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Safety Challenges in Dental SettingsSeptember 25, 2020

Jay Afrow DMD, MHA, Surveyor, Ambulatory Health Care

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It’s Actually:• Patient assessments• Informed consents• Invasive procedures• Pain management• Low and high-level

disinfection• Instrument sterilization• Aerosol generating

procedures

• Medication administration, prescribing, and reconciliation

• Maintenance of emergency medications and supplies

• Utilization and storage of hazardous materials, gasses and energy

“It’s Just Dental”

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Applicable to Dental

Human Resources• Qualifications (HR.01.01.01, HR.01.02.05, HR.01.02.07)• Staff Orientation (HR.01.04.01)• Training and Education (HR.01.05.03)• Competency Assessment (HR.01.06.01)• Performance Evaluation (HR.01.07.01)• Credentialing and Privileging (HR.02.01.03)• Provider Orientation (HR.02.02.01)

State requirements:• DMD- Licensure/Sedation/CBCT/CPR• RDH-Licensure/Scope/ Anesthesia/CPR• DA- Registration/Certifications/CPR

(https://www.danb.org/Meet-State-Requirements/State-Specific-Information.aspx)

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Dental Hygienist• Dentist authorizes patient care • Dentist must be present when hygiene

care is provided• May administer local anesthetic, if

requirements met (35 states)Direct Access Dental Hygienist with supervision (25 states)• Can initiate treatment without the

authorization of a dentist• Can treat the patient without the

presence of a dentist under indirect supervision

Direct Access Dental Hygienist without supervision (17 states)• Do not require supervision by a dentist

to provide hygiene care• Can work in their own officeDental Therapists (13 states)• Midlevel providers who are trained to

offer preventive and some restorative services, such as filling cavities.

• Therapists work under general supervision with collaborative agreement which would allow a therapist to provide care when the dentist is not physically present.

(https://www.adha.org/scope-of-practice)

RDH Scope of Practice

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Applicable to Dental

National Patient Safety Goals• Patient identification (NPSG.01.01.01)• Medication and Solution Labeling (NPSG.03.04.01)• Medication Reconciliation (NPSG.03.06.01)• Hand Hygiene (NPSG.07.01.01)

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Universal Protocol

UP.01.01.01Pre-procedure verificationUP.01.02.01Dental Site Marking:

• Paper • Electronic record

• ToothUP.01.03.01Time out:

• Activity ceases• Involves the patient• Documentation

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Applicable to Dental

Provision of Care• Assessments (PC.01.02.03)• Pain assessment and tx. (PC.01.02.07)• Abuse/Neglect identification (PC.01.02.09)• Treatment plan (PC.01.03.01)• Emergency protocols (PC.02.01.09)• Learning needs assessment (PC.02.03.01)• Sedation/Anesthesia (PC.03.01.01-7)

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Applicable to Dental

Medication Management• High alert/ hazardous (MM.01.01.03)• Look alike/ sound alike (MM.01.02.01)• Formulary (MM.02.01.01)• Storage/Security (MM.03.01.01)• Emergency meds and supplies (MM.03.01.03)• Labeling (MM.05.01.09)• Dispensing (MM.05.01.11)• Antimicrobial Stewardship (MM.09.01.01)

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Applicable to Dental

Septocaine

Carbocaine

Has the organization considered any dental medications for the“Look alike/ sound alike” medication list

©Jay Afrow

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Local Anesthetics

Local Anesthetic Cartridges

• Manufacturer IFU• Wiping prior to use with

appropriate product• Cartridge storage

• Extra cartridges on the field• Extra cartridges on the countertop

– CDC: Poor practice but no rule

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Hazards in Dental

Butane Torch

Amalgam Capsules Compressed Gas

Sharps Container X-ray tube

37% Orthophosphoric Acid9.5% Hydrofluoric Acid

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• Applicable dental products should be on the organization’s hazardous material inventory

• Appropriate storage, handling, and disposal process

• Eye Wash Stations if caustic or corrosive chemicals are used

• Flammable item storage• Sharps (burs, wires, bands, needle recapping,

hand scrubbing)• Laser Safety• Appropriate PPE available and worn

Exposure to Hazardous Materials

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Disposal of Hazardous Materials

If the office places or removes amalgam:Federal EPA requirement (7/14/20):

