Hu-Friedy

THE ESSENTIAL GUIDE TO INFECTION CONTROL

TABLE OF CONTENTS

Part 1: Getting Started as an Infection Control Coordinator

Responsibilities of the Infection Control Coordinator ........................................... 1.1

Culture of Safety ................................................................................................................ 1.2

Hand Hygiene ....................................................................................................................... 1.3

Personal Protective Equipment ..................................................................................... 1.4

Environmental Surfaces ................................................................................................... 1.6

Barriers .................................................................................................................................. 1.7

Dental Unit Waterlines ..................................................................................................... 1.9

Putting Into Practice with Protocol Development .................................................. 1.10

Resources for the Infection Control Coordinator .................................................... 1.11

The Basic Steps of Writing A Protocol........................................................................ 1.12

Part 2: Instrument Reprocessing

Instructions for Use .......................................................................................................... 2.1

Chairside to Transportation ............................................................................................ 2.2

Instrument Reprocessing Area ...................................................................................... 2.3

Receiving, Cleaning & Decontamination ..................................................................... 2.4

Preparation & Packaging ................................................................................................. 2.5

Sterilization .......................................................................................................................... 2.6

Sterilization Monitoring ................................................................................................... 2.6

Record-Keeping ................................................................................................................... 2.8

Storage & Patient Prep .................................................................................................... 2.9

Sharps Injuries .................................................................................................................... 2.9

Reprocessing Do's & Don'ts ............................................................................................ 2.10

Hu-Friedy

THE ESSENTIAL GUIDE TO INFECTION CONTROL

PART 1: GETTING STARTED AS AN INFECTION CONTROL COORDINATOR

1.1

Infection control is the cornerstone to any successful dental practice. While transmission of infectious agents and diseases in the dental setting is rare, it does happen.1-4 Lapses in infection control often involve simple and routine infection prevention procedures such as treating dental unit waterlines or heat-sterilizing handpieces.1-4 For this reason, the Centers for Disease Control and Prevention (CDC) encourages making infection prevention a priority and an integral part of creating a culture of safety.5

Both the CDC and Occupational Safety and Health Administration (OSHA) state it is essential that at least one infection control and prevention coordinator be assigned in all dental practices. Whether it’s an individual position or included as part of the job duties of a dental assistant, an office manager or dental hygienist depends on the size and demands of the dental practice.5 In addition to the practice benefits, there are many benefits to the individual that accepts the role of infection control coordinator. The role can provide an opportunity to gain valuable leadership and coaching experience, subject matter expertise and, by taking on additional responsibility, it can make the individual a more valuable asset to the practice.

The infection control coordinator must have training or be willing to be trained in infection prevention. They must also stay on top of updates in infection prevention protocols, manage the inventory of personal protective equipment and reusable patient care items, train the staff, and monitor the program.6,7

Where does this person start? How do they ensure that evidence-based guidelines, regulations, standards, and best practices are being adhered to? How do they create the protocols necessary to be in compliance? What governing agencies do they need to be aware of?

Part 1 of this guide is designed to lead the infection control coordinator through the first crucial steps of setting up an infection control program. Part 2 will take a deep dive into the critical topic of instrument reprocessing, including best practices in instrument transportation, cleaning and sterilization. Together, these guides will provide you with a strong foundation and the confidence necessary to tackle the important role of your practice’s infection control champion.

Let’s get started!

RESPONSIBILITIES OF THE INFECTION CONTROL COORDINATOR

• Create written infection prevention protocols(policies and procedures) based on currentguidelines, regulations, and standards

• Keep the program consistent with currentregulations, requirements, policies,and procedures

• Adhere to state and federal requirementsand assess best practices

• Provide ongoing training as needed and conductannual OSHA bloodborne pathogen training

• Oversee infection control program and act asa resource to the rest of the staff

• Keep equipment in working order and ensurethat staff is trained to use office equipmentand that they follow instructions for use (IFUs)and adhere to the safety requirements

• See that necessary infection prevention suppliesare available, including personal protectiveequipment (PPE) for staff and patients

• Continually review policiesand standard operatingprocedures to identify gapsand outdated material

• Maintain related permits,licenses, immunizationrecords, copies ofall manufacturerIFUs and otherdocuments

• Monitor compliancethrough checklists,interviews, andobservations

1.2

CULTURE OF SAFETY

Applying a culture of infection control safety to the dental setting can bring the team together. Helping your team understand the process of implementation ultimately increases their level of compliance.

Many areas within the dental practice need written protocols, training, education, and monitoring systems. As an infection control coordinator, it is your responsibility to create training modules and protocols for the team. It can seem overwhelming, but a good first step is to review the chain of infection to help your team understand the concepts of infection control and prevention. Then you can move on to prevention strategies and guidelines.

CHAIN OF INFECTION

GOVERNMENT AGENCIES THAT OVERSEE INFECTION CONTROL IN DENTISTRY

A source that allows

the pathogen to survive & multiply

(e.g. blood)

The presence of enough

pathogens to cause disease

A susceptible

host

A mode of transmission

from the source to the host

A point through which the pathogen

can enter the host

By reinforcing effective infection control strategies with your team, you can help prevent the spread of disease by interrupting one or more links in the chain of infection.

Centers for Disease Control & Prevention (CDC)The mission of the CDC is “to protect America from health, safety, and security threats.” The recommendations and guidelines set forth by the CDC for infection prevention are generally adopted by state dental boards and legislatures as law.

Occupational Safety & Health Administration (OSHA)The mission of OSHA is “to assure safe and healthful working conditions for working men and women by setting and enforcing standards and by providing training, outreach, education and assistance.” As part of the U.S. Department of Labor, their requirements are the law.

U.S. Food & Drug Administration (FDA) The FDA governs many things in dentistry, including drugs, medical devices, and electronic products that give off radiation.

U.S. Environmental Protection Agency (EPA) The EPA controls the disposal of toxins such as amalgams and hospital-grade disinfectants, which have to be approved before you can use them for cleaning and disinfecting clinical contact surfaces.

State Dental Boards Your state dental board develops and enforces the laws surrounding infection control. The laws that they put into place generally meet or exceed the guidelines and mandates from OSHA, the CDC, FDA, and EPA.

Health Departments The local and state health department is also a resource and can help through crises and challenges.

HELPFUL TIP

One simple way of assessing the needs of your dental practice is to review the Guidelines for Infection Control in Dental Health-Care Settings – 2003 and utilize the CDC checklists included in the 2016 Summary of Infection Prevention Practices in Dental Settings.

The checklists were developed to help ensure that offices have infection prevention practices in place to ensure a safe working environment. It also gives the infection control coordinator the tools to systematically assess staff compliance and provide feedback.

1.3

HAND HYGIENE TIPS

• Hand washing must be done if there is the possibility that debris, blood, or body fluids such as saliva are present.

• Alcohol-based hand sanitizers can be used in the medical setting when hands are free of debris.

• Hands must always be washed before putting gloves on and after taking them off.

• Make sure hand hygiene products are medical-grade and will not degrade glove materials.

• Read and follow the label directions, paying special attention to recommended application and contact time.

• Hand hygiene is always the last step to the removal of personal protective equipment.

HAND HYGIENE

Hand hygiene is the single most effective way to break the chain of infection and prevent the spread of bacteria in healthcare settings.5,8-9 Depending on the procedures to be performed and the state of the healthcare worker’s hands, proper hand hygiene practices should include the use of all of the following: plain or antimicrobial soap, alcohol-based hand sanitizers and skin moisturizers.

For dental examinations and nonsurgical procedures, clinicians can use soap (plain or antimicrobial) and water or an alcohol-based hand antiseptic to clean or disinfect hands

prior to donning exam gloves and immediately following their removal. When hands are visibly soiled, they should always be washed with soap and water first. It is always good practice to ensure hands are completely dry before donning a new pair of gloves as wet hands can attract pathogens. For surgical procedures, perform a surgical hand scrub before putting on sterile surgeon gloves.

