___.Searching the Internet for the underlined keywords leads to interesting information. The recycling revolution that has swept America and the world since the late 1980’s has been a huge success in many ways. People are more conscious of how much trash they produce and very often they modify their behavior by recycling an item rather than wasting it. Instead of just working with consumers at the end of the waste flow, it now goes upstream to the headwaters of the waste problem: the industrial designer’s desk.... Instead of designing things to be thrown away, the industry should be rewarded for making sure its products and packaging can be easily composted or reused.
___.Rather than looking at our production systems as one way and linear, we should redesign them to be cyclical, as in nature, where there is no such thing as “waste” and materials are kept in the production cycle. Zero Waste is emerging as a paradigm shift, a new, comprehensive socio-technical system that addresses our resource use from product design to disposal.
___.The UK is equally on the verge of a recycling revolution according to its environment minister, Elliot Morley. Its ‘Big Recycle’ campaign aims to raise awareness of recycling and better waste management, and will involve activities across more than 200 local authority areas. As recently as September 2006, the Council of one of the most enlightened cities in the world, Oxford, gave its approval to a new scheme that aims to more than double the city’s recycling rate, from 19% to well over 40%. And this is just the beginning...
Recycling now has general support
___.“There must be a reason why some people can afford to live well. They must have worked for it. I only feel angry when I see waste. When I see people throwing away things we could use.” (Mother Teresa (1910-1997), A Gift for God, 1975.
“This country must make every effort to stem the rising tide of garbage and industrial waste through a more aggressive use of waste minimization and recycling practices. America as a nation is filling landfills faster than it can establish new ones. The waste problem is not going away, and it can no longer be neglected. “(George Bush, Message to Congress, 23 Jun 89)
___.“The case for recycling is strong and the bottom line is clear. Recycling requires a trivial amount of our time. Recycling saves money and reduces pollution. Recycling creates more jobs than land-filling or incineration. And a largely ignored but very important consideration, recycling reduces our need to dump our garbage in someone else’s backyard”. (David Morris of the Institute for Local Self-Reliance)
___.“Solid wastes” are the discarded leftovers of our advanced consumer society. This growing mountain of garbage and trash represents not only an attitude of indifference toward valuable natural resources, but also a serious economic and public health problem. (Jimmy Carter)
___.“Two years after calling recycling a $40 million drain on the city, New York City leaders realized that a redesigned, efficient recycling system could actually save the city $20 million and they have now signed a 20-year recycling contract. Recycling diverted nearly 70 million tons of material away from landfills and incinerators in 2000, up from 34 million tons in 1990-doubling in just 10 years. Recycling is an industry comparable in size to auto and truck manufacturing” (National Recycling Coalition)
___.“Everyone knows recycling means less trash going to our landfills. But the greatest environmental benefits of recycling are related not to landfills, but to the conservation of energy and natural resources and the prevention of pollution when a recycled material, rather than a raw material, is used to make a new product (Medical University of South Carolina).
___.“The (compulsory) 3 Rs are as follows: Reduce the amount and toxicity of trash you discard; Reuse containers and products; repair what is broken or give it to someone who can repair it; Recycle as much as possible, which includes buying products with recycled content” (Al Gore’s rendition of Government’s site www.epa.gov/msw/reduce.htm)
Riding the wave...
Cautious at first, the orthodontists caught on fast!
___.Medicine practitioners have used and reused their instruments for millennia. A famous orthodontist, John Ravenscroft Patrick, claimed that his arch “can be used in many successive cases.” (The Archives in Dentistry 1884 p. 32 (paper presented before the Illinois Medical Society at their 30th annual meeting, May 1880).