– Amalgam separator for wastewater– Compliance with ADA BMP

ADA Amalgam Best Management Program– Requires recycling of:– Empty amalgam capsules– Contact and non-contact amalgam– Amalgam traps and filters– Extracted teeth containing amalgam

https://www.epa.gov/eg/dental-effluent-guidelines-documents Amalgam Capsule

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Minimizing the Risks Associated with Radiation

• Organization determines lead apron inspection frequency, method and tracking

• Ensure outer surface is intact• What is the radiation dosimetry

monitoring process for organization?• Dental Cone Beam CT is exempt from

all TJC CT requirements. However, there may be state inspection, policy, and education requirements

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Equipment Maintenance

Maintenance per manufacturer’s instructions for useEquipment that may be present

• Patient monitoring equipment• Nitrous oxide systems• Compressors and vacuum systems• Autoclave or sterilizer• Automatic instrument washer• X-ray units• Cone Beam CT• Amalgam separator• Lasers • Dental treatment units

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Select a Guideline

AAMI-Association for the Advancement of Medical Instrumentation

AORN-Association of Perioperative Registered Nurses

APIC-Association for Professionals in Infection Control

CDC-Center for Disease Control HICPAC-Healthcare Infection

Control Practices Advisory Committee

WHO-World Health Organization

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Guideline VariationAAMI

Sterile packs are labeled with the sterilizer used, cycle/load number, operator and the date of sterilizationDocumentation Load number Contents and description of load Exposure time, temperature and

pressure Operator identification BI results, if applicable Bowie Dick, results if applicable Chemical indicator results Any chemical indicator failures

found in packs

CDCSterile packs are labeled at a minimum with the sterilizer used, cycle or load number, and the date of sterilizationDocumentation Logs for each sterilizer cycle

are current and include results from each load and comply with state and local regulations

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Useful App for CDC Guideline

https://www.cdc.gov/oralhealth/infectioncontrol/dentalcheck.html

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Spaulding Classification

Risk of Infection

(Level)

Dental Examples Definition MinimumDisinfection

Level

Level of Microbicidal

ActionLow

(Non-Critical)• BP cuffs, • Cords and tubing• Lead Aprons• Environmental

surfaces

Items in contact with intact skin.

Low-Level Disinfection

Kills vegetative bacteria, fungi and lipid viruses

Moderate(Semi-

Critical)

• X-ray sensors*• Material syringes*• Intraoral camera*• Curing lights*

Items that encounters mucous membranes or non-intact skin but does not penetrate them

High- Level Disinfection

Kills all microorganisms, except high numbers of bacterial spores

High(Critical)

• Instruments • Needles• Handpieces• Dental Burs

Equipment/device that enters sterile tissues, including the vascular system

Sterilization Kills all microorganisms

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Low Level Disinfection

Use disinfection product per IFU (Contact Times)

If surface is difficult to clean/disinfect or it’s not recommended by manufacturer’s IFU, utilize appropriate covering

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IFU Example Curing Light

• Curing light must be used with barrier sleeves to avoid patient contact and cross contamination.

• After each use, moisten a gauze or soft cloth with an anti-microbial surface disinfectant and wipe the surface and lens.

• ACCEPTABLE CLEANERS: • Cavicide™ products • Isopropyl alcohol-based cleaners • Ethyl alcohol-based cleaners • Lysol® disinfectant

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IFU Example Intraoral Camera

• The handpiece should only be used with a Camera Sheath that prevents any infection hazard to the patient.

• Use a new disposable Camera Sheath for each patient.• Do not autoclave the Camera Handpiece. • Do not immerse the Camera Handpiece in liquid of any kind. • Cleaning products containing the ingredients listed below are

prohibited for use. • Ammonia • Ammonium Chloride • Benzene • Cavicide™

• CaviCide1™ • CaviWipes™ • CaviWipes1™ • Denatured alcohol • DisCide® Ultra • Ethanol • Ethylene Glycol Monobutyl Ether • Glutaraldehyde • Iodine solutions • Isopropyl alcohol (higher than 70%) • Lysol ® • Methyl Ethyl Ketone • Opti-Cide³ ® • Phenol based compounds

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IFU Multiple-use Plastic Dental Dispensers

DO:• Apply disposable barrier

sleeves/wraps over multiple-use dental dispensers before use with each patient.

