Description:
There are doubts about whether dental devices will be as effective when they
are procured from developing countries at half or a third of their price
Introduction
Dental devices include dental prosthesis like dentures, used
with the support of soft and hard tissues surrounding the oral cavity, custom
made for every individual to replace missing teeth.
Outsourcing is the process of contracting a business
function, previously performed in-house, to an external provider. From
feasibility study to design, research to development, prototype to production
and everything in between can be outsourced. One of the major reasons for
outsourcing is to focus on core business but in reality the focus has shifted
to cost savings.
Concerns
Ignorance
There is a growing concern is that dentists and their
patients may be using outsourced products without even being aware of it. Such
ignorance can often lead to the use of substandard products that can adversely
affect the health of Americans.
Dental offices often send work order to the closest dental
work laboratory, known for quality. Some of these laboratories outsource the work
to overseas and restrict themselves to administrative duties. The imported
product is checked by their skeleton staff for quality and minor adjustments
are undertaken in-house. After
relabeling and repackaging, the dental prosthesisfinally ends up at the dental
offices.
Cost vs Quality
Dental prosthesisis often outsourced due to low cost of the
overseas product. it is cheaper than comparable American dental prostheses by anywhere
between 33 and 50%. Dentists often use outsourced dental prosthesison patients who
negotiate for a better price and on those who do not have any dental insurance.
New dentists are also known to use outsourced dental prosthesis, when they
first start their practice, for financial reasons. The quality including
material and fixture of the outsourced dental prosthesis is likely to degrade
to harmful levels as cost becomes the only criterion for outsourced products.
Lead Poisoning
One of the major concerns is the presence of lead in
outsourced dental prosthesis. Lead is a hazardous substance for adults and has
serious health risks for growing youngsters. Lead poisoning is often not
discovered until irreversible damage has taken place and is usually due to exposure
from swallowing or breathing lead particles.
Regulations
The Food and Drug Administration (FDA) requires laboratories,
which outsource dental work to overseas, to give information related to
outsourcing to the dentists. In reality, dentists obtainsuch information only
upon request and the obtained information is usually not passed to the patient
as it is not mandatory.
The FDA also oversees imported medical devices or devices
that are relabeled, repackaged or manufactured. All medical devices with
problems need to be reported but adverse reactions surrounding medical devices
are rarely reported.
Therefore, the National Association for Dental Laboratories
(NADL) is concerned about the public’s safety and wants all laboratories dealing
with dental work to:
·
Register with a state agency
·
Have at least one Certified Dental Technician
(CDT)
·
Use FDA approved materials
·
Disclose materials used in dental prosthesis
·
Disclose the point of origin of manufacture
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