Why Single Use of Endodontic Files Makes Sense For You and Your Patients

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John Shaw
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2 Why Single Use of Endodontic Files Makes Sense For You and Your Patients The cost of doing business increases every year. That fact is certainly not lost on dental practitioners, who are constantly seeking ways to reduce operating costs in their practice wherever they can. For many dentists who use rotary and hand endodontic files, this often involves trying to save money by stretching the life of the files to get the most uses from each instrument as possible. It s natural to look for every opportunity to keep costs down DENTSPLY Tulsa Dental Specialties works to make our quality instruments affordable for all practitioners for that very reason. However, research shows that multiple use of endodontic files actually raises serious issues of safety, liability and product viability issues that you as a concerned practitioner should consider. Yes, it s important to have a successful and profitable practice. Yet there are enough hazards involved with multiple use of one-time use files that it makes sense to consider all the research. Once you know the facts, you ll see that single use of endodontic files makes good sense economic and in every other way for your patients and for your dental practice.

3 Defining Single Use Issue 1 Safety What exactly does the term single use mean, and how does it affect your practice when it comes to endodontic files? First, the U.S. Medical Device User Fee and Modernization Act of 2002 mandates that all medical devices must be categorized as single use or reusable. To clarify the issue even further, the U.S. Air Force Dental Investigation Service publication, In Control, recently posed the question whether endodontic files should be considered single-use disposable items. The publication cited that although some devices may be used multiple times, it may often be safer, as well as more efficient and cost-effective to consider them single use. Maintaining rigorous safety methods is vital for the dental profession. That s exactly why it s so important to be clear on this point: no matter how well an instrument is sterilized, research shows that bacteria and tissue remnants remain on the instrument. Any additional use of these instruments, therefore, greatly increases the potential for cross-infection to every subsequent patient. There is substantial research and support concerning these safety and health issues, all of which build a strong case for single-use of endodontic files: Every patient is a potential carrier of infection. Virox Technologies Inc., an antimicrobial technology company based in Ontario, Canada, offers an Infection Control Protocol for dentistry and provides online continuing education for U.S. Air Force dental personnel. As in other areas of the healthcare industry where the philosophy already exists, Virox encourages dental practitioners to institute a Standard Precautions procedure that considers all patients to be infected with pathogenic organisms. For that reason, certain basic infection control procedures must be used during the care of all patients. According to the protocol, the only safe approach is to assume that every patient is a carrier. Decontamination methods for sterilizing instruments do not remove the risk of cross-infection to other patients. The HIV Dental Education Association, in the May 2001 edition of its Infectol newsletter, states that instruments such as reamers, files and certain burs are difficult to clean and cross-infection is a risk. Decontamination techniques used routinely in general dental practice cannot activate the infective protein responsible for transmitting such diseases as Variant Creutzfeldt-Jakob Disease. In her July 2002 Primary Dental Care article, Variant Creutzfeldt-Jakob Disease A Problem for General Dental Practitioners? Christine L. Whitworth wrote there have been more than 100 deaths recorded from variant Creutzfeldt-Jakob disease (vcjd). The incubation period for CJD may be up to 40 years and the number of asymptomatic carriers in the population could be as many as 100,000.

4 Confirmed iatrogenic transmission of other human transmissible spongiform encephalopathies raises the possibility of cross-infection from apparently healthy persons who are incubating vcjd. According to Whitworth, decontamination techniques routinely used in general dental practice are incapable of inactivating the infective protein responsible for transmitting the disease. The presence of PrP in circulating B-lymphocytes in patients with confirmed vcjd should be of concern to dentists undertaking surgical treatments, or even placing a matrix band subgingivally, states the article. Any instrument contaminated with the blood of such a patient may carry the risk of iatrogenic transmission. Those practitioners who carry out endodontic treatment, periodontal or implant surgery have the additional concern that PrP may be present in the dental pulp and gingival tissues of patients with vcjd. Sterilization against some infectious agents is not 100 percent effective. Moreover, only a small percentage of dental practitioners even possess the equipment needed to sterilize endodontic files for possible re-use. The decontamination technique recommended for inactivation of PrP-infected instruments by the Spongiform Encephalopathy Advisory Committee (SEAC) is 18 minutes or six consecutive three-minute cycles at 134 degrees in a vacuum autoclave with the caveat that this method does not completely inactivate the infective agent. A study of decontamination methods used in general dental practice found that only three percent of dentists surveyed possessed a vacuum autoclave. Some abnormal prion proteins responsible for diseases are resistant to sterilization efforts. Furthermore, autoclaving the instruments can actually stabilize the proteins on the metal. A symposium on Transmissible Spongiform Encephalopathies (TSEs) and their implication for dental practice generated lively debate at the September 2002 Pan European Festival of Oral Science, an inaugural meeting of the Pan European Federation of the International Dental Association. Professor Collinge, of the Prion Disease Group at UCL/Middlesex Hospital, told the audience that the abnormal prions causing vcjd and TSEs are an insoluble, detergent and protease resistant form of a normal protein that occurs naturally in the body. He described experiments designed to simulate transmission on surgical instruments. In five to 30 minutes of contact time with a mouse brain, vcjd prion-contaminated stainless-steel wires, which had been washed and sterilized, could transmit vcjd as efficiently as an injection of a vcjd infected brain homogenate. Adherent prion proteins that have not been removed from the wire by cleaning and sterilizing, act as a template to stimulate further prion protein propagation. In the stainless-steel experiments, autoclaving actually stabilized the prion protein to the metal. Endodontic files and restorative matrix bands can harbor proteinaceous material in crevices that are impossible to access. Dr. Andrew Smith, at the University of Glasgow Dental School, further highlighted the importance of not reusing single- use metal items. Endodontic files and matrix bands, he said, could harbor proteinaceous material due to the micro and macro crevices on the surface. These crevices are impossible to access and clean with detergent.

