S02 Attachment E - LegionellaContractAppC-Dental Infection Control Standards.doc

Infection Control Standards for VA Dental Clinics 21 October 2013

CONTENTS

3Introduction

4Authors

5Assistant Under Secretary for Health for Dentistry

5Acknowledgement

6Empowerment

7Occupational Exposures

8Clinical Application of Infection Control

8Instrument (RME) Classification

Critical

Semi-Critical

Non-Critical

9Immunizations

9Hand Hygiene

9Eating, Applying Make-Up, Handling Contact Lenses

10The Operatory

10Operatory Upholstery

10Operatory Set-Up

11Clinical Attire

11Scrubs

11Protective Personal Equipment (PPE)

12Gowns

13Double Gloving

13Eyewear

14Masks

14Shoes, Hair Covers and Shoe Covers

14PPE Usage

15Disinfectants

16Clean/Sterile Instrument Storage

17Restocking Unused Packs

17Setting Up for Treatment: Clean vs. Sterile

17Burs, Drills, Posts, Implant Components (References to burs applies to drills in this document)

18Diamond Coated Instrument

19Endodontic Files, Reamers, etc

19High Volume Evacuation (HVE) and Saliva Ejector (SE) Valves

20Devices on the Air/Water Lines

21Treatment Room Preparation

21Labeling Medicaments, Solutions on the Field

21Disposable Items

22Oral Surgical Procedures

23Implant Tracking

24Biological Implants-Tissue Program

24How Do All Personnel Know It's Clean/Sterile?

25Waterlines

25The following is the recommended waterline protocol for VA Dental Services

25Testing protocol

25Action Levels

26Feed Water (water supplied to the reservoir)

26Sterile saline or sterile water for surgical procedures

27Anesthetic Carpule Disposal

28Contaminated Instrument Transport to SPS's Soiled Instrument Pick-Up Location

30Waste Amalgam/Extracted Teeth; Precious Metal Recovery

30Radiology

31Panoramic Radiography

31Dental Hygiene Considerations

31Dental Laboratory Considerations

33Ultrasonic Cleaners

33Shell Blaster

33Spills

33Writing SOPs for Dental RME

34Purchasing RME

34Non-VA RME

34Electrosurgery/Electrocautery and Laser Devices

35The following discussion may help make local determinations regarding laser and electrosurgery considerations.

35Ventilation

35Smoke Evacuators

36Using an Evacuator

36Service and Companion Animals

37Prion Diseases

37Health Care Associated Infections

38The following criteria meet the definition of a post-invasive procedure infection

38The following are not considered HAI

39Website References

41Attachments

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.

The primary goal of any infection control program is to protect patients, health care workers and their families from transmissible diseases. Standard precautions, a basic tenet 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

Infection Control Consultant, VA Office of Dentistry

Chief, Dental Service

Huntington VA Medical Center

Huntington, West Virginia

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, 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 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.

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.

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.

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:

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.

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:

Ideally the dental service will have a centrally located room for sterile and clean instrument storage. 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. Wherever sterile supplies are stored for greater than 24-48 hours, temperature and humidity need to be monitored and appropriate measures taken if the ranges are exceeded.

Published standards for temperature and humidity control include the 2011 Association for the Advancement of Medical Instrumentation (AAMI) ST79, paragraphs 3.3.6.5 and 3.3.6.6, and the January 4, 2012 VA Interim Guidance for Ventilation Requirements in Sterile Processing. Your local SPS will be the resource for your facility's requirements.

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 left side of the stack – newly reprocessed packs are placed on the right 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.

Restocking Unused Packs:

Depending upon local policy, SPS may not want personnel to return unused sterile packs to the clean storage area. For example, staff removes an oral surgery pack from the clean room, anticipating the need. The patient doesn't show for the appointment. Local policy might state it's not permissible to restock the pack in the clean room, but it may be permissible to keep the pack in the operatory, behind cabinet doors, and have available to use on another patient. If not used that day, the pack would be reprocessed by SPS.

