

A case for single use
By JT Walker, C Budge, M Vassey, JM Sutton, ND Raven, PD Marsh, P Bennett
This article considers the evidence underpinning the UK Health Department’s guidance that root canal instruments must be treated as single use as a precaution to reduce any risk of variant Creutzfeldt-Jakob disease (vCJD) transmission.
Summary
Some instruments such as endodontic files are inherently difficult to clean and may come into contact with peripheral nerves known to carry vCJD. Hence, the provision of clear and unambiguous advice to dentists from the Department of Health in a communication Advice for dentists on re-use of endodontic instruments and variant Creutzfeldt-Jakob Disease (vCJD) will ensure that endodontic reamers and files are treated as single use to further reduce any risk of vCJD transmission through dentistry.
by Archie Morrison, DDS, MS, FRCD(C), and Susan Conrod, DDS
Abstract
Purpose: The complex miniature architecture of dental burs and endodontic files makes precleaning and sterilization difficult. Devising a sterilization protocol for endodontic files and dental burs requires care, and some have suggested that these instruments be considered single-use devices. One purpose of this study was to determine the effectiveness of various sterilization techniques currently used in dentistry for the resterilization of dental burs and endodontic files. The second aim was to determine whether new dental burs and endodontic files, as supplied in packages from the manufacturer, are sterile.
Materials and Methods: The sterility of new (unused) and used dental burs and endodontic files before and after various sterilization procedures was analyzed. New burs and files were tested immediately after removal from manufacturers' packaging, with or without prior sterilization. Burs and files that had been used in various dental offices were precleaned, packaged, resterilized and then tested for various pathogens. Each item was individually removed from the sterilization packaging, transferred by sterile technique into Todd-Hewitt broth, incubated at 37°C for 72 hours and observed for bacterial growth.
Results: Sterilization procedures were 100% effective for unused burs and unused files but were less than 100% effective for all other test groups. Contamination rates following sterilization ranged from 15% for one group of used burs (p = 0.01) to 58% for one group of used files (p < 0.001).
Conclusions: Dental burs and endodontic files, as packaged by the manufacturer, are not sterile and should therefore be sterilized before first use. The resterilization procedures tested here were not adequate, and more rigorous sterilization procedures are needed. If such procedures cannot be devised, these instruments should perhaps be considered single-use devices.
By Nicholas J.V. Hogg, MSc, DDS, and Archibald D. Morrison, DDS, MSc, FRCD(C)
Abstract
Objective: The transmission of pathogens from one patient to another via contaminated devices has been a high- profile issue in infection control. Although single-use devices have been promoted as a preventative strategy, resterilization of instruments has been a common practice in dentistry. The purpose of this study was to investigate the rate of bacterial contamination of instruments resterilized for use in oral and maxillofacial procedures in a hospital-based clinic.
Methods: The experiment was a prospective randomized controlled study. The test group consisted of burs that had been used in surgical procedures. These burs were grossly debrided before being cleaned and gas sterilized in the central sterilizing department of the hospital. The burs were transferred in a sterile fashion into a culture medium selected to grow oral bacteria. The control group comprised new unused instruments treated in an identical fashion before culturing. All burs were incubated and monitored daily for 72 h.
Results: The rate of bacterial contamination in the test groups was significantly higher than in the control group (p < 0.05).
Conclusions: Reuse of instruments can be cost-effective if the safety of patients can be assured; however, there is increasing evidence that the sterilization process may not be completely effective. Consideration should be given to the classification of certain types of dental burs as single-use devices if sterilization cannot be guaranteed.
MeSH Key Words: cross infection/prevention & control; dental instruments; disinfection methods; equipment reuse
Sterilization of instruments ensures that they are free of “all microbial life including microbial spores which1 are the most difficult of micro-organisms to kill.” If the sterilization process is effective in killing bacterial spores, it will also be effective against mycobacteria and all viruses, including herpes simplex virus, hepatitis and HIV.1
Resterilization is “the repeated application of a terminal process designed to remove or destroy all viable forms of microbial life, including bacterial spores, to an acceptable sterility assurance level.”2 Resterilization of instruments used on one patient for reuse on another has been common practice in dentistry and oral and maxillofacial surgery. Some instruments used in oral and maxillofacial and orthopedic procedures, such as bone drills and saws, are Class I instruments as defined by the United States’ Food and Drug Administration and can be reused if sterility can be guaranteed.3 However, there is now evidence that the sterilization process is complex and that if strict adherence to an effective protocol is not followed, contamination of instruments may result.