Repeated hand washing, antiseptic application and glove use can result in dry skin or other skin conditions such as dermatitis. Because of this, medical-grade, glove-compatible hand moisturizers should be used regularly to maintain healthy, unbroken skin-the body’s natural defense against infections. The use of a therapeutic cream can help restore the skin’s natural moisture barrier while delivering necessary nutrients to the skin. As an example, Hu-Friedy’s Skin Repair Cream contains Olivamine®, a patented blend of ingredients that delivers all of the essential nutrients necessary for optimal skin health including amino acids, vitamins, antioxidants, and methylsulfonlymethane (MSM). For all types of hand hygiene products, look for those specifically designed for use in healthcare settings and follow the product manufacturer’s label for instructions. In particular, take note of the recommended product application method and, in the case of antiseptics, the required amount of time that the product should remain wet on the skin. Antiseptics with a high alcohol content such as Hu-Friedy’s Sterillium Comfort Gel®, which contains 85% alcohol, kills 99.99% pathogens within 15 seconds. Products with lower alcohol content will require larger dosages and longer contact times. Finally, it is important to emphasize with your staff that gloves do not take the place of proper hand hygiene.

A great resource for hand hygiene is the 2002 CDC Guideline for Hand Hygiene in Health-Care Settings10 which you can share with your team. After researching the guidelines from the CDC, your state dental practice act, and other resources for hand

1.4

hygiene, you can work with the staff to review best practices for the office’s specific settings.

From there, you can move on to teach your staff about the other areas that have been identified as needing training.

HOW TO ENCOURAGE HAND HYGIENE

Studies indicate the rate of compliance for proper hand hygiene in the healthcare field is about 40%.10 For that reason, visual cues have been shown to be a valuable tool in hand hygiene, decreasing the rate of infection.11 Simple things from posters to statements on compliance posted in the setting can help increase compliance throughout the day.12 The Hu-Friedy Hand Essentials Hand Care Guide 13 is a great example of a tool that the whole dental team can use.

PERSONAL PROTECTIVE EQUIPMENT

Personal protective equipment (PPE) refers to wearable equipment that is specifically designed to protect the healthcare provider and patient from exposure to infectious agents. PPE effectively covers personal clothing and skin likely to be soiled with blood, saliva, or other potentially infectious materials. The PPE that should be made available include gloves, face masks, protective eyewear (for both the clinician and the patient), face shields, and protective clothing. Lack of or improper personal protective equipment can put both the

clinician and the patient at risk.

GLOVES

Gloves must be worn when there is a potential for contact with blood, body fluids, mucous membranes, open wounds, or contaminated equipment.5,18

Exam Gloves Single-use, disposable exam gloves are intended for examining patients and performing non-invasive procedures. They should always be changed between patients and when torn or punctured. Only medical-grade, powder-free gloves cleared by the Food and Drug Administration (FDA) can be used. Exam gloves are available in a variety of materials, including nitrile, latex, and vinyl and are generally made to be able to be worn on either hand. It is important to keep in mind that some individuals may be allergic to natural rubber latex. If your practice is using latex exam gloves primarily, it is prudent to have options available for use with a patient or by a clinician with latex allergies. Other considerations when choosing an exam glove for your team can include fit, comfort, tactile sensitivity, and durability.

Sterile Gloves Patient exam gloves are not intended for surgical procedures such as biopsies, periodontal surgery, apical surgery, implant surgery, and the surgical extraction of teeth. For surgical procedures, perform a surgical hand scrub before putting on sterile surgeons’ gloves. Sterile or surgical gloves are labeled as such and come sterile in individually packaged pairs, commonly with hand-specific designs for enhanced ergonomics.

Utility Gloves Utility gloves are vital and yet underutilized. The CDC recommends the use of puncture- and chemical-resistant utility gloves when cleaning instruments and performing housekeeping

1.5

tasks involving contact with blood, other potentially infectious materials, or chemicals.15-18 Puncture-resistant utility gloves are designed to provide protection during operatory cleanup and reprocessing of instruments. It is important that each clinician have their own pair of well-fitting utility gloves.16

Unlike exam or surgical gloves that are for single use only, some utility gloves can be sterilized, washed, or disinfected for reuse. For example, Hu-Friedy’s Lilac Utility Gloves can be autoclaved up to five times for ease of use and care. Prior to donning, utility gloves should be inspected for punctures, tears, cracks or other signs of deterioration and replaced when necessary.17-18 When utility gloves are worn during the cleaning step, gown or jacket sleeves should be tucked in and cuffs should be folded over to prevent liquids from accidentally contacting bare skin.

PROTECTIVE EYEWEAR

Protective eyewear must be worn by both clinicians and patients during procedures that are likely to generate airborne debris, splashes or sprays of blood or other body fluids. It is especially important when high-speed handpieces are being used. The protective eyewear for a patient may also help with sensitivity to the overhead light.

Reusable protective eyewear should be cleaned with soap and water and disinfected between patients when visibly soiled.15,20

OSHA requires all employers to supply eyewear or face shield protection for all their employees. Eye protection should be made of impact-resistant plastic and include side protection in compliance with American National Standards Institute (ANSI) Z87.1-2010.20 Reader glasses do not take the place of protective eyewear.

FACE MASKS

Because not all masks are made the same, only face masks designated as a medical device by the FDA, generally referred to as surgical masks, should be used in dental settings. Healthcare personnel should wear a surgical mask that covers both their nose and mouth during procedures and patient-care activities likely to generate splashes or sprays of blood or body fluids. A surgical mask protects the patient against microorganisms generated by the wearer and also protects dental healthcare personnel from large-particle droplet spatter that may contain bloodborne pathogens or other infectious microorganisms. Though the mask may offer some protection from airborne pathogens, it is not meant to take the place of evaluating patient and clinician health before delivering treatment. It is important that the mask fits well or it will not filter the air.19 Masks should not be worn down around the chin or neck as it creates an opportunity for cross contamination.

WHAT TO LOOK FOR IN A MASK

No one mask works for everyone. When choosing a mask, there are several considerations.

Masks should: • Create a seal over the nose and mouth • Have a filtration level of at least 95% • Allow for breathing • Work well with eyewear to limit fogging • Fit face well, covering the nose and mouth

PROPER GLOVE USE TIPS• Change exam gloves between patients• Do not wear the same pair of exam gloves for

more than one patient • Do not take exam gloves off and put them

back on as they are single-use and the material can be compromised

• Do not wash exam gloves for purpose of reuse• Remove any glove that has been torn, cut,

or punctured, then perform hand hygiene and put on new gloves

• Do not use wet utility gloves to package a clean and dry instrument or set-up

1.6

PPE REVIEW

Can face shields protect employees instead of safety goggles or spectacles? Face shields alone do not protect employees from impact hazards. Face shields may be used in combination with safety goggles or spectacles to protect against impact.

Is training required before eye and face protection is used? Yes, training must be provided to employees who are required to use eye and face protection. The training must be comprehensive, understandable, and recur annually, and more often if necessary. This training should include at a minimum:

• Why the eye and face protection is necessary and how improper fit, use, or maintenance can compromise its protective effect

• Limitations and capabilities of the eye and face protection

• Effective use in emergency situations

• How to inspect, put on, and remove

• Maintenance and storage

• Recognition of medical signs and symptoms that may limit or prevent effective use

For more information from OSHA, click here.

When a surgical mask is used, it should be changed between patients or during patient treatment if it becomes wet.15,19 Have a variety in the office with different filtrations (i.e. N95 with high filtration should be available should a patient with possible TB present).18

PROTECTIVE CLOTHING

A gown or lab jacket must be worn during procedures or activities where contact with blood, saliva, or other potentially infectious materials is anticipated.

Gowns are a barrier that protects the skin and clothing from debris, aerosols, fluids, and other materials. They should be removed when leaving the operatory, lab, or sterilization area and should not be worn in eating areas, lobbies, lavatories, or offices. They should be changed daily or when visibly soiled.15 They need to be knee-length and have a cuff at the wrist to ensure that fluid doesn’t penetrate the skin. Please note that scrubs do not take the place of PPE.

Protective gown should never be worn outside of the operatory, sterilization area, and lab. To counteract this issue, put up more clothing hooks in the operatory, lab area, and sterilization area to give staff more places to place their gowns when not in use.

PPE IN INSTRUMENT REPROCESSING

One of the areas where personal protective equipment is of utmost importance is in the instrument reprocessing area. Healthcare professionals that work in this area have the possibility of being exposed to every single patient’s pathogens that were treated in a given day. Therefore, each task may require additional protection and must be looked at individually. For example, if you anticipate splashes or splatter in the task you are undertaking, the addition of a water-resistant apron and a splashguard or face shield can help prevent disease transmission and chemical exposure. Please note this topic will be covered in greater detail in Part 2 of this guide.