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. 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.

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.

Burs not used intra-orally in the clinic, such as denture adjusting burs and polishing burs used chair side, may be reprocessed if the manufacturer so states.

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."

Given the varying manufacturers' instructions regarding the reuse of diamond coated instruments and the absence of literature stating these devices can be thoroughly cleaned, the infection control consultants advise that reprocessing these diamond coated devices, if permitted by the manufacturer, be undertaken with the full concurrence of the local SPS. Local facilities may wish to consider these single patient-use devices.

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. 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.

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

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. RME HVE and SE valves are to be processed according to manufacturer's autoclaving instructions, and after each patient use.

As the intent is to terminally sterilize valves between patients, and not necessarily to present a sterile valve to the next patient, it is permissible for SPS to autoclave the disassembled valve components unwrapped. After autoclaving, SPS personnel may reassemble the valves according to manufacturer's instruction, including replacing failed O-rings and lubricating O-rings. The valves can be delivered in bags to dental services, labeling the bags as clean, such as Clean, not Sterile.

At time of publication, at least one manufacturer plans to bring to market single patient-use, disposable HVE and SE 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." Handpiece motors fall into this category, and are to be sterilized according to manufacturer's instructions.

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. For example, sterile packs should not be opened prior to lunch, in anticipation of the after-lunch planned procedure.

Barriers are an effective means to minimize contamination of non-critical items and work surfaces, such as light handles. If the barrier has been breached, disinfection must follow barrier removal.

Digital Radiograph Sensors, Intra-Oral Cameras, Electronic Periodontal Probes, Occlusal Analyzers, and Lasers:

As semi-critical devices, ideally these electronic devices should be heat sterilized or subjected to high level disinfection. However, most of these electronic devices are not able to be reprocessed by these methods. Per CDC, semi-critical items that cannot be reprocessed by heat sterilization or high-level disinfection should, at a minimum, be barrier protected by using an FDA-cleared barrier. CDC reports digital radiography sensor plastic barriers have a failure rate of 44%. Per CDC, after barrier removal, sensors are to be cleaned and disinfected with an intermediate level disinfectant.

Labeling Medicaments, Solutions on the Field:

All medicaments, solutions, etc. for use during patient care needs to be labeled, whether on or off the clean/sterile field. Examples include irrigating solutions, etchant and astringents. Two person verification of the label is indicated unless a single health-care worker is preparing both the secondary dispensing package and will also be administering. Secondary containers are not to be pre-labeled – i.e., the secondary container should be labeled at the time of medicament transfer. Dental services are advised to check with their local medication management policy.

Disposable Items:

Other factors being equal, disposable items are preferred over RME. The market has multiple items available for single patient use and disposable – alginate bowls, patient napkins and holders, temporary cement packets, etchant dispensers, surgical scalpel handles with attached sheathed blades, for examples – and we can anticipate more options in the future. Dental Services are encouraged to explore such options.

Oral Surgical Procedures:

Per the ADA and CDC, surgical procedures are those involving the incision, excision, or reflection of tissue that exposes normally sterile areas of the oral cavity, such as:

· biopsy

· periodontal surgery

· apical surgery

· implant surgery

· surgical extraction of teeth (flap elevation, bone removal or tooth sectioning)

The ADA and CDC state that sterile irrigation is to be used during these procedures, and is the standard for VA oral surgery procedures. A typical dental unit is not able to deliver sterile irrigants through its reservoir system. Sterile irrigant delivery can be accomplished by dripping sterile irrigant from a sterile syringe, such as a bulb syringe, onto the surgical site. At time of publication at least one manufacturer offers an equipment system that delivers sterile irrigants via sterile reservoir and sterile lines through the sterile handpiece. At least one manufacturer offers a device to deliver sterile irrigants via a handheld device (not the surgical handpiece) to the surgical site. The Monject™ curved tip syringe, at time of publication, does not come in sterile condition. Therefore it is not appropriate to deliver surgical irrigation.