In the past decade, single-use devices (SUDs) have been promoted in many dental and medical practices as a strategy to prevent the transmission of blood- and tissue- borne pathogens from patient to patient. This practice has also been influenced by high-profile legal cases that have brought the issue of SUDs to the attention of the media and the public.4 For example, in Toronto in 2002, a case involving a patient who contracted the hepatitis B virus via contaminated electroencephalogram electrodes resulted in a $27.5-million settlement against the neurologist and hospital.4 SUDs are convenient and their use has become widespread in hospitals around the world. However, the use of disposable instruments does not come without a significant cost to the health care system as well as environmental concern.5
Why are endodontic instruments re-used? In a nutshell... to save costs. Material costs are indeed reduced by re-using endodontic instruments. If, however, the costs for single use instruments are compared to the additional costs arising from re-use, such as costs for instrument reprocessing, sterile storage and keeping proper records, the anticipated saving shrinks to a minimum that bears no relation to the possible drawbacks of multiple instrument use.
Current discussions are focussing more and more on the topic of multiple-use. Looking at the mandatory quality management and the extended infection control requirements for dental practices, it can be assumed that this subject will gain even more importance in the near future and that the re-use of endodontic instruments will be questioned even more critically.
The aim of this brochure is to discuss the pros and cons of instrument re-processing and re-use and to help the dentist in making a decision. This brochure is based on German and European statutory and formal requirements for infection control and quality management in a dental practice.
Implications and Consequences of Reuse
by the Department of Health
This publication draws attention to the hazards and risks associated with reprocessing and reusing single-use medical devices. It covers the legal issues and regulatory requirements of such actions. It also considers the implications of damage to the materials or construction of the device and inadequate decontamination procedures.
RESEARCH SUMMARY
A comparison of decontamination methods used for dental burs
by C. L. Whitworth, M. V. Martin, M. Gallagher and H. V. Worthington Br Dent J 2004; 197: 635-640
Objectives
This study investigated the bacterial and fungal contamination of used dental burs. A novel assay system for comparison of efficacy of pre-sterilization cleaning techniques for dental burs was used to evaluate manual scrubbing, enzymic agents and washer-disinfectors.
Methods
Thirty dental burs contaminated during cavity preparation were analysed for micro biological total viable counts and species of bacteria and fungi present. To simulate clinically contaminated burs, a culture of Streptococcus sanguis NCTC 7863 was used to inoculate unused dental burs, alone and combined with blood, saliva or a mixture of blood and saliva. Contaminated burs were subjected to six pre-sterilisation cleaning techniques and the log reduction in contamination achieved by each method was assessed.
Results
The microbial count from used dental burs ranged from 0 to 6.92x104 CFU ml-1. Many potentially pathogenic species were identified. The decontamination assay demonstrated that autoclaving alone was not sufficient to sterilize dental burs. Manual scrubbing in air was less efficacious than manual scrubbing under water (p<0.001). The most effective method of pre-sterilization cleaning for dental burs was a washer-disinfector.
Published in Dental Economics by Mary Govoni, CDA, RDA, RDH, MBA
Summary
Burs and diamonds can be particularly difficult to clean, therefore increasing the risk of cross-infection. Hand-scrubbing of these items may be the most effective means of removing debris; however, it poses a greater risk of spatter exposure or puncture injuries to the team members who are performing this function. And although burs should be heat-sterilized in packages, they are frequently placed in chemical sterilants and stored in large bur blocks in the treatment rooms that are not packaged, and therefore potentially recontaminated prior to use.
Not only does the reuse of single-use items pose a risk of cross-infection, it can decrease efficiency in terms of the time spent in cleaning and disinfecting these difficult-to-clean items and the time necessary for chemical sterilization. Using new disposables each time, such as disposable burs, can actually increase efficiency and possibly comfort for the patient. Since the burs are always sharp and can cut tooth surfaces more quickly than reusable burs, a procedure can be completed in a shorter time.
Microcopy
P.O. Box 2017
Kennesaw, Ga 30156-9017
P: 800.235.1863
F: 770.423.4996
011M (Ball) 25 Pack
QTY: 2
X
$97.00
011M (Ball) 25 Pack
QTY: 2
X
$97.00
Microcopy respects the privacy of our customers and pledges to not sell or give out your email address or login information to any 3rd party. You will receive occasional emails from Microcopy alerting you to new products, or related company information.
