CDA Essentials 2016 • Volume 3 • Issue 6

20 / 48

20 | Volume 3 Issue 6
News and E vents
Protect your patients and your reputation:
WATCH FOR NONCOMPLIANT
PRODUCTS
It’s difficult to know exactly how
big the problem is, precisely
because noncompliant products—
grey market and counterfeit
items—are distributed through
unauthorized, and therefore
untrackable, channels. “There’s
no way to accurately monitor
this,” says Mr. Teitelbaum. “But
based on DIAC’s survey of dentists, I
estimate that about 15% of consumable
dental products used in Canada today are
noncompliant.”
To comply with Health Canada regulations,
dental products must have a valid Health
Canada product licence
(
mdall-limh/index-eng.jsp)
and be sold by a manufacturer
or dealer with a valid Health
Canada establishment licence
(
mdel-leim/index-eng.jsp).
Grey market products may look
similar to—or even exactly
like—a product licensed for
sale in Canada, but have been rerouted from
their intended markets. “What this means to
the dental practice is that the product was
exported by a manufacturer from somewhere
in the world, passing through many hands
before making its way to North America,”
says Mr. Teitelbaum. “Nobody really knows
how these products were shipped, stored or
handled, so the consistency of a product’s
quality and its overall condition is anyone’s
guess.”
Telltale markings like “Not for sale in North
America” or country-specific product numbers
can reveal if a product is part of the grey
market, but other signs are more difficult to
detect. Mr. Teitelbaum recommends always
checking the packaging and its contents
against the picture in the catalogue to make
sure the product you receive is the same as
advertised. “The pictures usually depict a legal
product, but the product you actually receive
could be different,” he explains. “The name
could be a little bit different or it may have a
different package size, colour or shape.”
Use of noncompliant dental products is a problem in Canada that puts patient safety and
dentists’ reputations at risk, according to Bernie Teitelbaum, recently retired executive
director of the Dental Industry Association of Canada (DIAC).
Compliant (l.) vs.
Noncompliant (r.)
packaging update from
Carestream.
➌
➊
Medical device license cancelled in Canada (l.)
vs. valid license (r.)
➋
Luting Plus (top) authorized for sale
vs. Luting 2 (bottom) not authorized
in Canada.