ENVIRONMENTAL SURFACES

In the dental operatory, environmental surfaces (i.e., a surface or equipment that does not come into contact with patients directly) can become contaminated during patient care. Although they have not been associated directly with transmission of infection to either DHCP or patients, these surfaces, especially ones touched frequently (e.g. light handles, unit switches, and drawer knobs), can serve as reservoirs of microbial contamination, which must be managed through barrier protection and regular cleaning and disinfection.

1.7

Clinical Contact Areas Clinical contact areas are those that come into contact with contaminated instruments, devices, hands, or gloves. Use FDA listed barrier protection to protect as much as possible during treatment, especially in areas that are difficult to clean, such as the X-ray head and switches. When barriers are not used, clinical contact surfaces must be cleaned and disinfected between patients by using an EPA-registered hospital disinfectant with an HIV, HBV claim (i.e., low-level disinfectant) or a tuberculocidal claim (i.e., intermediate-level disinfectant).

Housekeeping Surfaces Housekeeping surfaces (e.g., floors, walls, sinks) have a limited risk of disease transmission and can be cleaned with detergent and water or an EPA registered hospital disinfectant if visibly contaminated with blood.

Surface DisinfectionWhen breaking down the room or cleaning and disinfecting the surfaces with an EPA-grade disinfectant, you must wear personal protective equipment, including a mask, eye protection, a gown, and chemical- and puncture-resistant utility gloves.

There are two steps involved in disinfecting a surface area. The first step is to clean the surface, removing debris and blood so that the disinfectant can penetrate the surface. The second step is to apply the disinfectant according to the directions on the label. Often this involves thoroughly saturating the area to be disinfected and allowing the surface to remain visibly wet for the specified duration of time. Remember that allowing the disinfectant to dry is part of the process. Many surface disinfectants today both clean and disinfect. Always read the manufacturer’s label and directions for use.

BARRIERS

Using surface barriers to protect computer equipment and clinical contact surfaces, particularly those difficult to clean, could save time for the office and limit exposure to chemicals.

Barriers that are used to protect equipment or areas of the office should be designated as non-permeable, FDA listed medical devices. They come in many sizes and forms, including clear wrap, wrap with adhesive, bags, sheets, and tubing. Make sure they fit well and stay in place. They should also be easy to place and remove.

You can have clinicians in the practice review the items and surfaces in the operatory and choose a protocol for post-care: either barrier protection and/or cleaning and disinfecting. A good resource is the CDC’s Summary of Infection Prevention Practices in Dental Settings.5

Disinfectants are specifically designed to be used on hard, inanimate surfaces and objects.

Categorized as pesticides by the EPA, disinfectants either destroy or irreversibly inactivate infectious viruses, fungi, and bacteria.

To be utilized in healthcare settings, disinfectants must state that they are a “Hospital Disinfectant” and have an EPA registration number on the label.

Over-the-counter products such as household bleach do not take the place of an EPA-registered disinfectant. It is federal law to know and follow the label directions.They include where, how much, how often, and when to use the disinfectant as well as how to store and dispose of it.

Do not make your own wipes.The bleach in cotton two-by-twos can render the disinfectant inert.19,21

For details about your product, click here.

For details about disinfectants in general, click here.

EPA-APPROVED DISINFECTANTS AND HOW TO USE THEM

1.8

BARRIER PROTOCOL

First, clean and disinfect the area at the start of the day and then place the barrier protection. Because barriers can become contaminated, they are single-use items. They should be removed and discarded between patients while wearing utility gloves.

Carefully remove the barrier so that you do not contaminate the surface you are protecting. Large bags can be removed by turning them inside out as you remove them. After removing the barrier, examine the surface to make sure it did not inadvertently become soiled. If contamination is evident, the surface should be cleaned and disinfected.

After removing gloves and performing hand hygiene, the healthcare professional should place clean barriers before the next patient. At the end of the day, remove all barriers and clean and disinfect all environmental surfaces (clinical contact and housekeeping surfaces) in the operatory as per the guidance provided above.

All items that enter the mouth that cannot be heat sterilized will require both barrier

protection and cleaning and disinfection. It is important to follow the instructions for use for all product including barriers, cleaning and disinfection products. Dental handpieces (including the low speed motor) and other devices not permanently attached to air and waterlines do not fall into this category. They must be cleaned and heat-sterilized according to manufacturer instructions.5

DIGITAL SENSORS

Because digital sensors are sensitive and come in contact with mucosa, saliva, and blood, they require special handling. FDA listed barriers can be used to cover the sensor. Barriers should be changed between patients. After the surface barrier is removed, the sensor is ideally cleaned and heat sterilized or high-level disinfected according to the manufacturer’s instructions. If the item cannot tolerate these procedures, the sensor should at least be cleaned and disinfected with an intermediate-level EPA-registered hospital disinfectant.

Consult manufacturers regarding compatibility of heat sterilization.

HOW LONG MICROORGANISMS LIVE ON SURFACES

Microorganisms can live on surfaces for a long time which is why following proper cleaning and disinfection protocol is critical to ensuring the safety of the patient and clinician.

M I C R O O R G A N I S M L E N G T H O F T I M E

MRSA 7 days — 7 months

Hep A 2 hours — 60 days/2.5 months

Herpes 4.5 hours — 8 weeks/2.5 months

Rotavirus 6 days — 60 days/2.5 months

Hep C 6 weeks/1.5 months

Hep B Less than 1 week

Fl 1 — 2 days SOURCE: BMC Infectious Diseases 2006

1.9

THE DANGERS OF IGNORING WATERLINES

In September 2015, nine pediatric patients in Georgia were exposed to M. abscessus after contaminated water was used during their pulpotomies, which introduced the bacteria into the chamber of the tooth during irrigation and drilling.22 This specific bacteria is ubiquitous in the environment and can pose a contamination risk, leading to severe infections.

DENTAL UNIT WATERLINES

Another important aspect of infection control and prevention within the operatory is the cleaning and maintenance of dental unit waterlines. Colonies of microorganisms, or biofilm, have a strong tendency to form on the inside of the tubing that transports water from the dental unit to the handpieces and air-water syringes. The biofilms continue to grow and multiply and have the potential to contaminate patient treatment water.

Research shows microbial counts can be as high as 200,000 colony-forming units per milliliter (CFU/mL) within five days of installing a new dental unit waterline. This rapid growth is due to a number of factors, including waterlines with small diameters, water warming to room temperature, slow water flow, and low overall water usage.18

Because of the presence of biofilm, the CDC recommends that water used for routine dental treatment meet EPA regulatory standards for drinking water (fewer than 500 CFU/mL of heterotrophic water bacteria). When performing surgical procedures, sterile solutions must be used in conjunction with devices specifically designed for their delivery.

If water is not properly cleaned and maintained, dental units cannot produce water that meets these drinking water standards and should not be used for patient treatment. Therefore, waterlines must be properly maintained and monitored, following the recommendations for monitoring water quality provided by the manufacturer of the unit or waterline treatment product. In addition, water and air should be discharged for a minimum of 20–30 seconds after each patient, from any device connected to the dental water system that enters the patient’s mouth (e.g., handpieces, ultrasonic scalers, and air/water syringes).18

The infection control coordinator needs to know how and when to monitor the waterline. You must know the instructions for use for the dental unit,

as well as the waterline cleaner and maintenance products and understand how to keep the water at or below 500 CFU/mL of heterotrophic water bacteria.18

“To prevent infections associated with waterlines, dental practices should follow manufacturer guidelines to disinfect waterlines, monitor water quality to ensure recommended bacterial counts, use point-of-use water filters, and eliminate dead ends in plumbing where stagnant water can enable biofilm formation,” writes the CDC. “Health care providers should promptly report suspected outbreaks of infectious diseases to public health authorities so that an investigation can be initiated and appropriate control measures implemented.”18

It is important to utilize a complete dental unit waterline system that both cleans and maintains the water in order to remove the microbial contamination. Utilizing a proper maintenance product is also necessary to help prevent the waterborne organisms from attaching and forming in the tubing again between cleaning protocols.

