Medical Laser Safety Program 2015 - Medical …academicdepartments.musc.edu/vpfa/operations/Risk Management... · Medical Laser Safety Program Page 3 of 18 INTRODUCTION The Medical

MEDICAL LASER SAFETY PROGRAM

UNIVERSITY RISK MANAGEMENT Radiation Safety Office

19 Hagood Avenue, Suite 301 Charleston SC 29425

843-792-4255

July 2015

Medical Laser Safety Program

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Introduction ..................................................................................................................... 3

Roles and Responsibilities .............................................................................................. 3

Laser Safety Committee (LSC) ................................................................................................................. 3

Laser Safety Officer (LSO) ........................................................................................................................ 3

Laser Safety Liaison (LSL) ........................................................................................................................ 4

Laser Operator (LO) .................................................................................................................................. 5

Other Health Care Professionals (HCPs) and Students ........................................................................... 5

Laser Hazard Classification ............................................................................................. 6

Class 1 ....................................................................................................................................................... 6

Class 2 ....................................................................................................................................................... 6

Class 3R (IEC Class 1M, 2M, and FLPPS 3a) .......................................................................................... 6

Class 3B .................................................................................................................................................... 6

Class 4 ....................................................................................................................................................... 6

Embedded Lasers ..................................................................................................................................... 7

Laser Acquisition, Transfer, and Disposal ....................................................................... 7

Hazard Control Measures ............................................................................................... 8

Controls for Class 1, 2 and 3R Lasers ...................................................................................................... 8

Controls for Class 3B and Class 4 Lasers ................................................................................................ 8

Laser/Laser Systems Used in Research ................................................................................................. 11

Protective Equipment .................................................................................................... 12

Laser Protective Eyewear (LPE) ............................................................................................................. 12

Laser Protective Barriers and Curtains ................................................................................................... 12

Other Personal Protective Equipment (PPE) .......................................................................................... 13

Area Warning Signs ...................................................................................................... 13

Training ......................................................................................................................... 13

Non-Beam Hazards ....................................................................................................... 14

Standard Operating Procedures .................................................................................... 16

Medical Surveillance ..................................................................................................... 17

Accident Reporting ........................................................................................................ 17

Record Keeping............................................................................................................. 18

APPENDIX A – Class 3B and 4 Laser System Registration Form

APPENDIX B – Eye and Skin Maximum Permissible Exposure

APPENDIX C – Laser Protective Eyewear Selection Chart

APPENDIX D – MUSC Laser Standard Operating Procedures Form

APPENDIX E – Laser Safety Checklist


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INTRODUCTION The Medical University of South Carolina (MUSC) established the Medical Laser Safety Program to assure safe use of lasers/laser systems in health care applications and protect the health and safety of students, faculty, staff, the community and the environment. This program is written in accordance with American National Standard Institute (ANSI) Z136.1 (Safe Use of Lasers) and ANSI Z136.3 (Safe Use of Lasers in Health Care) as well as applicable State and Federal regulations.

ROLES AND RESPONSIBILITIES Laser Safety Committee (LSC)

The LSC is a subcommittee of the Radiation Safety Committee. This committee consists of eight or more members who by their knowledge and experience are qualified to make judgments and recommend policy in the area of laser safety. Committee members shall be appointed by Vice President of Clinical Operations and Executive Director/CEO of the Medical University Hospital Authority (MUHA) in consultation with the various deans, directors, and department heads.

The LSC has the authority to suspend, restrict, and terminate the operation of a laser/laser system if it is deemed that the laser hazard controls are inadequate.

The LSC responsibilities include:

1. Establish and maintain policies, procedures, and guidance for the control of laser hazards;

2. Approve Class 3B and 4 laser Standard Operating Procedures (SOPs); 3. Review all applicable new or revised laser safety standards; and 4. Oversight of the MUSC Medical Laser Safety Program.

Laser Safety Officer (LSO)

The LSO will work with the individual Principal Laser User to ensure the safety standards of each laser/laser system are adequate. The LSO shall be appointed by the President of MUSC and has the authority to monitor and enforce the control of laser hazards and to affect training of personnel involved with the use of laser technology and applications.

The LSO has the authority to suspend, restrict, and terminate the operation of a laser/laser system if it is deemed that the laser hazard controls are inadequate or presents an imminent danger.

