Tuesday, October 23, 2018

Ultradent Pledges $25,000 for Hurricane Florence and Hurricane Michael Relief Efforts

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Ultradent Pledges $25,000 for Hurricane Florence and Hurricane Michael Relief Efforts

and Announces Special Discount Program to Help Affected Dentists Rebuild Practices

It’s always great to see and work with a company that strives to always do the right thing.  That is just one of the reasons I’m a big supporter of Ultradent.  Their company motto is “Improving Oral Health Globally” and believe me when I say “they mean it!”

 

Here is the latest announcement from Ultradent regarding helping those trying to recover from the recent hurricanes:

In response to the catastrophic devastation caused by Hurricane Florence and the most recent damage caused by Hurricane Michael, Ultradent Products, Inc., has pledged $25,000 to All Hands and Hearts Smart Response. These funds will be used to aid in the rescue, relief, and rebuilding efforts of those affected by the storms.

In addition to these donations, Ultradent is offering to help dentists whose practices have been damaged by these hurricanes. Ultradent has offered any dentist whose office has sustained substantial physical damage by Hurricanes Florence or Michael $500 worth of free consumable product, plus 40% off all consumable products and 15% off all equipment purchases exceeding the initial $500 on that order. Through this offer, Ultradent hopes to provide some aid in the rebuilding efforts of the dental community.

Ultradent’s president, Dirk Jeffs, says, “Care is an important core value at Ultradent, and we want to extend a helping hand and show our care for the people who have been affected by these devastating storms.”

Ultradent has a strong culture of giving. The company contributed to relief efforts associated with the Pulse Nightclub shooting, Typhoon Haiyan, the earthquakes in Haiti and Ecuador, and Hurricanes Sandy, Harvey, and Irma. Additionally, Ultradent has donated more than 1.6 million pounds of food over the past 10 years to the Utah Food Bank. Ultradent also contributes to various national and international dental humanitarian missions. To find out more about Ultradent’s disaster relief efforts, please visit www.ultradent.com/relief.

 

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About Ultradent Products, Inc.

Ultradent Products, Inc., is a leading developer and manufacturer of high-tech dental materials, devices, and instruments worldwide. Ultradent’s vision is to improve oral health globally. Ultradent also works to improve the quality of life and health of individuals through financial and charitable programs. For more information about Ultradent, call 800.552.5512 or visit ultradent.com.

Monday, October 22, 2018

Impressions from America's Dental Meeting ADA Hawaii 2018

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In case you’ve all been worried about me… like I know that would happen… I’ve spent the last few days in Honolulu at the 2018 American Dental Association meeting.
 
Now before you all hit the comments section with jokes about how hard I must have worked, let me tell you.  I honestly did work!  In fact, considering how far some folks had to travel, the meeting was very well attended.  Sometimes when a meeting is in an exotic tropical location, folks spend more time on the beach than at the meeting.  this time, however, I spoke with lots of dentists who had traveled for some down time, but were serious about attending both lectures and the exhibits.
 
AS most of you know, I am part of the Cellerant Best of Class that selects products every year that we feel are truly “Best of Class”.  We also have an area on the exhibit floor for the panel members to lecture to attendees and it also allows the attendees to be able to interact with the winning products.  Because of that setup (which we do at every ADA meeting), we get a tremendous opportunity to speak with doctors.
 
What I discovered is that dentistry is thriving again.  Since the economy tanked in the late 00’s, experts have been analyzing data on a yearly basis and determining that dentistry was “flat”; basically not shrinking but also not growing.  What I learned in Honolulu is that the “flat” trend is over and the “up trend’ has begun.  Our Cellerant Best of Class lecture area was continually busy every day and every course was sold out.
 
Doctors are excited about dentistry and are planning and purchasing accordingly.  I had 5 different events during the 3 day meeting that allowed me to interact with the doctors in attendance and I can tell you, those crowds were enthusiastic about our future.
 