1.10

Incorporating a dental unit waterline cleaning and maintenance protocol is simple. Various waterline treatment products are available to address microbial contamination and potential health risks. One of the more popular product types for both cleaning and maintaining waterlines uses chemical agents. Table 1 above lists the criteria that should be used when choosing a product for your office. Just remember to follow the manufacturer’s instructions for use for each product. With Hu-Friedy’s Team VistaTM Dental Unit Waterline Cleaner, cleaning and maintaining waterlines is a quick and easy process that includes shocking the waterlines monthly and adding daily irrigant drops to maintain the waterlines. Click here to view or print the Hu-Friedy Step by Step Instruction Guide.

OSAP has a great resource for the infection prevention coordinator: the Waterline Tool Kit. This kit provides a comprehensive overview of the background and process necessary to keep the waterline safe, incorporating CDC recommendations and resources.24

PUTTING INTO PRACTICE WITH PROTOCOL DEVELOPMENT

Protocol-based practices are systematically developed, taking into consideration the individual circumstances of delivery of care.25 They are a benefit to medicine, increasing understanding of the steps involved to be in compliance and improving patient care. Developing a protocol is an ongoing process that involves continual evaluation.

The first step in developing protocol is to assess the needs of your practice against the CDC Guidelines, state board laws and regulations, etc. Ask yourself what needs to be done, and then review once again the regulatory requirements and recommendations. At that point, you can also research best practices — that is, the steps followed to ensure the best results. Encourage staff input to make sure that you’re developing a protocol that works for your practice.

Once you’ve gathered the relevant information and input, you can begin to develop a written plan. Include a brief description of the problem or contributing factors, and make sure the information is based on scientific evidence. List the preventive measures and tasks that your staff should take, and include the details in question words such as who, what, when, where, why, and how. (There is an example of what a protocol should look like in the hand hygiene protocol below.)

At that point, you can draft and edit the policies and procedures behind the protocol and obtain approval from your supervisory staff member.

TABLE 1: What to look for in dental water treatment solutions

1. Works quickly

2. Exhibits broad-spectrum antimicrobial activity

3. Disrupts biofilms

4. Nontoxic

5. Nonpyrogenic

6. Nonallergenic

7. Noncorrosive

8. Compatible with rubber and synthetic materials

9. Does not interfere with dental procedures

10. Environmentally friendly

SOURCE: Dental water line infection control: A work in progress

Waterline treatment steps

1.11

With the information in place, you can begin to educate the staff on the new protocol, communicating the need to adhere to it, as you will be monitoring and evaluating their use of the protocol.

After evaluating the protocol in the practice, you can make any necessary revisions. Even if they are also available electronically, all of a practice’s protocols should be printed and stored together in one binder in the central sterilization area, easily and readily accessible by all staff members. All instructions for use for all infection prevention related equipment and products should be similarly organized and kept together with the practice protocols for easy reference.

RESOURCES FOR THE INFECTION CONTROL COORDINATOR

CDCThe “Summary of Infection Prevention Practices in Dental Settings: Basic Expectations for Safe Care” includes infection prevention checklists.5 The “Guidelines for Infection Control in Dental Health-Care Settings — 2003” is also a good resource to keep handy.18

OSHAOSHA has an abundance of resources, including Safety and Health Topics: Dentistry, Medical & Dental Offices: A Guide to Compliance with OSHA Standards and Recommended Practices for Safety and Health Programs. This last document is an excellent resource, providing a step-by-step approach to implementing infection control protocol in the practice: osha.gov.

State Dental BoardsFind your state and download the infection control regulations: ada.org.

OSAPThe Organization for Safety, Asepsis and Prevention has a plethora of resources on infection prevention. They also offer an annual training session and an annual meeting. Start here by reading “The Role of the ICPC”. Sign up for their monthly newsletter to stay abreast

of the latest infection prevention news and education specifically tailored to the dental industry. To learn more about the benefits of becoming a member to OSAP, please click here.

CE CoursesLook for qualified infection control speakers who are focused on sharing the guidelines and regulations instead of opinions and products. You can also find on-demand webinars on Hu-Friedy’s website.

Hu-FriedyFor a more comprehensive and updated list on infection control resources, please click here.

DENTAL PRACTICE PROTOCOLS AND POLICIES CHECKLIST

Following are some areas that may require written protocols or policies per CDC Guidelines and your local state dental board:

p Exposure Control Plan

p Immunization Policy

p Hand Hygiene

p Respiratory Hygiene/Cough Etiquette

p Sharps Safety

p Safe Injection Practices

p Personal Protective Equipment

p Environmental Infection Prevention and Control

p Cleaning, Maintenance and Monitoring of Dental Unit Waterlines

p Sterilization and Disinfection of Patient-Care Items and Devices

p Cleaning and Sterilization Monitoring

p Dental Setting Response in the Event of a Reprocessing Failure or Error

p Education and Training Plan

p Routine Monitoring and Evaluation of the Infection Prevention and Control Program

1.12

CONCLUSION

Hopefully, as the new infection control coordinator, you feel comfortable knowing you know the steps to get started in your new role. Most of all, you should know the governing agencies and know where you can access key resources.

In the subsequent e-book (don’t worry, there are only two!), you’ll learn more about instrument reprocessing: everything from the flow of dirty to clean to how to transport, package, sterilize, and store instruments. And of course, we’ll share the do’s and don’ts and provide helpful tools and resources. By then, you’ll be well on your way to commanding the position of infection control coordinator with the utmost responsibility.

THE BASIC STEPS OF WRITING A PROTOCOL

Protocol-based practices are systematically developed, taking into consideration the individual circumstances of delivery of care.25 They are a benefit to medicine, increasing understanding of the steps involved to be in compliance and improving patient care. Developing a protocol is an ongoing process that involves continual evaluation.

Review regulator y requirements and recommendations

Assess needs: What needs to be done?

Research best practices and encourage staff input

Develop a written plan, which should include:

A brief description of the problem or contributing factors (evidence-based)

Preventive measures and tasks

The who, what, when, where, why, and how of the protocol

Draft and edit the policies and procedures

Obtain approval

Train and educate staff

Monitor and evaluate use of protocol

Review the protocol and make necessary revisions

HANDHYGIENEPROTOCOLPurpose Maintainproperhandhygiene.Principle(Why)

TheCDCstatesthathandhygieneisthesinglemostimportantmeasureforpreventingthespreadofbacteriainhealthcaresettings.TheCDCGuidelinesstate"Forroutinedentalexaminationsandnonsurgicalprocedures,handwashingandhandantisepsisisachievedbyusingeitheraplainorantimicrobialsoapandwater.Ifthehandsarenotvisiblysoiled,analcoholbasedhandrubisadequate.”Forsurgicalprocedures,surgicalhandscrubmustbeperformedbeforeputtingonsterilesurgeons’gloves.“Lotionsareoftenrecommendedtoeasethedrynessresultingfromfrequenthandwashingandtopreventdermatitisfromgloveuse."

Policy(Who,WhenWhereandWhat)

• Handhygieneisamandatorytaskforalldentalstaff.• Properhandhygienemustbeperformedbeforeandaftertreatingall

patients,beforeacleanorasepticprocedure,afterbodyfluidexposure,aftertouchingpatientsurroundings,immediatelyafterabreachininfectioncontrol,beforeputtingongloves,andaftertakingglovesoff.

• Handhygienemustbeperformedclosesttothepointofcontact,i.e.immediatelyuponentrytopatientoperatoryorsterilizationareaandafterpersonalprotectiveequipmentisremovedpriortoexitingoperatoryorsterilizationarea.

• Teammembersmustuseapprovedsoapwithwaterforhandwashingwhenhandsarevisiblysoiled(dirt,bloodorthepossibilityofotherbodyfluidsincludingsaliva).Whenhandsarefreeofdebris,teammembersmayuseapprovedalcohol-basedhandrub.

• Forsurgicalprocedures,cliniciansmustperformasurgicalhandscrubbeforeputtingonsterilesurgeons’gloves.

• Foralltypesofhandhygieneproducts,teammembersshouldfollowtheproductmanufacturer’slabelforinstructionsandtheproperapplicationtechniqueasshownintheHu-FriedyHandEssentialsHandCareGuidepostedineachoperatoryandinthesterilizationroom.

PPERequired n/aApprovedEquipmentandProducts(How)

Hu-FriedyHandEssentialsLotionSoapHu-FriedySterilliumComfortGelHandAntisepticHu-FriedyHandEssentialsSkinRepairCreamBetadineSurgicalHandScrub

Preparedby: JaneDoe,DAApprovedby: Dr.Smith,DDSApprovalDate: 4/1/2017NextReviewDate: 4/1/2018

Sample protocol to staff

CLICK HERE TO REQUEST A FREE STERILIZATION OBSERVATION BY A HU-FRIEDY EXPERT

We will provide an in-depth assessment of your practice’s instrument processing and infection prevention protocols against the current CDC Guidelines for Infection Control in Dental HealthCare Settings.