You can elect to not receive these messages at any time by clicking the Unsubscribe link within the email. Be sure to use a valid email address when you register/sign in so that you can reset your password or, if need be, cancel your account, at any time.
STANDARD TERMS AND CONDITIONS OF SALE
SPECIAL EXPORT TERMS AND CONDITIONS OF SALE
RETURNS POLICY
Microcopy will accept returns from US and Canada direct customers once an approved Return Authorization number has been recorded. All returns older than 1 year will require a 15% restocking charge. No returns will be accepted after 3 years from original ship date. All shipment of goods outside of the continental US is final.
REMOVE
0110M (1)
Medium Grit
25/PK
$48.50
Reference F/G | 801-018 |
Head Diameter | 1.8 mm |
Head Length | 1.6 mm |
Overall Length | 19.2 mm |
Reference F/G
801-018
Head Diameter
1.8 mm
Head Length
1.6 mm
Overall Length
19.2 mm
No other grits offered for this shape
REMOVE
0112M (2)
Medium Grit
25/PK
$48.50
Reference F/G | 801-018 |
Head Diameter | 1.8 mm |
Head Length | 1.6 mm |
Overall Length | 19.2 mm |
Reference F/G
801-018
Head Diameter
1.8 mm
Head Length
1.6 mm
Overall Length
19.2 mm
No other grits offered for this shape
REMOVE
0116C (4)
Coarse Grit
25/PK
$48.50
Reference F/G | 801-018 |
Head Diameter | 1.8 mm |
Head Length | 1.6 mm |
Overall Length | 19.2 mm |
Reference F/G
801-018
Head Diameter
1.8 mm
Head Length
1.6 mm
Overall Length
19.2 mm
Medium (0116M)
Bridge/Operative
Ball
Beveled Cylinder
Dbl Inverted Cone
Egg
End Cutter
Flame
Flat End Cylinder
Flat End Taper
Mod. Flat End Cylinder
Interproximal
Football
Gross Reduction
Inverted Cone
Mod. Bevedled Cylinder
Mod. Flat End Taper
Occlusal Reduction
Pear
Occlusal Reduction
Depth Cutter
Endo
End Cutting
Finishing
Guide-Pin
NeoSpiral
0110M (1)
Medium Grit
25/pk
$48.50
3120 Moon Station Rd, NW | Kennesaw, GA 30144 | 800.235.1863
Dear Customer,
Sometimes the smallest gesture can have the biggest impact. Let me explain. Given the current weariness of everyone during this unprecedented time, it’s more important than ever for us as dental professionals to help the community feel safe and comfortable about coming back to dental offices. We know everyone is anxious and we should be doing anything and everything we can to remove that anxiety. The thing at the forefront of everyone’s mind is infection control and cleanliness. As the market leader of SPU (single-patient-use) burs, we firmly believe that one way you can reduce your patients’ fears about cleanliness is by using a fresh bur for every procedure. It’s been proven time and time again that multi-use burs cannot be sterilized 100% of the time. Ease your patients’ minds by showing them the sterile packet and opening the bur in front of them. This shows that you’re using sterile products, but more importantly it shows them that you care—it shows your dedication to them and their health, and that you are doing your part in easing their minds during this time. It’s a small gesture, but it will make a big impact. We have started a new campaign titled SPU4U. Educating the patient that you and your practice are single-patient-use for THEM.
You got this.
Paul Tucker
CEO | Microcopy
CAUTION:
Rx Only. These instructions, in whole or in part, are not a substitute for formal training in diamond dental burs. Appropriate professional education is STRONGLY RECOMMENDED prior to using this device clinically.
DESCRIPTION:
Microcopy NeoDiamond burs are manufactured from a single piece of high-quality stainless steel plated at the operational end with a natural diamond grit. The diamond burs are further plated with a unique protective coating formula. The range includes patterns designed to meet the needs of all surgery and laboratory applications. The burs are packed in a plastic pouch in a dedicated cleanroom facility and terminally sterilized using Gamma Irradiation. These burs are identified as sterile single-use devices and NOT be re-processed and/or re-used.
INDICATIONS
Microcopy NeoDiamond diamond burs can be used to cut a wide variety of materials encountered in dentistry. These include tooth material such as enamel, dentin and bone, dental materials such as amalgam, composite, glass-ionomer cements, polymer and ceramics and precious and non-precious alloys.