To back that up, the vendors I spoke with also reported good visibility with good sales.  I did not get a chance to hear actual attendance numbers, but all indications point to a very exciting future for our profession.

Tuesday, October 16, 2018

Anthem to Pay Record $16 Million for HIPAA Violations Exposing 79 Million Patient Records

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Anthem has agreed to a fine by the Department of Health and Human Services that is the largest fine ever paid for exposing patient Protected Health Information.  The fine is 16 million dollars.
 
The company states it is unaware of any illegal action that has happened due to the breach, but that might be difficult to prove.  The company is the second largest health insurer in the United States and currently insures 40 million people as well as selling individual and employer coverage in places such as California and New York.
 
The payment is in lieu of any and all civil penalties that the Department of Health and Human Services might have imposed.
 
The sad and embarrassing part of this story is that the breach was facilitated by a spear-phishing attack that convinced Anthem employees to divulge usernames and passwords.  Having that information then allowed the bad guys to eventually get System Administrator privileges.  This, in turn, let them run rampant through the system.
 
The data breach was discovered in 2015 which always makes you wonder who else has had a breach we have yet to learn about…

Monday, October 15, 2018

Evaluation of the Goby Electric Toothbrush

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I’ve been tinkering with and using the Goby powered toothbrush for several months now and I have to say I’ve come away impressed.
 
Quite honestly, I feel I owe the folks at Goby an apology.  I had expected a device that was less expensive than major brands and would show it… but I was wrong.
 
The device feels solid in your hands and is well made.  I’ve used it for a few months now and it still looks and performs as if it had just come out of the box.  Those that know me know I *love* the color black and the black brush they sent me hasn’t faded, scratched, skuffed, or weathered in the lather and toothpaste.
 
By eliminating the big retail sales distribution chain, they’ve been able to keep their costs low which also being able to keep the quality high.  The device has a 2 minute timer broken down into 30 second segments.  This lets you know you’ve brushed one quadrant long enough and it’s time to move on to the next one.  After 2 minutes, it shuts itself off automatically.
 
It is an oscillating brush head that I’ve found to be the right size to fit everywhere in my mouth… even those areas that can be hard to reach.
 
The charger is USB and comes with an AC adapter.  You can plug it into any outlet OR the USB port on your laptop.  The charger is also very small and can even be taken apart for trips.  The stand that charges the device is composed of 2 parts.  The part that actually holds your brush and keeps it vertical and a small “paddle” or “slab” that fits into the stand and provides the charge.  This “paddle” can be removed from the stand during travel.  How does it charge the brush?  There is a small magnet in the “paddle” that attaches it to the right spot on the back/bottom of the handle and allows the brush to charge. I find that to be genius.
 
I’m also impressed with the cost of the brush heads.  Most companies charge well over $10 for one and some can be more than $15.  Goby brush heads are $6 apiece.  You can buy them from their website, or you can go on auto shipment and receive a package every 2 months.  That’s a great way to know you are keeping your brush young and flexible so it can do its job.  Doing auto shipment is the best way to go.
 
When you consider that you can get all of this for a $50 payment, I’m impressed.  I’m advising patients who are on a budget to get a Goby and save themselves some dollars in the process.  If you’ve always wanted an electric toothbrush but the cost has kept you away, take a look at the Goby.
 
This product is highly recommended!!!

Thursday, October 11, 2018

FDA Approves Expanded use of Gardasil 9 to Include Individuals 27 Through 45 Years Old

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The leading cause of oral and pharyngeal cancer in the US is HPV 16 which is a strain of the Human Papilloma Virus (hence HPV).  Because of that simple fact, for years now, experts have been advocating for inoculation of both girls and boys with Gardasil with is the HPV vaccine.  Now the FDA has approved the use of Gardasil to the age range of 27 to 45 years old.  Read on for the info from FDA…
 
 

The U.S. Food and Drug Administration today approved a supplemental application for Gardasil 9 (Human Papillomavirus (HPV) 9-valent Vaccine, Recombinant) expanding the approved use of the vaccine to include women and men aged 27 through 45 years. Gardasil 9 prevents certain cancers and diseases caused by the nine HPV types covered by the vaccine.

