Dentists responsible for lab work under TGA

If you're a dentist who imports products directly from overseas or throws a couple of mirrors – or worse, some bovine grafting material or the like – into your suitcase and brings them it into Australia to use on patients, you will know by now that changes to the Therapeutic Goods Act that come into effect from 4 October 2004 will spell the end of this. We hope you do anyway!

Basically the changes mean that anything you use in your dental practice that comes into contact with a patient as a medical device must be listed on the Australian Register of Therapeutic Goods (ARTG) by an Australian 'sponsor'. The sponsor is responsible for ensuring that the medical device meets all the regulatory requirements, including applying to the TGA to have the product entered on the ARTG. The payment of any associated fees and annual charges is the responsibility of the Australian Sponsor. It is an offence to use and/or import a product that is not on the ARTG.

Products that were previously exempt such as mouth mirrors and impression materials must now be listed. So, from an economical perspective, you need to source your products locally from a reputable Australian supply company who will be able to provide you with the details of the TGA listing.

Now underline this bit in red pen – you, as the dentist, are legally responsible for ensuring everything you place in the patient's mouth is listed. Like your boat, you're house, your practice, your reputation? Then if you think you can save a few beans by buying overseas or from suspect suppliers, think again. You will be caught – either by the TGA because you or your imports will be stopped in customs – or you will be in a lawsuit from an affected patient and your insurance supplier will suddenly never be in the office when you call. If you are importing/bringing product into Australia, you are classified as a potential sponsor and must list the products and pay the associated TGA listing fees.

The lab

Now that we've gotten that one out of the way, there is the lab scenario to look at. The first issue to broach is that the TGA is not interested in listing devices such as crowns, dentures, ortho appliances, mouthguards, et al, for every individual patient; rather, they are interested in listing the components of the products. While a crown is no doubt greater than the some of its parts, the TGA views it as exactly that.

The lab you buy from must use products to make your prosthetics and appliances that are listed on the ARTG. If they don't, you, NOT they, may be in trouble. So, again, don't skimp on your lab work. This is especially true if you are sourcing your lab work from overseas. No exemptions here, the products used in imported lab work also come under the provisions of the Act, and because all this is fairly new, you may end up deemed being the importer! Beware of those packages addressed to you from overseas that don't go through customs, you may save a few dollars initially but when it comes back to bite… ouch!

It's fairly easy to contact the local lab and get a rundown of the products used in a particular appliance. You can also ask them if the components of the devices they manufacture are listed on the ARTG. They would in turn ask their supplier for the ARTG number for all the products used and pass it on. Again, it is early days, but I would envisage that it will become commonplace for the lab to supply this information when they deliver the job (just like you can look on food packaging to see the contents).

This legislation is brand new, so there are grey areas that may well be the subject of "test cases" in the courts in years to come as and when they need to be formally dealt with.

For example, consider the scenario where the laboratory you are using is outsourcing your work overseas (with or without your knowledge) to some obscure place where their brother–in law's best friend's mother's ex gives them a great deal on some alloy. The lab, being the importer, but not regulated (as is the case in some states), has no idea about the TGA. Now all the crowns you placed in your patient's mouths are going green, and the lawyers are rubbing their hands together. Oh, and the guy at the lab has closed down, left the country and now sells bicycles in that same obscure country you'd never heard of. Again, this area is grey at present, but in effect, you, the dentist would probably be found responsible.

While you are at it, you may also want to check your lab's infection control procedures. Infection control procedures in the majority of laboratories leave a lot to be desired, especially in states where there is no regulation for laboratories at all. Most fish and chip shops are inspected by the department of health more than any dental laboratory would be. It is imperative that you are aware of your laboratory's infection control procedures and that they are being adhered to and followed on at your end, because this is one area where the real nasties will sneak into your surgery and again the buck will often stop with you. To lighten the load, it may be wise to use a laboratory that carries a recognised product liability insurance policy.

Most dental laboratories have been getting a beating over the last few years with the introduction of the GST, the expense of

implementing and maintaining Occupational Health and Safety (OH&S) systems, deregulation in some states and tightening of laws in others and now God forbid, another three nasty letters – T-G-A. Some labs have already taken this onboard and will ensure compliance with it to give added value to their customers. This of course spells expense for anyone who wants to play it safe, but better to be safe than sorry. However, if you're a gambler and you still want to source your lab work from the person working out of Aunt Maud's laundry it's your call, or maybe a call from the TGA.

The author wishes to thank Mike Flood from the TGA and Roy Hardman from Right Time Business for their assistance in preparing this article.

Terry Whitty is president of the Australian Commercial Dental Laboratories Association (NSW) Branch and the proprietor of Australian Orthodontic Laboratories.