___.By the mid ’70s, when we started commercially the ortho-dontic recycling, this activity was low-key, to be transformed later into a dirty word by manufacturers. Starting in the early ‘80s, universities and practitioners alike began to announce findings favorable to recycling, such as:
___.“Can be of great aid to the profession, both economically and ecologically” (Buchman DJL, Effects of recycling on metallic direct-bond orthodontic brackets, Am. J. Orthod. Dentofac. Orthop. 1980; 77: 656-666)
___.“Recycling produces a bracket indistinguishable from a new one.” (Vlock RS, In-office bracket reconditioning, J. Clin. Orthod. 1981; 15: 635-7)
___.“Bracket recycling, by either chemical or heat treatment methods, when compared to non-treated brackets, shows no significant difference in corrosion potential.” (Harriot SE, The corrosion susceptibility of the metallic orthodontic bracket/wire interface, Master’s thesis, Univ. of Louisville, 1994, Louisville KY)
___.“Recycling permits cost reduction.” (Gorelick L, Bonding, the state of the art. A national survey. J. Clin. Orthod. 1979; 13: 39-53)
___.“Improved methods for recycling of bonded brackets will cut down the costs further.” (JCO/interviews, Dr. Bjorn U. Zachrisson,on iatrogenic damage on orthodontic treatment (Part 2), J. Clin. Orthod. 1978; 12: 208-220)
___.“If, under strong magnification, the bracket slot appears undistorted, and the bracket base and mesh are still in good shape, I see no reason not to use them at least one more time.” (JCO interview, Dr. Homer W. Phillips on bonding, Part 2, J. Clin. Orthod. 1980; 14: 462-480
___.“The idea of recycling arch wires has changed a long, difficult procedure into a simple, fast appointment.” (Alexander RG, Practical points to produce efficiency, (Part 3), J. Clin. Orthod. 1975; 9: 636-644)
___.“Recycling space within your office may have more possibilities than you would think.” (Hamula W, Orthodontic office design, J. Clin. Orthod. l992; 26: 651-57)
___.“Recycled ceramic brackets have been found to provide shear bond strengths adequate for clinical use. Moreover, they exhibit bond failures mostly at the bracket/adhesive interface, without causing enamel damage" (Martina A, Laino A, Cacciafesta V, Cantiello P, “Recycling effects on ceramic brackets: a dimensional, weight and shear bond strength analysis”, European J. Orthod. 1997; 19[6]: 629-36.)
___.“Recycled brackets are not statistically different from the new ones. In NBC’s broadcast of March 9, 1998, some of the information was watered down, omitted, in some cases misrepresented” (Fisher T A, e-mail to Ortho-Cycle regarding NBC-TV’s Dateline of February 1998 presentation of his thesis “An in vitro comparative study of new and recycled orthodontic brackets”, Univ. of Iowa, Iowa City).
___.“There is no evidence that any patient has been injured as a result of wearing recycled brackets. The recycling process to which brackets are subjected involves a combination of intense cleaning and heating which effectively decontaminates and sterilizes brackets” (Alberta Dental Assoc., Updaters, February 1997, “Recycled orthodontic brackets”)
___.“The Ortho-Cycle method did not alter the mechanical properties of the bracket... Hardness, theoretical tensile strength and microstructure were similar to those of the control... Company Esmadent‘s process falls in the range of carbide precipitation leading to a decrease in corrosion resistance” (Buchman DJL, Am. J. Orthod. Dentofac. Orthop 1980; 77: 656)
___.“A real-life test... was extended for three reuse cycles involving 100 cases of GAC brackets. All the reconditioning has been performed by Ortho-Cycle Co... Each cycle has lasted 11/2 years and the characteristics of each series of brackets were investigated and compared... The reuse of dissolution’ reprocessed appliances becomes an effective way by which the clinician can keep overhead costs lower, while the cost of new appliances is steadily climbing... For the average clinician, the repeated use of delicate appliances demonstrates that with proper reconditioning, it is possible not only to save, but also to achieve a performance similar to that of the new ones” (Buchwald A,A three-cycle in vivo evaluation of reconditioned direct-bonding brackets, Am. J. Orthod. Dentofac. Orthop. 1989; 95: 352).
___.“The only safe way for bracket reconditioning is to remove the adhesive chemically (Ortho-Cycle system)”. (Tenti FV, Atlas of Orthodontic Appliances, Fixed and Removable, Caravel, Genova 1986: 305)
___.“All respondents felt that they should be told if recycled brackets were to be used, and any savings arising from their use passed on to the consumer” (Miles ORG, Greenslade M, Harkness M, Patient and parent opinion of the reuse of recycled orthodontic brackets: an international comparison, Brit. J. Orthod. 1997; 24[4]): 329-32)
___.“A survey of 300 members of the British Orthodontic Society showed that 47.5% of respondents recycled metal brackets. Only 7.2% of the orthodontists who recycled brackets informed their patients that recycled brackets were used” (Coley-Smith A, Rock WP, Bracket recycling-who does what, Brit. J. Orthod. 1997; 24[20]: 172-4)
___.“There may be an economic benefit to both dentist and patient if recycled brackets can be purchased at a lower cost than new devices. This may allow dentists to offer patients a slightly lower fee or to reduce overall fees by decreasing overhead costs” (Alberta Dental Assoc., Updaters, February 1997, Recycled orthodontic brackets]
___.“Dentists are not required to inform patients that they are reusing a product, if that product can be safely and effectively reused” (Alberta Dental Assoc., Updaters, February 1997, Recycled orthodontic brackets).
