Lawmaker Urges Regulation Of Dental Restorations To Protect Patient Safety

Main Category: Dentistry
Article Date: 21 Feb 2008 - 1:00 PDT

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Florida Rep. Stan Jordan, R-Jacksonville, announced that he has filed legislation backed by the Florida Dental Laboratory Association to implement more stringent regulations to protect patients receiving the dental restorations affixed into the mouths of millions of Americans each year.

Dental-restoration products - the porcelain crowns, dentures and bridges that American dental patients have permanently seated in their mouths - are currently under-regulated, with few legal requirements for technicians to be certified and no mandates for dentists to document or disclose the source of dental work to patients, Jordan said Tuesday.

Although dentists prescribe the type of device they need for a dental patient, the product is actually manufactured by a dental technician employed by a dental laboratory, which could be located in the United States or anywhere in the world. Due to the growing number of Americans seeking dental restorative treatment and the growing pressure by some dentists to cut costs and increase profit margins, much of the dental work Americans carry in their mouths is now imported from countries such as China, Pakistan, the Philippines and India.

Jordan's legislation, HB 923, will require all dental laboratories to disclose to dentists where a product was manufactured and what materials were used, and provide certificates of authenticity. It further requires dentists to include these records in a patient's dental chart so patients can request the information and so health officials can track and trace a dental restoration to its source should a health problem later emerge. Finally, the bill requires dental laboratory technicians to maintain continuing education every two years.

"Such common-sense regulations are critical, we support them 100 percent and we thank Rep. Jordan for his leadership on this issue," said Bennett Napier, co-executive director of the Florida Dental Laboratory Association. "Many dental devices are made from porcelain fused to metal or from metal-alloys. If manufactured incorrectly, these products could be contaminated with unacceptable levels of lead or other toxic heavy metals that could make patients sick -- especially if they come from some third world countries that don't have the same dental material standards that are used in the United States."

If a patient does become ill from exposure to such toxic materials, chances are they would report their health issue to a medical doctor - not their dentist, Napier said. Without adequate records to track the faulty product to its source, it is difficult for health officials to respond to protect other patients.

"I believe it is an urgent priority to correct this problem and establish a paper trail for these products," Jordan said. "It's not very often that industries ask for tighter regulation of themselves, but the Florida Dental Laboratory Association and the National Association of Dental Laboratories have been speaking out about the need to protect patients as the number of dental restorations manufactured by foreign dental laboratories increases each year."

The National Association of Dental Laboratories -the leading trade group for the $5.5 billion U.S. dental-restoration products industry - has formally asked the Food and Drug Association to protect patient safety and require labeling and disclosure of the source of dental devices to patients, ensuring all such products can be traced back to the laboratory that made them.

The Association has also testified before the Presidential Interagency Working Group on Import Safety to urge the federal government to recognize the need for more stringent oversight, including promoting certification of dental technicians employed at both domestic and foreign laboratories, mandating that dental laboratories register with the Food & Drug Administration or with state health departments, as well as increasing inspections of the content and quality of imported dental-restoration products.

Linda McGee, owner and operator of Suncoast Ceramic Studio, a Brandon-based dental laboratory, said she urgently supports Rep. Jordan's bill.

"I am proud of the dental crowns, bridges, dentures and other dental restoration products that I and our technicians manufacture out of the highest-quality materials," McGee said. "Our industry makes medical devices for the patient based upon a prescription from a licensed dentist. Because these products will be with that patient, in some cases, for the rest of their lives, it is too important to leave an open door for unsafe or untraceable materials."

The Florida Dental Laboratory Association is a trade association dedicated to advancing the dignity, honor and efficiency of those engaged as operators and technicians of dental laboratories, to advance their standards of service to the dental profession through education and to establish cooperation among the profession.

The Florida Dental Laboratory Association