36C26319Q0469-004.docx

Infection Control Standards for VA Dental Clinics 21 October 2013 Revision History Log

10/2/2017 3/08/2017

1/12/2017 2/17/2016 10/27/2015

9/11/2015

Page 4: Introduction Page 16: Clean/Sterile Instrument Storage Page 18: Dental Supplies Page 19: Burs, Drills, Posts, Implant Comp.

Page 20: Diamond Coated Instrument Page 20: Endodontic Files, Reamers, etc Page 21: Dental Shade Guides Page 21: High Voumne Evacuation (HVE) Page 23: Devices on the Air/Water Lines.

Page 19: Burs, Drills, Posts, Implant Comp.

Page 37: Ultrasonic Denture Cleaning Equipment section.

Page 40: Service and Companion Animals section.

Office of Dentistry (OoD) Patricia E. Arola, DDS, MHA, FAGD, FACHE

Susan C. Bestgen, DDS Gregory M. Smith, DDS Michael A. Joseph, DDS, MSD Scott A. Trapp, DDS, MBA, MPH

IMPORTANT: Click here to see MORE revisions

CONTENTS

Introduction VA Dentistry held its first infection control seminar, chaired by former Chief of the San Diego Dental Service, Dr. George Carroll, in Los Angeles, California. A task force, led by Dr. Carroll, published the first VA Dental Services monograph on the topic, Infection Control, in 1987. Several revisions to this VA dental monograph have been published over the years. OSHA issued its 1991 Bloodborne Pathogens Standard (29 CFR Part 1910.1030) and its current standard precautions (formerly universal precautions) recommendations. The CDC published Guidelines for Infection Control in Dental Health-Care Settings – 2003, which serves as a comprehensive and important guideline. VA's reusable medical equipment directives, VHA Directive 2009-004, Use and Reprocessing of Reusable Medical Equipment (RME) in Veterans Health Administration Facilities, and VHA Directive 2009-031, Improving Safety in the Use of Reusable Medical Equipment through Standardization of Organizational Structure and Reprocessing Requirements, require medical/dental RME be reprocessed according to the manufacturer's instructions, and places many RME responsibilities under the Chief, SPS. The RME Directives further require all personnel involved in RME reprocessing be trained, with documentation of initial training, proficiency and annual competency. A basic tenet of infection control is that, other factors being equal, single patient-use, disposable products are preferable to reusable medical equipment.

The primary goal of any infection control program is to protect patients, health care workers and their families from transmissible diseases. Standard precautions, the foundation of infection control, means all patients are treated as if they have a transmissible bloodborne pathogen. Bloodborne pathogen Infection control protocols are defined by the patient's procedure, not by the patient's diagnosis.

Practitioners are reminded that, although HIV may have provided the impetus for today's infection control practices, there are other bloodborne pathogens more prevalent and more readily transmitted than HIV. Fortunately a vaccine exists for hepatitis B (HBV), and health care workers are encouraged to be vaccinated. Hepatitis C (HCV) is another concern, and at publication, a vaccine unfortunately does not exist. An important component of each VA facility's Exposure Control Plan is prompt post-exposure referral to Employee Health Services for evaluation and recommendations.

The following is adapted from prior VA Dentistry Infection Control monographs, and continues to be true today:

Limitations to achieving an ideal infection control program include ingrained habits, dental clinic space, and fiscal and staffing resources. Facility and equipment design as well as available services and supplies within each clinic may also create problems. Concern has been continually expressed by dental health care workers that the pressure to be productive precludes implementing extensive infection control programs because the time taken to accomplish these procedures would seriously diminish treatment time. Our answer to these concerns is that infection control procedures must be properly performed, and therefore, allotted adequate time. The safety of patients and dental health care providers must have priority over all other considerations.

Authors:

Bradley M. Kasson, DDS Infection Control Consultant, VA Office of Dentistry Chief, Dental Service Fargo VA Health Care System Fargo, North Dakota

Michael A. Joseph, DDS, MSD Infection Control Consultant, VA Office of Dentistry Chief, Dental Service Huntington VA Medical Center Huntington, West Virginia

Scott Trapp, DDS, MBA, MPH Infection Control Consultant, VA Office of Dentistry Chief, Dental Service St. Louis VA Health Care System St. Louis, Missouri Assistant Under Secretary for Health for Dentistry:

Patricia E. Arola, DDS, MHA, FAGD, FACHE Department of Veterans Affairs Washington, District of Columbia

Acknowledgement:

Thank you to those involved with the five versions of Infection Control for VA Dental Services. These five versions served as the groundwork for this current document. Thanks to John B. Tullner, DDS; George W. Carroll, DDS; Shannon E. Mills, DDS; Robert J. Whitacre, DDS, MS; Gayle W. DeBoom, DDS, Terry G. O'Toole, DDS, and Gregory G. Zeller, DDS, MS.