___.“No statistically significant differences were found between the groups or against an untreated control” (Crotty OP, Davies EH, Jones SP, The effect of cross-infection control procedures on the tensile and flexural properties of super-elastic nickel titanium wires, Brit. J. Orthod. 1996; 23[1]; 37-41)
A Very Brave Man
By Norman Wahl, DDS, MS, MA
___.As a historian responsible for the ongoing series “Orthodontics in 3 millennia” in the American Journal of Orthodontics and Dentofacial Orthopedics, I had occasion to review the topic of orthodontic recycling. I had been a satisfied user in the years before my semiretirement, but other than that, I hadn’t given it much thought.
___.Then as I leafed through the literature (make that “surfed the Web”), I began to realize that anyone having the temerity to offer a service designed to depress the sales of new brackets and expect orthodontists to place secondhand hardware into the mouths of their patients must be a very brave man.
___.But in 1976 Claude Matasa, a chemical engineer with experience in orthodontic materials, was convinced that there was a place for the reconditioning of orthodontic brackets. After all, hospitals recycle instruments that have contacted sick people. And when you go to the tearoom, do you expect to use new silverware?
___.So all Claude had to do was figure out how to turn out a product that was unmarred, uncontaminated, and irreproachable; convince orthodontists that it would be to their advantage to use them; get the stamp of approval from product-safety agencies; make a profit; and ... watch his back.
___.With the help of his partner, Eugenia, who was an engineer in her own right, Claude started Ortho-Cycle in a converted garage in Los Angeles. The idea of bracket recycling was not new. Esmadent, a dental supplier, was already into it. But in Claude’s eyes, their method of removing the adhesive—charring—was detrimental to the metal’s integrity, so Claude started using hydrolysis and dissolution. Not only did Ortho-Cycle’s process preserve the bracket’s physical properties, but it solved the problem of decontamination (how could any germ survive such a witches’ brew?) and prevented the leeching out of deadly nickel and chromium ions. Before long Esmadent gave up recycling.
___.However, it took almost 25 years before Claude could solve the problems caused by electro-polishing, the technique used to restore the bracket’s shine—it removed too much metal. The answer was a process used in metallurgy called high-energy centrifugal burnishing that causes only one tenth as much dimensional change in the brackets.
___.In his desire to make his product equal to or better than the original, Claude put his metallurgical mites under the microscope to discover that “new” does not always equal “perfect.” Many defects in manufacturing were found. This was partly explained by the fact that only a sampling of each batch is thoroughly inspected. Not so with Ortho-Cycle, which performs as many as five separate inspections before a bracket is sold. He also found that most new brackets were assembled in countries having questionable standards of sanitation.
___.As expected, orthodontic suppliers were not about to watch this upstart cut into their sales. They countered with everything from labeling their brackets “Single Use Only” to outright lawsuits, when in 1996 Ormco/Sybron sued for patent infringement. The Orthodontic Manufacturers Association (OMA) had six years earlier also brought pressure to bear with a Fight Back segment on NBC-TV attempting to frighten the public away from accepting recycled brackets, but the AAO reported receiving few consumer calls.
___.Neither were clinicians amused. Typical of their reaction was a comment made on Dateline NBC by Dr Douglas Durbin of Lexington, KY, who said that “the ‘war’ inappropriately started and waged by Ormco and others is the lowest form of attack. …” AAO’s president Dr Donald Poulton also gave his blessing when he said that “these brackets are safe and effective.”
