Orthodontic braces are regulated by Directive 93/42/CE as amended in 2007. Their entry onto the European market is subject to CE marking. When purchasing new braces, one should check that the mark is present before sending the braces to our laboratory.
To avoid disputes with suppliers of braces, the Evernew Corporation decided that it was responsible for guaranteeing the proper operation of all braces processed in its laboratory, and for traceability, whether for new braces coated with precious metal or for reprocessed braces. From the first, the 93/42 Directive has been the subject of dispute between manufacturers and laboratories which reprocess braces. The manufacturers have classed bands and brackets as “single use” devices.
- It is wrong to put bands in the “single use” category because they have to be tried on the patients. The practitioner should refuse to buy bands displaying the logo and should ask the manufacturer for user instructions requiring that the bands be decontaminated / sterilised,
- It is fair to class brackets as “single use” devices because the practitioner does not have the technology to check that a bracket which loses adhesion during a treatment is still compliant.
The European Community intends to put reprocessing businesses on the same footing as manufacturers. We welcome this, while continuing to invest in quality.
We set out appropriate technical terminology in the hope that our readers will use it henceforth:
The processing of a medical device, and particularly of dental braces, consists of altering the state of the surface to modify its properties, in particular retention, sliding action and resistance to corrosion.
Refurbishment consists of restoring to a medical device all the characteristics of a new product. The product can be put back on the market as a new product. The act of depositing or replacing a layer of precious metal on a dental brace is a refurbishment operation.
Reprocessing consists of cleaning and decontaminating / sterilising a medical device so that it can be re-used.
Repackaging consists of transferring medical devices from one form of packaging to another. A supplier of braces who receives them in packs of 100 and takes out 10 to sell them to an orthodontist carries out a repackaging operation.
Recycling consists of using products at their end of their life to make new products, for example by transforming old tyres into floor mats. Recycling does not exist in the medical sector, and the expression “recycling dental braces” is inappropriate. It’s not a medical term. Instead one can speak of refurbishment or reprocessing. It is unfortunate that the word recycling is still used by suppliers and manufacturers regulated by the Medical Devices Directive 93/42. They should be familiar with its terminology. What’s worse is that sometimes we have to use this word to make ourselves understood, but we always put it in brackets.
Clearly, one should no longer say that a practitioner “recycles” his dental braces, rather that he reuses them following reprocessing by a specialist laboratory or by his own efforts.