The LSO responsibilities include:

1. Develop and implement the MUSC Medical Laser Safety Program;


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2. Maintain inventory of all Class 3B and 4 laser/laser systems at MUSC; 3. Assign principle laser user a Controlled Laser Authorization (CLA) number

for use of laser/laser systems 4. Ensure laser/laser system is properly classified and labeled; 5. Review and ensure that all manufacturer safety guidelines for safe use of

Class 3B and 4 laser/laser systems are followed; 6. Conduct hazard evaluations for Class 3B and 4 laser/laser systems, as

necessary; 7. Approve Class 3B and 4 SOPs and ensure prescribed control measures are

in effect and observed; 8. Ensure appropriate personal protective equipment (PPE) is available, in

good working condition and used as intended; 9. Ensure that all maintenance and service on Class 3B and 4 laser/laser

systems is performed by properly trained and/or licensed technicians; 10. Provide ANSI approved warning signs and labels; 11. Provide general laser safety training; 12. Investigate laser/laser system accidents; and 13. Periodically audit laser use facilities.

Laser Safety Liaison (LSL)

The LSL shall be knowledgeable of applicable ANSI standards and associated State and Federal regulatory requirements including educational and training requirements, potential laser hazards and associated control measures, and all operating procedures pertaining to laser safety for lasers and laser systems under the LSL’s control.

The LSL responsibilities include:

1. Register each Class 3B and 4 laser/laser system under their supervision with the LSO;

2. Verify laser/laser systems are properly classified and labeled; 3. Identify laser hazards present and implement appropriate laser hazard

controls. Immediately correct any unsafe conditions identified. 4. Review and follow all manufacturer safety guidelines for safe use of Class 3B

and 4 laser/laser systems; 5. Develop and maintain SOPs for all Class 3B and 4 laser/laser systems in a

readily available location. Submit SOPs to LSO and LSC for review and approval prior to operation of the laser/laser system;

6. Identify authorized personnel who are approved to operate and/or maintain a Class 3B and 4 laser/laser systems. Provide current and up to date information to LSO;

7. Ensure laser operators have received specific laser/laser system training and follow established SOPs and all other applicable safety policies (control measures, PPE, training, etc.);

8. Ensure all maintenance and service on Class 3B and 4 laser/laser systems is up to date;


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9. Immediately notify the LSO in the event of a suspected overexposure or an accident occurs involving a Class 3B or 4 laser/laser system;

10. Notify the LSO of any changes in procedures, modifications to existing laser/laser systems, or relocation/transfers in writing;

11. Properly dispose of laser or laser system components in coordination with LSO; and

12. Maintain a copy of this program as well as pertinent records (registration, SOPs, training documents, etc) at the laser use facility.

Laser Operator (LO)

Only a LSL or LO are authorized to operate and/or maintain a Class 3B or 4 laser/laser system. Each LO works under the supervision of the LSL. The LO is responsible for knowing the potential laser hazards and associated control measures, and all operating procedures pertaining to laser safety for lasers and laser systems under their operation.

The LO responsibilities include:

1. Know and comply with manufacturer safety guidelines and applicable ANSI standards and State/Federal regulations;

2. Know and comply with the requirements of this program as well as associated SOPs and other safety procedures;

3. Complete required laser safety training prior to operation of a Class 3B or 4 laser/laser system;

4. Use PPE in accordance with manufacturer guidelines and ensure PPE is in good working condition prior to use; and

5. Promptly report to the LSL any malfunctions, accidents, or injuries. Stop operations immediately if unsafe conditions arise.

Other Health Care Professionals (HCPs) and Students

Laser/laser systems pose a danger to HCPs and students who are active team members in a procedure but not responsible for laser operation, or are working in the vicinity of such systems.

HCPs and students responsibilities include:

1. Know and comply with the requirements of this program as well as associated SOPs and other safety procedures;

2. Complete required laser safety training prior to work in areas where a Class 3B or 4 laser/laser system is operated; and

3. Use PPE in accordance with prescribed training and ensure PPE is good working condition prior to use.


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LASER HAZARD CLASSIFICATION

All lasers and laser systems in the U.S. are categorized into one of several classes. Corresponding labels affixed to the laser or laser system positively identify the class. These laser classifications are detailed in ANSI Z136.1, ANSI Z136.3; the Federal Laser Products Performance Standard (21 CFR 1040.10 and 1040.11); and the International Electrotechnical Commission (IEC). The manufacturer is required to provide hazard classification of laser/laser system. In the event that a laser/laser system has been modified or classification is not available, the LSO will determine the hazard classification.

Class 1 a) Do not emit harmful levels of radiation during normal operation. b) An example of this type of laser is the laser used in compact disc players.

Class 2 a) Emit accessible laser light in the visible wavelength spectrum. b) Capable of creating eye damage through chronic exposure. c) In general, the human eye blink reflex will limit exposure to 0.25 seconds or

less (aversion response); therefore, eye protection is afforded through the aversion response.

d) An example of a Class II laser is the laser used in the supermarket checkout counter.

