Under a Watchful Eye

New business models are evolving which bear no resemblance to the conventional dental laboratory. Some laboratory businesses have become merely pass-through brokers, shipping orders from US laboratories offshore and then back for re-distribution and sale by their customers. Others have established themselves as specialty design centers, creating virtual designs of crowns, bridges, and partial dentures and nothing more. Still others operate merely as re-packagers and re-labelers.

This tangled web of custom-made oral device manufacture has not only brought increased liability risks to the dental technology industry but also invited closer scrutiny from the US Food and Drug Administration (FDA). Responsible for the protection of the American public, the FDA has also extended its reach overseas as the bureau struggles to inspect those FDA-registered supply-chain establishments in Asia that are manufacturing the increased number of parts and complete cases flowing in and out of countries such as China.

"This industry is quickly transforming from a cottage industry into a global presence," says Laura Sheppard, CDT, director of quality and compliance for Dental Services Group™, a network of dental laboratories. "As requirements stiffen, strengthen, and escalate to higher levels, it is critical that dental laboratories become compliant with FDA manufacturing standards and regulations."

Although the standards and regulations requiring dental laboratories to comply with good manufacturing practices (GMPs) and quality systems have been in effect since 1997, Sheppard says they went unnoticed by most dental laboratories because a majority of them did not have to register with the FDA, which kept them largely immune from FDA inspection. However, the new business models springing up in the industry and the flood of offshore products inundating the US are changing all that. "We know that the FDA is looking more closely at FDA-registered business models that fall outside the normal dental laboratory model," says Gary Morgan, CDT, who is vice president and compliance advisor for SafeLink™ Consulting Inc, a business and risk management consulting service. "Foreign manufacturers, importers, or anyone making Class II medical devices, such as snore guards or sleep apnea devices, are the primary focus." And that fact has many laboratories overseas scrambling to ensure their operations meet US standards.

That does not mean, however, that laboratory businesses falling outside these three business models will avoid FDA scrutiny. "All dental devices are medical devices," explains Mary Borg, SafeLink’s president and senior compliance advisor. "What is so hard for laboratories to understand is that they are using Class I and II materials regulated by the FDA. And the crowns, bridges, veneers, and dentures being made with those Class II materials are going into a patient’s mouth, which by law makes it mandatory that all laboratories, regardless of size, incorporate FDA-regulated good manufacturing practices and a quality control system into their business."

Protecting the patient from harm is the responsibility of all those involved in the manufacturing supply chain—from the makers of the materials, parts, and equipment used to those assembling the final finished product. They must make sure that what they are using to produce the end product and how they are producing it is safe for the end user. The FDA’s role in the process is to ensure the efficacy and safety of those products by governing the methods used in and controls used for "the design, manufacture, packaging, labeling, storage, installation, and servicing of finished medical devices intended for commercial distribution in the US," according to Part 820 of the Code of Federal Regulations Title 21.

Most laboratory businesses already have some form of quality control system and GMPs in place for addressing common problems or day-to-day operations, such as remakes, complaints from clients, equipment maintenance, job descriptions for each employee, and a training regimen for technicians. What is missing in most businesses is the documentation that accompanies each of these daily routines, as well as documentation from the vendors who are supplying the materials, equipment, and outsourced restorative parts used in the manufacturing process, to show that they are also compliant with GMPs.

"It’s really basic logic and most laboratories have instinctively put some of these systems and controls in place," says Bennett Napier, CAE, co-executive director of the National Association of Dental Laboratories (NADL). "The point of the matter is that it exists on paper. You have a defined documented plan or standard that fits your business model and all your employees know what that plan is and are following it." A quality control system extends to all levels of the production process, maximizing consistency and providing a paper trail to trace and identify the source of a problem should it arise.

That includes everything from documenting that the technician performing a particular function is properly trained for the task and follows the defined steps involved in its completion to keeping records on proper equipment maintenance based on manufacturer’s guidelines. "A QC system helps more quickly identify gaps in your manufacturing processes and how to correct the problem so it doesn’t reoccur, which saves you money in material and labor costs," Napier continues. "With no QC system in place, tracing the break in the chain that triggered a negative event such as material failure or remake is like finding a needle in a haystack."