Thank you also to Dr. Susan Bestgen, Director of Operations and Dr. Gregory Smith from the VACO Office of Dentistry and to Ms. Teresa Wells, Director, Ms. Rosie Fardo, Deputy Director, and Ms. Sherri Bull, Health System Specialist, VA National Program Office for Sterile Processing.

Dental Infection Control Policy:

VA Dental Clinics differ from each other: a single VA dental infection control policy that fits all dental clinics is not realistic. Therefore each dental facility needs to create its own policy, based upon VA standards, including the standards in this document.

Local VA hospitals have addressed infection control and the OSHA Bloodborne Pathogens Standards in multiple local policies. Some ideas to consider:

VA Dental Services, when writing dental infection control policies, may wish to reference existing hospital policies rather than rewrite them in the dental infection control policy. The dental infection control document might use hyperlinks to existing hospital policies, such as Hand Hygiene, Exposure Control Plan, Vaccinations (including hepatitis B), Management of Environment Equipment and Supplies, Standard and Transmission Based Precautions, Biological Implants, Medication Management and Exposure Management, among others. Such linked references will keep the dental infection control policy current as the linked polices are updated. The dental policy can then address only items not specifically addressed in existing hospital policies. The dental infection control policy should be approved by the local Infection Control Committee.

Dental Services are advised that a process to evaluate engineered devices, as per the Needlestick Safety and Prevention Act, should be included in the infection control policy. This evaluation system seeks input from front-line providers regarding the efficacy and safety of such devices. A sample CDC evaluation form is included as part of the attached Sample Infection Control Document. (Attachment 4)

The USAF Dental Evaluation & Consultation Service (DECS) website routinely evaluates products, including infection control products and engineered safety devices. Evaluators are encouraged to review this resource for additional product information. http://www.afms.af.mil/decs/

Empowerment:

Dental Services are strongly encouraged to develop an empowered staff, such that any member of the dental team can and should challenge and correct any other member, without fear of intimidation or retaliation, when infection control breaches are noted. Although the dental service chief is ultimately responsible, maintaining proper infection control involves all team members working together. Each team member is expected to accept comments professionally and courteously.

Occupational Exposures:

Any dental staff member sustaining a percutaneous exposure, mucous membrane or eye exposure must report the injury to the supervisor and follow the post-exposure policy outlined in the local Exposure Control Plan. This should include seeking immediate consultation with Employee Health Services for examination and recommendations. Documentation of the incident in the employee's health record is required. The ASISTS electronic documentation program is used to complete forms, such as 2162, Report of Accident, and Form CA-1, Department of Labor Federal Employees Notice of Traumatic Injury and Claim for Continuation of Pay/Compensation.

Clinical Application of Infection Control VA is required to follow manufacturer’s reprocessing instructions. Some manufacturers have published instructions not compatible with VA protocol. For example, many dental equipment manufacturers have published instructions based upon desk-top gravity displacement autoclaves. These autoclaves are not used in VA, nor are they planned to be used. When selecting equipment and instruments, it is important to follow local protocol for RME purchase approval. Part of the approval process will be for SPS to evaluate reprocessing instructions. If the reprocessing instructions are found incompatible with VA requirements, the facility will avoid spending money on equipment it can’t use.

Dental clinics are encouraged, as much as possible, to gain consensus on equipment, instruments and supply inventories. Reduced inventories of similar equipment, instruments and supplies helps reduce costs, complexity, and the potential for errors.

Instrument (RME) Classification:

The Spaulding Classification System is widely recognized as a means to evaluate instrument reprocessing protocol. Although not every instrument fits neatly into one category, in general this classification serves as an excellent tool.

· Critical: Instruments which penetrate soft tissue or bone

· Reprocessing: heat sterilization

· Semi-Critical: Instruments which touch mucous membranes or non-intact skin

· Reprocessing: if heat tolerant, heat sterilization. If not heat tolerant, high level disinfection. (High level disinfectants should not to be performed in the dental service.)

· Non-Critical: Instruments which contact intact skin

· Reprocessing: disinfection. An EPA-registered hospital disinfectant (low level disinfectant) is the minimum standard. If the instrument is visibly contaminated with blood or other potentially infectious material (OPIM), an EPA-registered hospital disinfectant with a tuberculocidal claim (intermediate level disinfectant) is to be used. Dental Services are encouraged to default to an intermediate level disinfectant for use throughout the clinic, as the presence of blood or OPIM is likely. Any disinfectants used in the dental clinic should have local Infection Control Committee approval.