Issue 2 - Multiple Use = Reduced Cutting Efficiency Further research has shown that using endodontic files in multiple cases actually reduced their cutting efficiency.

These operational issues involve: With each use of a file, cutting efficiency is reduced.

All files evaluated rapidly deteriorated during the machining of dentin. This decline in efficiency was significant but different within, as well as among, brands.

5 Issue 2 - Multiple Use = Reduced Cutting Efficiency Further research has shown that using endodontic files in multiple cases actually reduced their cutting efficiency. Ultimately, this reduces operating efficiencies in a dental practice and affects patient satisfaction and your practice s bottom line. These operational issues involve: With each use of a file, cutting efficiency is reduced. A study that appeared in the September 1995 Journal of Endodontics (JOE) evaluated the performance of seven different brands and types of files on human dentin. All files evaluated rapidly deteriorated during the machining of dentin. This decline in efficiency was significant but different within, as well as among, brands. The authors suggested that the endodontic files be disposable. All stainless steel files are prone to dulling when machining dentin. In an article titled Stainless Steel Endodontic Files Should be Disposable, published in Practical Endodontics in August 1995, the authors stated that all files wear with use. The study tested ten of the following files and brands: K-File (Maillefer), K-File (Sjodings), H-File (Maillefer), H-File (Sjodings), S-File (Sjodings), Flex-R (Union Broach), and K-Flex (Kerr). All evaluated files deteriorated rapidly when machining dentin. Repeated sterilization of rotary nickel-titanium files decreases cutting efficiency. A 1999 study published in Oral Surgery, Oral Medicine and Oral Pathology investigated the cutting ability of 36 ProFile rotary nickel-titanium instruments. The results showed that repeated sterilizations of these endodontic files showed a decrease in cutting efficiency and caused an alteration of the instruments superficial structure. Before Use After Three Uses After One Use These photographs clearly illustrate the differences in the condition of a popular nickel titanium rotary file before use, after one use and after three uses. The file was used according to manufacturer's directions in extracted teeth: multi-rooted molars with moderate curvature. (SEMs - 200x magnification, 6/06.) Use of sharp instruments is more cost effective, increases patient comfort and reduces operator fatigue. Authors of a study in 1995 that appeared in Practical Endodontics proposed that from a cost-effective point of view, all endodontic files should be considered disposable after one use because it is nearly impossible to institute a positive system in a dental office to ensure that files are optimally efficient if reused. In addition, the study proposed sharp instruments should always be used for root canal preparation to optimize cost effectiveness, increase patient comfort, and reduce operator fatigue. Repeated reprocessing of some endodontic files can lead to breakage during patient treatment. According to the U.S. Air Force Dental Investigation Service: Due to the physical construction of some devices cleaning tooth and tissue debris from the device safely and efficiently may also be difficult...after repeated reprocessing cycles, alteration of some types of endodontic files occurs, potentially leading to breakage during patient treatment. If you aren t already using single-use products, the above factors coupled with the knowledge that burs and endodontic instruments exhibit signs of wear during normal use may make the decision to consider them single-use more practical.

6 One Patient, One Use DENTSPLY International, Inc., is a leading developer and manufacturer of endodontic files for the dental industry. Because we distribute these products in more than 120 countries, we are advocating a global policy of one patient, one use for partners around the world who use our endodontic files. Therefore, it all comes down to taking care of your patients and your practice. There are too many reasons why you shouldn t re-use single-use endodontic files and too many risks if you do. This important issue can be viewed from two perspectives. On the one hand, if you use endodontic files only once, you will go through many more files than you do now, which may impact your practice economically in the short run. However, if you use the file only once, you will be: Ensuring the safety of your patients; Protecting yourself and your practice from future liability; Reducing your time performing procedures; Improving cutting efficiency with new files; Reducing the risk of instrument breakage; Reducing time required to clean, bag and sterilize instruments; and Minimizing or negating inadvertent accidents to dental assistants during the cleaning and handling of contaminated instruments. In actuality, this choice is the most reasonable and cost-effective in the long run for all concerned.

7 DENTSPLY Tulsa Dental Specialties DENTSPLY International, Inc E. Skelly Drive, Suite 300 Tulsa, OK (fax) BRSFU 10/06B

SINGLE USE MEDICAL DEVICES POLICY

SINGLE USE MEDICAL DEVICES POLICY First Issued by/date BWW /BKW March 2001 Issue Version Purpose of Issue/Description of Change Planned Review Date 2 Update May 2011 Named Responsible Officer:- Approved