The ability to produce and deliver a safe and effective product and replicate that consistency day in and day out is particularly valuable to businesses involved in manufacturing thousands of one-of-a-kind custom devices each year. "Financially, it’s important for our company that we can address, trace, and correct problems as they arise," Sheppard explains. "Anytime we have non-conformance in product, materials, or service, the ability to trace and solve that problem saves us money. It also translates into a positive for our customers and for the patient. "

That is particularly true if a patient presents with a health issue such as an allergic reaction to the metal used in a crown or bridge or with a restoration that has failed or fractured in the mouth. "We have had clients call us and ask what materials were used in a particular restoration because the patient had inflammation around the gum line for example," says Jerry Ulaszek, CDT, president of Artistic Dental Studio Inc. in Bolingbrook, Illinois, a laboratory that is certified by the Dental Appliance Manufacturers Audit System (DAMAS). "We have complete documentation on that restoration and every other restoration fabricated in our laboratory and are able to track all the materials used, down to the lot number, as well as the processes used in its manufacture."

Both Sheppard and Ulaszek believe that having an internal quality control system not only positions them ahead of the competition, but also adds value to their businesses and increases the quality and consistency of the products they produce. Most importantly, it means their businesses are operating at a federally recognized standard. "I would think that as a dentist you would want to be able to tell your
patients that you are using a lab that can do that," Sheppard says. "We can tell our clients at any point in time about every material used in any product we deliver."

Managing a documented internal quality control system is only half of the process. It also means controlling patient-contact materials from outside vendors, such as manufacturers of porcelains, alloys, and even outsourced restorative parts or final restorations. Most industry manufacturers have obtained the International Organization for Standardization (ISO) 9000 certification and sell only FDA-registered materials, but it is crucial to ask for documentation to verify that. "To maintain control over the quality of the materials you purchase and use in the fabrication of the restorations you sell requires qualifying that vendor as having a GMP and quality control system in their manufacturing process," Borg explains. "And that includes any milling center, partial-framework producer, or offshore partner. You need to receive a written statement, affidavit, or a current copy of the ISO certificate. This is an essential part of a quality system."

Borg also suggests doing due diligence by physically visiting the facility and assessing its quality system, paying close attention to their ability to track the lot numbers of the materials being used.

"If I am sending a prosthetic part to another facility to have that part manufactured, it is now out of my control," says Morgan, who also owns Morgan Dental Laboratory in Austin, Texas. "I need to verify if that part is safe for my client’s patient by having the outsource facility provide documentation proving that they are following FDA-required good manufacturing practices and quality control systems."

For clients who service populations that require low-cost restorative alternatives, Dental Services Group contracts offshore suppliers but had to switch several times before finding one that met their quality standards. "We have representation that has made countless trips to the site," Sheppard says. "We require that the offshore laboratory not only satisfies and meets US health standards, but also has a manufacturing quality standard in place with the same evidence of traceability, education, tracking, and trending that we have in our laboratories."

Both Sheppard and Ulaszek will admit that going through the procedures needed to integrate GMPs and quality control systems into laboratory production processes is not easy. Compliance language is an amalgam of foreign terms and confusing acronyms that can often be difficult to translate and apply to the day-to-day activities that take place in the laboratory. Employees struggle and often resist "by-the-book" processes and documentation that must be strictly followed from restoration to restoration. And finding someone to devote the hours of work involved in setting up, integrating, and maintaining the required documentation is also often difficult. "Each of our laboratories has an appointed and dedicated quality representative whose responsibilities are to set up, carry out, and monitor the QS/GMP system," Sheppard says.

Several different options are available for establishing a quality control program to begin the compliance process. Because the FDA does not require laboratories to have a third-party certified system in place, some laboratory owners opt to design their own with the help of guidance documents from the FDA or with other tools like DIY Quality Connection on CD from SafeLink (www.safelinkconsulting.com) or the DAMAS manual from the NADL (www.nadl.org). Then they decide whether or not to become certified through a third-party audit. Some laboratories have attained international certification through the ISO 13485 or 9000 programs. As in the case of both Dental Services Group and Artistic Dental Studio, a qualified consulting firm can be brought on board to assess the quality system and to make recommendations or guide the laboratory through the entire training and integration process.