We are fortunate to practice in an environment surrounded with professional support staff. VA dental personnel can devote their time to clinical duties, while Sterile Processing Service (SPS) attends to reprocessing our semi-critical and critical devices. For contaminated instruments reprocessed by SPS, dental personnel's responsibilities are to remove gross bioburden and to deliver the instruments to the SPS pick-up location. Ideally that location is a Soiled Utility Room. That room is to have a Biohazard label at the entrance. Similarly, the instrument transport containers, used to get instruments from the dental service to SPS, are to be closable and are to have Biohazard labels.

Dental Services are advised to work closely with local SPS regarding contaminated instrument storage. If a soiled utility room is not available for the dental service, SPS will advise regarding other closed systems for contaminated instruments, such as a closed cart system.

Immunizations:

Practitioners are referred to local policy and Employee Health Services for information regarding immunizations, including the hepatitis B vaccination.

Hand Hygiene:

Practitioners are referred to VHA Directive 2011-007, Required Hand Hygiene Practices and to local policy regarding hand hygiene products and protocol. In general, alcohol hand rubs are an excellent choice when no soil is visible on the hands or when Clostridium difficile is not suspected. Soap and water are recommended if visible soil is present, or if Clostridium difficile is suspected. Hand hygiene should be accomplished immediately before donning gloves and again immediately after removing gloves. Hand hygiene should also be accomplished if changing gloves is needed mid-procedure. Hand hygiene should be accomplished before handling medication, before inserting or handling any invasive device for patient care (whether or not gloves are used), and after contact with inanimate surfaces and objects (including medical equipment) in the immediate vicinity of the patient. All health care workers who provide direct, hands-on care to patients should not wear artificial fingernails or extenders. Fingernails should be short and clean. Jewelry, if not prohibited by local policy, should not interfere with glove use. Nail polish is discouraged as chips can lead to bacterial harbors.

The hand rub dispenser should be in the dental operatory, readily accessible to staff.

Personal hand care products (lotions, hand rubs, etc.) should not be brought to the dental clinic. Appropriate hand care products should be provided by the hospital after approval of the appropriate committee(s), such as Commodities and Infection Control.

Work Area The use and wear of personal protective equipment is defined in the OSHA Bloodborne Pathogens Standard under 1910.1030(d)(3). This Standard further defines that all personal protective equipment shall be removed prior to leaving the work area. OSHA defines the term “work area” as the area where work involving exposure or potential exposure to blood or other potentially infectious materials exists, along with the potential contamination of surfaces. This definition may vary depending upon local dental service design. The dental service work area shall be defined locally to delineate the boundaries where a potential risk of occupational exposure exists. These boundaries define the work area and when personal protective equipment is to be removed in accordance with the OSHA Bloodborne Pathogens Standard 1910.1030(d)(3)(vii). It shall be the responsibility of the Chief of the Dental Service to define the clinical and administrative “work areas” in consultation with VISN Lead Dentist, local environment health, infection prevention specialist and sterile processing service. The Association for the Advancement of Medical Instrumentation (AAMI) ANSI/AAMI Standard ST79 notes that work areas should be posted as restricted-access (including, but not limited to, access only to authorized personnel) because of the presence of infectious materials.

As noted in OSHA’s explanation of the final rule: it should also be understood that the decision not to use personal protective equipment is to be made on a case-by-case basis and in no way is to be generally applied to a particular work area or recurring task. Employees must exercise their professional judgment in making such a decision and should be aware that they may be asked to explain the reasons for their course of action. For example, OSHA believes that disregarding the use of personal protective equipment because there is concern that the appropriate personal protective equipment may be alarming to the patient or because the patient population is perceived to be "low risk" are not legitimate reasons.

Eating, Applying Make-Up, Handling Contact Lenses:

Food and drink are prohibited in areas where there is potential for occupational exposure to blood or saliva (i.e., clinical areas), radiography rooms, dental laboratories, and where clean medical/dental supplies and instruments are present. Ideally a VA Dental Clinic is arranged so that administrative space is clearly separate from clinical space.

Refrigerated food must be in separate refrigerators from refrigerated medications and medical/dental supplies, and not in areas described under no food or drink above.

Make-up is not to be applied and contact lenses are not to be handled in the same areas defined for no eating or drinking.

The Operatory:

The dental operatory should present a neat, uncluttered appearance. Everything within a 3-6 foot radius of the patient's face, when spatter/spray is being generated, will potentially become contaminated. This zone should have nothing within it not needed for the procedure, and nothing that can't be disinfected, discarded or readily cleaned. Dental supplies and equipment which are not needed for the procedure should be put in closed drawers or cabinets or be covered to protect from spatter, etc.

Operatory Upholstery:

Manufacturers upholster patient operatory chairs and staff operatory stools with various materials. Cloth upholstery is not appropriate, as it cannot be effectively cleaned. Leather upholstery may have cleaning instructions prohibiting disinfectants. Pleated or seamed upholstery can make cleaning difficult. Smooth upholstery which can be disinfected is preferable. If so desired by the dental service, manufacturers may be able to provide replacement upholstery for existing chairs.

