Cross-contamination

        It is impossible to transmit a disease through the reuse of orthodontic appliances if the processing is done properly. The same is not valid, however, for the brand-new ones. Since the manufacture of expensive, mesh-based attachments is labor-intensive, most are assembled in remote countries where health consciousness may be questionable. Our reusable attachments have been accepted for marketing as equivalent to new by the Food and Drug Administration (FDA) and by the International Standards Organization (ISO). None of our technicians touch used attachments unprotected. Before any handling, the adhesive is removed using chemicals that dissociate and dissolve organic matter at temperatures above those used for steam sterilization but well under that of stainless steel sensitization. It is impossible to break the carbon-carbon bonds in polymers and leave microbes alive. After this first mandatory chemical sterilization, all attachments are once more steam sterilized before packaging under UV radiation. While recyclers have shunned the NBC-TV Dateline investigation, we have invited them, well assured and proud of our processing procedures.

 

Safety

        According to the American Association of Orthodontists (AAO), counsel, "even if a bracket could become detached and the patient could swallow it, this usually will not result in an injury to the patient" (Bowers S, Am. J. Orthod. Dentofac. Orthop. 1993:103; 194). Metal and ceramic orthodontic attachments are classified by the FDA as category I devices, i.e., the least potentially dangerous, being noninvasive and nonintrusive. Compare these with the other commonly reused single use only medical devices that are classified as category III and are surgically inserted. According to the Canadian Hospital Association, surgically inserted medical devices which contain  plastics that are difficult to clean and sterilize (such as hemodialysis filters, angioplasty balloons, implantable generators, pacing electrodes and pacemakers, cardiac catheters, colonoscopy snares, cardiopulmonary bypass cannulae, and laparoscopic and endoscopic equipment) are all currently reused in spite of the fact that all of these are labelled as "single use only devices".

         The Food and Drug Administration (FDA) places all medical devices into one of three classes, I, II, III. Each class dictates the degree or extent of regulatory control needed to assure safety and effectiveness of the device. A higher class corresponds to a higher potential danger (mostly invasive devices). The orthodontic brackets and bands are in class I, which is the least stringent regulatory category. All the devices shown above, except direct bonding orthodontic brackets and bands, are invasive and contain plastic parts. Indeed, the combination of metal and plastic makes those devices less suitable for cleaning and sterilization. In contrast, stainless steel and ceramics attachments lend themselves perfectly to reuse ! In Australia, 58% of the hospitals surveyed in 1994 have reused single-use medical devices such as these listed above [1], and their number has for sure increased since. In Canada, after a thirty-six-months follow-up, the rate of cardiac pacemaker-related complications was the same for both the new and recycled devices. As we have claimed it since years for orthodontic appliances, the quality of the pacemakers selected for reuse was found to exceed that of the new ones due to a better inspection and lack of early component failure [2]. In the US, although FDA has maintained that there is, in general, a lack of data to support the reuse of disposable device[3], has allowed Ortho-Cycle's refurbished orthodontic appliances to be marketed as being substantially equivalent to the legally marketed predicated devices, i.e. to the brand new ones (1991). To object against the reuse in the mouth of devices made of the best stainless steels from fear of contamination is equivalent to giving up eating in public places. How many times the silverware in restaurants is sterilized ?

REFERENCES

1. Collignon PJ & al., Reuse in sterile site of single-use medical devices: how common is this in Australia, Med. J. of Australia 1996; 164(9):533-6

 

2. Canadian Hospital Association, Yearly Report 1998

 

3. FDA, Compliance Guide 7124.6, 1987

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