NADL Co-Executive Director Answers JDT Unbound's Questions
NADL Co-Executive Director Answers JDT Unbound's Questions
Were you surprised to hear of this case? The NADL board of directors and executive staff had discussed this possibilty for about five years. The probability of this type of case happening increased with the increase in the number of restorations coming in from foreign dental laboratories. This is not to say that work from foreign dental laboratories is not of high quality, most is and is likely safe for use. However, the material standards in some countries, or the supply chain controls are not as stringent as they are proposed to be in the U.S.
NADL has members who use offshore laboratories what is your advice to them? The same due diligence that we recommended in the JDT Unbound on using offshore laboratories. They need to do due diligence on selection of the laboratory and monitoring of activities, processes, material controls of any foreign partner. Those laboratories that do outsource offshore need to be able to reasssure their dental clients the type of documentation they can provide on materials and share their monitoring activities of foreign outsource partners including if they inspect and visit the facility on a regular basis.
NADL members who do not use offshore laboratories and those who use reputable offshore laboratories may feel under attack for the bad actions of bad laboratories. What can they do to reassure their dental clients that the restorations they manufacture are safe? This is no different than it would be if the material problems had occurred in a domestic laboratory. They need to be able to provide the same documentation of material content as any other lab would. Good practices include Identalloy and IdentCeram and other documentation available from dental manufacturers.
Any idea how frequent adulterated materials coming in from offshore are? No, there is no definitive information. According to the FDA field agent in Anchorage, Alaska, less than 1 percent of off shore restorations are inspected before they come in.
Have there ever been any cases of adulterated materials in U.S.-manufactured restorations? Not sure if adulterated or not. However, there have been material failures for some dental materials where products were recalled due to cracking but they were not deemded unsafe just prone to breakage.
What kind of affect will this situation have on the domestic dental industry? Depending on the level of media exposure, in the short term, it is expected that laboratories that do a higher level of off shore outsourcing may see a decline in work. Additionally, the broader domestic industry may also see a dip in cases coming in as patients may be leery for a time period to finalize pending dental work until such time they feel confident in the system. It is all dependent on the level of media exposure and patient awareness.
What was the ADA's reaction when you told them? They were not suprised per say.
Should people assume that all restorations coming from China are bad? No, it is expected that the vast majority of foreign manufactured and domestically manufactured restorations are safe for use.
Will NADL change its stance on using offshore laboratories? No. Its a global market. Uniform standards for manufacturing and material controls should apply to domestic and foreign laboratories.