Left: Leather, seamed upholstery. Disinfectant not recommended per manufacturer.

Right: Vinyl, smooth upholstery. Disinfectant recommended by manufacturer.

Operatory Set-Up:

In the operating room, a circulating nurse is available to provide needed supplies to the scrubbed team. Dental services with a float assistant can emulate the operating room model. This model is important for VA Dental Services – a "circulating" or float assistant who can retrieve additional needed items mid-procedure.

Room set-up requires careful thought regarding what will be needed. When the procedure has begun, retrieving additional items will require careful consideration regarding infection control. Items in drawers can't properly be removed with contaminated gloves. The assistant may wish to have additional gloves, such as food handler gloves, available to temporarily don over the contaminated gloves while retrieving items. Another option is to include an instrument for retrieval purposes in the set-up, such as a cotton forceps. The cotton forceps can be placed on a countertop away from the other instruments, keeping the working end clean while using it for retrieval. And, as mentioned in the previous paragraph, a circulating assistant is the best option.

Clinical Attire:

Personal Protective Equipment (PPE) is required for clinical procedures when exposure to blood or other potentially infectious material (OPIM) is likely to occur. PPE is addressed in following paragraphs. Any PPE requiring laundry services is the employer's responsibility – employees are not to launder PPE. The level of PPE required is dependent upon the procedure. For example, performing an oral examination does not require the same level of PPE as does an extraction. In the examination scenario, gloves, and perhaps mask and eyewear may suffice. Any procedure involving spray, splash and/or spatter requires gown, mask, gloves and eyewear.

Doctor "white lab coats" are not appropriate for PPE usage, as they are not fluid resistant and the wrist area does not close tightly. Your facility might require wearing such a coat over scrubs when leaving the clinical area.Not appropriate for PPE purposes

Scrubs:

Scrubs are an excellent option for clinical personnel to wear, and are defined as a uniform, not as PPE. Generally the local facility will provide scrubs for employees. If permitted locally, employees may also purchase, wear and launder their own scrubs.

Protective Personal Equipment (PPE):

OSHA states that PPE must not allow blood or saliva to pass through to clothing, skin, or mucous membranes. Each dental service chief should assure that staff is consistent regarding selection of PPE for any give procedure.

Dental personnel are referred to the local facility's policies regarding PPE, usually found in a Standard and Transmission Based Precautions document. Gloves and masks should not leave the dental treatment room. Depending upon local policy, the clinic layout and the procedure performed, a clean PPE gown might be permitted to be worn to another room. Although the CDC, in Guidelines for Infection Control in Dental Health-Care Settings – 2003, has defined "visible soil" as the standard to change gowns, using a high-speed handpiece with water coolant or using an ultrasonic scaler generates contaminated spatter that is not readily visible. Therefore performing such procedures would dictate the gown not be used for treating another patient, and that it be discarded (disposable gowns) or laundered (cloth gowns) after use on that patient. However, if only an examination is performed while wearing the gown, and the gown isn't otherwise contaminated, it should be permissible to wear that gown to another treatment room.

The clinic layout will impact a decision regarding gowns. For example, it would not be appropriate to wear a gown, even a clean gown, through a waiting room. Each facility should define a line beyond which PPE is not worn. Clinical PPE should not be worn into the dental lab, or into non-clinical areas such as private offices, the waiting room, scheduling office, break room, etc. Ideally the VA Dental Clinic can be configured so that clinical areas are separate from administrative areas.

The dental laboratory section of this document addresses non-clinical PPE in the dental laboratory.

Gowns:

Standards related to gowns are thoroughly defined by ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities and AAMI Technical Information Report AAMI TIR11:205 Selection and use of protective apparel and surgical drapes in health care facilities. Based upon these standards facilities should begin to ensure that gowns minimally conform to a ANSI/AAMI PB70 barrier performance level 1. If the facility provides reusable gowns these gowns should comply with ANSI/AAMI ST65 Processing of reusable Surgical textiles for use in health care facilities include methods for tracking the number of uses and reprocessing requirements. If dental services find the laundry service does not track the number of uses, then it is recommended to start exploring other options such as the exclusive use of disposable gowns.

Gowns are to be fluid resistant and extend from the base of the neck to below the knees. They are to be long sleeved with a secure fit at the wrists. Gloves are to cover the wrist area such that there is no exposed skin between the gloves and the gown. To comply with covering the base of the neck, front closure gowns should be closed to the neck. Disposable gowns are a viable option. Gowns should be replaced immediately if penetrated by blood or other potentially infectious material.

Snap front disposable gown. Ideally would have no pockets.