___.Not only were they deemed safe and effective, but Ortho-Cycle was given a CE mark by the prestigious Scandinavian Institute of Dental Materials. Today the company stands at the forefront of bracket reconditioning with more customers than ever, despite stiff competition. Along they way, they have:
___.· Saved money for orthodontists and their patients.
___.· Brought attention to manufacturing defects and helped improve standards for new brackets.
___.· Improved the environment by reducing the amount of harmful chemicals being dumped
___. into our_groundwater.
___.· Helped legitimatize the overall concept of medical and dental recycling.
___.Hopefully, Claude Matasa no longer has to watch his back....
A disdained, tormented duckling has grown to be a swan:
Ortho-Cycle Co. at its 30th anniversary
___.“He (C G Matasa) has developed an elevated but practical recycling process for orthodontic appurtenances that has saved millions of dollars for practitioners (and patients) in the cost of their armamentaria. By replacing adhesive’s charring with its dissolution, and metal electro-polishing with a method used by manufacturers, burnishing, he has allowed his company, Ortho-Cycle, to be both ISO and CE certified by the prestigious Scandinavian Institute for Dental Materials. Aside from its economic effect, the recycling of stainless steel devices reduces the amount of harmful chromium and nickel ions which, if dumped, pollute our groundwater. Today, even the intrusive and comparatively difficult-to-sterilize pacemakers and catheters are often recycled. I have personally read the manufacturer letters sent to Professor Matasa, some with grudging recognition of his avant-garde discoveries”.
___.T. M. Graber1
Introduction
___.In the 1990s (last inquiry), one third of American ortho-dontists and one half the British3 recycled their brackets.
___.Most of the devices orthodontists use are made of steels containing nickel and chromium. Both are heavy metals, the dumping of which is regulated. In the absence of the oxygen needed to render these steels “stainless” and the presence of chlorides that corrode them, both metals dissolve and contaminate the ground water. At longer exposure at levels above 0.1 parts per million, nickel leads to heart and liver damage4, while chromium affects liver, kidney, circulatory, and nerve tissues5.
___.Although the number of such devices that are dumped by clinics seems insignificant, the US Government had to take special measures in the case of discarded batteries and light-up shoes. On the other hand, the amount of technology and labor put into some orthodontic devices is enormous (mini-brackets are sold, weight per weight, at a price about three times that of gold bullion).
From Hollywood to... Hollywood.
___.Foreseeing a bright future for recycling direct-bonding brackets and later bands with tubes, in 1976 a couple with a solid background in chemical engineering and research started Ortho-Cycle Company (OC) in Hollywood, California, little knowing that fate would ultimately call them to Hollywood, Florida.
___.Eugenia Matasa’s analytical skills and Claude Matasa’s years in chemical research and exposure to orthodontic attachments (Lee Pharmaceuticals, Unitek), allowed them to develop a recycling method that was different from that launched at about the same time by Esmadent Division of Esma Chemical, South Holland, Ill. Instead of charring the adhesive, they subjected the cross-linked polymer (the adhesives’ matrix) to hydrolysis and dissolution. Aside from being able to completely remove the mesh-ingrained filler, they saved the stainless steel from a phenomenon known as “sensitization.” Within a certain range of temperatures starting at 350oC, the steel’s carbon combines with its chromium (essential, as its oxide provides the invisible, impervious layer of chromium carbide that renders the metal “stainless”)6. This film not only deters cohesion of the grains, but it is also readily soluble in weak acids.
___.The new method also harmlessly solved a problem that would haunt the profession: the need for decontamination. Indeed, the conditions needed to break the polymer were more than enough to kill any organism. Instead of the attachments becoming heavily oxidized, as in the alternative adhesive charring method, they were barely darkened. This considerably reduced their exposure to electro-polishing, a process then considered necessary to provide the sought-after silvery shine.
St. Louis. As this new activity was in conflict with his employer, Unitek Corporation, Claude chose to deepen his metallurgical knowledge by moving to St. Louis and working for Consolidated Aluminum, today part of the giant Alusuisse/ Alcan, the world’s leading supplier of sophisticated alloys. Working at a specialized lab, Industrial Testing, Eugenia started a detailed study of the attachments found on the market to assess variations in microstructure of the metal and expose them to particular treatments.
