Infection control: What are proper protocols for reprocessing orthodontic instruments?
Charles John Palenik, MS, PhD, MBA, MPH; M. Gabrielle Thodas, DDS, MSD; and Eve Cuny, MS
Part I. Statement of the Problem
The Centers for Disease Control and Prevention (CDC) categorizes patient-care items as critical, semicritical, or noncritical based on the potential risk of infection during their use.1 The categories come from a classification system proposed by Earle H. Spaulding in 1968.2Essentially, critical items (eg, surgical instruments, needles, files, rasps, blades, burs, scalers) are defined as those that penetrate soft tissue, contact bone, or enter into or contact the bloodstream or other sterile tissue of the oral cavity. Semicritical items contact mucous membranes or nonintact skin but do not penetrate soft tissues, contact bone, or enter into or contact the bloodstream or other normally sterile tissue of the oral cavity; these include dental mouth mirrors, amalgam condensers, reusable dental impression trays, and dental handpieces. Lastly, noncritical items, such as radiograph heads/cones, blood pressure cuffs, lead x-ray aprons, stethoscopes, facebows, and pulse oximeters, are those that contact intact skin.1-3
Critical and semicritical items need to be cleaned and sterilized by heat between uses. Semicritical items that are heat-sensitive must at least be cleaned and treated with a high-level disinfectant, though handpieces should be heat-sterilized between uses. Noncritical items are to be cleaned and treated with a low-level disinfectant; but if blood is present, then an intermediate-level disinfectant is used.1,3A recent article from Italy discussed the handling of orthodontic instruments, supplies, and accessories.4 It specifically asked which items are critical, semicritical, and noncritical, and if reused, how should they be reprocessed?
Orthodontic practices often have busy daily patient schedules requiring significant (and rapid) turnover of critical and semicritical items. This involves proper instrument processing, including cleaning, packaging (singly or in cassettes), and heat sterilization. However, which semicritical items should be sterilized? And, which ones can be cleaned and disinfected between uses?
There are many nonsterile items that upon arrival are assorted into dispensing containers and sometimes undergo try-in (size determinations) selections on a patient cast or even chairside. Some items are dispensed from a spool or a common O-ring, such as heat-sensitive polyurethane chains and ligatures ties.
Dr. Thodas, an academic orthodontist, and Professor Cuny, a dental infection preventionist, will provide insight concerning classification of items used to treat orthodontic patients and which reprocessing methods are needed and most effective.
Part II. The Orthodontist's Perspective
Drs. Barenghi and Di Blasio's recent letter to the editor of the Journal of American Infection Control, "Orthodontic instruments and supplies: Are they semicritical or critical items?" is thought-provoking.4 Orthodontic practices and residency programs must carefully balance the demands of busy schedules involving multiple chairs, providers, and support staff with the proper management of clinically used orthodontic instruments, devices, and supplies.
The categories of patient-care items identified by the CDC based on the classification system proposed by Spaulding (as discussed above in Part I) seem quite clear. However, what seems clearly defined when reading an article or during a staff meeting can lose its clarity when personnel are pressured by the demands of a busy schedule and having to meet patient needs. Well-defined policies and procedures are required in which all providers are thoroughly trained and routinely monitored for compliance.
A number of factors must be considered when developing policies and procedures for the proper reprocessing of orthodontic instruments, devices, and supplies. These include manufacturers' recommendations, sterilization turnaround time, purchasing and inventory, dedicated cassettes for certain procedures (eg, arch-wire adjustments, band fittings, and cementation materials), the number of providers and patients, storage constraints, staffing available to provide the sterilization, ordering, other essential services, and regulatory requirements from the US Food and Drug Administration (FDA) regarding reprocessing of single-use devices (SUDs).5,6
It is generally agreed that orthodontic instruments and devices used in the delivery of patient care fall into the semicritical category.2 Items such as distal end cutters, hemostats, band removing pliers, and photography mirrors become contaminated during use in the mouth. Also, materials become contaminated chairside during arch-wire adjustments, appliance activation, and fitting of orthodontic bands through handling by operator gloved hands.
Information regarding handling and processing of these instruments is widely disseminated. Packaging and method of sterilization are among the decisions clinics need to make. Instruments can be packaged individually, but this can be inefficient and time-consuming and must take into account that hinged instruments should be sterilized with the hinges open. The use of cassettes allows proper handling of hinged instruments, the efficient use of sterilizers, and storage space and organization of instruments by procedure type. Several different types of sterilizers can be used.
So, what is the proper management of orthodontic supplies such as, brackets, bands, buttons, arch wires, coil springs, etc? Ideally, using these items as SUDs would resolve the problem. However, not all items are available as SUDs. Arch wires are packaged individually and some brackets are pre-pasted. Orthodontic bands can be placed in small-accessory cassettes for sterilization. Non-SUDs should be stored in a well-organized, clean area for dispensing in a controlled manner. Supplies such as coil springs, elastic chains, and ligatures can be pre-cut, while buttons and burs can be placed in paper pill cups and brought chairside with the unused portions discarded. Brackets needed for a particular procedure can be placed on disposable bracket pads and either brought directly chairside or stored in self-sealing sterilization pouches until the patient arrives. Unit-dosing of orthodontic supplies reduces the challenges of disinfection and the need for decontamination.