Class 3R (IEC Class 1M, 2M, and FLPPS 3a) a) Normally not hazardous when viewed momentarily with the unaided eye, but

may pose eye hazards when viewed through collecting optics (e.g. microscopes and binoculars)

b) Intermediate powered laser: power output 1-5 milliwatts (mW) for continuous wave (CW) [Class 3R/3a only]

c) Increased controls when viewed through optical instruments (e.g. binoculars, telescopes, or microscopes).

Class 3B a) Will cause injury upon direct viewing of the beam and specular reflections. b) Moderate powered laser: power output 5-500 mW CW or less than 0.03 joule

(J) for a pulsed system (i.e. pulse width less than 0.25 seconds). c) An example of a Class IIIB laser is an argon laser (CW, λ=488 nm) with

radiant power of 0.5 W or less.

Class 4

a) Includes all laser systems with power levels greater than 500 mW CW or greater than 0.03 J for a pulsed system.

b) Pose eye hazards, skin hazards, fire hazards, and potential laser generated air contaminants. Viewing the beam or specular reflection or exposure to diffuse reflections can cause eye and skin injuries.


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c) An example of a Class IV laser is carbon dioxide (CO2) laser (λ=10,600 nm).

Embedded Lasers

Lasers with a higher hazard classification are sometimes incorporated into laser products or systems with a total lower hazard classification. Under normal, intended use, the lower classification will prevail. In cases where the laser is accessible (i.e. alignment or service, etc), compliance with the hazard classification of the embedded laser/laser system is required. This can include laser registration, temporary control area designation, abbreviated standard operating procedures (SOPs), and other controls. Consult the LSO to determine adequate controls.

LASER ACQUISITION, TRANSFER, AND DISPOSAL

LSLs must notify the LSO of all Class 3B, 4, and embedded Class 3B or 4 laser/laser systems in operation on the premises under control of MUSC through completing a Laser Registration Form. Upon request, the LSO can conduct a hazard evaluation and make recommendations regarding specific safety requirements pertaining to proposed use including SOPs, control areas, PPE and training. For new purchases, initial notification will be in the form of a copy of the purchase requisition provided by MUSC/MUHA purchasing department to the LSO. It is still the responsibility of the LSL to submit the laser registration form to the LSO prior to installation. The laser registration form is provided in Appendix A or can be found on the MUSC Radiation Safety website at (http://academicdepartments.musc.edu/vpfa/operations/Risk%20Management/radsafety/index.htm).

Each registered laser/laser system will be assigned a Controlled Laser Authorization (CLA) number and provided with a laser identification tag. The Iaser identification tag shall be visibly placed on the laser/laser system and will display the CLA number, serial number, and location.

Written notification shall be submitted to the LSO when a laser/laser system has been relocated, transferred (external or internal), removed from service, or significant modification to existing laser/laser system are proposed.

Internal transfers: the transferee is required to submit a new laser registration form to the LSO. Upon review, a new laser identification tag will be provided.

Class 3B or 4 laser/laser systems, any components or laser-related materials (local exhaust ventilation [LEV] filters or tubing, etc.) should be disposed in accordance with applicable MUSC policies and State and Federal regulations. For assistance with proper disposal methods, the LSL should contact the LSO.


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HAZARD CONTROL MEASURES

Controls for Class 1, 2 and 3R Lasers

When used as intended and following manufacturer safety guidelines, Class 1, 2 and 3R laser/laser systems are generally low hazard devices; however, additional safety requirements may apply.

Laser radiation exposure must be kept below Maximum Permissible Exposure (MPE) under all conditions of operation or alignment, calibration and other maintenance procedures.

Laser/laser systems must have IEC or FDA FLPPS compliant product label. Label should be visible during normal operation and shall not be covered or removed. (EXCEPT FOR CLASS 1)

Equipment modifications that affect label claims require an updated hazard evaluation. In addition, service or repair to the laser/laser system may require changes in control measures. Contact LSO prior to servicing or system modification.

Area warning signs shall be clearly displayed to warn of laser use. Remove or cover warning sign when laser is not in use. Area Warning signs are provided by the LSO. (CLASS 2 and 3B)

Use of microscope and other optical viewing instruments should be reviewed by the LSO prior to operation. (CLASS 3R)

Controls for Class 3B and Class 4 Lasers

In addition to the aforementioned control measures, additional requirements for Class 3B and 4 laser/laser systems apply. Control measures for Class 3B and 4 lasers are designed to reduce eye and skin exposure to hazardous levels of radiation and mitigate other hazards associated with laser systems. The major causes of laser accidents include:

Eye exposure during alignment Misaligned optics and upwardly directed beams Available eye protection not used Equipment malfunction Improper methods of handling high-voltage circuits Intentional exposure of unprotected personnel Operators unfamiliar with laser equipment Lack of protection from ancillary hazards Improper restoration of equipment following service Protective eyewear worn not appropriate for laser in use Failure to follow Standard Operating Procedures (SOPs)

Control measures are classified as engineering control measures and administrative and procedural control measures. Engineering controls are those that are incorporated into the laser system and the laser use environment. Administrative and procedural


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controls are methods or instructions which specify rules and/or work practices to supplement engineering controls and may require use of PPE. An example of an engineering control measure would be a laser beam stop, and an example of an administrative and procedural control measure would be SOPs developed for a particular laser system. When feasible, engineering controls are always the preferred method to provide for safety.