___.Faced with criticisms and a stronger competitor, Esmadent had to end its bracket-recycling activity. In fact, its method was easy to comprehend because the company, aside from the service, sold Big Jane, a do-it-yourself kit comprising a furnace and an electro-polishing bath, making all too obvious the system’s faults. Learning from this, the other companies offering orthodontic recycling based on the same system started to claim instead a “gentle heating” of the attachments.
New Orleans. In 1979, the production part of Ortho-Cycle moved to New Orleans where the operation grew enough to employ some 30 people. Entrusting production to Netty Matasa, Claude’s wife, made it possible for Claude to pursue other activities. His knowledge of brackets and the way they worked was deepened with the purpose of making the reconditioned ones as good as—or even better than—the new ones. Indeed, to maintain low cost, manufacturers cannot afford but a statistical inspection, a common procedure wherein only a low percentage of a batch are thoroughly inspected, the rest being deemed acceptable to be sold. Not having to manufacture the attachments, Ortho-Cycle focused instead on their inspection which is performed in five separate steps, leading to the incidental uncovering of major manufacturing mistakes.
___.Although familiar with the chemistry of the orthodontic materials, Claude was involved rather with direct-bonding adhesives (Bond-Eze) and knew little about the clinical treatment itself. This became evident at a memorable meeting of the American Association of Orthodontists (AAO) in New Orleans, in 1980, when a clinician revealed that the “.022” brackets he’d bought, actually had a slot width of .018"! The existence of this nonsensical, two-slots anomaly is still debated today.7
___.Despite this and pursuing the stated goal, the team developed a system that could discriminate out of a multitude of brands and systems the brackets of a certain manufacturer and line and determine the prescription. The table shows an early attempt.8
 |
___.The limited number of manufacturers and prescriptions at that time (mainly Ricketts, Andrews, Roth, and Hilgers), allowed Claude to develop and tests against the originals a method capable of measuring torques with a precision of 3% and angulations within 2%.
___.After an intense effort and secure in the belief that it could offer any clinician his or her preferred system, Ortho-Cycle started to place ads in the American Journal of Orthodontics (AJODO) offering to buy used brackets. The problem they had to face was the poor condition in which the brackets were offered for purchase. At the time, the average clinician didn’t think of salvaging debonded brackets—most were damaged. An analysis of the debonding process9 (figure), led OC to the recommendation, now followed by many practitioners, to insert into the bracket’s slot the proper gauge (.018" or .022") before peeling it.
___.A significant improvement came later in the form of Dr. Maclay Armstrong’s Lift-Off debonding instrument (LODI): With it, the proportion of undamaged, debonded brackets was so high that Unitek, which acquired later the patent, removed from its debonding kit the Bracket Saver, a handle ending with a piece of rectangular wire having of the proper width.
Hollywood, Florida. In 1986, due to the need to satisfy its many customers from Central and South America, the company moved again to Hollywood, this time in Florida.
___.After a decade of debates regarding attachment reconditioning in the specialty’s journals and after Ortho-Cycle had sent out innumerable fliers and set up exhibits at orthodontic meetings all over the world, bracket reconditioning started to become widespread. Among the first investigators to become interested in the suitability of the process was D L Buchman10 who showed, as a result of his attempt—and that of Esmadent and another early competitor (who also quit recycling)—to recycle, that “the company OC method did not alter the mechanical properties of the bracket metal.” He was probably also the first to demonstrate that the changes he found (a “general structural weakening”) were due to the attachment’s thermal treatment.
___.Later on, Maijer and Smith11 advised that such heat-treated brackets “should be watched extremely carefully, if used at all,” while Wheeler and Ackerman12, advised single use, requiring careful selection and proper recording. A few years earlier, Park and Shearer13 had made clinicians aware that the release of heavy metal ions due to heating between 400o C and 900o C may cause soft tissue hypersensitivity. In his Atlas of Orthodontic Appliances, Tenti14 added that such an exposure leads to metal softening, which generates problems with torque. In the UK, Regan & al.15 showed that “the thermal process produced significantly reduced bond strength when compared to the chemical process in the case of cast bases” … [and was] … “definitely not recommended.”
___.Although superior to others, Ortho-Cycle’s chemical process still required flash electro-polishing to shine the attachments: aside from removing oxides, the process also removes some metal. According to Hixon et al,16 “the slot increased in size in linear response to the increasing number of cycles.” In Ortho-Cycle’s case, however, a high-tech study performed by a forensic expert, Prof. Dr. M. W. Haller, Penn State Univ. at Harrisburg,17 showed that “the changes induced by recycling were dramatically less than the variability allowed in the manufacture of the new brackets.”