Part III. Criteria for Sterilization and Disinfection of Orthodontic Instruments and Materials
It is clear that most of the devices and instruments used in orthodontic treatment fall within the semicritical category, according to Spaulding's classification.2 Some instruments and devices may become contaminated during use, either through handling with a clinician's gloved hands or contact with orthodontic devices that have been in the patient's mouth and then manipulated or adjusted outside of the mouth. These items would include wire cutters, crimping pliers, and three-pronged pliers, among others. It is unlikely one would encounter critical instruments or devices in a nonsurgical orthodontic practice.
Most orthodontic practices are fast-paced, multiple-chair clinics with several qualified personnel performing various procedures. These personnel include orthodontists, dental assistants, registered dental assistants, and, in some states, registered dental assistants with specialty training and certification in orthodontics. Strategies to ensure proper management of used semicritical orthodontic instruments and devices may include ensuring adequate inventory; having dedicated sterilization staff to quickly clean, prepare, and process used items; organizing cassettes or packs with items needed for a specific procedure (eg, band placement, band removal, Invisalign®, etc); and using dynamic air removal steam autoclaves, which have a faster cycle time than gravity sterilizers due to more efficient removal of air to pressurize the sterilizer chamber. Dry-heat sterilizers may also be used, but they tend to have prolonged cycles and reach temperatures high enough to damage some items, such as dental handpieces.
Regardless of the method of sterilization, instruments should be packaged prior to sterilization and remain in their intact package during storage.1 Hinged orthodontic instruments should be arranged in the sterilization cassette or packaging with the hinges held open. This not only allows for more efficient drying, but also permits the sterilizing agent (steam or heat) to penetrate into those areas.
Previous articles have discussed the use of alternative methods and materials for the reprocessing of reusable orthodontic instruments and devices.4 The manufacturer's instructions for use should always be referenced when determining the method of reprocessing, though for some items, such as orthodontic separators, there may not be any reprocessing instruction. If the manufacturer does not provide instructions on how to reprocess an item it should be managed as a SUD, and there should be no attempt to reprocess the item through heat sterilization or chemical disinfection.
The FDA, which regulates medical (and dental) devices, issued a statement in 2000 regarding reprocessing of SUDs.5 The statement makes it clear that the FDA would consider any party reprocessing and reusing a SUD a manufacturer subject to the same regulatory requirements of the original manufacturer. This includes demonstrating to the FDA data showing the efficacy of the reprocessing method, using validation methods identified by the FDA. Devices used in orthodontic practices that the FDA specifically identified as SUDs in 2003 include dental burs, diamond burs, metal orthodontic brackets, and plastic orthodontic brackets.6
One way to manage items such as separators and brackets is to unit-dose only the amount needed for an individual patient and keep the dispenser or spool in a clean storage area. This will reduce the potential need to decontaminate items that have been in the clinic setting.
About the Authors
Charles John Palenik, MS, PhD, MBA, MPH
President and Chief Executive Officer, GC Infection Prevention and Control Consultants, Indianapolis, Indiana; Infection Prevention Writing Support
M. Gabrielle Thodas, DDS, MSD
Clinic Director, Assistant Clinical Professor, Department of Orthodontics, Arthur A. Dugoni School of Dentistry, University of the Pacific, San Franscico, California; Diplomate, American Board of Orthodontics
Eve Cuny, MS
Director, Environmental Health and Safety, Associate Professor, Diagnostic Sciences, Arthur A. Dugoni School of Dentistry, University of the Pacific, San Francisco, California
1. Kohn WG, Collins AS, Cleveland JL, et al. Guidelines for infection control in dental health-care settings—2003. MMWR Recomm Rep. 2003;52(RR-17):1-61.
2. Spaulding EH. Chemical disinfection of medical and surgical materials. In: Lawrence C, Block SS, eds. Disinfection, Sterilization, and Preservation. 4th ed. Philadelphia, PA: Lea & Febiger; 1968:517-531.
3. Miller CH. Instrument Processing. Categories of patient care items. In: Miller CH. Infection Control and Management of Hazardous Materials for the Dental Team. 6th ed. St. Louis, MO: Elsevier; 2018.
4. Barenghi L, Di Blasio A. Orthodontic instruments and supplies: are they semicritical or critical items? Am J Infect Control. 2017;45(2):210-211.
5. US Food and Drug Administration. Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals. August 14, 2000. https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm107172.pdf. Accessed March 8, 2018.
6. US Food and Drug Administration. Medical Devices; Reprocessed Single-Use Devices; Termination of Exemptions from Premarket Notification; Requirement for Submission of Validation Data. Fed Register. 2003;68(83):23139-23148.