• Use new, uncontaminated gloves when handling multiple-use dental dispensers.

• Avoid contact of the reusable parts (e.g., the body of the multiple-use dental dispenser) with the patient’s mouth.

DO NOT:• Reuse the multiple-use dental

dispenser if it becomes contaminated.

• Reprocess a contaminated multiple-use dental dispenser by using chemical wipes or disinfectants.

• Immerse multiple-use dental dispensers in a high-level chemical disinfectant. This may damage the dispenser and the material contained

SOURCE: FDA Infographic www.fda.gov/MedicalDevices/ ProductsandMedicalProcedures/ DentalProducts/ucm404472.htm

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Manufacturer’s Instructions for Use (IFU)

The manufacturer’s instructions for use (IFU) will advise the end user what cleaning, disinfection, and sterilization processes the item can undergo or tolerate

• “The product may be wiped with a surface disinfectant, high level disinfected, or sterilized” (Quote from IFUs)

The end user must determine how the item is cleaned, disinfected or sterilized based on the type of patient contact (Spaulding Classification)

Impression Gun

Unit dose compositeCapsule dispenser

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Dental Burs

• Single or Multiple Use

• Single, bulk, or blister pack

• Sterile or non-sterile

• Complex MIFU

• Diamond versus Carbide

• Burs range in cost from $0.49- $20.00+ Diamond Carbide

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Dental Bur Reprocessing IFU - Example

Cleaning:

1. If you choose to reprocess burs, avoid delaying following use as this increases the chance of debris drying on the working area. If debris does dry on the burs, they must be cleaned manually with a brush.

2. Burs can be ultrasonically cleaned when inserted in bur blocks or holders to prevent damage from rubbing or vibrating against each other or hard surfaces. An ultrasonic cycle of 5 minutes using a neutral-pH ultrasonic cleaner is recommended.

3. After the ultrasonic cycle, use a brush to remove remaining debris and rinse under running water.

4. Immediately dry the burs thoroughly with an absorbent towel or paper tissue.

5. After the cleaning process, inspect and discard any burs that show signs of damage or corrosion.

Sterilization:

1. Dip the burs in an anticorrosive lubricant prior to the sterilization cycle. Place the burs in bur blocks or sterilization trays. Put the bur blocks or trays in a sterilization pouch and seal.

2. In the wrapped condition…. For the pre-vacuum steam sterilization method, 132°C minimum for 4 minutes. For the gravity sterilization method, 132°C minimum for 15 minutes. Distilled water must be used in any steam sterilization process.

3. The burs must be allowed to go through the full drying cycle before they are removed from the sterilizer. The drying time is 20 minutes for pre-vacuum and 15 minutes for gravity steam sterilization.

4. Before re-using the burs, check for signs of rust or corrosion. Do not use any burs that are corroded or damaged.

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Sterilization

1. Wipe/Flush during procedure2. Enzymatic Spray (if needed)3. Cleaning

1. Manual2. Automated

4. Inspect/ Package 5. Sterilization 6. Storage

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Instrument Transportation

If cleaning is delayed, keep moist:1. Spray on detergent2. Wet towel

OSHA 29 CFR 1910.1030(d)(2)(viii)Immediately or as soon as possible after use, contaminated reusable sharps shall be placed in appropriate containers until properly reprocessed. These containers shall be:

– Puncture resistant; – Labeled or color-coded– Leakproof on the sides and bottom

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Instrument Processing Location

Divide the instrument processing area, physically or, at a minimum, spatially, into distinct areas for:– Receiving, cleaning, and decontamination– Preparation and packaging– Sterilization– Storage.

Clean-to-soiled air flow is desired, but not required if one room is used for the complete process.Guidelines for Infection Control in Dental Health-Care Settings (2003) Instrument Processing Area

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Dirty Instrument Cleaning

Personal Protective Equipment (PPE) is worn and includes:– Face mask/shield – Fluid resistant gown covering arms– Gloves used should be durable to prevent tearing and leaking of

chemicals and/or contaminated fluids when the user’s hands are under water

PPE worn during dirty instrument cleaning process is not worn in the patient treatment area

If hand washing instruments, appropriate brushes and cleaning products used following IFU

Ultrasonic or automatic washers have the correct cleaning products and testing per IFU

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Handpiece Lubrication

Use lubricant spray for handpieces per product instructions

Attach handpiece to air line or air station to remove excess lubricant per spray or handpiece instructions for use

Excess spray can damage peel packages during sterilization process

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Instrument Reprocessing

Do not write or stamp on paper side of peel packages

Do not fold inner peel packagesInspect packages prior to storage

– Water or burn marks– Punctures– Dirty or rusted instruments– Staining from lubricant

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IFU Examples

Dental Handpieces Composite Placement Gun The Composite Gun may be

wiped with a surface disinfectant, high level disinfected, or sterilized

Plastic Cheek Retractor Autoclave @ 120°C / 248°F for

30 minutes.