___.For two decades, Ortho-Cycle tried to mitigate the problem by subjecting to controlled, flash electro-polishing only the bracket side, the base remaining unchanged while the slot, being recessed, was practically unaffected. Adding to this improvement over other the companies that subjected the whole attachment to electro-polishing, Ortho-Cycle applied two methods that were later adopted by the whole industry: the topical etching of bonding bases and their silanation.
___.Although large foils were previously etched by GAC to be cut to Microloc® bases, the etching of each separate base, be it with undercuts or mesh, was new. Also new was their bracket silanation, a procedure later applied by others to ceramics. In his master’s thesis testing Ortho-Cycle reconditioned attachments, Scarola18 concluded that “the adhesive bonds to reconditioned brackets can be rendered as strong as those to new brackets.” In another study, “A three cycle in vivo evaluation of reconditioned direct bonding brackets” it was concluded that “with proper reconditioning, it is possible not only to save, but also to achieve a performance similar to that of the new brackets.”19
___.In an attempt to help some clinicians overcome the bracket bases electro-polishing performed by others, Ortho-Cycle launched for a while Ortho-Sil, a silane solution. As a similar product was soon used to prime ceramic brackets (3M’s Scotch-Prime), the product was withdrawn out of fear of causing enamel breakage. A similar venture was the sale of a blue, 35% phosphoric acid etching gel. In contrast to the gel supplied by manufacturers in syringes, Ortho-Cycle chose to sell it by the half gallon to call attention to the high prices manufacturers were asking for common materials. Interestingly, years after discontinuing the sale of this product, O-C is still being asked for it, probably because the supply lasted so long.
___.The purchase of used brackets, which was organized as a consignment, raised the problem of selection: not all types were in demand, and not all of these were deemed acceptable for reuse. A thorough examination of the brackets led O-C to become an authority on what was in demand and which features were sought. Aside from indicating the favorite manufacturers and prescriptions, the results showed that, as an example, the prevalence of preadjusted brackets had climbed from 65% in 1984 to 84% in 1990, while the .022" slot remained predominant in the US and Canada (the opposite to that in Europe).
___.Instead of keeping such information to itself, the company started to spread it at exhibitions and conferences throughout the world and in papers submitted to professional journals: a list of the latter two can be found at www.Matasa.net. Conversant in Spanish, German, and French but conferencing in English, Claude often vexed translators by interrupting them whenever they erred.
___.This scientific activity ultimately led to an adjunct professorship for Claude at the University of Illinois at Chicago as well as to honorary professorships at several European universities. The amount of information requested by the profession soon exceeded the fliers’ ability to convey, so in 1987 Ortho-Cycle switched to a quarterly sent to orthodontists throughout the world: Phoenix without Ashes, referred to the attachment’s renewal without charring.
___.Renamed in 1994 The Orthodontic Materials Insider, the newsletter expanded its horizons to other matters of interest to the specialty, as well as to research performed in the company’s lab. The number and variety of appliances sent to be cleaned, sorted, and decontaminated (or sold) gave Ortho-Cycle a unique opportunity. Examining millions of attachments, it could provide information regarding wear characteristics and the techniques used by clinicians. In addition to critically examining the appliances received, it began to test various products. The resulting accomplishments will make the topic of another presentation.
___.Returning to the newsletter, at its tenth anniversary hundreds of accolades were received from orthodontists all over the world, including well-known luminaries. Some of these were published in its December 1997 issue.20 Several articles published in The Insider were reprinted in major journals everywhere, including the AJODO; a list of these can be found on the Internet.21
___.In time, being exposed to myriad attachments worldwide, Ortho-Cycle became a kind of Consumer Reports for what was in and what was out. The company’s toll-free number became all too often used for consultations, instead of for placing orders. As Claude traveled extensively and he couldn’t answer promptly: in time, these calls reached a manageable number.