“Today’s approval represents an important opportunity to help prevent HPV-related diseases and cancers in a broader age range,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. ”The Centers for Disease Control and Prevention has stated that HPV vaccination prior to becoming infected with the HPV types covered by the vaccine has the potential to prevent more than 90 percent of these cancers, or 31,200 cases every year, from ever developing.”

According to the CDC, every year about 14 million Americans become infected with HPV; about 12,000 women are diagnosed with and about 4,000 women die from cervical cancer caused by certain HPV viruses. Additionally, HPV viruses are associated with several other forms of cancer affecting men and women.

Gardasil, a vaccine approved by the FDA in 2006 to prevent certain cancers and diseases caused by four HPV types, is no longer distributed in the U.S. In 2014, the FDA approved Gardasil 9, which covers the same four HPV types as Gardasil, as well as an additional five HPV types. Gardasil 9 was approved for use in males and females aged 9 through 26 years.

The effectiveness of Gardasil is relevant to Gardasil 9 since the vaccines are manufactured similarly and cover four of the same HPV types. In a study in approximately 3,200 women 27 through 45 years of age, followed for an average of 3.5 years, Gardasil was 88 percent effective in the prevention of a combined endpoint of persistent infection, genital warts, vulvar and vaginal precancerous lesions, cervical precancerous lesions, and cervical cancer related to HPV types covered by the vaccine. The FDA’s approval of Gardasil 9 in women 27 through 45 years of age is based on these results and new data on long term follow-up from this study.

Effectiveness of Gardasil 9 in men 27 through 45 years of age is inferred from the data described above in women 27 through 45 years of age, as well as efficacy data from Gardasil in younger men (16 through 26 years of age) and immunogenicity data from a clinical trial in which 150 men, 27 through 45 years of age, received a 3-dose regimen of Gardasil over 6 months.

The safety of Gardasil 9 was evaluated in about a total of 13,000 males and females. The most commonly reported adverse reactions were injection site pain, swelling, redness and headaches.

The FDA granted the Gardasil 9 application priority review status. This program facilitates and expedites the review of medical products that address a serious or life-threatening condition. 
 
The FDA granted approval of this supplement to the Gardasil 9 Biologics License Application to Merck, Sharp & Dohme Corp. a subsidiary of Merck & Co., Inc.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Wednesday, October 10, 2018

FAQ Regarding the EPA Ruling on Mandatory Amalgam Separators in Dentistry

EPA developed these FAQs based on the Dental Office Category Rule at 40 CFR Part 441. Dental facilities may be subject to additional or more stringent state or local requirements than those in the rule.

Who must comply with this rule?

The vast majority of dental facilities that discharge wastewater into a publicly owned treatment works (POTW) (e.g., municipal sewage system) are subject to this rule (“dental dischargers”). However, there are some exceptions.

Dental dischargers that do not place dental amalgam, and do not remove dental amalgam except in limited emergency or unplanned, unanticipated circumstances are exempt from any further requirements as long as they certify as such in a one-time compliance report to their Control Authority.

Dental dischargers that exclusively practice one or more of the following specialties are not subject to any of the rule’s requirements, including submission of a one-time compliance report to their Control Authority:

• Oral pathology
• Oral and maxillofacial radiology • Oral and maxillofacial surgery
• Orthodontics
• Periodontics
• Prosthodontics

Additionally, mobile units are not subject to any of the rule’s requirements, including submission of a one-time compliance report to their Control Authority. A mobile unit is a specialized mobile self-contained van, trailer, or equipment used in providing dentistry services at multiple locations.

Dental facilities that do not discharge their amalgam process wastewater into a POTW are also not subject to any of the rule’s requirements, including submission of a one-time compliance report to their Control Authority. For example, dental facilities that discharge amalgam process wastewater into a septic system are not subject to this rule.