Hu-Friedy

THE ESSENTIAL GUIDE TO INFECTION CONTROL

PART 2: INSTRUMENT REPROCESSING

Pre-cleanerDetergents

Wrap & PouchesChemical Indicators

Biological Monitoring

UltrasonicWasher-Disinfector

AutoclaveHandpiece Lubricator

InstrumentsCuring Lights

Ultrasonic Scaler TipsHandpieces

INSTRUCTIONS FOR USE

A key task of the infection control coordinator’s duties in instrument reprocessing is to become familiar with the manufacturer’s instructions for use (IFU) for the equipment found in the sterilization area, their accompanying supplies and the reusable medical devices used for patient care. By understanding the relevant IFUs and how they should be used together, you can establish protocols that incorporate efficient, effective, and compliant policies and procedures.

Once you have reviewed all the IFUs for reprocessing reusable dental instruments and equipment, make a list of the processes and procedures and review them with the dental team along with the CDC’s categories of patient-care items (Table 1). Note that dental handpieces, low-speed motors, and reusable prophylaxis angles must never be high-level or surface disinfected. Instead, these devices must always be heat sterilized according to the manufacturer’s IFU.5

A successful infection prevention program hinges on properly written protocols and a knowledgeable and well-trained staff. The Essential Guide to Infection Control provides the dental team with a great starting point. Whatever your role or level of experience with infection prevention, this two-part eBook provides practical methods that can be used to help:

• Comply with best practice and industry standards in infection prevention

• Ensure patient and employee safety• Reduce risk and liability• Operate at optimal efficiency

Part 1: Getting Started as an Infection Control Coordinator led your team through the critical steps of establishing an effective and compliant infection prevention program. This included the identification of a

champion, a review of regulations and guidelines, and protocol development.

In Part 2: Instrument Reprocessing, the champion and dental team take a deep dive into the seemingly complex process of cleaning and sterilizing dental instruments. Each step in dental instrument reprocessing is critical to maintaining a safe, healthy and efficient environment for you, your staff and your patients. From transportation and cleaning to sterilization and storage, this guide breaks it down step by step into easy-to-implement best practices and highlights the applicable guidelines and regulations that come into play. By the time you finish Part 2, you will be well on your way to becoming an infection control champion.

The journey continues!

2.1

2.2

Additionally, all new reusable products should be cleaned and sterilized before the first use in order to remove any debris left from the manufacturing process. Please note single-use devices cannot be used more than once and should be disposed of in accordance with the manufacturer’s IFU.

Organizational Tip:Collect copies of all IFUs, organize them, and place them together in a binder near or in the sterile section of the reprocessing area for easy and quick reference. Review, replace, and update the binder annually or whenever new products or equipment are used.

CHAIRSIDE TO TRANSPORTATION

Prior to chairside cleanup, clinicians should remove all personal protective equipment (PPE) related to patient-care and don puncture- and chemical-resistant, heavy-duty utility gloves. All disposable sharps, single-use items, and waste should be separated and properly disposed of before transporting patient-care items to the sterilization area. Every patient room should have a puncture-resistant sharps container and hands-free trash receptacle that are easily accessible to a seated clinician. Instruments should then be checked for coarse impurities such as composite material, which should be removed chairside. If instruments will not be cleaned promptly following patient treatment, a pre-cleaning

detergent or product such as Hu-Friedy’s Enzymax® Spray Gel should be applied to the instruments’ surfaces. This will help prevent debris from drying onto the instruments making it easier to remove during the cleaning process. Instruments noted with excessive wear, defects or damage should be separated so they can be removed from service or recycled once they have been cleaned and sterilized.

The final step in preparing the instruments for transportation to the reprocessing area is to place them in a rigid, leak-proof container. This is both an Occupational Safety and Health Administration (OSHA) requirement and part of the CDC’s guidelines stating that personnel should “minimize handling of loose contaminated instruments during transport,” and “use work practice controls (e.g., carry instruments in a covered container) to minimize exposure potential.”18,26

Incorporating sterilization cassettes like Hu-Friedy’s Instrument Management System (IMS) allows for safe transportation, reduced instrument handling, efficient instrument processing, and much more. Whether or not your office uses IMS, a tray or tub with a locking lid can be used to safely transport instruments, cassettes, and other reusable patient-care items to the sterilization area for processing.

INFECTION CONTROL CATEGORIES OF PATIENT-CARE ITEMS

* Although dental handpieces are considered a semicritical item, they should always be heat sterilized between uses.

SOURCE: Centers for Disease Control & Prevention, 2003

Table 1

CATEGORY DEFINITIONPOTENTIAL RISK OF DISEASE TRANSMISSION

METHOD OF DECONTAMINATION

DENTAL INSTRUMENT/PATIENT-CARE ITEM

CriticalPenetrate soft tissue, contact bone, or enter into or contact the bloodstream or other normally sterile tissue of the mouth

Very high to high SterilizationSurgical Instruments, periodontal scalers, scalpel blades, surgical dental burs

Semicritical

Contact mucous membranes, or non-intact skin, but will not penetrate soft tissue, contact bone, or enter into or contact the bloodstream or other normally sterile tissue of the mouth

ModerateSterilization or high-level disinfection

Dental mouth mirror, amalgam condenser, reusable dental impression trays, dental handpieces*

Noncritical Contact intact skin Low to noneIntermediate- to low-level disinfection

X-ray head/cone, blood pressure cuff, stethoscope, facebow, pulse oximeter

2.3

INSTRUMENT REPROCESSING AREA

It is important to ensure the dental team understands the proper flow of instrument reprocessing. The CDC recommends every processing area to be divided into four sections to control quality and ensure safety: 18

1. Receiving, Cleaning & Decontamination

2. Preparation & Packaging

3. Sterilization

4. Storage

Proper PPE must be worn at all times when reprocessing contaminated patient equipment. This includes the use of utility gloves, clinic gown or jacket, mask, and protective eyewear. Scrubs are not considered PPE. Contaminated utility gloves should only be worn on the dirty side of the sterilization area and should be disinfected according to the the manufacturer’s IFU. Gloves are not required when removing wrapped cassettes or packs from the sterilizer once the sterilization cycle has been completed.

Sterile Cassette Storage

Steam Sterilizers

Automated Handpiece Cleaner (optional)

Operatory Prep Area

Dental Instrument Washer

Waste ReceptaclesChutes for regular waste and sharp/biomedical articles

Wrapping Drawers

Drying Drawers(optional)

Rinsing Sink

Drying Rack

Utrasonic Countertopor Recessed

ORGANIZATION• Instruments, accessories, and disposables

are standardized by procedure type

• Easy to locate and identify each procedural set-up

• Closed, sterile packages present a professional chairside image

• Requires less counter space than a tray and pouch system

STAFF SAFETY• Virtually eliminates hand scrubbing

• Provides safe transportation of instruments

• Minimizes handling of contaminated sharps to reduce risk of injury and exposure to bloodborne pathogens

INSTRUMENT INTEGRITY• Instruments are held securely in place with silicone rails

• Reduces chance of damage, lost or misplaced instruments

• Instruments are held in proper position for optimal cleaning (i.e. hinged instruments in open position).

EFFICIENCY• Spend more time chairside with patients and less

time locating instruments

• Ease of staff training with standardized set-ups

• Reduces set up and cleaning time

• Reduces need for manual sorting of instruments into pouches

• Entire cassette can be placed into ultrasonic or dental instrument washer and autoclaved for facilitated cleaning and sterilization

WHY USE A CASSETTE-BASED INSTRUMENT MANAGEMENT SYSTEM?

CLEANING PREPARATION STERILIZATION STORAGE

2.4

RECEIVING, CLEANING & DECONTAMINATION

Once contaminated cassettes or instruments have been transported to the dirty side of the sterilization area, they should be immediately processed. Cleaning is always the first step in the sterilization process as soils, residues, and heavy contamination can serve to protect pathogens on the instrument surface and prevent them from being sterilized. Dried-on debris can be difficult or nearly impossible to remove.

