Laser Safety: Is Your Dental School Ready? William Leavitt, D.D.S., - - PowerPoint PPT Presentation

Laser Safety: Is Your Dental School Ready?

William Leavitt, D.D.S., M.P.A.

University of Nevada at Las Vegas School of Dental Medicine

Scott Benjamin, D.D.S.

Midwestern University, Glendale, AZ College of Dental Medicine

Disclosure: William Leavitt, D.D.S., M.P.A.

• UNLV, School of Dental Medicine
• Associate Professor Department of Clinical Services
• Laser Safety Officer
• Board-Recognized Laser Educator for the State of Nevada
• ADEA’s Lasers in Dentistry Special Interest Group (LiD-SID)
• Chairman

Disclosure: Scott D. Benjamin, D.D.S.

• Midwestern University CODM, Glendale, AZ
• Adjunct Professor
• ANSI Standards Committee Z136 on Laser Safety
• Dental Representative & Voting Member
• ADA Standards Committee on Dental Products
• Chairman of Working Group 6.58 on Dental Lasers
• Academy of Laser Dentistry
• Past-President
• Laser and Health Academy
• Clinical Lecturer
• Compendium of Continuing Dental Education
• Technology Section Editor
• Dentsply Sirona Dental Inc., Charlotte, NC
• Consultant and Director of Laser Education
• National Dental Inc., Barrie, ON, Canada
• Clinical Director

Program Objectives:

• 1. Define laser classifications & laser terminology.
• 2. Appling best practices to a comprehensive

dental laser safety program.

• 3. Describe of the role and responsibilities of a
• Laser Safety Officer (LSO).
• Deputy Laser Safety Officer (DLSO).
• Laser Safety Site Contact (LSSC).

Laser Safety Standards

The parent document that defines terminology and measurements. It addresses the general safety aspects of laser use, which includes but are not limited to industry, defense, home use, and healthcare.

American National Standard (ANSI) for the Safe Use of Lasers Z-136.1-2014 Laser Institute of America; Publisher

ANSI Standard Z136.1 for Safe Use of Lasers

Laser Safety Standards

ANSI Standards Z136.5-2009 Safe Use of Lasers in Education Institutions Standards ANSI Z136.3-2011 (USA) & CSA Z386-2013 (Canada) Safe Use of Lasers in Health Care

Safe Use of Lasers in Health Care ANSI Z136.3-2011 Safe Use of Lasers in Health Care CSA Z386 (Canada) Safe Use of Lasers in Education Institutions ANSI Z136.5-2009

Common Laser Safety Acronyms “The Alphabet Soup of Lasers”

AEL

• Accessible Emission Limit

ANSI

• American National Standards Institute

CSA

• Canadian Standards Association

CW

• Continuous Wave

DLSO

• Deputy Laser Safety Officer

Er,Cr:YSGG –Erbium, Chromium: Yttrium Scandium Gallium Garnet Er:YAG

• Erbium: Yttrium-Aluminum Garnet

FLPPS

• Federal Laser Product Performance Standard

HCF

• Health Care Facility

HCLS

• Health Care Laser System

HCP

• Health Care Personnel

HeNe

• Helium-Neon

Hz

• Hertz (Pulses per Second) Symbol: F

J

• Joule (Watts per Second)

J/cm2

• Joules/Square Centimeter (Fluence)

LCA

• Laser Controlled Area (NHZ)

LGAC

• Laser Generated Airborne Contaminants

LIA

• Laser Institute of America

American National Standard (ANSI) for the Safe Use of Lasers Z-136.1-2014 Laser Institute of America; Publisher

Common Laser Safety Acronyms “The Alphabet Soup of Lasers”

LPE

• Laser Protective Eyewear

LSO

• Laser Safety Officer

LSSC

• Laser Safety Site Contact

LTCA

• Laser Treatment Controlled Area (NHZ)

MPE

• Maximum Permissible Exposure

Nd:YAG - Neodymium: Yttrium Aluminum Garnet NEMA

• National Electrical Manufacturers’ Assoc.