To determine if the EPA rule applies to your facility, see § 441.10 (Applicability).


What are the basic requirements of the rule?

The requirements for dental dischargers subject to the rule are detailed in the rule. Here, they are summarized as follows:

Ensure the removal of dental amalgam solids from all amalgam process wastewater via amalgam separator(s) or equivalent device(s) that meet the standard of the final rule. See § 441.30(a)(1-2) for an existing source and § 441.40 for a new source.
Implementation of two best management practices. See § 441.30(b) for an existing source and § 441.40 for a new source.
Comply with reporting requirements. See § 441.50(a).
Maintain and make available for inspection certain records documenting compliance. See § 441.50(b).

What are the compliance deadlines?

Dental dischargers (under any ownership) that were discharging into POTWs prior to July 14, 2017 (“existing sources”), must be in compliance with the standards by July 14, 2020, and submit a one-time compliance report certifying such by October 12, 2020.

Dental dischargers whose first discharge to a POTW occurs after July 14, 2017 (“new sources”) must be in compliance with the standards immediately and submit a one-time compliance report certifying such within 90 days after first discharge to a POTW.

If the dental discharger transfers ownership, what are the deadlines for a new owner to submit a one-time compliance report?


If an “existing source” dental discharger transfers ownership, the new owner must submit a new one-time compliance report to the Control Authority by October 12, 2020, or if the transfer occurs after July 15, 2020, no later than 90 days after the transfer. If a “new source” dental discharger transfers ownership, the new owner must submit a new one-time compliance report to the Control Authority no later than 90 days after the transfer.

Does this rule require standards for the type of amalgam separator I install?

Yes. For an existing source see § 441.30(a)(1-2). For a new source, see § 441.40.

Do I have to replace my existing separator?

It depends. § 441.30(a)(1)(iii) of the rule allows dental dischargers that had installed and were using an amalgam separator prior to June 14, 2017 to continue to use it until June 14, 2027 if it is functioning properly and does not need to be replaced. This is referred to as a “grandfathering” provision or clause. The facility must still file a one-time compliance report certifying such by October 12, 2020. If the amalgam separator meets the standards of the rule, see § 441.30(a)(1-2), the grandfathering provision need not apply.

If a dental discharger covered by the grandfather clause transfers ownership, the new owner may continue using the grandfathered separator until June 14, 2027 if it is functioning properly and does not need to be replaced. The new owner must still file the one-time compliance report.

What are the correct dates that are relevant to the grandfathering provision in § 441.30(a)(1)(iii)?


In the original Federal Register publication of the final rule, there was a typographical error in one of the dates in the grandfathering provision. The corrected version of the provision is: “A dental discharger subject to this part that operates an amalgam separator that was installed at a dental facility prior to June 14, 2017, satisfies
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the requirements of paragraphs (a)(1)(i) and (ii) of this section until the existing separator is replaced as described in paragraph (a)(1)(v) of this section or until June 14, 2027, whichever is sooner.” (emphasis added)

I have a wastewater retaining tank technology that collects all amalgam process wastewater and my dental facility does not discharge any amalgam process wastewater to a POTW. Am I exempt from the Dental Office Category Rule?


Yes. See § 441.10(e). As long as the dental facility does not discharge any amalgam process wastewater from the tank or otherwise, it is not subject to any of the rule’s requirements, including submission of a one-time compliance report to their Control Authority.

My dental facility has a technology that removes amalgam from wastewater as efficiently as an amalgam separator, but it is a different type of device, and therefore does not qualify to meet the ISO standard for amalgam separators. Does this device satisfy the requirements of this rule?
The rule includes a provision at § 441.30(a)(2) that allows the performance standard of the rule to be met with the use of an amalgam-removing technology other than an amalgam separator (i.e., equivalent device). EPA included this provision to allow use of amalgam removal devices that are equivalent to amalgam separators in several respects (e.g. the percentage of removal of mass of solids) but that may not fall under the amalgam separator classification. The equivalent device is required to meet the same requirements and removal efficiencies, as specified in § 441.30(a)(1-2) or § 441.40.

