Written by Eric J. Thorn, Esq Tuesday, 31 January 2012 19:00
With the ever-increasing globalization of our economy, there is a growing national momentum of states recognizing the vital need to protect their citizenry by ensuring minimum standards with respect to the manufacture of dental prosthetics.
Dental laboratory registration has already been adopted by Pennsylvania, Texas, Florida, South Carolina, and Oklahoma and is already otherwise regulated in Illinois, Ohio, Kentucky, and Missouri. Dental laboratory legislation has also recently been filed in Virginia, Georgia, Minnesota, New York, and New Jersey. State dental associations in California and Washington are currently advancing proposals related to dental laboratories as well.
LEADERSHIP BY THE DENTAL PROFESSION
A major reason for the growing wave of activity to establish state registration of dental laboratories is the leadership of dentists and state dental associations. Dr. Scott Miller, a prosthodontist and chairman of the Virginia Dental Association’s (VDA’s) Dental Lab Regulations Task Force, believes that there is an increasing trend of leadership from dentists and state dental associations in the area of dental laboratory registration. He recently stated, “If we are to maintain the highest standard of care, we absolutely need to do everything within our power to ensure that we are receiving the most accurate information about the materials that we are using. We owe it to our patients.”
A Changing World
Essentially, the global economy is changing the environment in which dental laboratories operate. As the healthcare professionals responsible for their patients’ well-being, dentists are demanding more accountability from dental laboratories to identify the point of origin of fabrication and the content of materials contained in the dental prosthetics devices that are delivered to them.
Asked to comment for this article, Dr. Gordon J. Christensen offered, “I have been a consistent voice in how to effectively address some of the challenges that impact the relationship between the dentist and the dental laboratory. These challenges include lack of minimum education standards, rapidly advancing technology, and increased off-shore competition. The current activity that is taking place around the country in terms of states requiring dental laboratory registration and minimum education and disclosure requirements is a necessary foundation to facilitate positive change.”
Dr. Christensen pointed out that, “For the last 7 years, Drs. William Yancey and I—and during the last few, Dr. Burney Croll—have spearheaded a Dental Laboratory Technology Summit in Chicago bringing together the ADA, the National Association of Dental Laboratories, the National Board for Certification in Dental Laboratory Technology, and other allied organizations and manufacturers to focus on the dentist/dental lab relationship. I am proud to share that the ADA and others have become proactive on policy changes that can help dentists and the laboratory industry and profession. It is important that all dentists at the grassroots level understand that we must individually and collectively lead the adoption of the necessary changes at the local and state dental society level.”
There is a growing national trend of state dental associations advancing proposals and legislation to establish materials disclosure and registration of dental laboratories.
In Virginia, a recent proposal, the Virginia Dental Laboratory Safety Act, which was adopted by the VDA’s House of Delegates at their September 2011 meeting, has been filed as legislation in the Virginia legislature. Commenting on the proposal that he helped craft, Dr. Dag Zapatero explained, “We do not want to get in the way of any new technology, nor do we want to restrict how any dentist practices dentistry. We merely are asking that labs who do business with dentists in the state of Virginia register with our state. Registration is the only method we have to assure point of origin and material disclosure which is what we are really asking for the continued health and safety of our patients in the Commonwealth.”
In California this past November, the California Dental Association’s (CDA’s) House of Delegates voted on House Resolution 6 calling for legislation to establish dental laboratory registration and require labs to disclose patient contact materials content and point of origin to the dentist.
The California Dental Laboratory Association (CDLA) and the Dental Laboratory Owners Association of California adopted a Joint Statement of Support for the resolution. CDLA president, Steve Simon, CDT, who spoke at the CDA’s Reference Committee Meeting, stated, “Establishing these basic standards for disclosure and registration represents a significant step forward for dental laboratory technology in California.”