Laser controls are designed to ensure skin and eye exposures do not exceed the applicable MPE limit. The MPE defines the maximum safe exposure without hazardous effect or adverse biological changes in the eye or skin. The MPE depends upon the wavelength and exposure duration. Eye and skin maximum permissible exposure for common continuous wave (CW) and single pulse lasers are provided in Appendix B.

An important consideration when implementing control measures is to distinguish among operation, maintenance, and service. Control measures are based on normal operation of the laser system. When either maintenance or service is performed, it is often necessary to implement additional control measures.

Engineering Controls

Engineering controls for Class 3B and 4 lasers/laser systems are listed below. All Class 3B and 4 lasers at MUSC are covered by this policy, and should have the listed design features unless otherwise approved by the LSO. If the system is purchased in the United States, the system has, as part of the design features, the controls stated below. This is often indicated on the laser by a “statement of certification”.

A protective housing shall be provided for each laser system. The protective housing shall be interlocked such that removal of the protective housing will prevent exposure to laser radiation. Interlocks shall not be defeated or overridden during normal operation of the laser.

Service access panels that allow access to the beam during operation shall either be interlocked or require a tool for removal and have an appropriate warning label.

A Class 3B laser should have a key controlled master switch. A Class 4 laser shall have a key controlled master switch. The key shall be accessible only to authorized individuals.

All viewing portals, display screens, and collecting optics shall be designed to prevent exposure to the laser beam above the applicable MPE for all conditions of operation and maintenance. Accessory viewing ports must be clearly identified as protected or not. Unprotected viewing ports will require the use of eye protection equipment.

A Class 3B laser should be provided with a remote interlock connector. A Class 4 laser shall have a remote interlock connector. The remote interlock connector will decrease the laser beam power to safe levels when activated.

A Class 3B laser should have a permanent beam stop in place. A Class 4 laser shall have a permanent beam stop in place.


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An alarm (for example, an audible sound such as a bell or chime), a warning light (visible through protective eyewear), or a verbal “countdown” command should be used at start-up of a Class 3B laser, and shall be used with Class 4 lasers. For Class 4 laser systems, the warning should allow sufficient time to take appropriate actions to avoid exposure to the laser beam.

Whenever possible, Class 4 lasers should be operated and fired from a remote location.

Administrative and Procedural Controls

SOPs, with safety controls, shall be readily available for operation and maintenance of the laser system.

Each laser operator shall have the education and training level commensurate with degree of hazard and responsibility.

A list of authorized laser users shall be created and maintained. The LSL shall submit this information to the LSO.

Alignment procedures shall be developed to ensure that eye exposure to the primary beam or to a diffuse or specular reflection does not exceed the MPE.

A laser treatment controlled area (LTCA) shall be designated for all unenclosed beam paths. The LTCA is defined as the area where laser radiation is in excess of the MPE. Appropriate control measures must be implemented in the LTCA.

The laser facility shall be designed in such a way to limit spectator access to the LTCA.

Service personnel must comply with appropriate control procedures for the laser system and have education and training commensurate with the laser system.

Proper eye protection devices, specifically designed for the laser radiation, shall be worn when engineering or other administrative and procedural controls are inadequate to eliminate exposures above the MPE.

Periodic laser safety facility and equipment audits shall be conducted by the LSO.

Class 3B and 4 Laser Treatment Controlled Area (LTCA)

A. The area designated as the controlled area for Class 3B laser facilities shall have the following adequate control measures:

Operation only by qualified and authorized personnel. Appropriate warning signs posted within area (if deemed necessary) and at all

entryways. Limited spectator access. Visitors must be approved by the LSO. Appropriate beam stops for terminating potentially dangerous beams shall be in

use, except for laser beams applied to tissue for surgical or therapeutic purposes.

Only diffuse-reflective surfaces on non-optical structures in or near the beam path where possible.

Appropriate eye protection for all personnel within the area. Laser beam positioned well above or below eye level.