Does this rule have record keeping requirements for dental dischargers?

Yes. See § 441.50.


Does this rule have inspection or maintenance requirements for dental dischargers?

Yes. See § 441.30.

What information must be in my one-time compliance report?

See § 441.50. A sample one-time compliance report that includes the information required by the rule may be found at www.epa.gov/eg/dental-effluent-guidelines.

• Note to dental dischargers: Please contact your Control Authority to ensure that you have obtained the correct form from your Control Authority. In addition, you may be subject to additional reporting requirements in accordance with state and local law.

Where should dental dischargers send their one-time compliance report? Who is my “Control Authority?”

Dentists should obtain and send their one-time compliance report to their pretreatment Control Authority. Your Control Authority is either a local wastewater utility, a state environmental agency, or a U.S. EPA Regional Office.

If your dental facility is in Alabama, Connecticut, Mississippi, Nebraska or Vermont: your Control Authority is your state agency. Contact information for each state is available at www.epa.gov/npdes/contact-us-national-pretreatment-program (select the “State Agency Contacts” tab).
For dentists in all other states: contact your U.S. EPA Regional Office, your local wastewater utility, or your state agency Pretreatment Coordinator to identify your Control Authority. Pretreatment contact information for EPA headquarters, EPA Regions, and state agencies is available at www.epa.gov/npdes/contact-us-national-pretreatment-program (select the appropriate tab).

My practice is in compliance with the standards in the rule and has submitted a one-time compliance report. It is now changing ownership. Do I or the new owner need to submit a new one-time compliance report?
Yes. If a dental discharger transfers ownership of the facility, then the new owner must submit a new one-time compliance report to the Control Authority. See above for compliance deadlines and § 441.50(a)(4).

Is there a website where I can submit my one-time compliance report electronically?

Check with your Control Authority.

Does the final rule prohibit the use of oxidizing or acidic cleaners in dental unit water lines, chair-side traps, and vacuum lines?


Yes. The clause that follows (“including but not limited to...”) is not an exhaustive list of oxidizing or acidic cleaners or qualities that make a cleaner oxidizing or acidic. For example, a cleaner that is oxidizing would be prohibited even if its pH is between 6 and 8.

Does the prohibition on the use of oxidizing or acidic cleaners in dental unit water lines apply to cleaners used in the water supply lines that connect to items such as handpieces, ultrasonic scalers or air/water syringes?


No. The purpose of the best management practice (BMP) specified in § 441.30(b)(2) is to prohibit the use of cleaners that solubilize mercury from dental amalgam in the wastewater lines in a dental facility. In developing the rule, EPA did not evaluate the use of cleaning products that may be used in dental equipment that is connected to water supply lines such as handpieces, ultrasonic scalers, or air/water syringes. While de minimus amounts of such products may eventually be indirectly discharged through a wastewater line in a dental facility, the prohibition in § 441.30(b)(2) was not intended to prohibit dental unit water line cleaning products when those products are used in water supply lines to ensure the safety of the water that dentists place in their patient's mouth.

Is the amalgam collected in the separator considered a hazardous waste under the Resource Conservation and Recovery Act (RCRA)?


Yes. The amalgam collected in a separator is likely to be a hazardous waste under RCRA due to the mercury and silver content of the amalgam. However, dental offices producing less than 100 kg of hazardous waste/month AND less than 1 kg of acute hazardous waste per month are considered “Very Small Quantity Generators” (VSQGs are regulated under § 262.14) and are exempt from most RCRA requirements for the disposal of their hazardous waste (Note that VSQGs were formerly called “conditionally exempt small quantity generators” (CESQGs) but were renamed in November 2016). EPA generally does not expect dental offices collecting amalgam waste to be above the VSQG threshold.