Front entry disposable gown

Gloves:

Gloves must always be worn when touching blood, saliva, or mucous membranes, and when touching blood-soiled items, body fluids or secretions, as well as surfaces contaminated with them. "If it's wet, don't touch it with your bare hands" serves as a useful guide. Change gloves immediately, with appropriate hand hygiene, if a glove becomes compromised during patient care.

Sterile gloves are to be worn by the surgical team for surgical procedures.

Hand hygiene is to be accomplished before donning gloves and immediately after removing gloves.

Clinical patient care gloves are not to be washed.

Heavy utility gloves may be worn for room cleaning and disinfection. These gloves may be disinfected and reused. These gloves are not to be used in direct patient care.

Double Gloving:

No studies to date indicate double gloving will impact the likelihood of seroconversion in the event of an exposure incident. However, there is less likelihood the operator will have contaminants on his/her hands at the completion of a procedure. If double gloving is elected, that decision should be based upon the procedure and the likelihood of glove tearing or perforation, rather than by the patient's diagnosis. Wearing different colored gloves for each layer will help identify when the outer glove has been breached.

Eyewear:

Protective eyewear must include lateral protection, such as side shields, and should be worn for any procedure likely to generate spray, spatter or splash, or if there is a risk of foreign bodies contacting the operator's eyes. Eyewear should be cleaned between patients as instructed by the eyewear manufacturer.

Patients should be given protective eyewear to use during procedures. Reusable patient eyewear should be disinfected between patients. Disposable, single patient-use eyewear for patients may be another option.

Masks:

Masks should be worn for any procedure likely to generate spray, spatter or splash. A face shield, while protecting the eyes, needs to be supplemented with a mask when spray, spatter or splash are generated, such as with a handpiece or ultrasonic scaler.

Masks are to be changed between patients. Masks are not to be worn outside the dental operatory.

Exception: See section on transporting contaminated instruments to the soiled area. It may be permissible under local policy to wear the mask to the soiled area.

It is inappropriate to have a mask, even a clean mask, dangling from the neck while outside the dental operatory.

Masks should be changed when wet. Consideration should be given to changing the mask after one hour usage, if practicable to do so.

Masks with attached plastic shields are an excellent choice, providing mask and eyewear PPE in one device.

Practitioners are referred to local policy regarding use of high filtration masks while attending to airborne precaution patients, such as patients with active tuberculosis. These masks must be fit tested and are reserved for special precaution situations. Dental care for patients with active tuberculosis is recommended to be limited to emergent care only. After the patient initiates antibiotic therapy, infectious disease can determine when the transmission risk has been managed.

Shoes, Hair Covers and Shoe Covers:

Practitioners are referred to local policy regarding shoes and wearing hair and shoe covers. Safety dictates that employees wear clinical shoes that protect the foot from falling sharps. Clinical shoes should therefore not have open toes or other openings through which falling sharps could readily enter or through which fluids could readily contact skin. Staff may opt to keep dedicated clinic shoes in the facility.

No reasonable expectation of splash, spray or spatter e.g., examination, removable prosthodontics

Reasonable expectation of splash, spray or spatter e.g., operative, fixed prosthodontics, endodontia, prophy

(Utility gloves optional) Recommended:

Required with spray Manufacturer may require for non-spray

Manufacturer may require Optional

Disinfectants:

Sterilant/High Level

Sterilant/High Level

Disinfectants are commonly referred to by the CDC terminology: low, intermediate, or high level. High level disinfectants are sterilants, and are not indicated for use within dental clinics. Any use of high level disinfectants is relegated to SPS. Intermediate level disinfectants (tuberculocidal claim) are recommended for dental clinic usage. There is no single disinfectant product that meets the needs for every situation, and dental clinics, in conjunction with local infection control and commodities committees, will determine which product(s) suit the need. No matter which disinfectant products are selected, it is important that dental personnel understand the manufacturer's instructions, including how to clean visible bioburden prior to disinfection, and contact time. Contact time refers to wet contact with the disinfectant. Disinfectants are entering the market with shorter contact times than earlier products, which increases compliance and maximizes efficiency. The disinfectant label will advise regarding what PPE is recommended during use: dental personnel should minimally don gloves and eyewear, and wear a mask if the disinfectant is sprayed. Full PPE (gowns, gloves, masks and eyewear) is encouraged.

Dental services are encouraged to use disinfectants pre-mixed (ready to use) from the manufacturer. These products will be labeled with expiration dates, instructions for use, including contact time and cleaning instructions, and the organisms against which the product is effective. If mixing disinfectants on station, the label should minimally include this information.

Dental Services are encouraged to use disinfectants that are cleaner/disinfectants. These products may be used to first clean an area of visible bioburden, then can be applied again as a disinfectant.

Timers should be used to determine the manufacturer's recommended disinfectant contact time has elapsed.

