Although there are thousands of foreign and U.S. dental
laboratories not all of them provide their dentists with high quality dental
lab products and services. The infamous dental case, reported by the NADL, concerning an
Ohio Woman in 2008 that after a chemical analysis of her 3-unit dental bridge
found “unsafe levels of lead in the porcelain on the restoration” made from
China is all to well known in the dental community, but still concerns many
dental professionals today. The materials being used and quality of dental
restorations from foreign and U.S. dental laboratories is still a major concern
for the dental lab industry, dental professionals, and their patients.
Provided
in this article is a brief
overview of the concerns that the dental community and the United States
Government have with low quality, and potentially unsafe imported and domestic dental
lab products. Discussed next are considerations when choosing a dental laboratory,
so new and experienced dentists can ensure
their dental practice is an ongoing success and ultimately provide the best dental
health care services to their patients.
Imported dental restorations (and those fabricated
domestically) are medical devices that must meet U.S. Food and Drug
Administration requirements. Foreign laboratories, like U.S. Laboratories, are
required to register their establishment, list medical devices, report medical
device defects, and manufacturing in accordance with the quality system
regulations. Although foreign and domestic dental labs are required to comply
with these regulations, the FDA cannot regulate the contents of all imported
and domestic dental lab products for assured safety. The FDA told NADL back in
2007, that it was concerned with safety management of the “increase
in dental restorations coming in from foreign dental laboratories” and, more
recently, the FDA revealed an all-time high of 38% of dental restorations being
imported from foreign labs.
U.S. States including Texas, Missouri, South Carolina, North
Carolina, Kentucky, Illinois, Ohio, Pennsylvania, Virginia, Florida, Minnesota
and Oklahoma are the only states that require some existing administrative or governmental
laws regulating dental laboratories and/or technicians. Only 10 states require
some regulations: material and point of origin disclosure, lab registration, at
least one CDT for each lab or continuing education certification. Having only
10 out of 50 states that require
regulations of dental labs and products, such as certification and material
origin disclosure, is alarming when the public’s health is at risk. It should
be a right for a patient to know what is being sold to them and where it is
coming from, especially when it comes to medical devices that must be
biocompatible with the oral cavity.
Infection
control and material safety in dental lab products are the main concerns when
dental labs can go unregulated without the requirement of a license and/or
certified dental technicians. In one such case in Springfield, Ohio, a man
arrested over unrelated incidents at his home, police found an unsanitary dental
lab in his basement. The “basement lab” was broadcasted by a local
news station in Ohio, Local 12 News, and the man responsible for the alarmingly
unsanitary dental lab told the news station that he learn dental work while he
was in prison, taking a one year certificate course. In order to be a certified
dental lab technician, a lab technician must have 5 years of experience along
with certified courses; however, there are no laws in Ohio that required a
dental lab and/or dental technician to be certified. Therefore the reported
“basement lab” in Ohio, even though unacceptable, was not illegal because of
the lack of laws and regulations. In over 40 states in the U.S., anyone can
operate a “dental laboratory” without a required license.
The National
Association of Dental Laboratories (NADL) and American Dental Association (ADA)
have supported material disclosure to dentists and their patients. They also
support stricter FDA regulations for dental labs and dental products for all 50
states, not just for only 10 states.
In 2007, the Food
and Drug Administration and Federal Government officials collaborated with the
National Association of Dental Laboratories (NADL) to address concerns about
the regulation of imported dental lab products and the lack of FDA regulation for
U.S. dental labs. FDA’s representatives told “NADL that there was concern about the government’s ability to
adequately track the material safety of import dental restorations being used
by U.S. consumers.” So the NADL
concluded they would develop a framework of “best practices and guidelines for
the dental laboratory industry” to help the FDA improve import safety for
dental restorations to ultimately protect the dental health of U.S. dental
patients. Since then very little has been done on the legislative side of all
50 states to improve regulation of dental products and labs, hence currently only
10 states are minimally regulated.
In a 2008
ADA member survey, 45% of their dental patients requested material content
information for a dental restoration or inquired about the materials that may comprise
a restoration. Surprisingly, a 2009 ADA member survey showed that 65% of
dentists believed that dental labs and technicians in their state are
licensed.
"Such common-sense regulations are critical because in
many cases, the dental technician--not the prescribing dentist--makes the
selection of dental materials that will be used for a particular patient's
restoration," said Bennett Napier, CAE co-executive director of the
National Association of Dental Laboratories. "Without having some
requirement for the person or manufacturer creating the device to have the
appropriate knowledge and training, the issue of material selection and/or
safety is left to chance."
The bottom line is dentist’s need to be able to reassure
their patients of the type of documentation they can provide about the origins
of their dental restorations and what type of quality they are paying for.
Furthermore, dental practices and dental patients need to be aware and educated
about the differences and opportunities available when choosing dental
restorations from a foreign or domestic dental lab.
Low quality, or ill-fitted dental lab products can make your
patient unsatisfied and bring the quality of services you provide to a damaging
level, giving your patient a reason to find another dentist. When this happens
the dentist is usually to blame by the patient so it’s imperative to know what
level of quality you are getting to prevent any dissatisfaction. Dentists need
to make decisions not based solely on price but also on quality, customer
service, accessibility, remakes, and effective communication.
When choosing the best dental lab for quality dental lab products, consider these
tips to make the success of your dental practice and the public’s health a top
priority:
·
Do they use certified materials and implant
components?
·
What are the material origins used to make the
restoration?
·
What are the origins of the restorations?
·
Do they outsource any of their dental work to
foreign labs?
·
If they outsource to foreign labs, make sure you
are provided with the FDA registration number and compliant with ANSI and ISO
standards.
·
Are they a certified dental lab (CDL)?
·
Do they employ at least one certified dental
technician (CDT)?
·
Physically visit and inspect the dental lab on a
regular basis.
·
Build a relationship with your dental lab to
ensure effective communication.
About the company
Iverson Dental Laboratories is a cutting edge dental lab that utilizes
advances in dental technology and procedures to fabricate high quality dental lab products and excellent dental lab services. As a certified
dental laboratory, they specialize in all-ceramic restorations, dental
implants, cosmetic and digital dentistry. They strongly
believe in using certified materials and authentic manufacturing components to
fabricate all their restorations. They proudly make 100% of their dental
products in-house at their Southern California lab, allowing them to have one
of the fastest turnaround rates in the industry. They also pride themselves on
having the lowest remake and adjustment rate in the industry at 2.6%.
To inquire more about quality dental lab products and services, please
visit http://www.iversondental-labs.com.
What to look for in a dental lab to ensure
quality are also discussed to help new and experienced dentists ensure their
dental practice is on going success and ultimately provide the best quality
services to their patients.
No comments:
Post a Comment