A generator must count all of the hazardous waste it generates in a calendar month, not just the amount of amalgam, to determine what RCRA generator category is appropriate. If you believe you may qualify as a “Small Quantity Generator” (dental office that produces 100-1000 kg of hazardous waste per month AND less than 1 kg acute hazardous waste per month) or a “Large Quantity Generator” (dental office generates more than 1000 kg of hazardous waste per month OR more than 1 kg of acute hazardous waste per month), please contact your state hazardous waste authority to understand your requirements for the management of hazardous waste. Links to state environmental agencies are on EPA’s website at www.epa.gov/hwgenerators/links-hazardous-waste-programs-and-us-state-environmental-agencies

What about state and local requirements?

The EPA rule is a floor (i.e. a minimum requirement), not a ceiling, for regulating discharges of dental office wastewater to POTWs. There may be additional requirements under state or local law that go beyond those in EPA’s Dental Office Category Rule.

Where can I find more information?

The Federal Register notice for the rule, along with other information, can be found on EPA’s Effluent Guidelines website at www.epa.gov/eg/dental-effluent-guidelines.

Tuesday, October 9, 2018

How New Technology will impact Treatment Planning

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As a writer, every once in a while you get lucky.  You happen to find a subject that strikes home with your audience and it takes off better than you might have initially expected.  That has happened to me recently with an article I wrote on high tech treatment planning.  I’ve received some nice public and private comments on the article.  For me its a tremendous honor.  As the Technology Evangelist, I look upon my job as being the person who points out the great advantages new products and ideas bring to us.  That’s it in a fairly complete description.  So, of course, whenever I get feedback I’m incredibly honored by that.
 
Here’s the article…
 

One of the true game changers in our profession as of late has been the development of cone beam computed tomography (CBCT). That combined with the market penetration of digital radiography, which is now well over 50 percent, has created an environment of visual co-diagnosis that has dramatically changed the way we communicate with patients and the way we diagnose.

I’m a huge supporter of visually-based technologies for the simple reason that human beings rely heavily on their sense of sight. Whether it’s computer images, photos or working under high magnification, the ability to see well gives you the ability to “do” well.

Combining multiple factors of visually-based practice systems allows for greater efficiency of treatment and greater predictability of outcomes.

For the past two or three years, I’ve been encouraging development of integration between cone beam scans and the file sets created by chairside digital impression systems. I’d be thrilled to see a continually updated patient where an initial 3D scan is taken and then updated with data from the digital impression system whenever a new chairside scan is done. Imagine keeping a 3D digital record of your patients that’s constantly updated to reflect their current situation. That would be incredible!

However, another new process has caught my eye as of late. Many of you have probably heard of VR, or virtual reality. The idea is to wear goggles that create a “virtual world” where it feels like you’re actually inside a video game. VR looks to be one of the next big things in the gaming world, for real estate tours, and potentially for education and tourism. However, short of perhaps patient education, VR doesn’t have much of a potential in the dental industry for the foreseeable future.

While VR my not have dental applications on the immediate horizon, a technology referred to as AR just may hold promise. AR stands for “augmented reality” and is defined by whatis.com as “The integration of digital information with the user's environment in real time. Unlike virtual reality, which creates a totally artificial environment, augmented reality uses the existing environment and overlays new information on top of it.”

Let’s stop and consider that for a moment. Imagine the possibility (as I mentioned above) of the merged cone beam and digital impression files. Now, let’s imagine that you’re prepping for a bridge on teeth #4-6. You prep the teeth, scan the case with the acquisition unit and then merge the clinical scan with the cone beam data. At this point the doctor can don the AR goggles that are loaded with your patient’s digital 3D data, and when you look at the patient, you’ll actually see the 3D rendering “on the patient.” This allows you to check for proper clearance and proper draw.

 

For the full article, you can finish reading at Dental Products Report.