NHOD

• Nominal Ocular Hazard Distance

NHZ

• Nominal Hazard Distance

nm

• Nanometer (1 Billionth of a Meter)

OD

• Optical Density Symbol(s): D(λ), Dλ,

PPE

• Personal Protective Equipment

PRF

• Pulse-Repetition Frequency (Hertz) Symbol: F

SOP

• Standard Operating Procedure

TL

• Threshold Limit

TRT

• Thermal Relaxation Time

W/cm2

• Watts per Square Centimeter (Irradiance)

WL

• Wavelength of Light Energy Emitted

American National Standard (ANSI) for the Safe Use of Lasers Z-136.1-2014 Laser Institute of America; Publisher

ANSI Laser Classifications

Class 1 Laser Systems

Any laser or laser system containing a laser that cannot emit laser radiation at levels that are known to cause eye or skin injury during normal operation. Class 1M Laser Systems Considered incapable of producing hazardous exposure unless viewed with Collecting optics. Class 2 Laser Systems Visible lasers considered incapable of emitting laser radiation at levels that are known to cause skin or eye injury within the time period of the human eye aversion response (0.25 seconds). Class 2M Laser Systems Emits in the visible portion of the spectrum, and is potentially hazardous if viewed with collecting optics. Class 3R Laser Systems A laser system that is potentially hazardous under some direct and specular reflection viewing condition if the eye is appropriately focused and stable. Class 3B Laser Systems Medium-powered lasers (visible or invisible regions) that present a potential eye hazard for intrabeam (direct) or specular (mirror-like) conditions. Class 3B lasers do not present a diffuse (scatter) hazard or significant skin hazard expect for higher powered 3B lasers operating at certain wavelengths.

ANSI Laser Classifications

Class 4 Laser Systems

• “High-powered lasers (visible or invisible)

considered to present potential acute hazard to the eye and skin for both direct (intrabeam) and scatter (diffused) conditions. Also have potential hazard considerations for fire (ignition) and byproduct emissions from target or process materials.”

• “Is a hazard to the eye or skin from the direct beam, may pose a

fire hazard or diffuse reflection hazard, and may also produce laser generated air contaminants (LGAC) and hazardous plasma radiation.”*

All Dental and Medical Surgical Laser Systems

*American National Standard (ANSI) for the Safe Use of Lasers Z-136.1-2014 Laser Institute of America; Publisher

American National Standard Requirements for Lasers by Classification*

Class

Control Measures Training Laser Safety Officer (LSO) Engineering Controls

1

Not Required Not Required Not Required Not Required

1M

Required Application Dependent Application Dependent Application Dependent

2

Not Required Not Required Not Required Not Required

2M

Required Application Dependent Application Dependent Application Dependent

3R

Not Required Not Required Not Required Not Required

3B

Required Required Required Required

4

Required Required Required Required

*American National Standard (ANSI) for the Safe Use of Lasers Z136.1-2014 Table 1-1; 3 Laser Institute of America; Publisher

Other Safety Concerns & Considerations (Non-Beam Hazards)

• Electrical Hazards
• Respiratory Hazards
• Fire Hazards
• Human Factors
• Control Measures
• Engineering Controls /

Safety Mechanisms

• Infection Control

Respiratory Hazards - Laser Plume

Laser Generated Airborne Contaminants (LGAC)

• Laser Generated Airborne Contaminants (LGAC)

are the biological hazard of gas fumes created when tissue is ablated (vaporized), also referred to as the Laser Plume or Surgical Smoke.

• LGAC can contain vital strains of the

Human Papilloma Virus (HPV) and other organisms.

• High Volume Evacuation (HVE)

should Always be used with-in 2 inches of the emission point of the laser to remove the laser plume.