The method of cleaning must be as safe as possible for the personnel involved. According to OSHA standards, “all procedures involving blood or other potentially infectious materials shall be performed in such a manner as to minimize splashing, spraying, spattering, and generation of droplets of these substances.”26

Using an automated system such as an ultrasonic cleaner or washer disinfector will improve cleaning effectiveness and decrease worker exposure to sharps and bloodborne pathogens.8 Only equipment cleared by the Food and Drug Administration (FDA) for use in a medical setting should be utilized. Residential or commercial dishwashers should never be used to reprocess medical devices — the temperatures, cycle times, and detergents used have not been validated for use with these devices. Additionally, their use may violate device warranties, cause corrosion, and/or premature wear.

Hand scrubbing should be avoided if possible. It raises the risk of sharps injuries and exposure to aerosols and bloodborne pathogens. If hand scrubbing is absolutely necessary, wear puncture-resistant utility gloves and use a long-handled brush to allow enough clearance between your hands and sharp points.

If the instruments will be held for a period of time before cleaning and have not already been pretreated (as noted above), they should now be sprayed with an enzymatic pre-cleaner or placed in an enzymatic solution for pre-soaking. The enzymes help break down debris. Follow

the label directions for the pre-soak: it will likely include rinsing before cleaning the instruments. High-level disinfectants (also known as cold sterilants) are not intended for presoaking or using as holding solutions.

When using an ultrasonic cleaner, always follow the instructions for use for the cleaning device, the detergent, and the instruments being cleaned. Pay close attention to the time of exposure, detergent concentration, and temperature based on the IFUs. Keep the ultrasonic lid on during use to prevent aerosols from entering the air, change the detergent daily or more often if needed, avoid overloading the ultrasonic, follow weight limits and ensure all instruments are submerged in the solution. Never add instruments or cassettes to an ultrasonic that is already in use.

HU-FRIEDY CLEANING MONITORS

ULTRASONIC & WASHER-DISINFECTOR

The cleaning step is critical to proper instrument reprocessing. Improper cleaning resulting in unremoved debris prevents proper sterilization. To assure your cleaning process achieves the highest quality results, a cleaning monitor is recommended. The monitors contain a non-toxic soil that mimics the presence of blood and tissue on an instrument surface. Full removal of the test soil indicates an effective cleaning process. For the ultrasonic cleaner, the cleaning monitor provides insight into cavitation, time, temperature, and detergent concentration. As a multi-parameter test, the cleaning monitor is a superior test to traditional foil testing, which only provides an indication of cavitation. For the washer-disinfector, the cleaning monitor tests for time, temperature, water impingement, detergent effectiveness, and spray arm function. These tests are easy to read and provide reliable and accurate results. Including cleaning monitors in your daily or weekly cleaning protocols is a good way to ensure consistency, reliability, and effectiveness in your cleaning process. Click here to learn more about cleaning monitors.

2.5

When selecting an ultrasonic detergent, there are many options. A dual enzymatic cleaning detergent will provide accentuated cleaning. Hu-Friedy’s Enzymax and Enzymax Earth Ultrasonic Detergents include both a protease enzyme (breaks down proteins in blood and saliva) and an amylase enzyme (breaks down carbohydrates and starches). In addition, Steelgard™ agents protect instruments from harmful minerals found in water that contribute to buildup, spotting, and corrosion.

If using a dental instrument washer, the manufacturer will recommend a length of soaking time, ratio of detergent concentration, and cycle time. Reference the IFUs for both the dental instrument washer itself as well as the instruments being placed into the washer, as not all instruments can be cleaned in a washer. In addition, prior to considering the use of a dental instrument washer in the practice, a water test must be performed to assess the water quality (water hardness, water conductivity, and pH-value). Poor water quality can result in unsatisfactory cleaning results, including stains, spots, and corrosion on instruments.

After cassettes and instruments have gone through the cleaning cycle, they must be rinsed and thoroughly dried. If you use a dental instrument washer, the system will do the rinsing and drying. If using an ultrasonic cleaner, your protocol should include rinsing cassettes and instruments with tap water to remove any chemical residue and allowing the instruments to air dry thoroughly. Rinsing with hot water can help accelerate the drying process, as it encourages evaporation. Note that some cassette and instrument IFUs may recommend using demineralized water during this step. If using cassettes, utilize drying racks or stand them on edge to allow for proper drainage and to promote

air circulation. Fans should never be used to dry instruments or cassettes as they may cause cross contamination between dirty and clean items.

It is imperative that cassettes and instruments are completely dry before they are packaged for sterilization to help prevent cross contamination, corrosion, and discoloration. If packages go into the sterilizer wet, they will come out wet. If the packages come out wet, the paper on the pouch or wrap can funnel any moisture or bacteria from your hands through the paper, compromising the package’s sterility. This is referred to as “wicking.”

PREPARATION & PACKAGING

Prior to packaging, evaluate the condition of the instruments and check for any remaining debris or contamination as well as any broken, cracked, rusted, or damaged instruments. If damaged, package separately, sterilize, and remove from service. An environmentally friendly option is to recycle your instruments through a program like Hu-Friedy’s Environdent® .

Packaging used in the sterilization process must be an FDA-cleared medical device such as Hu-Friedy’s Bagette® Sterilization Pouches, Hu-Friedy Sterilization Wraps or Sterilization Containers. FDA-cleared packaging has been tested for use in a sterilizer and is permeable to either the chemical or steam used in the sterilization process.27

WHAT SHOULD I DO WITH HANDPIECES AFTER TREATMENT?

When packaging instruments and cassettes, it is important to ensure that the packaging does not have open gaps.

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. Although these devices are considered semi-critical, studies have shown that their internal surfaces can become contaminated with patient materials during use. If these devices are not properly cleaned and heat sterilized, the next patient may be exposed to potentially infectious materials.5

2.6

Sterilization wrap and pouches come in a variety of sizes. It is imperative to follow the IFU for the packaging. For example, many wrap IFUs call for the use of two sheets either sequentially or simultaneously when wrapping packages for sterilization.

When utilizing pouches, avoid overloading by laying contents flat in a single layer and allowing for at least one finger width of space between the instruments or cassettes and the inside edge of the pouch.

Unless otherwise indicated, most packaging is for single use only. That includes plastic tubing, wrap, and plastic or paper pouches.

Be sure to place an internal chemical indicator or integrator inside every instrument package prior to sterilization. If the internal indicator is not visible from outside the package, an external indicator, such as autoclave monitor tape, should be used on the outside of the package. Never cut an indicator or integrator to shorten it or use it in multiple packages. Using a non-toxic marking pen or ink, label packages with the date and load. If you have multiple sterilizers, you should also note which sterilizer was used. When using pouches, always write on the plastic side. When using wrap, only write on the tape.

STERILIZATION

After critical and semi-critical patient-care items have been wrapped or prepared to maintain sterility during storage, they must be heat sterilized. The most common and most widely accepted best practice is steam sterilization (autoclave). Other methods include dry heat and unsaturated chemical vapor sterilization, however these are not widely used today. Most instruments are validated for use with steam sterilization. Follow the sterilizer and instrument manufacturer’s IFUs to set the proper sterilization cycle and only use sterilizers cleared by the FDA for use in medical settings.

Sterilization Tips:

• Every sterilizer must be routinely inspected and maintained. Please follow manufacturer’s IFU.

• Understand manufacturer’s IFU for which sterilization cycle to use (i.e., pouches cycle, packs, etc).

• All sterilizers have a weight or load capacity. Know what this is for all of your sterilizers and adhere to those maximums. Cassettes help to stay compliant with these requirements.

• Don’t stack pouches and wrapped cassettes on top of one another in the sterilizer. This can prevent the sterilizing agent from reaching the instruments inside. Use appropriate racks as recommended by the equipment manufacturer.

• Always allow the sterilizer to complete its full cycle, including drying, before removing any items. Packages should be completely dry and allowed to cool to room temperature before handling to avoid contamination.16 Packages removed prematurely or are wet upon removal are not considered sterile.

• Never store sensitive items or sterile packages, including pouches and wrapped cassettes, above the sterilizer where they may be exposed to released moisture.

STERILIZATION MONITORING

There are three ways to monitor the sterilizer: mechanical, chemical, and biological. Every sterilization pack and load should be monitored with both mechanical and chemical indicators.18 External and internal indicators (if visible) should be checked after each sterilization cycle is complete. If internal indicators are not visible, as is the case with a wrapped cassette,

2.7

STERILIZATION MONITORING TIPS

• Chemical indicators should not replace biological indicators, as only a biological indicator consisting of bacterial spores can measure the microbial killing power of the sterilization process.