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All windows, doorways, and open portals covered to prevent the laser radiation above the applicable MPE outside the laser facility. Window barriers will be non-flammable and meet MUSC infection control policies for maintenance and cleaning.

Secured storage of laser equipment.

B. In addition to Class 3B requirements, facilities using Class 4 lasers shall have the following controls:

All entryway controls designed to allow for rapid egress and admittance into LCTA under emergency situations.

A “Panic Button” shall be clearly marked and readily accessible to laser personnel. When activated the “Panic Button” will reduce the output power of the laser to levels below the MPE. The following are acceptable examples of “Panic Buttons”.

o Key switches to deactivate the laser; o Master switch on power source to turn off power. o Red mushroom-type button on control panel or other readily accessible

location within the area. Limited Access Entryway - The LSL shall implement one of the following

mechanisms to protect personnel. The LSO will be available for consultative services.

o Non-Defeatable (non-override) Entryway Safety Controls – non-defeatable entryway controls will reduce the output power of the laser to levels below the MPE when the door is opened unexpectedly.

o Defeatable Entryway Safety Controls – defeatable entryway controls, with an override for safety latches and/or interlocks, may be used if it is clearly evident that there is no laser radiation hazard at the point of entry. Only adequately trained and authorized personnel may operate the overrides to enter the facility.

o Procedural Entryway Safety Controls – All authorized personnel shall be trained, and proper personal

protective equipment (PPE) shall be available upon entry. A secondary barrier (laser curtain) shall be used to block the laser

radiation at the entryway. At the entryway, there should be a visible or audible indication that

the laser is in operation.

Laser/Laser Systems Used in Research

Non-clinical research laser/laser systems will comply with the requirements set forth in ANSI Z136.1. Research involving human subjects shall comply with ANSI Z136.1 and ANSI Z136.3. Contact the LSO for further guidance on non-clinical research laser/laser systems requirements.


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PROTECTIVE EQUIPMENT

Laser Protective Eyewear (LPE)

Laser protective eyewear (LPE) of adequate optical density and wavelength for the Class 3B or 4 laser/laser system in use must be provided and worn when potential laser radiation exposure exceeds the MPE. LPE may include goggles, face shields, spectacles or prescription eyewear with appropriate filter materials or reflective coatings. LPE will be selected to withstand either direct or diffusely scattered beams. Flammability factors will also be considered. Consult the laser/laser system manufacturer’s safety guidelines or LSO for LPE selection. An eyewear selection chart for wavelengths of 400 to 1400 nm is provided in Appendix C.

LPE shall be:

1. Clearly labeled with optical density and wavelength protection that is provided. Color coding or other distinguishing identification is recommended for multi-laser facilities or multiple wavelength laser/laser systems.

2. Inspected prior to each use and in accordance to manufacturer guidelines. 3. Stored and maintained following manufacturer’s recommendations. Damaged or

worn LPE shall be removed from service and replaced.

In addition, the following special considerations should be taken into account:

Fiberoptic Procedures – LPE shall be worn whenever the distal end of the fiber is open and exposed. In procedures where it is feasible that fibers may break or become disconnected, all personnel within the LTCA shall be required to wear LPE.

Endoscopic Procedures – If procedural controls are adequate, the LSO may determine that LPE is not required.

Microscopes and other optical viewing instruments – Appropriate protective filters shall be used. When filter protection is not incorporated into equipment (i.e. accessory viewing port), appropriate LPE will be worn.

Patient eye protection – When patient eyes are potentially exposed to laser radiation exceeding the MPE, appropriate protective eyewear must be worn. For procedures where the patient is conscious or under conscious sedation, spectacles, goggles, periorbital goggles, or corneal shields LPE will be used. Under general anesthesia, wet towel cloths or other similar non-flammable materials will be used.

Laser Protective Barriers and Curtains

Windows and entryways in the LTCA will be covered with a filter or barrier that reduces any transmitted laser radiation to levels below the applicable MPE. When the human skin MPE is exceeded, filters and barriers must be constructed of an appropriate flame retardant material. Only wet or flame retardant drapes should be used in the operative field.


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Factors in barrier selection include:

1. Ability to withstand direct and diffusely scattered laser beams; 2. Flammability; and 3. Decomposition products

Other Personal Protective Equipment (PPE)

Shields, helmets, hearing and/or skin protection may be required due to laser and ancillary hazards. Follow manufacturer safety guidelines and/or consult the LSO for appropriate PPE selection.

AREA WARNING SIGNS

Area warning signs shall be conspicuously displayed at all entryways to the LTCA and, if necessary, within the LTCA. Warning signs must have appropriate signal word, precautionary statement (refer to Table 1) and detail the laser type, emitted wavelength, pulse duration, maximum output and hazard classification of the laser/laser system. Remove or cover area warning signs when laser/laser system not in use. Area warning signs can be obtained by contacting the Radiation Safety Office at 792-4255.