A bottle of sterile saline or sterile water, once opened, can be used for other patients for the remainder of the workday, provided the bottle's lip hasn't been contaminated. To maintain lip sterility, it cannot touch any surface. Liquid must be poured with physical separation from the receiving container. The opened bottle is to be labeled with the date opened. This labeling requirement should not be confused with the Joint Commission Standard that injectable, reusable medications, once opened, are to have a 28 day expiration date written on the bottle. Such multi-dose vials are to be discarded 28 days after first use unless the manufacturer specifies otherwise (shorter or longer).

Sterile surgical gloves should be worn for surgical procedures. Every attempt should be made to minimize contacting anything other than the sterile instruments and the patient. For example, sterile 4x4 gauze may be used to adjust the light. The gauze, now no longer sterile, should not be placed in the sterile field.

For biopsy procedures the specimen bottle should be opened during set-up preparations. The bottle should not be placed in the sterile field. After securing the specimen, it can be immediately transferred to the open specimen bottle. After the procedure and prior to discharging the patient, the bottle can be closed with clean hands and the bottle labeled.

Non-amalgam containing extracted teeth should be placed in a biohazard waste labeled container

· Your local facility might accept using the sharps container for extracted teeth

· Refer to the section Waste Amalgam/Extracted Teeth; Precious Metal Recovery for information regarding extracted teeth containing amalgam

Implant Tracking: Non-Biological Implants Non-biological implants for use in dentistry, such as titanium implants, include items ordered through the prosthetic service that are intended to stay in the oral cavity and be covered with tissue. The process will typically involve the dentist placing a CPRS consult to the prosthetics service to order the correct implant using the Prosthetic Request/Device Menu.

· Immediately before use, the dentist should perform a final inspection of the product to insure that it is sterile and ready for use

· An implant tracking method needs to be in place, in part to be able to notify patients should an implant recall occur

· Tracking is to include lot numbers, serial numbers, and expiration dates as they apply

· Include any information regarding devices that were wasted or contaminated during the procedure

· Some dental services have found a CPRS Prosthetics consult provides a tracking system

· Many dental services have also found it useful to enter the implant data into an electronic dental implant log located on the dental service specific drive, or report the data to a facility implant coordinator for tracking purposes

· VHA Directive 2009-062, Management of Non-Biological Implantable Devices should be referenced for additional information. (see Website References) Biological Implants-Tissue Program:

Dental services are advised to refer to any local policies on biological implants and/or tissue program for additional information. Biological implants used in the dental service typically include allograft and xenograft bone derived from human and animal origin respectively, as well as collagen membranes. Many facilities have determined that tissue products will be stored in a central facility location to monitor the temperature and humidity -- commonly the facility blood bank. Dental Services must have a biological implant tracking system in place in case of a recall.

· Immediately prior to use, the dentist should perform a final inspection of the product to insure that it is sterile and ready for use.

IMPLANT CATEGORIES

How Do All Personnel Know It's Clean/Sterile?

There have been cases of dental personnel inadvertently using dental instruments that didn't go through sterilization. The instruments were wrapped for sterilization, but never entered the autoclave. Although dental personnel are supposed to check the physical monitors (external tape and internal chemical monitor), it isn't difficult to imagine overlooking these monitors. One means to help personnel verify sterility is for the assistant to leave the internal monitor in plain view, so the dentist, upon entering the room, can see the monitor. After cleaning a treatment room, some indicator of cleaning is helpful to prevent a patient being seated in an unclean room. Among ideas to demonstrate the room is ready…place a clean, folded patient napkin on the patient chair.

Waterlines:

The Environmental Protection Agency (EPA), American Public Health Association and the American Water Works Association have defined the standard for US potable water – not to exceed 500 colony forming units (cfu) per milliliter of water. The Centers for Disease Control and Prevention (CDC) and the American Dental Association (ADA) have recommended dental unit water line (DUWL) deliver water should meet the U.S. potable water standard – not to exceed 500 cfu/ml of water. Dental services should routinely test water coming out of the DUWLs to meet this standard, have an action plan to meet this standard and to address a DUWL that exceeds this standard.