___.The spread of recycling and the company’s success did not escape the attention of orthodontic manufacturers. Among these, GAC, in a letter to the editor of the AJODO, protested against an article on recycling written by Claude, portraying Ortho-Cycle as an “indirect, but very significant competitor”.22 Alarmed, the Orthodontic Manufacturers Association (OMA) induced NBC-TV in 1990 to air a Fight Back broadcast in which David Horowitz tried to scare the public away from using reconditioned attachments. Because his warnings came some 15 years too late, it had little impact, except that it convinced Claude to detail his process in the December 1990 issue of his Phoenix.
___.Aside from calumnies whispered by sales people, Unitek/3M’s lawyer, TJ DiPasquale, published on behalf of OMA and under the column “Litigation and legislation update,” an article against recycling,23 invoking the rules of the Food and Drug Administration (FDA). The points made were infection risks, functional reliability, physical qualities, liability, and economic and ethical issues. The article did not mention Ortho-Cycle as the company was already permitted by the Administration to market its devices.
___.Politically, OMA’s fight was justified as already many clinicians supported recycling: among these were Vlock24, Lew and Djeng,25 Mayhew and Kusy26, and Guess et al.27 The issue has caused another clinician to comment, in a letter to the editor, on DiPasquale’s article, showing that the lawyer was “wrapping the issue in legalese did not obscure his self-serving interest” and that in plain language, his contentions were “a red herring, obfuscating the real issue.”28
___.In 1996, Ormco/Sybron sued Ortho-Cycle on behalf of OMA, in a Los Angeles Federal Court for patent infringement, the defendant being culpable of reconstructing the manufacturer’s Diamond brackets. As it was obvious that the real reason was the defendant’s recycling, and the fact that no jury would condemn an activity without which we would be submerged under our own trash, the accuser, after attempting to drain the organization’s resources, withdrew its claims. In parallel, however, the OMA printed a brochure to be displayed in waiting rooms wherein patients were assured that the respective clinician did not use reconditioned attachments. An argument in both cases was a recent thesis from the University of Iowa, An in vitro comparative study of new and recycled orthodontic brackets. Its author, Dr. Todd Fisher, was also invited to participate in a “scare report” by NBC-TV, but he declined. Later on, after his thesis was used time and again by OMA’s members, he felt obliged to write Dr. Matasa that the information he provided was “watered down, omitted and in some cases misrepresented.”
___.The fight continued, as in a Dateline NBC TV report of 1998, a reputed clinician, Dr. D. Durbin of Lexington, KY, was summoned by the mother of a patient on whom he had used reconditioned brackets. Along with clips from his office, the report showed images from Ortho-Cycle Co., where a team of six had been previously invited to film whatever they could find useful for their report. The result was so biased that it prompted Dr. Durbin to claim that: “the ‘war’ inappropriately started and waged by Ormco and others is the lowest form of attack. I believe their offense is destined to be regretted greatly and that they, someday will wish they were a leader in environmentally conscious conservation of resources and should have initiated bracket recycling/sterilization themselves.” (Actually, another member of OMA, Lancer Orthodontics, had earlier tried (unsuccessfully!) to get into this activity which it considered an “environmentally conscious conservation of resources”
___.Asked to take a position on the NBC-TV broadcast, the American Association of Orthodontists (AAO) said that it “generated little consumer interest. The AAO received few calls from consumers following the broadcast.” In addition, AAO president Dr. Donald Poulton noted that “these brackets are safe and effective,29 i.e. the very words used by the FDA as justification for drug acceptance.
___.This position was actually a continuation of articles published in the AJODO. In one of these, Dr. Donald E. Machen, an orthodontist, lawyer, and judge, showed that “providing certain safeguards are incorporated into the recycling process, recycled brackets may be used” and that “no court cases had been found against recycling.”30 In another article, AAO counsel Sally Bowers showed that “neither the FDA rules, nor policy guidelines, nor other case laws specifically provide patients with the right of informed consent before the use of recycled brackets” and that “even if a bracket could become detached and the patient could swallow it. This will not result in an injury to the patient.”31
___.The above troubles and problems spurred Ortho-Cycle to rise above criticisms and get the best marks available. Adhesive dissolution was suitable because it protected the steel against sensitization while decontaminating the attachments at the same time. In contrast, the use of flash electro-polishing to shine the latter was debatable. On one hand, it gives steel added protection against corrosion, but on the other, it removes metal. While the bottom of the slot is too recessed to be affected, electro-polishing may thin tie-wings and power arms.