CONTRAINDICATIONS TO USE
Use of Microcopy NeoDiamond is contraindicated on any patient who is allergic to any of the components of the product. Do not reuse. Microcopy NeoDiamond are single-use. Attempts to reuse these products will adversely affect their performance.
CLINICAL PRECAUTIONS AND WARNINGS:
Instrument head diameter 01/10 (mm) - ISO |
Maximum permissible speed (RPM) |
Recommended operational speed (RPM) |
007 - 010 | 450,000 | 100,000 - 220,000 |
011 - 014 | 450,000 | 70,000 - 220,000 |
015 - 018 | 450,000 | 55,000 - 160,000 |
019 - 023 | 300,000 | 40,000 - 120,000 |
024 - 027 | 160,000 | 35,000 - 110,000 |
028 - 031 | 140,000 | 30,000 - 95,000 |
032 - 040 | 95,000 | 25,000 - 75,000 |
041 - 054 | 95,000 | 15,000 - 60,000 |
055 - 070 | 60,000 | 12,000 - 40,000 |
080 - 100 | 45,000 | 10,000 - 20,000 |
CLINICAL USE:
Microcopy NeoDiamond burs can be used to cut a wide variety of materials encountered in dentistry. These include tooth material such as enamel and dentin, dental materials such as composite, glass-ionomer cements, polymer and ceramic and precious and non-precious alloys. Our range of diamond burs provide maximum cutting efficiency and effortless access through tough diamond for both endodontic treatment and crown removal.
Holding the bur in the pouch by the operative end, push the stem end through the plastic far enough to insert into the handpiece collet. Immediately insert the stem into the handpiece collet and tighten before releasing the grip on the operative end and discarding the empty pouch.
STORAGE (PRE-USE):
Store in a dry and clean environment at ambient temperature.
Protect instruments in general against chemicals, acids, heat and extreme temperature variations.
STERILE PRODUCT SHELF LIFE:
TRACEABILITY:
Each package includes Lot number on its label.
This number must be quoted in any correspondence regarding the product.
APPLICABLE SYMBOLS:
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Manufacturer | Indicates the medical device manufacturer. |
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Do not reuse | Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure. |
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Do not resterilize | Indicates a medical device that is not to be re-sterilized. |
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Sterilized using irradiation | Indicates a medical device that has been sterilized using irradiation. |
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Batch Code | Indicates the manufacturer's batch code so that the batch or lot can be identified. |
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Consult instructions for use | Indicates the need for the user to consult the instructions for use. |
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Use by date | Indicates the date after which the medical device is not to be used. |
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Do not use if package is damaged | Indicates a medical device that should not be used if the package has been damaged or opened. |
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CE marking | Indicates European Conformity Mark. |
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Authorized European representative | Indicates the Authorized representative in the European Community. |
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Keep Dry | Indicates a medical device that needs to be protected from moisture. |
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DEVICE for professional use only |
(ref US FDA CDRH) Indicates device shall only be used by a trained professional. |
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Medical Device | Indicates device is designed and intended for medical use. |
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Catalog Number | Indicates the manufacturer's catalog number so that the medical device can be identified. |
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Single Patient – Multiple Use | Indicates a medical device that may be used multiple times in a single operation. |
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Max speed | Indicates Max speed |
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Wear eye protection | Indicates that eye protection must be used. |
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Wear a mask | Indicates that a face mask must be worn. |
CONTACT INFORMATION:
![]() |
Microcopy Dental |
![]() |
Obelis S.A |
![]() |
0483 |
This section is deivided into 2 sections to allow a quick and practical access to the Instructions For Use (IFU) of Microcopy products. Upon request you can contact Microcopy to order a free of charge copy of any IFU. More details below.
1. Current Valid IFU
NEODIAMOND
IFU for NeoDiamond
Upon request, you can contact Microcopy to order a free of charge copy of any IFU. Timetable of receiving the IFU: by Email - 2 working days, by mail - 7 working days.
If you would like to conact our webmaster for any comments or suggestions, please feel free to do so at This email address is being protected from spambots. You need JavaScript enabled to view it..
CAUTION:
Rx Only. These instructions, in whole or in part, are not a substitute for formal training in carbide dental burs. Appropriate professional education is STRONGLY RECOMMENDED prior to using this device clinically.