Dr. Thomas Stewart, the immediate past president of the CDA, chaired the CDA Dental Laboratory Task Force that developed the proposal. When asked why he feels it is important for dentists to lead on the issue of dental laboratory materials disclosure and registration, Dr. Stewart said, “We are practicing dentistry in an increasingly dynamic environment. It is incumbent on the institutions charged with promoting the profession of dentistry to take leadership to advance the appropriate and necessary measures that will enable us to continue to provide the highest standards of care.” The CDA House of Delegates passed House Resolution 6 which was then referred to the CDA Government Affairs Council. It is anticipated that legislation will be forthcoming and that early work on a bill will begin with the California Legislature when their legislative session convenes in January 2012.
In Minnesota, the Minnesota Legislature’s State Senate passed dental laboratory legislation with a convincing vote of 62 to 2 in the spring of 2011. In the second part of their biennial legislative session which begins in February of 2012, the legislation will begin to work its way through the Minnesota House of Representatives where it has already been referred to committee.
In Georgia, legislation requiring disclosure of materials content and point of origin disclosure has recently been filed.
In Washington state, the Washington State Dental Association continues to refine an initial proposal that would require materials and point of origin disclosure. Discussions with the Washington State Dental Laboratory Association have begun, and it appears that a revised proposal is likely by the summer of 2012.
Proponents of similar proposals maintain that requiring dental laboratory registration is necessary to provide essential infrastructure to protect the health and safety of dentists and their patients by establishing clear communication channels between dental laboratories and dental manufacturers and the FDA, should there be a recall on a dental material or equipment related to a health or safety issue that could ultimately impact the dentist and/or his or her patients.
While incidents such as the well-publicized lead in crown cases that occurred in Ohio are thankfully rare, other batch level materials recalls are not uncommon.
When asked about Florida’s approach, Stan Jordan, a retired Florida legislator who sponsored the Florida legislation, stated, “Dental laboratory registration is the most cost-effective way to monitor compliance with materials disclosure and point-of-origin disclosure requirements. Labs that do not comply risk revocation of their registration or denial of renewal. Without a registration requirement, there is no meaningful way to enforce any minimum standard.”
Mr. Jordan added, “Dentists’ ability to verify that a laboratory has a current registration is a quick and easy way for dentists to know that they are working with a lab that is up to date on their minimum standards and education requirements. This gives dentists another tool to help ensure patient safety.”
In short, establishing a state Dental Laboratory Registration adds another important level of protection for the health and safety of dentists and their patients.
LABORATORIES' REACTIONS TO REGISTRATION
One question that naturally comes to mind when considering establishing laboratory registration is whether the dental labs would resist lab registration as too costly or too burdensome. Asked about the possible push-back from dental laboratories, Bennett Napier, the executive director of the National Association of Dental Laboratories responded, “Dental laboratories in the United States represent an over $6 billion industry and our organization gives a national voice to the more than 10,000 domestic laboratories. When considering the issue of dental laboratory registration we asked ourselves this same question. We conducted a third-party market study that was sent to more than 6,000 domestic dental laboratories. We had a very high response rate of over 25% and the message was clear.”
The results of the market study, which were presented at the ADA’s 2009 Future of Dental Technology Conference in Chicago in August of 2009, showed that 76% of dental laboratories nationwide support required registration of dental laboratories. Also, 88% of dental laboratories support each dental laboratory employing at least one certified dental technician.
“While at first blush this may seem counter-intuitive,” Mr. Napier explained, “what we have found is that dental laboratories support this measure as it verifies that legitimate players are providing dental laboratory services to dentists. By means of registering with a state board of dentistry, the laboratory proves it is committed to adhering to the legal requirements and following the ethical standards in place for other members of the dental team.” Mr. Napier added, “We are pleased to see proactive leadership from dentists and state dental associations and societies on the issue of lab registration. It is a very positive trend.”
Disclosure: Mr. Thorn holds a paid staff position with National Association of Dental Laboratories.
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