• Surgical masks must be worn.

The Dental School is Considering Incorporating Its First HCLS / Laser into the School’s Curriculum

What Laser Safety Considerations Need to Be Addressed Before Acquiring a HCLS / Laser? Consideration #1:

• What University/Institution’s laser policies are presently in place?
• Does the institution already have a laser safety committee?
• Does the dental school have a member of the committee?
• Does the dental school need its own laser safety committee?
• Does the institution already have a Laser Safety Officer (LSO)?
• Who will be the dental school’s LSO or DLSO?
• Will each clinic or simulation lab need to have a specified

Laser Safety Site Contact (LSSC) and if so, who?

Laser Safety Officer’s (LSO) Responsibilities

• The institution’s “expert” on the care, maintenance, & safe operation of the lasers.
• Verifying the classifications of the lasers and laser systems (HCLS) used.
• Ensuring that appropriate protocols have been established & are properly followed.
• Overseeing & ensuring that all personnel are appropriately trained
• n the laser’s use and safety.
• Controlling & managing the passwords or keys for activating the laser.
• Ensuring that all of the required labels and signs are appropriate and are in place.
• To ensure that the laser protective eyewear & devices are in good condition.
• To periodically inspect the functionality of the laser systems & safety features.
• Reporting any significant laser related injury to the laser manufacturer.
• Assuring the necessary records required government regulations are maintained.

(Documenting: maintenance programs, training records, audits, SOP, etc.)

• Overseeing the Deputy Laser Safety Officer (DLSO) and

Laser Safety Site Contact (LSSC), if those positions are deemed necessary.

Deputy Laser Safety Officer (DLSO) & Laser Safety Site Contact (LSSC)

Deputy Laser Safety Officer (DLSO)

• “If deemed necessary, a DLSO should be appointed by management or the LSO

to perform the duties and fulfill the responsibilities of the LSO when the LSO is not available in large HCF. For institutions with multiple divisions or locations, a system of DLSOs may be deemed necessary.

Laser Safety Site Contact (LSSC)

• “If deemed necessary, in facilities with diversity of laser use and use sites, a LSSC

should be appointed by management or the LSO to oversee all operational aspects of laser safety at each site where lasers are being used, in large HCF (e.g., outlying clinical areas such as ophthalmology clinic, day surgery unit, neonatal intensive care unit, dermatology clinic, etc.).

American National Standard (ANSI) for the Safe Use of Lasers Z-136.3-2011 Section 1.3 Laser Institute of America; Publisher

What Laser Safety Considerations Need to Be Addressed Before Acquiring a HCLS / Laser?

Consideration # 2:

• Obtain the FDA 510(k) Marketing Clearance Summary for the HCLS.
• It Contains the HCLS’s Indications for Use.
• Can Be Downloaded from the FDA’s ww.fda.gov/MedicalDevices

(continued)

Consideration # 3:

• Determine the Nominal Ocular Hazard Distance (NOHD)
• The NOHD Defines the Nominal Hazard Distance (NHZ)

Which Determines the Laser Treatment Controlled Area (LTCA)

“The Danger / Warning Zone”

• NOHD is HCLS / Laser Specific
• NOHD Ranges from ~5 to ~89 Feet
• The NOHD is Required by the FDA to be

Designated in the Device’s Owner’s Manual / Operating Instructions.

What Laser Safety Considerations Need to Be Addressed Before Acquiring a HCLS / Laser?

(continued)

Warning Signs New Signage per ANSI Z136.1-2014

• Must be placed at every entrance into the

NHZ/LCTA/ Operatory.

• Should only be displayed

when the laser is in use.