Waterline testing is to be accomplished by a laboratory certified (EPA or state) to perform environmental testing. VA Microbiology Laboratories perform clinical tests, and have not been approved for environmental testing.

The following is the recommended waterline protocol for VA Dental Services:

1. Dental unit water lines (DUWL) must be accessible for treatment – daily and for shocking, as needed. That requires a water bottle (reservoir) on the unit or some means to access the DUWLs.

a. Replace/change any units with direct connection to municipal water.

2. Provide an ongoing water treatment program. There are multiple choices. Among the most common are those that involve placing a tablet in the reservoir and those that have a reservoir draw-tube which treats the water.

Testing protocol

a. Test each line separately

b. Remove all handpieces and any other equipment reprocessed by SPS before drawing samples from the lines. Air-water syringe tips should be removed. The air-water syringe itself, if not changed between patients (e.g., if barrier + disinfection is accomplished by dental personnel), should remain on the line while drawing the sample.

c. Quarterly

d. Use a lab certified to do water testing

e. Report results to the Infection Control Committee

Action Levels

f. If >200 cfu but <500 cfu

i. Shock all lines in the unit (i.e., the dental treatment room)

1. Leave the air-water syringe on the line if not reprocessed by SPS

ii. Line can stay in service

iii. No retest needed after shocking

1. Maintain the unit's place in the quarterly testing sequence

g. If >500 cfu

i. Take line out of service (the >500 cfu line only – other sub-500 cfu lines may stay in service)

ii. Shock all lines to unit per manufacturer's instructions

1. Leave the air-water syringe on the line if not reprocessed by SPS

iii. Retest the >500 cfu line before returning it to service

h. If shocking and retesting again yields >500 cfu

i. Line remains out of service

ii. Contact dental equipment manufacturer and waterline treatment manufacturer for recommendations on options, such as repeat shocking or line replacement

Feed Water (water supplied to the reservoir)

i. Generally tap, distilled, de-ionized or sterile water is acceptable (see manufacturer’s recommendations). Also, at least one manufacturer has a sequential cartridge system which produces treated water for the reservoir.

Note: All recent Legionella occurrences in VA have involved municipal water. There is no advantage to filling dental unit reservoirs with sterile water. Typical dental units are not designed to deliver sterile water, and therefore this does not meet sterile water surgery requirements. Sterile water in reservoirs does not prevent biofilm formation in DUWLs.

Sterile saline or sterile water for surgical procedures

Note: Placing sterile saline/water in a dental unit reservoir does not constitute sterile irrigation at the surgery site

j. Surgical procedures are those involving the incision, excision, or reflection of tissue that exposes normally sterile areas of the oral cavity, such as:

i. biopsy

ii. periodontal surgery

iii. apical surgery

iv. implant surgery

v. surgical extraction of teeth (flap elevation, bone removal or tooth sectioning)

At time of publication at least one manufacturer offers an equipment system that delivers sterile irrigants via sterile reservoir and sterile lines through the sterile handpiece. At least one manufacturer offers a device to deliver sterile irrigants via an assistant handheld device to the surgical site. These systems do not require waterline testing, as sterile irrigant is used in a sterile system.

At the end of the work week, the water reservoir may be removed and drained, allowing the reservoir to dry over the weekend.

· Tablet treatments added to the reservoir have expiration timeframes after mixing, commonly 2-4 weeks, depending upon the manufacturer. Emptying the reservoir weekly ensures no solution becomes expired.

· If tablet system reservoirs are not emptied weekly, the dental service will need to identify how tablet expiration is monitored. An expiration label on the reservoir is one example.

· If using a draw-tube system, water may not be effectively treated until it is drawn into the tube. (Checking with the draw-tube manufacturer is recommended.) Allowing the reservoir to dry reduces the risk of biofilm forming in the…