There are differences in the three third-party certification programs. Morgan explains that ISO is the highest level of general manufacturing certification and is an internationally recognized manufacturing standard. ISO 13485 is a set of standards revised in 2003 that specifically address the design and manufacture of all medical devices. DAMAS, on the other hand, is based on the quality system management principles of both the ISO and the FDA but is geared specifically toward the dental laboratory industry. None of these standards addresses all FDA requirements and that is why Morgan says it pays to have a knowledgeable outside consulting firm to review any program the laboratory establishes and to help incorporate FDA-specific requirements that apply to its particular business model. "Every laboratory and every management team is different with different challenges that need to be addressed," Napier says.

Both Artistic Dental Studio and some laboratories in the Dental Services Group opted for the DAMAS certification program. "Liability protection was a major factor in our decision to become DAMAS-certified," Ulaszek says. "This is one more way Artistic Dental can ensure that our clients’ patients are provided with safe restorations and that we protect ourselves from a health hazard situation." Before becoming DAMAS-certified, Ulaszek says his laboratory could tell clients if a noble or high-noble alloy was used to manufacture a particular restoration but had no system for tracking the lot number of that alloy or even the brand of alloy if that purchase record had been purged. Now they keep all of that information on file.

Earlier in the GMP process, four of the Dental Services Group laboratories were heavily involved in the manufacture of Class II medial devices and as such had contracted with an outside FDA consultant and proactively registered with the FDA. Because the first version of DAMAS did not address Class II intraoral devices for snoring and/or obstructive sleep apnea, these laboratories independently pursued federal GMP standards. "But when DAMAS began aligning more closely with FDA standards, management decided that as many of our laboratories as possible should become DAMAS-certified," Sheppard recalls. It took 6 to 9 months of weekly phone calls with the appointed quality representatives to implement DAMAS in each of their laboratories, she says. Now all but the smallest of their 26 operations have an established DAMAS program and have gone through the third-party audit process.

Once certification is attained, it must also be maintained. For DAMAS-certified laboratories, that means a third-party audit each year for the first 3 years, a remote document review in the fourth and fifth years, then back to a third-party audit in the sixth year and so on. Currently, 43 laboratories have attained DAMAS certification, with 100 more involved in the DAMAS process, according to the NADL. "We don’t expect every laboratory to go through the DAMAS certification process, but every lab needs to find a system that works for them and that is compliant with FDA standards," Napier explains. "I think laboratory owners understand the changes and the shift taking place in this industry. You can’t wing it anymore."

But US laboratories are not the only ones pursuing GMP and quality control standards to become FDA-compliant. In May 2010, the NADL received permission to expand DAMAS to the Asian market. In January 2011, Veden Dental Labs, an ISO 9001:2008, ISO 13485:2003, SGS-certified dental laboratory in Zhuhai City, China, became the first Chinese laboratory to undergo the DAMAS third-party audit process. "We are doing this for our domestic laboratories," Napier says. "Because we own the system and approve the auditors, we can control the standard to ensure that offshore laboratories being used by our domestic operations meet the same FDA compliance standards." Napier believes this move will greatly minimize liability for US-based laboratories that are using offshore services.

For overseas laboratories servicing the US market, DAMAS certification provides the credibility and legal assurances that many domestic operations are looking for in an offshore partner. "Because DAMAS is a laboratory-specific quality assurance program and Veden interacts with US dental laboratories, we believe it is important for Veden to reach that next level to provide a better service to our US customers," says Sophia Wu, Veden’s deputy general manager. "We want our partners to know that everything we do here is consistent with the same high quality standards as in the US."

