Dr. Jeffcoat’s March JADA editorial, "The Life and Times of a Good Idea," touches on important issues related to dental products, including the ADA Seal of Acceptance.
The alert clinician may have noticed that ADA acceptance is not as prominently displayed on dental devices as it used to be. Nowadays, you will frequently find the characteristic CE mark on all sorts of products, including dental products. This is the mark that signifies European Certification.
Why is the CE mark found on products sold in the United States? The answer is simple. The standards or specifications, which are the foundation for certification, are most commonly based on international standards, the so-called ISO standards. These standards, which are issued by the International Organization for Standardization in Geneva, are used in certification programs in many countries, although some national regulations may be added in some countries.
It is important to realize that representatives of the ADA and the American National Standards Institute, or ANSI, play a leading role in the development of ISO standards. In fact, the original dental ISO standards published some 40 years ago were identical to, or slight modifications of, the ANSI/ADA specifications in current use at that time. These specifications have been revised over the years, with active participation in the ISO work by the American dental industry, independent researchers and representatives of academia in the United States.
In fact, many active ANSI/ADA specifications now are adopted ISO standards, and that is the way it should be. The certification process would be impossible if a number of countries would have different standards for certification. It would leave manufacturers in an impossible situation if they were to make similar products according to different specifications. The result would then undoubtedly be that industry would make products according to the specification of one or two major countries with the largest market share.
So, why is the CE mark found on products sold in the United States? I expect this is for practical reasons and to keep the cost down. Europe is presently the largest market for dental products with its approximately 400 million inhabitants. The growth of the European markets by the European community’s expansion toward the east will result in an increase in population to 600 million people. The United States’ approximately 260 million people and Japan’s 130 million are small markets compared to Europe.
Therefore, manufacturers tend to rationalize the labeling to that covering the major markets, but it is important to keep in mind that the standards forming the bases for the certification have a strong impact from American know-how. It also should be noted that dental products cannot be sold in Europe without having the CE mark.
Another matter is the clinical relevance of the ISO standards in the context of general dental practice. These standards, like the original ANSI/ADA specifications, are based mainly on assessment of physical properties, and they are used primarily to measure quality control. The parameters measured in the standards are often not predictors of clinical performance, and they frequently have minimal clinical backing. Thus, there is a need for active participation of clinicians at all levels, as pointed out in Dr. Jeffcoat’s editorial.
It is also important to keep in mind that improvements of materials referred to in product promotion usually are based on in vitro testing with questionable clinical relevance. Therefore, it is important to ask for clinical documentation of any claim made. If that cannot be provided, be cautious and suspicious about the claims made and continue to request supporting clinical documentation.
Note also that in certification/acceptance programs that require clinical data, the testing will have been carried out according to the criteria of the "controlled clinical trial"; that is, it demonstrates how the materials will perform under the ideal, well-defined clinical conditions. The results from these trials may differ markedly from those in everyday, real-life general practice.1
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