safety of the patient.
(PRWEB) June 14, 2016
With strong regulation in the manufacturing of sleep devices, the National Association of Dental Laboratories is informing dentists, through its “What’s In Your Mouth?” (WIYM) campaign, that this level of regulation is not prevalent in the manufacturing of all medical devices.
The Food and Drug Administration began regulating medical dental devices in 1994, requiring sleep device manufacturing laboratories to be FDA-registered, outsourcing to be executed with full and proper disclosure and materials to be FDA-registered and accepted, according to The Regulatory Side of Oral Sleep Devices. Yet, other dental devices and restorations – such as crowns and bridges – go largely unregulated and into patients’ mouths.
“The dental laboratory technician who manufactures sleep devices and dental restorations is rarely seen by the patient, yet is always in the foreground of a successful device,” says Laura Sheppard, CDT, TE, a certified dental technician and owner and managing partner of Device Masters Dental Laboratory in Michigan, a Certified Dental Laboratory (CDL), and NADL board member.
Unlike the EU, Sheppard says U.S. dental lab technicians are not required to have a formal education, specific training or 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,” says 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.”
“We all know that oral healthcare should be offered with the best and safest services possible,” says 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.”
WIYM raises public awareness of regulations, standards, transparency, safety issues and the important role that the dental laboratory and dental laboratory technician play as part of the oral health care team.
For dentists to ensure their patients are getting quality restorations, NADL suggests dentists find out if their state requires minimum dental laboratory standards, stay informed on with legislative updates and find out if the laboratory they work with is certified and the technician that fabricates their restoration is certified.
The National Association of Dental Laboratories is the unified voice of the dental laboratory profession supporting dentistry and serving the public interest by promoting high standards. NADL accomplishes this by providing programs, services and networking opportunities to meet the evolving technical, educational, professional and business needs of dental laboratories.