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Wondering how you can ease your company’s burdens of capturing and reporting for the Sunshine Act transparency laws? Join CBI and the Dental Trade Alliance Aug. 18 for the can't-miss Sunshine Act Transparency Reporting Workshop for Dental Manufacturers and Distributors for the latest information and tips specific to the dental industry.

Featured speakers will include Kavo Kerr Group Chief Compliance Officer Gina Marie Nese, Carestream Health Chief Compliance Officer Pam Mellon, Henry Schein Vice President Regulatory Affairs Nancy Landis, Ivoclar Vivadent Director of Corporate Education Jude Fabiano, DDS, and Berkley Research Group's Ed Buthesiem and Cheray Sieminski.

As DTA member companies continue to look for new ways to innovate and thrive, grants for research and development have become an important part of the process. Recently, DTA talked with the Small Business Innovation Research and Small Business Technology Transfer’s Dental Small Business Coordinator R. Dwayne Lunsford, PhD. He is the initial point of contact for dentists, dental manufacturers and others seeking a federal grant from those two programs.

“Its goal is to jump start or help American small business thrive from a technological standpoint. It’s for companies doing research and development to get first product out the door,” said Dr. Lunsford, who is also the director of the microbiology program at the National Institute of Health’s (NIH) National Institute of Dental and Craniofacial Research.

At a recent DTA Regulatory and Standards meeting with the FDA at their Silver Spring campus, FDA Center for Devices and Radiological Health and the Center for Disease Control officials requested that DTA ask for input from industry to develop a better description for a syringe when not used for sterile injection. The term syringe (as used by the dental community) has become very broad. It encompasses hundreds of devices that dispense a variety of non-sterile pharmaceuticals and medical device products. One U.S. dental distributor shows more than 500 syringe listings in their current catalog. FDA and the Center for Disease Control believe it would be in the best interest of practitioners and patients to avoid any possible confusion and develop a more descriptive term than just using the term syringe for a wide range of dispensers.

The American dental manufacturing and supply industry exists in a global marketplace, which makes having an export plan vital to companies’ success. Recently, we sat down with Vice President - International of Ivoclar Vivadent, DTA Export Committee Chairman and IDM President Christian Brutzer who shared how the export committee can help members at any stage in their export business plan.

What are the three biggest benefits that the Export Committee provides DTA members?

Mr. Brutzer: The Export Committee comprises of members with extensive international experience who share their general information and knowledge about market places, int. tradeshows and regulatory/import procedures. The meeting agenda regularly covers this wide range of topics and by attending, members can network free of charge with the experienced members. Further, the minutes are published on the member section of the DTA website and thus can be a source of information for members that want to branch out into new, international markets. We further identify and sometimes support common exhibition space at selected international tradeshows such as the IDS, Dentech China and FDI.

One element of our argument against the medical device tax is that the Affordable Care Act contains little additional dental coverage. The Obama administration conceived the tax to counter what they claimed would be a ‘windfall’ to medical device companies because more Americans would have health insurance, therefore using more services and increasing profits for these companies. Dental companies got the tax and no windfall sales or profits!

The Physician Payment Sunshine Act  (Sunshine Act) requires most companies that make, package, distribute, market or sell health care products to document and report nearly all direct and indirect financial interactions with various health care professionals (HCPs) to the federal government.

The Sunshine Act does not preempt more stringent state laws and reporting requirements (e.g., Vermont, Massachusetts) and these laws include broad definitions of HCPs, products and some include bans on meals and gifts.

In March, DTA participated in a meeting of the 2014 ADA Standards Committee on Dental Products (SCDP) in Charlotte, N.C. The SCDP looks at standards for all types of dental products and equipment from basic toothbrushes and sealants to  complex devices, including digital radiography and CAD/CAM. The SCDP ensures practitioner and patient safety by determining fundamental design and manufacturing standards that can be easily adhered to in the U.S. by domestic manufacturers and their global counterparts.

Jay CrowleyAll U.S. devices are required to have a unique device identification bar code on the device or the packaging starting in September 2014 for Class III devices, Class II devices by September 2016 and Class I devices by September 2018, but you should be preparing for these changes today. That’s the message DTA members received during the March 5 UDI (Unique Device Identification) Implementation Workshop in Silver Spring, Md., featuring keynote speaker Jay Crowley, former head of the UDI initiative for FDA.

Background: The Kids’ Healthy Mouths Ad Council public service campaign launched on August 14, 2012 with the distribution of public service advertising (PSAs), public relations outreach, social media engagement, 2 minute videos and a website, 2min2x.org.  Based on extensive target research, a campaign theme was developed:  Kids will spend a lot of time doing all sorts of things. Let’s get them to spend two minutes twice a day brushing their teeth.  Known as the Children’s Oral Health campaign, this effort directly communicates the importance of regular brushing behaviors and is targeted both to English and Spanish speaking parents and caregivers of children aged 0-12 with an emphasis on lower income and minority populations.

The DTA has played a lead role in the conception, development and management of the program with the Ad Council as part of the Executive Committee of the Partnership.  The DTA Foundation is the sponsoring organization for the campaign.

DTA's Christian Brutzer was installed as the President of the Board of the International Dental Manufacturers at the February Chicago Dental Society Midwinter Meeting.  Mr. Brutzer will serve for two years in this role and will lead IDM, work closely with the World Dental Federation (FDI), and act as an advocate for increasing access to oral health care for the global population. 

 

(Left to Right) Friedrich Herbst, Executive Director of IDM, Pam Clark, Past President of the Australian Dental Industry Association and Christian Brutzer, VP of Ivoclar Vivadent and newly installed President of IDM. 

 

 

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