Clean/Sterile Instrument Storage:

Storage of sterilized reusable medical equipment (RME) is based upon the Association for the Advancement of Medical Instrumentation (AAMI) standard ANSI/AAMI ST79 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities and implemented in the VA through VHA Directive 1116(2) Sterile Processing Service March 23, 2016. ANSI/AAMI ST79 requires that RME is to be stored in a controlled environment that includes temperature, humidity monitoring along with air exchange requirements. VHA Directive 1116(2) defines the storage of RME in the dental service as satellite storage. “Satellite storage is a dedicated storage room for clean or sterile supplies. Satellite storage areas often include storage of critical and semi-critical RME. Areas such as exam room cabinets, crash carts, patient room supply cabinets (including point-of-use cabinets not located in a dedicated storage area), and nurse servers are not considered satellite storage unless in these areas items are stored for greater than 72 hours.” Ideally the dental service will have a centrally located room for sterile and clean instrument storage. Facilities are encouraged to pursue a central location in the dental clinic. Among the reasons for a centrally located storage area are, 1) inventory control, so that sterile items may be rotated (first in, first out) and, 2) temperature and humidity monitoring.

ANSI/AAMI ST79 and VHA Directive 1116(2) define the standards and the process for handling sterile but unused RME after removal from the dental service controlled environment satellite storage area. ANSI/AAMI ST79 states that unused items that previously have been packaged, sterilized, and issued to a controlled environment may be returned to the sterile storage area if the integrity of the packaging has not been compromised and there is no evidence of contamination; such items should be the first to be dispensed when needed. This will require that the area to which the RME is issued such as the dental treatment room be a controlled environment that meets the ANSI/AAMI ST79 standard if it is stored in the area for more than 72 hours as defined in the VHA Directive 1116(2). Local facilities should work with the RME and Infection Control Committees along with subject matter experts from SPS and dental service to develop local SOPs based upon the limitations and resources of the local facility to minimally meet these requirements.Event-related Shelf Life for RME Shelf life of packaged sterile instruments should be considered event-related. There is a moderate level of evidence that shows an event must occur to compromise package sterility. Events include multiple instances of handling that leads to a loss of package integrity, moisture penetration or exposure to airborne contaminants. Based upon published evidence the CDC Guideline for Infection Control in Dental Health Care Settings, the Association of perioperative Registered Nurses (AORN) Guidelines for Perioperative Practice and ANSI/AAMI ST79 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities recommend that the shelf life of packaged sterile items should be considered event-related.

If the RME is issued to an uncontrolled environment where temperature and humidity are not monitored the items are not to be returned to clean storage. The RME can be kept in the uncontrolled environment for up to 72 hours and at that time must be sent for reprocessing if not sooner.

Your local Infection Control Committee, RME Committee and SPS will be the resource for your facility's requirements. Should these monitors be out of range, local policy will dictate procedure to follow.

Although event related sterility is now standard VA SPS practice, sterile packs should be rotated on a first in, first out basis. A common practice is to store SPS's sterile items bookcase style. Dental staff draws from the right side of the stack – newly reprocessed packs are placed on the left side. (Note: the laminated shelving in the image is not the SPS preferred shelving material.)

Many prepackaged sterile expendables have manufacturer indicated expiration dates which must be followed.

Dental Supplies Various dental supplies used intraorally are packaged in a variety of methods. Some are provided in individual, single-use, presterilized packages such as dental burs and others are provided in bulk packaging such as matrix bands. It is recommended that the manufacturer’s instructions for use be reviewed prior to placing dental supplies into service to evaluate if disinfection or sterilization instructions are provided. Particular attention should be placed upon the language used by the manufacturer to see if disinfection or sterilization is required, recommended or optional.

When the manufacturer requires or recommends specific disinfection or sterilization for single patient use dental supplies, VA Dental Services should implement such processes in collaboration with SPS. In the event that disinfection or sterilization is optional for single patient use dental supplies a local decision should be reached in collaboration with inflection control and SPS based upon a risk assessment and resources.

Storing Equipment and Supplies Not Ready for Patient Use Inventories of equipment/items/supplies not ready to use on patients need to be stored separate from equipment/items/supplies ready for patient use. The equipment/items/supplies not ready for patient use are not to be stored in operatories. For example, inventories of non-sterile intra-oral cutting burs and non-sterile endodontic files are not to be stored in operatories. If such items/supplies are stored in the dental clinic, they must be stored in a manner that clearly demarcates them from sterile items/supplies. Some facility SPS departments have the capability to store these non-sterile inventories in SPS. This is a local decision.