• The CDC’s 2003 recommendations suggest utilizing both an internal indicator, which shows if the chemical or steam reached the item, and an external indicator, which shows if the item was processed. There are some packages on the market that include both.

• Due to the sensitive materials contained in chemical indicators, it is important to store both processed and unprocessed indicators at room temperature and away from sources of heat, steam, and moisture.

Table 2

they should be checked when opening the package at chairside. The sterilizer itself should be tested at least weekly using a biological indicator.18 If you receive a failure at any step of monitoring, consult your autoclave and indicator instructions for use on what to do in the event of a failure. Do not allow the use of any items from a sterilizer pack or load linked to a failed test.

Mechanical indicators Autoclaves are equipped with gauges or readouts indicating the cycle time, temperature, and pressure for each instrument load. Many automatically log this data on a printout or capture it electronically and provide warnings when an error or failure has occurred.

Chemical Indicators Chemical indicators are either physical or chemical devices used to monitor one or more of the process parameters (time, temperature, and presence of saturated steam) of the sterilization cycle in packs and loads. These indicators provide easy-to-interpret visual cues, such as a color change, to indicate when they have been exposed to the proper sterilization parameters. There are various types (formerly referred to as classes) of chemical indicators and each

TYPE DESCRIPTION COMMON USES

Type 1: Process Indicator

Reacts to one or more of the process variables to show whether or not the pack has been exposed to sterilization

Monitor Tape, indicator strips, pouches

Type 2: Specific Test Indicator

Bowie-Dick tests Used for equipment control to evaluate sterilizer performance

Type 3: Single Critical Process Variable Indicator

Reacts to one critical process variable Rarely, if ever, used in dental settings

Type 4:Multi-Critical Process Variable Indicator

Reacts to more than one critical process variable Indicator strips

Type 5: Integrating Indicator

Reacts to all process variables; performance is comparable to biological indicator in saturated steam

Indicator strips; used as pack control and load control (that do not contain implants)

Type 6: Emulating Indicator

Cycle verification indicators designed to react to all critical process variables for specific sterilization cycles

Test for specific sterilization cycles. An end user will need to inventory a different emulating indicator for each sterilization cycle time and temperature run.

STERILIZATION MONITORING – CHEMICAL INDICATOR CATEGORY TYPES

SOURCE: ISO 11140-1:2014 Sterilization of health care products — Chemical indicators — Part 1: General requirements

2.8

type measures the sterilization variables a bit differently. Please review the types and their descriptions in Table 2 on the previous page.

Knowing the types of indicators available is important so that you can incorporate the appropriate one to fit your needs into your protocols. Most indicators found in the dental industry are Types 1, 4 and 5. Any of them are acceptable according to the CDC Guidelines. However, since integrating indicators such as Hu-Friedy’s Steam Sterilization Integrators are generally considered equivalent to the performance requirements for biological indicators, they are the most accurate type of internal chemical indicators.

If a chemical indicator indicates a failure, it means it was not exposed to the proper sterilization conditions. In such cases, the instrument pack or load should be re-sterilized.

Biological Indicators The CDC recommends monitoring sterilizers at least weekly with biological indicators and with every load of implantable devices. In the U.S., most states have adopted CDC recommendations as law. Check to see whether your state or provincial dental board or governing body has different requirements. A simple solution for remembering to do biological spore testing is to put it in the calendar with an alert to remind you, as well as assigning one person to perform this task.

Biological monitoring can be performed in two ways. The quickest option is to use an in-office incubator and spore monitoring vials such as Hu-Friedy’s SporeCheck™ In-Office Biological Monitor Test. This method can detect a failure within two to three hours and provides complete results within 24 hours giving you the peace of mind that your sterilizer is working properly. The other option is to use a mail-in spore monitoring program, but it can often take up to a week to receive results. Read your IFU for your sterilizer and follow the manufacturer’s instructions. Always use the proper test for your specific sterilizer and maintain a log of spore test results.

RECORD-KEEPING

Proper and detailed record-keeping is critical in responding to a positive monitoring result as well as demonstrating proper compliance to CDC guidelines. Retain sterilization records (mechanical, chemical, and biological) for a time period that complies with standards (e.g. three years), statutes of limitations, and state and federal regulations.28

STORAGE & PREP TIPS

• The shelf life of a sterilized pack can be based on either date- or event-related storage practices.18 Always check the integrity of the package and instruments before opening the package. Compromised packages need to be cleaned, repacked and sterilized again.

• Instruments should remain packaged until the clinician is ready to use them. This will help reduce the possibility of cross contamination.

• Reassure the patient of sterility by opening the sterile package in front of them. You can also be sure that no fomites or aerosols have impacted the instruments.

2.9

It is important to keep a log that includes all sterilization parameters for reference:

• Sterilizer identification number (if multiple)• Sterilization date/cycle• Duration & temperature of cycle• Contents of load• Confirmation of mechanical monitoring• Confirmation of chemical monitoring• Operator’s name• Weekly biological monitoring & maintenance

STORAGE & PATIENT PREP

If kept for any period of time prior to patient treatment, sterilized packages should be stored in a dry area with no chance of exposure to moisture. Avoid storing packs under sinks, near compressors, or over sterilization devices or ultrasonic baths. These are areas that can result in contamination of the instrument packaging.

Storage areas should be clean and free of debris, dust, or contaminated substances or instruments. Cleaning and maintenance of these areas should be performed on a regular schedule. If drawers or cabinets are used to store packs, ensure that opening and closing them does not compromise the packaging material.

SHARPS INJURIES

Sharps injuries occurring during instrument reprocessing are most commonly a result of not utilizing proper personal protective equipment and an instrument management system such as cassettes. They often happen when transporting and cleaning instruments. Here are three areas to focus on in order to avoid sharps injuries.

1. Utility Gloves

Always use utility gloves when handling instruments and cassettes following patient treatment. Using patient exam gloves instead of puncture and chemical resistant utility gloves puts the staff at risk for chemical exposure and sharps injuries. Utility gloves should not be bulky and should enable tactical sensitivity. Always order gloves to fit every member of the clinical team, label them with the clinician’s name and store them in an easily accessible spot.

2. Cassette-based Instrument Management Systems (IMS)

IMS is a great tool in the office. It not only reduces the handling of loose instruments that can lead to sharps injuries, but it helps prevent dulling, damage and loss of instruments. It also helps prevent overloading the instruments in the sterilizer and ultrasonic bath.29 In addition, properly utilizing IMS saves time in sterilization and helps everyone stay organized. It also helps team members keep instruments organized by procedure type and keeps them together so nothing is missing during a procedure.

3. Transportation

The CDC states, “Contaminated instruments should be handled carefully to prevent exposure to sharp instruments that can cause percutaneous injury. Instruments should be placed in an appropriate container at the point of use to prevent percutaneous injuries during transport to the instrument processing area.” 18 This prevents any possibility of spilling or dropping the instruments during transportation and lessens the risk of a sharps injury.

CONCLUSION

Instrument reprocessing is not a static function. It is something that needs to be reviewed and evaluated on a regular schedule. Take advantage of the list of resources in this eBook which include regulatory guidelines as well as educational webinars and articles. Reading the two parts of this guide and utilizing the resources provided will set you on the right track for success.

Want to find out how your practice’s instrument processing and infection prevention protocols line up with the Centers for Disease Control and Prevention (CDC) Guidelines for Infection Control and best practices in the dental office?

Find out with this short quiz from Hu-Friedy!