___.Faced with a similar problem, manufacturers have for decades used centrifugal, high-energy burnishing machines, which are basically Ferris wheels in which barrels perform complex, high-speed movements that allow the medium suspended in a surfactant solution to polish and harden the metal’s surface. Without losing metal, the attachments can be finished at a roughness less than 1m; the dimensional changes of up to 30m that take place are due to compression of the metal’s external layer. This phenomenon reduces crack initiation and propagation while rendering the part more resistant to corrosion and fatigue.32
___.Adopted by Ortho-Cycle in 2000, high-energy centrifugal burnishing revolutionized bracket reconditioning. Indeed, while this procedure allows powder-metallurgy (injection molding) manufactured brackets to become shiny, despite having had a rough and porous surface, in the case of used attachments; it had only to remove a thin oxide film. As a result, the dimensional changes achieved with the new process were less than one tenth that of adhesive charring and electro-polishing. Developing experts able to quickly distinguish brands and lines as well as identify prescriptions has taken years, considering that few orthodontists can identify the some 16 bracket shapes they use daily without using the distal markings. This significant accomplishment in quality, closely related to the integrity of the attachments, has prompted Ortho-Cycle to seek further recognition. A first step was to get several related certifications such as EN 46002 (1996), ISO 9001 (2000), and ISO 13485 (2003), The tough conditions required were the subject of an article.33
___.Ortho-Cycle’s ascent was continued with certification by the esteemed Scandinavian Institute of Dental Materials for a CE Mark, in accordance with the European Economic Community (Council Directive 93/42) for the production of medical devices for dentistry. The related face to face advertising and participation in meetings, as well as the many publications and conferences all over the world, have succeeded to expand Ortho-Cycle’s reputation, increasing its constituency.
___.When one compares new attachments with “Ortho-recycled” ones, he can find that the former are never sterilized or decontaminated, despite the fact that most are manually assembled in countries lacking high standards of sanitation. In addition, they are subjected only to a statistical inspection, common in an industry (only a small percentage of each batch is thoroughly inspected, the rest being deemed acceptable). In contrast, Ortho-Cycle subjects all its attachments to two decontaminations, one while removing the adhesive and the other, using autoclaves, just before shipment. Not spending on the manufacture the attachments, it dedicates a lot of time on their inspection, which is performed in five separate steps, process which often leads to the finding of major manufacturing errors.
___.The public, technological duel between manufacturers and Ortho-Cycle has continued beyond 2000 as it opposed the growing acceptance of medical recycling vs. the increased number of faulty attachments released by manufacturers. Dependent on manufacturers’ revenues, publishers have often accepted counter-responses invoking the now discredited “single use” claim, or the potential health problems associated with bracket reconditioning, unfortunately without offering Ortho-Cycle the opportunity for a rebuttal. Even when a counter-response does get accepted, the manufacturer is given the final word, or else the recycler’s rebuttal doesn’t show up in the journal’s Web site. Cases in point are articles published by CG Matasa both in France34 and Germany.35 This can easily mislead the reader, as it can be seen in the last duel where Dentaurum claimed that according to the laws, orthodontic brackets present a high risk.36 This is simply not true because, according to the FDA, metallic brackets are Class I, the least harmful class (high risks involves the use of catheters, angioplasty balloons, pacemakers, all Class III).
___.While it may be argued that patients do not normally have access to such information and that clinicians by now have had decades to make up their mind, such public debates are beneficial because they lead to less expensive and better, safer products. Always open to visitors, Ortho-Cycle Company has been and still is visited or even inspected by anybody desiring to understand what it’s doing and how it’s being done.
___.Started at a time when attachments were soldered on mesh or perforated bases by a handful of companies and “mini” or preadjusted brackets were just a dream, Ortho-Cycle’s offers, year after year, attachments less in demand to countries where orthodontics it’s still in the cradle.
___.Interestingly, Ortho-Cycle’s business suffers today by far less from the other recyclers’ competition than from the myriad of the new, poorly manufactured brackets that flood the market. A case in point is the answer to a question often raised: “Why the price of a reconditioned bracket offered by sale can be as high as that of a new one?” To this, the company simply answers that in the first case, “you are buying a fire-tested Cadillac instead of a Yugo” (inexpensive car offered by former Yugoslavia).
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