• Must Identify:
• Laser Classification
• Laser Radiation Symbol
• Potential Danger / Harm
• Required Eyewear (OD & WL)
• Wavelength
• Maximum Power

New Sign as of January 2014

Nominal Ocular Hazard Distance (NOHD)

• f Various Dental Diode Lasers*
• 10’ (3.1m) xLase (Fotona)

1,064 nm

• 30’7

(9.3m) Epic Pro (Biolase) 980 nm

• 5’ (1.5m) SIROLaser Advance (Dentsply Sirona) 970 nm
• 8’8” (2.7m) Gemini (Ultradent)

810 & 980 nm

• 8’7” (2.6m) ilase (Biolase)

940 nm

• 15’8” (4.77m) Epic (Biolase)

940 nm

• 38’9” (11.8m) ezlase (Biolase)

940 nm

• 6’ 8” (2m) Picasso (AMD)

810 nm

• 6’ 8” (2m) Picasso Lite (AMD)

810 nm

• 12’10” (3.9m) Precise LTM (CAO)

810 nm

• 6’11

(2.1m) Precise SHP (CAO) 810 nm

• 12’11” (3.94) SOL (DenMat)

808 nm

• 3’ (.90m) NV Microlaser (DenMat)

808 nm

* As reported by the manufacturers

Diode Lasers

Nominal Ocular Hazard Distance (NOHD)

• f Various Types of Dental Lasers*

Various Models of Lasers

• 7’9” (2.4m) LightScalpel

10,600 nm CO2

• 8’2” (2.5m) Solea

9,250 nm CO2

• 21’8” (6.6m) LightWalker DT 2,490 nm

Er:YAG

• 88’7” (27m) LightWalker DT 1,064 nm

Nd:YAG

• 21’8” (6.6m) LightWalker AT 2,490 nm

Er:YAG

• 88’7” (27m) LightWalker AT 1,064 nm

Nd:YAG

• 0’2” (.05m) Waterlase iPlus

2,780 nm Er,Cr:YSGG

• 8’7” (2.6m) Waterlase iPlus

940 nm Diode

• 3’10” (1.2m) Thor LLLT

810 nm 1W Laser cluster

• 3’10” (1.2m) Thor LLLT

660 nm 200mW Laser probe

* As reported by the manufacturers

Consideration # 4:

• Identify the Laser Filtration (L) / Optical Density (OD)
• f the Laser Protective Eyewear (LPE) / “Laser Safety Glasses”

Required When Using the HCLS.

• OD is Device Specific and Ranges from +3 to +7 for the

Wavelength of the HCLS.

• What Other Wavelengths / HCLSs / Lasers

Can Be Used with the Same LPE?

• The Optical Density of the LPE is Required

by the FDA to be in the HCLS’s Owner’s Manual / Operating Instructions.

What Laser Safety Considerations Need to Be Addressed Before Acquiring a HCLS / Laser?

(continued)

Required Optical Density for the Laser Protective Eyewear (LPE)*

* As reported by the manufacturers

Diode Lasers

+5 xLase (Fotona) 1,064 nm +5 Epic Pro (Biolase) 980 nm +5 Gemini (Ultradent) 810 & 980 nm +5 SIROLaser Advance (Dentsply Sirona) 970 nm +4 ilase (Biolase) 940 nm +4 Epic (Biolase) 940 nm +4 ezlase(Biolase) 940 nm +5 Picasso (AMD) 810 nm +5 Picasso Lite(AMD) 810 nm +4 Precise LTM (CAO) 810 nm +4 Precise SHP (CAO) 810 nm +4 SOL (DenMat) 808 nm +4 NV Microlaser (DenMat) 808 nm

Required Optical Density for the Laser Protective Eyewear (LPE)*

Various Models of Lasers

+5 LightScalpel 10,600 nm CO2 +4 Solea 9,250 nm CO2 +4 LightWalker DT 2,490 nm Er:YAG +7 LightWalker DT 1,064 nm Nd:YAG +4 LightWalker AT 2,490 nm Er:YAG +7 LightWalker AT 1,064 nm Nd:YAG +4 Waterlase iPlus 2,780 nm Er,Cr:YSGG +4 Waterlase iPlus 940 nm Diode +4 Thor LLLT 810 nm 1W Laser cluster +4 Thor LLLT 660 nm 200mW Laser probe

* As reported by the manufacturers

Consideration # 4:

• Protocols for Education, Documentation, Reprocessing

(Setup, Work Flow, & Infection Control Procedures) and Clinical Supervision.