DESCRIPTION:
Microcopy NeoBurr tungsten carbide burs are manufactured from either a single piece tungsten carbide or, from a tungsten carbide tip, brazed to a surgical grade stainless steel stem. The range includes patterns designed to meet the needs of all surgery and laboratory applications. The burs are packed in a plastic pouch in a dedicated cleanroom facility and terminally sterilized using Gamma Irradiation by a contract sterilizer. These burs are identified as single-use devices and should NOT be re-processed and/or re-used.
INDICATIONS:
Microcopy NeoBurr tungsten carbide burs can be used to cut or finish a wide variety of materials encountered in dentistry. These include tooth material such as enamel, dentin and bone, dental materials such as amalgam, composite, glass-ionomer cements, polymer and ceramic and precious and non-precious alloys.
CONTRAINDICATIONS TO USE:
Use of Microcopy NeoBurr is contraindicated on any patient who is allergic to any of the components of the product.
Do not reuse. Microcopy NeoBurr are single-use. Attempts to reuse these products will adversely affect their performance.
CLINICAL PRECAUTIONS AND WARNINGS:
Instrument head diameter |
Maximum permissible speed |
Recommended operational speed (RPM) |
007 - 010 | 450,000 | 100,000 - 220,000 |
011 - 014 | 450,000 | 70,000 - 220,000 |
015 - 018 | 450,000 | 55,000 - 160,000 |
019 - 023 | 300,000 | 40,000 - 120,000 |
024 - 027 | 160,000 | 35,000 - 110,000 |
028 - 031 | 140,000 | 30,000 - 95,000 |
032 - 040 | 120,000 | 25,000 - 75,000 |
041 - 054 |
95,000 | 15,000 - 60,000 |
055 - 070 | 60,000 | 12,000 - 40,000 |
041 - 054 | 45,000 | 10,000 - 20,000 |
CLINICAL USE:
Microcopy’s tungsten carbide burs can be used to cut or finish a wide variety of materials encountered in dentistry. These include tooth material such as enamel, dentin and bone, dental materials such as amalgam, composite, glass-ionomer cements, polymer and ceramic veneers and precious and non-precious alloys. The bur pattern will be selected to cut a specific material in a specific application.
Holding the bur in the pouch by the operative end, push the stem end through the plastic far enough to insert into the hand piece collet. Immediately insert the stem into the handpiece collet and tighten before releasing the grip on the operative end and discarding the empty pouch.
STORAGE:
In dry conditions and protected against contaminants. Protect instruments, in general, against chemicals, acids, heat and extreme temperature variations.
STERILE PRODUCT SHELF LIFE:
TRACEABILITY:
Each package includes Lot number on its label.
This number must be quoted in any correspondence regarding the product.
APPLICABLE SYMBOLS:
![]() |
Manufacturer | Indicates the medical device manufacturer. |
![]() |
Do not reuse | Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure. |
![]() |
Do not resterilize | Indicates a medical device that is not to be re-sterilized. |
![]() |
Sterilized using irradiation | Indicates a medical device that has been sterilized using irradiation. |
![]() |
Lot Code | Indicates the manufacturer's batch code so that the batch or lot can be identified. |
![]() |
Consult instructions for use | Indicates the need for the user to consult the instructions for use. |
![]() |
Use By | Indicates the date after which the medical device is not to be used. |
![]() |
Do not use if package is open or damaged | Indicates a medical device that should not be used if the package has been damaged or opened. |
![]() |
CE marking | Signifies European technical conformity. |
![]() |
Authorized European representative | Indicates the Authorized representative in the European Community. |
CONTACT INFORMATION:
![]() |
Microcopy Dental |
![]() |
DENTEQ Medical Technologies |
![]() |
0483 |
This section is deivided into 2 sections to allow a quick and practical access to the Instructions For Use (IFU) of Microcopy products. Upon request you can contact Microcopy to order a free of charge copy of any IFU. More details below.
1. Current Valid IFU - section for current valid documents.
NEOBURR
IFU for NeoBurr
2. Archived (previous) IFU's - obsolete versions of the documents.
NEOBURR
IFU for NeoBurr
Upon request, you can contact Microcopy to order a free of charge copy of any IFU. Timetable of receiving the IFU: by Email - 2 working days, by mail - 7 working days.
If you would like to conact our webmaster for any comments or suggestions, please feel free to do so at This email address is being protected from spambots. You need JavaScript enabled to view it..