Sterilize 273°F +/- 4°F for 10 minutes or 250°F +/- 4°F for 60 minutes

Sterilize 270°F for 15 minutes or 250°F for 20 minutes

Sterilize 270°F for 10 minutes or 250° F for 50 minutes

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Sterilization Monitoring

Process Indicators

Physical Indicators– Time, temperature, pressure of autoclave cycle

Chemical Indicators/Integrators– On and/or in each package to visibly show its

processedBiological Indicators (Spore Testing)

– Processed along with a load for sterilization verification

– Minimum weekly or guideline based – Spore testing in office or mail away– Appropriate for autoclave

Documentation requirements based on selected guideline

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Autoclave Maintenance

Daily– Clean External Surfaces…

Weekly– The sterilizing chamber and instrument

trays should be cleaned weekly… Monthly

– The system must be flushed once a month with Speed Clean Sterilizer Cleaner…

Annual – Maintenance by technicians at frequency

specified Document all maintenance procedures

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Infection Prevention Hierarchy

CoPs and

Rules and Regulations

CoPs and CfCs(Deemed Status)

Manufacturer Instructions for Use

Evidence Based Guidelines

Consensus Documents

Organization Infection Prevention and Control Policy

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Dental Waterlines

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CDC and Dental Waterlines

The CDC recommends that dental unit water used in non-surgical procedures measure less than or equal to (≤500 CFU/mL) of water, the standard set for drinking water by the Environmental Protection Agency (EPA).

Independent reservoirs or water-bottle systems alone are notsufficient.

Use sterile saline or sterile water as a coolant/ irrigation when performing surgical procedures.

Follow dental unit manufacturer’s instructions for maintaining and monitoring the quality of dental unit water.

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Example Dental Unit IFU

The Maintain│Monitor│Shock approach To optimize the quality of your dental unit

water, be sure to use a fresh tablet every time you refill a self-contained water bottle

Initially, test once per month. If monthly results meet goal for three successive months, the testing frequency can be reduced to once every three months.

Recommend 500 CFU/ml as an action level. If test results are greater than the action level, perform the shock treatment. Otherwise, continue daily waterline maintenance

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Observations

Hinged instruments must remain open during cleaning and the sterilization process

Should not be in the locked position

Damaged peel packages in storage

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Observations

Use Appropriate Products Instrument Manufacturer 1

– Wash instruments with a neutral pH(7) soap (Do not use Betadine, saline chlorhexidine solution, or any surgeon’s hand scrub)

Instrument Manufacturer 2 – Use stiff plastic cleaning brushes only – Use only neutral PH(7) detergents

because if not rinsed off properly, low PH detergents will cause breakdown of stainless protective surface and black staining. High PH detergent will cause surface deposit of brown stain, which will also interfere with smooth operation of the instrument.

pH 10

pH 7

pH 4.5

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Observations

Lack of qualified oversight of sterilization staffNo initial or ongoing staff competency in sterilizationDental not included in organization wide IC planDental not part of organization IC risk assessment Evidence-based guidelines not adopted Sterilization logs not following adopted guideline Single-use items reused BI lot numbers of test and control capsule do not match Storing clean instruments in dirty areas

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Questions

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These slides are current as of September 25, 2020. The Joint Commission reserves the right to change the content of the information, as appropriate.

These slides are only meant to be cue points, which were expounded upon verbally by the original presenter and are not meant to be comprehensive statements of standards interpretation or represent all the content of the presentation. Thus, care should be exercised in interpreting Joint Commission requirements based solely on the content of these slides.

These slides are copyrighted and may not be further used, shared or distributed without permission of The Joint Commission. Distribution of the speaker’s presentation other than in PDF format is expressly prohibited.

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