20
|
Volume3 Issue6
N
ews and
E
vents
Protect your patients and your reputation:
WATCH FORNONCOMPLIANT
PRODUCTS
It’sdifficult to knowexactlyhow
big theproblem is, precisely
becausenoncompliant products—
greymarket andcounterfeit
items—aredistributed through
unauthorized, and therefore
untrackable, channels. “There’s
noway toaccuratelymonitor
this,” saysMr. Teitelbaum. “But
basedonDIAC’s surveyof dentists, I
estimate that about 15%of consumable
dental productsused inCanada todayare
noncompliant.”
TocomplywithHealthCanada regulations,
dental productsmust haveavalidHealth
Canadaproduct licence
(
health-products.canada.ca/
mdall-limh/index-eng.jsp
)
andbe soldbyamanufacturer
or dealerwithavalidHealth
Canadaestablishment licence
(
health-products.canada.ca/
mdel-leim/index-eng.jsp
).
Greymarket productsmay look
similar to—or evenexactly
like—aproduct licensed for
sale inCanada, but havebeen rerouted from
their intendedmarkets. “What thismeans to
thedental practice is that theproductwas
exportedbyamanufacturer from somewhere
in theworld, passing throughmanyhands
beforemaking itsway toNorthAmerica,”
saysMr. Teitelbaum. “Nobody really knows
how theseproductswere shipped, storedor
handled, so theconsistencyof aproduct’s
qualityand itsoverall condition is anyone’s
guess.”
Telltalemarkings like “Not for sale inNorth
America” or country-specificproduct numbers
can reveal if aproduct ispart of thegrey
market, but other signs aremoredifficult to
detect.Mr. Teitelbaum recommends always
checking thepackagingand its contents
against thepicture in thecatalogue tomake
sure theproduct you receive is the sameas
advertised. “Thepicturesusuallydepict a legal
product, but theproduct youactually receive
couldbedifferent,” heexplains. “Thename
couldbea littlebit different or itmayhavea
different package size, colour or shape.”
Useofnoncompliantdental products is aproblem inCanada thatputspatient safetyand
dentists’ reputations at risk, according toBernieTeitelbaum, recently retiredexecutive
directorof theDental IndustryAssociationofCanada (DIAC).
Compliant (l.) vs.
Noncompliant (r.)
packagingupdate from
Carestream.
➌
➊
Medical device licensecancelled inCanada (l.)
vs. valid license (r.)
➋
LutingPlus (top) authorized for sale
vs. Luting2 (bottom) not authorized
inCanada.