Setting Up for Treatment: Clean vs. Sterile General dentistry procedures are not sterile procedures. Critical and semi-critical instruments are sterilized according to manufacturer's recommendations primarily to prevent cross contamination between patients. The patient must be treated with clean, appropriately reprocessed instruments. The intent, however, is not necessarily to introduce sterile instruments to the oral cavity – a significant difference from oral surgery. In general dentistry it is acceptable, while setting up, to touch the sterile pack's instruments with clean hands or clean gloves (do not need sterile gloves), understanding during the procedure many non-sterile items will be added – restorative materials, impression materials, etc. Contaminated instruments, of course, must be handled with gloved hands.

The intent with oral surgery is, as much as possible, to use sterile instruments on the patient. During instrument set-up, sterilized instruments should not be handled until sterile gloves have been donned. Room set-up also requires careful planning to prevent contacting non-sterile items after donning sterile gloves. For example, sterile 4x4 gauze may be used to adjust the light handle, being sure to keep the now non-sterile gauze off the sterile field after use. It is understood that oral surgery protocol will be the most careful we can perform, but will not duplicate sterile operating room conditions. Referencing the surgical wound classification system, even under the best of circumstances, oral surgery procedures are clean contaminated, which is defined as a non-traumatic surgical wound with minor break in sterile technique. The reader is referred (see Website References section of this monograph) to the Surgical Wound Classification chart for further information regarding this classification system.

Burs, Drills, Posts, Implant Components: (References to burs applies to drills in this document) Although some burs are marketed as multi-use, thoroughly cleaning them has been documented to be very difficult. Burs routinely come back from reprocessing with visible debris. Studies have been published calling for consideration of using single-use, sterile burs. In VA, all intra-oral burs are single patient-use, and intra-oral cutting burs (carbide burs, diamonds, for example) are to be sterile prior to use. Many manufacturers provide single use burs in sterile packaging. The option of single patient use, pre-sterilized burs is highly encouraged. Intra-oral cutting burs provided in non-sterile condition from the manufacturer are to be sterilized prior to use, according to the manufacturer's recommendations. A bur not marketed as single patient use may be reprocessed as long as the manufacturer states the bur can be reprocessed and the bur hasn't been used intra-orally. Once used intra-orally, all burs must be disposed.

Commonly used symbol for single use item

Non-carbide, non-diamond intra-oral polishing burs (rubber impregnated polishers, disposable polishing discs, for examples) do not need to be sterile prior to use unless so stated by the manufacturer, as a polishing bur is not a cutting instrument. The polishing bur, after intra-oral use, is to be discarded as a single patient-use bur. A polishing bur used extra-orally may be reprocessed if the manufacturer provides instructions.

Note: Multi-fluted finishing burs and finishing diamonds are to be sterile prior to use.

Implant drills are single patient-use drills, and are to be sterile prior to use.

Pin and post drills are single patient-use drills. Drills are to be sterile prior to use.

Pins, posts, and implant components such as abutments are to be sterile if so stated by the manufacturer.

Extra-oral clinical burs do not contact tissue. These extra-oral clinical burs, such as denture adjusting burs and polishing burs used chair side, shall be reprocessed according to CDC Guidelines by sterilization. Reprocessing and sterilization shall be completed according to the manufacturer’s instructions after each patient use.

Diamond Coated Instrument: (diamond burs addressed in preceding paragraph) Instruments with diamond coating, such as ultrasonic scaler tips, piezoelectric surgical tips and endodontic tips, present an evolving infection control topic. Some manufacturers of diamond coated instruments (Synthes, Piezosurgery®) state their diamond coated tips are to be sterile prior to use and they are single patient use – not to be reprocessed. Other manufacturers indicate their diamond coated tips can be reprocessed.

From Synthes, Inc. (orthopedic surgery equipment manufacturer):

"Warning

– Diamond burrs and cutting tools made of hard metal (carbide) cannot be reprocessed since diamond burrs cannot be cleaned properly, and the latter can break if used several times. They must therefore be discarded after each use."

From Piezoelectric®:

"WARNING Diamond coated inserts are SINGLE PATIENT USE ONLY. The diamond coated inserts are intended to be used on an individual patient during a single surgical procedure and then discarded. The diamond coated inserts must be sterilized only one time, prior to first use."

Due to the above concerns, SPS will not reprocess diamond coated instruments, including diamond coated ultrasonic scaler inserts. These devices, if used, are to be sterile prior to use, single patient-use, disposable items.

Note: Diamond burs are covered in the Burs, Drills, Posts, Implant Components section of this document.

Endodontic Files, Reamers, etc.

Endodontic files, reamers, broaches, and Gates-Glidden burs are to be sterile prior to use, preferably pre-sterilized from the manufacturer. They are single patient-use devices if contaminated during the procedure. These items may be reprocessed if, 1) they are not deemed single use by the manufacturer, and 2) they did not become contaminated during the procedure. Contamination occurs anytime the devices are used intra-orally, touched by contaminated gloves, or exposed to spray, spatter, or splash.