Table 1 – Area Warning Signs

Classification Signal Word Precautionary Statement

Class 2 CAUTION Laser Radiation – Do Not Stare into Beam

Class 2M1 CAUTION Laser Radiation – Do Not Stare into Beam or View

with Optical Instruments

Class 3R DANGER Laser Radiation – Avoid Direct Eye Exposure

Class 3B DANGER Laser Radiation – Avoid Direct Exposure to Beam

Class 4 DANGER Laser Radiation – Avoid Eye or Skin Exposure to

Direct or Scattered Radiation

Class 3B and 42 DANGER Laser Surgery in Progress- Eye Protection Required 1 Where accessible irradiance does not exceed the MPE based upon 0.25 s exposure. 2 Protection actions such as this should be used, if applicable.

TRAINING All faculty, staff and students who utilize or work in an area where Class 3B or 4 laser/laser systems are used must complete general laser safety training. General laser safety training will be provided by the LSO. Additional laser/laser system specific safety training including a competency assessment is required for LSLs and LOs prior to laser operation. The LSL is responsible for ensuring all LOs under his/her supervision have


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completed all applicable laser safety trainings. Training must be documented and retained on file. Visitors and guests of MUSC must complete laser safety training. Contact the LSO regarding training requirements prior to a guest visit. The introduction of new hazards to a work area will require immediate retraining. Update training must be completed by all faculty, staff and students:

1. Research (non-medical): retraining required every two years. 2. Healthcare:

Physicians – comply with applicable credentialing training requirements, but retraining interval not to exceed five years. All others – annual retraining required.

NON-BEAM HAZARDS Non-beam hazards exist in laser-related operations and can pose significant health and safety risks. Non-beam occupational and patient concerns must be addressed in addition to direct laser beam hazards within SOPs, where applicable. For assistance with non-beam hazard determination and mitigation, the LSL should contact the LSO. Electrical Hazards Some lasers use high-voltage power supplies, large capacitors, or capacitor banks that present a lethal shock hazard. Additional hazards of electrical equipment include resistive heating and ignition source. Electrical safety controls include:

a) OSHA [29 CFR 1910 S] requires additional controls and training for work on live circuits operating a more than 50 volts; note also that capacitors maintain a lethal charge even in de-energized and unLSLgged equipment. Use extreme caution if servicing laser power supplies.

b) Check the condition of electrical insulation, cords and cables. c) Ensure that electrical terminals are covered; repair or replace damaged

equipment. d) Ensure good equipment grounding (i.e. chassis/frame resistance to ground

limited to a few ohms). e) Follow good wiring practices (e.g. use GFCI outlets, no wires on the floor, no

overloaded circuits, etc.). f) Use equipment only for its intended/designed purpose. g) Keep equipment “power up” warning lights clearly visible.


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Laser Generated Air Contaminants (LGAC) Air contaminants may be generated when Class 3B or Class 4 laser beams interact with matter. When target irradiance reaches a threshold of about 107 W/cm2, target materials including plastics, composites, metals, and tissues may liberate toxic and noxious airborne contaminants. Generally, the LSL must ensure that any laser operation that creates visible smoke or LSLme has adequate local exhaust ventilation (LEV) in place; respirators are not an acceptable alternative to local exhaust ventilation. If, in addition to LEV, additional respiratory protection is required or worn voluntarily, consult the MUSC Health and Safety Manual - Respiratory Protection Program Policy. Infection Control Spread of infection shall be prevented by utilizing Standard Precautions. Refer to the MUSC Health and Safety Manual - Bloodborne Pathogen Exposure Control Policy for further information. Laser Dyes Dyes used as the optically active medium in some laser are often toxic and/or carcinogenic chemicals dissolved in flammable solvents. This creates the potential for personnel exposures above permissible limits, fires, and chemical spills. For each dye used, the LSL must have the Safety Data Sheet (SDS) available for staff review and ensure compliance with applicable MUSC policies governing hazardous chemical use and disposal. Compressed Gases and Cryogenics Hazardous gases may be used in laser applications; i.e. excimer lasers (fluorine, hydrogen chloride). Cryogenic fluids are used in cooling systems of some lasers. The SOP should contain references for the safe handling of compressed gases and cryogenics. Plasma Radiation Laser beam interactions with target materials may produce an intense plasma emission that can pose an eye and skin hazard. Similarly, targets heated to very high temperatures (e.g. in laser welding and cutting) may emit an intense light. The LSL must ensure adequate control measures are in place for such operations. UV and Visible Radiation Laser discharge tubes and pump lamps may generate sufficient UV and visible radiation to pose an eye and skin hazard. To address this issue, maintain the integrity of the laser housing and avoid operating any laser with the housing removed.