The NADL has received inquiries from laboratories in the Philippines, Vietnam, and Taiwan, according to Napier, and in response, they have contracted Intertek as a global partner to help train laboratories interested in DAMAS certification. With about 1,000 offices in more than 100 countries, Intertek has already heard from about 20 dental laboratories in China who contacted them in the fall of 2010 to get help setting up for 2011, Napier says.

After lead was found in a number of overseas products that were exported to the US in 2007, it prompted the current government to increase FDA oversight and funding. And certainly, the 2008 discovery of an Ohio patient with a lead-tainted crown manufactured overseas put the dental industry on the FDA’s radar. In 2009, the US government set aside $135 million to specifically target medical device inspections both in the US and overseas. For the first time, the government mentioned dental laboratories in the release but did not allocate a specific dollar amount for that particular initiative. And then in early 2010, the FDA announced it was establishing three branch offices in China to further monitor foreign-made products being shipped to the US, plus the agency hired about 1,300 new inspectors to increase audit coverage here and abroad.

Individual state legislatures have also started to get on board. Florida, Texas, and South Carolina have already enacted legislation that requires the point of origin to be revealed on the packaging of indirect restorations made overseas and re-packaged/re-labeled for sale to US dentists. And many other states are considering similar legislation. This is already required by the FDA but now can be enforced on a state level.

"We are seeing a heightened awareness and sensitivity by the FDA as to what dental laboratories are doing here and abroad," Morgan says. "And as they conduct more and more of these inspections, they will get a better sense of the different business models in the industry and how those business models should be regulated."

One of the biggest problems FDA auditors have is that dental laboratories do not fit the traditional production-line manufacturing model, where a device is being mass-produced using a single design. The fact that each design is unique and does not theoretically originate in the laboratory, but rather in the practice, exempts dental laboratories from many of the GMP and quality control regulations regarding design. "The dental laboratory’s defense has to be that the design control rests with the dentist and the material control with the manufacturer," Morgan says. "If you can provide specifications and documentation provided by the materials manufacturer along with the dentist’s prescription with documented preferences, then you can show exemption."

Because FDA inspectors are so new to the dental laboratory industry, some operations have found them to show some leniency by not levying monetary penalties on laboratories that demonstrate an attempt in implementing GMP and quality control compliance. "Typically, they point out which areas of the business do not meet standards, give the laboratory an observation letter, and allow the laboratory to set a timeframe for correcting the issues," Morgan says. "If they find you are doing nothing to comply, they can issue a 483 warning letter, set a timetable for compliance, and conduct a follow-up audit to ensure you have instituted corrective action." If the laboratory is not compliant by the second visit, the FDA can label the business’ products as adulterated or misbranded, which means they cannot be sold—effectively shutting down the business.

"Our first audit was 3 years ago," Sheppard says. "Our laboratory was taken completely by surprise." The inspector was there for more than 5 days in what Sheppard describes as an "arduous" audit. In the end, the inspector did not issue a 483 warning. An observation letter was issued with recommendations. Two years later, the FDA conducted a follow-up inspection to ensure corrective action had been taken.

Since then, several other laboratories in the Dental Services Group have undergone inspection with Sheppard on hand to determine what the inspector is looking for and to ask the right questions. "It’s so interesting because each of the audits has been so different, with the inspectors looking for different compliance issues," Sheppard says. "One of the keys to a successful audit is having someone on site during the inspection that is well-acquainted with the guidelines." She says role-playing with management and technicians is crucial to providing sufficient answers to an inspector’s questions. "Coach [your staff] to keep answers short and to the point, and not to volunteer information," she says. "For every question, from training to material handling, refer to procedures and standards provided." An answer of "sometimes, I do this," "we’ve always done it this way," or "I don’t know" will certainly trigger a deeper and more serious look into the production process.

Morgan believes FDA regulation and inspection will evolve in much the same way the Occupational Safety and Health Administration’s standards and inspections did. At some point, the FDA will begin doling out monetary penalties, which will ramp up adoption of GMP standards, or it will impose a federal mandate and develop a FDA guidance document specifically designed for dental laboratories.

"If you have been proactive and incorporated a GMP and QC process into your business, that’s terrific," Sheppard says. "But if you haven’t, you should start now."