• Develop a Scientific Based Didactic and Simulation

Curriculum for the Students, Faculty, & Appropriate Staff.

• Components of the Educational Program Should Include:
• Chemical Composition of Biological Tissue
• Laser Science
• HCLS Management
• Laser Safety
• Clinical Simulation

What Laser Safety Considerations Need to Be Addressed Before Acquiring a HCLS / Laser?

(continued)

Consideration # 5:

• Identify the Governmental (State etc.) Regulations and

Registration Requirements.

• Identify the Institution’s Biomedical Device Policies & Process

for Evaluation, Verification, Device Identification, and Labeling.

• Ensures Compliance with the Federal Laser Product

Performance Standard (FLPPS)

• Confirm and Establish the HCLS / Laser

Reprocessing / Infection Control Protocol.

• Assists and Confirms with the Laser Safety Committee in

Establishing the Inspection and Calibration Protocols to Ensure the HCLS functions properly.

What Laser Safety Considerations Need to Be Addressed Before Acquiring a HCLS / Laser?

(continued)

Federal Laser Product Performance Standard (FLPPS)

Manufacturers of laser products are required to certify that their products comply with the Federal Laser Product Performance Standard (Title 21, Code of Federal Regulations, Part 1040) promulgated and enforced by CDRH.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?FR=1040.10

Laser Policies, Procedures, and Safety Information Manuals, Forms, & Logs

_____ Facility’s Laser Safety, Policies____

Procedures, & Protocols Operating Instructions Training Manuals Registration & Regulatory Forms Training Verification Documents Incident / Accident Reporting Form Calibration & Inspection Logs Inspection & Maintenance Forms

The School Has Just Purchased Its First Class 4 Diode Laser.

What do you need to do to meet ANSI Z136 standards?

The LSO must:

• Ensure All necessary Documents are Obtained.
• Review Each Device’s NOHD.
• Preapprove Device’s NHZ & Respective Signage.
• Identify the LPE & their Respective Location(s).
• Test All the HCLS Making Sure They are

Working Properly.

The Dental School is Incorporating Its First HCLS / Laser into the School:

• 1. What is the primary measurement for deciding if

the new Class 4 laser will be safe in your environment??

• Nominal Ocular Hazard Distance (NOHD)
• 2. How will personnel know where the NHZ / LCTA is?
• Visible Tape Line, with Signage
• 3. In a dental operatory, what is the NOHD’s

center point?

• Headrest of operatory chair in supine

Laser Safety Summary

What Do You Need to Do to Be Safe & Compliant?

Considerations & Implementations: 1. Have a Laser Committee and Designate an LSO. 2. Obtain the FDA 510(k) Marketing Clearance Summary and Necessary Documents for the HCLS. 3. Define the Laser Treatment Controlled Areas (LTCA /NHZ). 4. Identify the Laser Protective Eyewear (LPE) / “Laser Safety Glasses” Required for each the HCLS. 5. Identify the Governmental (State etc.) Regulations and Registration Requirements. 6. Make Sure Everyone Receives Proper Laser Training. (Including Safety)

"It is not the strongest

• f the species that survive,

nor the most intelligent, but the one most responsive to change."

Charles Darwin

William Leavitt, D.D.S., M.P.H.

William.Leavitt@UNLV.edu

(702) 774-2641 Scott Benjamin, D.D.S. Education@DentalAIM.org (607) 563-3927

Discussion Laser Safety DO NOT Compromise!!

But It Doesn’t Have to be a Hassle!