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Fire and Explosion Hazards Broken laser fibers or accidental beam exposures (direct and/or reflected) to non-targeted materials can pose a fire risk (i.e. drape fires or plastics on laser system). In addition, laser surgical procedures may create a fire within the patient due to laser beam interactions (i.e. methane gas in bowels, foam positioning devices, endotracheal tubes, etc.). Control measures shall be implemented to minimize potential for fire and spread of fire. High-pressure arc lamps, filament lamps, and capacitors may explode if they fail during operation. Keep these components enclosed in the laser housing, which will withstand the maximum explosive forces that may be produced. Laser targets and some optical components also may shatter if heat cannot be dissipated quickly enough. Ensure adequate mechanical shielding when exposing brittle materials to high intensity lasers. Ionizing Radiation (X-rays) X-rays could be produced from two main sources: high voltage vacuum tubes of laser power supplies such as rectifiers and thyratrons and electric discharge lasers. Any power supplies that require more than 15 kilovolts may produce enough x-rays to be a health concern. Consult Radiation Safety for review and control of such hazards.

STANDARD OPERATING PROCEDURES In addition to the laser registration form, LSLs must submit written SOPs to the LSO and LSC for approval prior to use of a Class 3B, 4 and embedded Class 3B or 4 laser/laser systems. SOPs must include:

Hazard identification (including non-beam hazards) and mitigation; Manufacturer’s operation, maintenance and calibration procedures; Laser/Area specific operation and maintenance procedures and engineering and

administrative controls, if applicable; Safe alignment and service procedures (alignment methods are provided by

manufacturer); LTCA designation; Protective equipment; and Emergency procedures.

Embedded Class 3B and 4 lasers may also require written SOPs. Consult with the LSO regarding potential additional safety requirements. A copy of approved SOPs shall be maintained and readily available within the LTCA or work area where laser/laser system is operated. LSLs will review SOPs annually. If new hazards are identified or any modifications to procedures and/or laser are


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implemented, updated SOPs must be submitted to the LSO and LSC for approval. The MUSC Laser SOP form is provided in Appendix D.

MEDICAL SURVEILLANCE A medical program has been established to comply with OSHA regulations. Anyone whose work involves laser/laser systems or has the potential to be exposed to laser radiation should consult with Employee Health Services on an individual basis to determine if a regular schedule of medical surveillance is required.

ACCIDENT REPORTING All accidents and known or suspected overexposures must be reported to the responsible LSL immediately. Accidents causing injury or property damage will be reported to the LSO and Risk Management within 24 hrs. For immediate assistance, call 2-3333, on campus, and contact the Radiation Safety Office at 792-4255 (during normal business hours) or page the Radiation Safety On-Call contact at 27390 (after hours). Medical examinations will be performed as requisite. Examinations will be performed by an ophthalmologist when a suspected eye injury is caused by lasers operating in the retinal hazard region (400 – 1400 nm). Known or suspected overexposures should seek medical attention without delay at either Employee Health Services (57 Bee Street, MSC 213) or Student health Services (30-A Bee Street, MSC 980) during regular business hours. After-hour incidents should seek medical attention through emergency services.

Accident Investigation

Upon notification of a laser incident, the LSO will conduct an accident investigation. The following information will be obtained:

Name(s) of individuals involved or suspected to have been involved; Date, time, location of incident; LSL name and contact information; Laser/laser system type, characteristics and operating parameters at time of

incident; Description of events that happened including duration of exposure and injured

individual’s position relative to laser. Interviews with injured individual and witnesses will be conducted, if possible;

PPE in use at time of incident; and Facility configuration.

The LSO will prepare a detailed written report summarizing findings and recommended corrective actions to prevent accident reoccurrence. A copy of the report will be


Page 18 of 18

provided to the LSC and LSL. The LSL will implement and submit in writing corrective actions taken to the LSO. LSL shall retain a copy of the accident report and documented corrective actions on file.

RECORD KEEPING The LSL is responsible for maintaining all laser safety-related records. These include laser registration form, approved SOPs, employee/student training records, equipment maintenance and service records, safety audits and accident investigation reports and corrective actions. Records should be available for laser safety audits and upon request. Records shall be maintained following applicable MUSC record retention policies.

APPENDIX A – Class 3B and 4 Laser System

Registration Form

MEDICAL UNIVERSITY OF SOUTH CAROLINA

CLASS 3B AND 4 LASER SYSTEMS REGISTRATION

Page 1

LASER SAFETY LIAISON (LSL): __________________________________ EXT: ___________

LASER INFORMATION: (if additional space required, attach separate page)

LOCATION OF LASER: ________________ ____________ ___________ ____________ (Bldg.) (Floor) (Room) (Dept.)