Custom designed autoclavable endodontia file containers. (Dime for perspective only)

The "Bead Sterilizer" is not an acceptable device for VA Dentistry application.

Dental Shade Guides The Spaulding Classification places instruments into three categories based upon the usage and contact with the body according to the level of risk as previously mentioned within this standard. Certain items such as shade guides may be classified based upon use.

For example if the shade guide is used intraorally and may come in contact with mucosal tissues the item would be classified as semicritical and will require sterilization. If sterilization instructions are not available it is recommended to barrier protect the shade guide if used intraorally then disinfect.

If the shade guide is used extraorally to compare the shade guide to a crown received from the dental lab, then shade guide would be classified as noncritical and may be reprocessed by disinfection with the hospital approved intermediate level disinfectant.

High Volume Evacuation (HVE) and Saliva Ejector (SE) Valves:

In many aspects the HVE and SE valves are considered non-critical items. However, there are some difficulties with this definition as pertains to these valves:

· Disinfection only addresses the valve exterior. Without disassembly, the lumen and internal valve components are not addressed.

· No other VA RME is permitted to be considered "reprocessed" and maintain a contaminated lumen

· At publication, at least two valve manufacturers, via their reprocessing instructions, give no other option than autoclaving

· If the valve leaks, such as via O-ring failure, contaminants could contact the operator's gloves.

· Contaminants could readily then contact the patient's oral cavity, and require patient notification of an exposure incident.

· A failing O-ring would not be evident without valve disassembly

For the above reasons, these valves do not fit neatly into the non-critical Spaulding Classification definition.

It is imperative that Veterans Health Administration decontamination and sterilization procedures ensure Veteran safety without compromising processing efficiency. After reviewing various manufacturer instructions, Centers for Disease Control and Association for the Advancement of Medical Instrumentation Standards, and consultation with the VHA National Infectious Diseases Service, VA Dentistry and SPS recommends adherence to the below reprocessing procedure to minimize the potential risk of cross contamination and occupational exposure to bloodborne pathogens.

· Per manufacturer's instructions, it is acceptable to clean the dental evacuation valve 0-rings in place. The SPS staff will continue to disassemble HVE/SVE instruments, but may leave the 0-rings in place.

· The instruments are to be placed in the thermal washer disinfector and subsequently sterilized according to instructions for use.

· Both Dental Service and SPS staff are to inspect the 0-rings for signs of damage including but not limited to cuts, flat spots, and nicks on the surface.

· If a damaged 0-ring is detected, then it should be replaced by the end user per local policy.

· 0-ring replacement may be accomplished through a work order for Biomedical Engineering, use of an outside contracted vendor, or be performed by, trained dental service staff. SPS staff will not remove or replace the o-rings.

The intent is to terminally sterilize valves between patients, and not necessarily to present a sterile valve to the next patient. For reusable dental evacuation instruments:

· Dental Service shall apply enzymatic and send evacuation instruments to SPS after each patient use

· SPS will disassemble, clean, and decontaminate the evacuation instruments

· SPS will sterilize the evacuation instruments in an un-assembled state with the O-rings in place in sterile packaging and then send to the Dental Service

· Dental Service will reassemble the sterilized evacuation instruments prior to use

At time of publication, at least one manufacturer plans to bring to market single patient-use, disposable HVE and SE valves. Facilities are encouraged to weigh the cost of single patient-use, disposable valves vs. the costs involved with reprocessing reusable valves. No recommendation is made by the consultants regarding which valve to use.

Clean (i.e., terminally sterilized) valves may be placed on the unit after the room has been cleaned. It is not necessary to wait until the next patient is seated to place these valves.

Devices on the Air/Water Lines:

CDC states (Guidelines for Infection Control in Dental Health-Care Settings – 2003), "For processing any dental device that can be removed from the dental unit air or waterlines, neither surface disinfection nor immersion in chemical germicides is an acceptable method." The CDC further specifies (Summary of Infection Prevention Practices in Dental Settings – 2016), “Dental handpieces and associated attachments, including low-speed motors and reusable prophylaxis angles, should always be heat sterilized between patients and not high-level or surface disinfected.”

All types of dental handpieces and associated attachments including motors and reusable prophylaxis angles where the manufacturer instructions do not recommend heat sterilization will not be used, as it is a requirement that they be sterilized after each patient use.

Air-water syringes also fit into this category, but do not withstand heat reprocessing. Air-water syringes may be barrier protected and disinfected in the dental clinic.

Some motors require an adaptive connector between the hose and the motor. The connector may be considered part of the hose and therefore disinfected, remaining attached to the hose.

Treatment Room Preparation:

Sterile instrument packs are ideally opened in the patient's presence, in part to engender confidence in infection control protocols. If sterile packs are opened before the patient is in the room, the sterile packs should not be left unsecure.