Standards help dentists extract grey-market suppliers

2008-07-31

It was an announcement that had many Canadians running to the bathroom to examine their toothpaste tubes: in June of 2007, Health Canada issued an advisory that warned consumers about foreign-made toothpastes containing diethylene glycol, a chemical used in antifreeze.

Less than a month later, Colgate-Palmolive warned customers that a counterfeit of its Colgate-brand toothpaste was in the U.S. marketplace.

In May 2008, Health Canada re-issued its advisory, warning consumers to avoid buying foreign toothpastes containing diethylene glycol.

Those in the dentistry field, like in just about any industry in Canada, have plenty of concerns about low-quality or even hazardous products being distributed to dentists’ offices and their patients.

Dr. Benoit Soucy, the Director of Clinical and Scientific Affairs at the Canadian Dental Association (CDA), and the chair of the Canadian Advisory Council to the International Organization for Standardization (ISO)'s technical committee for dentistry (ISO TC 106), says that these concerns carry a particular weight in his field, where a patient’s health and safety could be put at risk by low-quality products and equipment.

He says using international standards for dentistry has helped reduce that risk in Canada.

"Dentistry is a very standards-intensive occupation," Dr. Soucy says. "We use a lot of different materials that must behave in a very specific fashion. We also have a lot of equipment that is manufactured by different manufacturers, and that has to be interchangeable and work with equipment made by other manufacturers. So having standards that describe how all these pieces of equipment should work together is very, very important."

The importance of dentistry standards in Canada is such that the Standards Council of Canada (SCC) holds the secretariat of ISO TC 106, and CDA provides the secretary, Nathalie Martel. Dr. Derek Jones, a dentistry professor at Dalhousie University in Halifax, N.S., is Chair of the technical committee. He says standards are needed to prevent health risks associated with using non-standardized products.

"They are necessary because with the materials, equipment and devices used in dentistry, there is the safety element. How safe are materials that contain certain elements? Fluoride, also arsenic, and other elements are in the materials and we have to look at limiting the amount that is permitted, and these are the sorts of issues that come into play in safety."

Dr. Soucy says because there are relatively few manufacturers that make product and equipment specifically for dentistry, the industry hasn't seen nearly as many cases of outright counterfeiting -- where a product or piece of machinery is made to imitate a reputable brand and is sold under that brand -- as industries that have more brand names associated with it.

However, he says, the CDA does have concerns about products that have entered the marketplace through non-proper channels, or the "grey market".

"We have more concerns of quality assurance standards that may not always be implemented properly, and products that are put on the Canadian market without going through the proper channels," he says. "That's a much, much more serious concern in dentistry. Products that have a need for a chemical reaction and that could be affected by warehousing conditions and the transporting conditions are of concern."

The problem is enough of a concern in Canada that the Toronto Academy of Dentistry hosted a panel discussion on the topic in November, 2007. During this session, representatives from manufacturers, research, the dental industry and the Canadian Government discussed how their areas are all trying to curb this problem.

The use of international standards in the supply chain is one key method of ensuring that materials used in dentistry have followed the proper channels on their way to dentists' offices.

Under Canada's Medical Devices Regulations, dentistry manufacturers that apply for a license to distribute materials used in dentistry within Canada must provide a valid certificate that shows their quality management system complies with ISO's standard for quality systems (ISO 13485:2003). In order to receive such a certificate, manufacturing companies are audited to ensure their procedures are in line with requirements set out in the standard.

Dr. Soucy says this helps ensure that materials are handled and stored properly on their way through the marketplace, and helps extract distributors that aren't following the proper supply channels.

"Usually (when there's a grey-market distributor selling a product), it's a new guy on the block, a new distributor, who tries to make a name for himself by selling products at a cost that is simply too low, and usually it's because he got those products somewhere outside of Canada and is re-importing them," Dr. Soucy says.

"You have to be very careful that things are actually provided by reputable distributors, and the number of distributors is very small; we essentially know the larger ones," he adds. "But what we have to be concerned about are the new players in the market. And a lot of the mail-order businesses fall in that category, and we try to educate, as much as we can, our (CDA's) members on licensing requirements and all the quality assurance standards."

Dr. Jones says the standards used in dental products in Canada help give the Canadian Dentistry industry a good international reputation.

"Canada has a very, very high-quality dental profession and the treatment for Canadians is probably amongst the best in the world," he says. "So it’s important that any devices, equipment or materials that are imported into Canada are at the level that we would expect to be using in the high-quality dental programs in Canada."

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