2.10

DO DON’T

Have and know the IFU for your sterilizer, cleaning equipment, instruments and other FDA-cleared medical devices

Go by what others tell you in place of reading the IFU

Use an enzymatic pre-cleaner or pre-soak in an enzymatic solution when you cannot immediately clean the instruments

Use a detergent or cleaner not developed specifically for use with medical instruments in place of an enzymatic cleaner

Utilize single-use disposable sterilization pouches and wrap

Reuse single-use sterilization pouches and wrap

Load the sterilizer according to the manufacturer’s instructions for use

Overload the sterilizer or lay packs on top of one another

Always cover instruments when transporting them

Transport loose instruments on a tray or carry them in your hand

Perform biological testing weekly or with every sterilization of an implantable device in the load

Move or relocate the sterilizer and not perform an additional spore test

Use an FDA-cleared washer-disinfector to clean instruments

Use a residential- or commercial-grade device to clean instruments and other medical devices

Wear utility gloves that are puncture and chemical-resistant in the dirty section of the sterilization area and when breaking down rooms or working with chemicals

Wear exam or household gloves in the dirty area of the sterilization area and when breaking down rooms or working with chemicals

Dry instruments thoroughly before packaging Load wet instruments or cassettes into sterilization packaging

Fill the pouch properly Overfill the pouch

Allow sterilization packs to run through the entire cycle, including drying, to avoid wicking of bacteria and viruses

Interrupt the sterilization cycle or remove packs while wet

Immediately put instrument packs in an enclosed cabinet, drawer or container after sterilization

Leave instrument packs on counter or remove instruments from sterilization packaging until immediately before use on patient

REPROCESSING DO’S AND DON’TS

2.11

RESOURCES FOR INSTRUMENT REPROCESSING

CDCGuidelines for Infection Control in Dental Health-Care Settings — 2003

Summary of Infection Prevention Practices in Dental Settings: Basic Expectations for Safe Care (includes infection prevention checklists)

Infection Prevention & Control Guidelines & Recommendations

Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008

OSHAOSHA Standards

OSAPThe Role of the ICPC

Knowledge Center

STATE DENTAL BOARDS Find your state & download the infection control regulations at ada.org

HU-FRIEDY EDUCATION: On-Demand Webinars

HELPFUL TOOLS: Hu-Friedy’s Reprocessing Guidelines

Hu-Friedy Infection Control Self Check

3 hour CE: Team-Centered Approach to Instrument Processing & Infection Control

Infection Prevention & Instrument Processing Recommendations

Instrument Processing

ARTICLES: Considerations for Processing Dental Instruments: Trays vs. Cassettes By Catherine Pawloski, RDH and Marie T. Fluent, DDS

On Your Mark, Cassette, Get Organized By Olivia Wann, JD, RDA

Give Me Some Space! Following CDC Guidelines for an Ideal Sterilization Area By Olivia Wann, JD, RDA

Instrument Cassettes: An Effective Infection Control Precaution By John Molinari, PhD; Jennifer A. Harte, DDS, MS; and Peri Nelson, BS

Instrument Cleaning: Why, Who, and How? By Marie T. Fluent, DDS

Why Instrument Processing Matters: The Reality By Mary Govoni, CDA, RDA, RDH, MBA

Navigating Infection Prevention Practices in the Dental Setting By Noel Brandon-Kelsch, RDH, RDHAP

Work Smarter, Not Harder in the Operatory By Jessica Wilson

KEY WEBINARS:

Protecting Yourself & Your Patient: Sterilization Protocol By Mary Govoni, CDA, RDA, RDH, MBA

Process Monitoring: Instrument Reprocessing & Waterlines By Karen Gregory, RN

2.12

1. Redd JT, Baumbach J, Kohn W, Nainan O, Khristova M, Williams I. Patient-to-patient transmission of hepatitis B virus associated with oral surgery. J Infect Dis. 2007;195(9):1311-14. Published May 1, 2007.

2. Radcliffe RA, Bixler D, Moorman A, et al. Hepatitis B virus transmissions associated with a portable dental clinic, West Virginia, 2009. J Am Dent Assoc. 2013;144(10):1110-8.

3. Dental Healthcare-Associated Transmission of Hepatitis C: Final Report of Public Health Investigation and Response, 2013. Oklahoma State Department of Health website.

4. Klevens RM, Moorman AC. Hepatitis C virus: an overview for dental health care providers. J Am Dent Assoc. 2013;144(12):1340-7.

5. Summary of Infection Prevention Practices in Dental Settings: Basic Expectations for Safe Care. Centers for Disease Control and Prevention. Published March 2016.

6. Hazard Communication Guidelines for Compliance. U.S. Department of Labor Occupational Safety and Health Administration. Accessed December 2016.

7. Model Plans and Programs for the OSHA Bloodborne and Hazard Communication Standards. U.S. Department of Labor Occupational Safety and Health Administration. Accessed August 2016.

8. Gould D. Hand hygiene in health care. J Hosp Infect 1994;28:15-30. 106

9. Pittet D, Hugonnet S, Harbarth S, et al. Effectiveness of a hospital-wide programme to improve compliance with hand hygiene. Infection control programme. Lancet 2000:356;1307-12.

10. Boyce JM, Pittet D. Guideline for Hand Hygiene in Health-Care Settings: Recommendations of the Healthcare Infection Control Practices Advisory Committee and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force. MMWR 2002;51(RR-16). Published October 25, 2002.

11. Cues, Scents Can Help Boost Hand Hygiene Compliance. Infection Control Today website. Published December 20, 2015. Accessed June 21, 2016.

12. Your 5 Moments for Hand Hygiene. World Health Organization. Published March 2012.

13. Hu-Friedy Hand Essentials Hand Care Guide. Hu-Friedy.

14. Guidelines for Environmental Infection Control in Health-Care Facilities: Recommendations of CDC and the Healthcare Infection Control Practices Advisory Committee (HICPAC). MMWR 2003;52(RR-10). Centers for Disease Control and Prevention. Published 2003.

15. Frequently Asked Questions – Personal Protective Equipment (Masks, Protective Eyewear, Protective Apparel, Gloves). Centers for Disease Control and Prevention. Updated July 10, 2013.

16. Miller CH, Palenik CJ. Infection Control and Management of Hazardous Materials for the Dental Care Team. Elsevier Health Sciences; 2014.

17. Perspectives in Disease Prevention and Health Promotion Update: Universal Precautions for Prevention of Transmission of Human Immunodeficiency Virus, Hepatitis B Virus, and Other Bloodborne Pathogens in Health-Care Settings. MMWR Weekly 1988;37(24);377-88. Published June 24, 1988.

18. Kohn WG, Collins AS, Cleveland JL, Harte JA, Eklund KJ, Malvitz DM. Guidelines for Infection Control in Dental Health-Care Settings — 2003. MMWR Recomm Rep 2003;52(RR-17). Published December 19, 2003.

19. Harte JA, Molinari JA. Personal Protective Equipment. In: Molinari JA, Harte JA, eds. Practical Infection Control in Dentistry, 3rd ed. Baltimore: Lippincott Williams & Wilkins, 2010.

20. Eye Safety. Centers for Disease Control and Prevention website. Updated July 29, 2013.

21. Rutala W. Disinfection, Sterilization and Antisepsis Principles, Practices, Current Issues, New Research, and New Technologies. 44:5(e1-e100). Published May 2, 2016.

22. Peralta G, Tobin-D’Angelo M, Parham A. Notes from the Field: Mycobacterium Abscessus Infections Among Patients of a Pediatric Dentistry Practice — Georgia, 2015. Morbidity and Mortality Weekly Report (MMWR) 65(13);355-6. Published April 8, 2016. Accessed August 2016.

23. Team Vista Dental Waterline Cleaner by Hu-Friedy: the Complete Waterline Security System. Hu-Friedy.

24. Dental Unit Waterline Toolkit. Organization for Safety, Asepsis and Prevention (OSAP) website.

25. Campbell NJ. Writing Effective Policies and Procedures: A Step-By-Step Resource for Clear Communication. New York, NY. AMACOM; 1998.

26. OSHA Bloodborne Pathogens Standard Title 29 Code of Federal Regulations, Part 1910.1030. Federal Register 56(235):64004-64182. Published December 6, 1991.

27. Rutala WA, Weber DJ. Choosing Sterilization Wrap for Surgical Packs. Infect Cont Today 2000;4:64-70.

28. Rutala WA, Weber DJ, et al. Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008. Centers for Disease Control and Prevention website. Updated February 15, 2017.

29. Sanchez E, Macdonald G. Decontaminating dental instruments: testing the effectiveness of selected methods. J Am Dent Assoc. 1995 Mar;126(3): 359-62, 364, 366 passim.

Hu-Friedy Mfg. Co., LLC: 3232 N. Rockwell St. | Chicago, IL 60618 | USA Telephone: 1-800-Hu-Friedy or 1-773-975-6100 | Website: Hu-Friedy.com

© 2017 Hu-Friedy Mfg. Co., LLC. All rights reserved. [841] N2776/1117

CITATIONS