Manufacturer Model Serial Number Class Use (Clinical

or Research) Laser Type Wavelengths(nanometer)

Max Output

CW, Pulsed, or Q-switched NOHD1

Coherent Novus Omni A123546 IV Clinical Krypton 521, 531,

647, 568 3 watts Pulsed – variable duration

16.14 m (53 ft)

1NOHD – Nominal Ocular Hazard Distance; provided by manufacturer RED sample entry




Max Output

CW, Pulsed, or Q-switched NOHD




Max Output





Max Output


MEDICAL UNIVERSITY OF SOUTH CAROLINA

CLASS 3B AND 4 LASER SYSTEMS REGISTRATION

Page 2

LASER OPERATOR INFORMATION: Please list all authorized laser operators:

Name of Operator Physician (Y or N)

If additional space required, attach separate page.

ADDITIONAL REQUIRED INFORMATION: (indicate as appropriate)

YES NO Manufacturer’s operation, maintenance, alignment and calibration procedures are readily available. All applicable personnel are familiar with its contents and location.

MUSC Laser Standard Operating Procedure form has been completed and is attached.

I CERTIFY that I have become familiar with the Laser Safety Manual of the Medical University of South Carolina and its laser safety procedures, and will implement the requirements contained therein.

DATE:_____________________________SIGNATURE:_________________________________

APPENDIX B – Eye and Skin Maximum

Permissible Exposure

Source: ANSI Z136.1 – 2007 American National Standard for Safe Use of Lasers, Laser Institute of

America, 2007.

APPENDIX C – Laser Protective Eyewear

Selection Chart

Source: ANSI Z136.1 – 2007 American National Standard for Safe Use of Lasers, Laser Institute of America, 2007.

APPENDIX D – MUSC Laser Standard Operating

Procedures Form

Medical University of South Carolina

Laser Standard Operating Procedure

1. LASER SAFETY CONTACTS

• Laser Safety Liaision(s)_______________________ phone: ___________

_______________________ phone: ___________

• MUSC Radiation Safety Office phone: 843-792-4255

• MUSC Employee Health phone: 843-792-2991

• Medical Emergencies phone: 911

2. LASER LOCATION

• Department: ____________________________________________________________

• Building: _________________________Room (s): ______________________________

3. GENERAL NON-BEAM HAZARD PROCEDURES (check all that apply)

A. Hazardous Materials (dyes, solvents, compressed gases, cryogenic liquids, etc.);

attach SDS if applicable

• All hazardous materials will be used in accordance with manufacturer’s

guidelines as well as applicable MUSC policies concerning chemical use and

disposal.

• Compressed gases will be properly secured.

• Appropriate personal protective equipment (PPE) will be utilized.

Other:

B. Electrical (high voltage, large current, etc.)

• Prior to use, system electrical cords and area outlets will be inspected. Any

problems with electrical outlets will be reported immediately to MUHA Facilities.

• Laser system will not be used when electrical cords are loose or frayed.

Other:

________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

C. Laser Generated Air Contaminants

• When plume is anticipated, smoke evacuator or wall line suction will be utilized.

• Personnel will wear surgical masks designed to filter 0.1 micron particulate

matter.

• Operation of plume management system and filter monitor will be checked prior

to procedure. Filter will be replaced, if necessary.

• All tubing, connectors, adapters, and wands will be changed by case and

disposed in accordance with MUSC biohazardous waste policies.

Other:

D. Fire

• A fire extinguisher will be readily available in procedure area. All personnel will

be familiar with its location.

• Sterile water and /or saline will be available at all times.

• Flammable liquids (alcohol, prevail, etc.), tapes, skin degreasers, prep solution,

lubricants, and drying agents will not be used during laser procedures.

• Laser-safe endotracheal tubes will be utilized in surgery involving airway or

neck and head region.

• Non-explosive anesthetics and localized ventilation will be utilized in surgery of

digestive tracts.

• Steps will be taken to avoid flammable gases near laser energy in operative

field (minimized O2 and N2O use, maximize air use).

Other:

E. Security

• Laser key will be stored in secure location to prevent unauthorized use. Key

switch will be removed from laser system when unattended.

________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

Other:

F. Other (specify): ________________________________________________

Procedures:(If additional space required, attach separate page)

4. LASER TREATMENT CONTROLLED AREA

A. Controlled Access to Laser Treatment Room

• The appropriate Danger laser area warning sign will be placed at eye level at or

near all entrances to the room.

• Laser protective eyewear labelled with the appropriate wavelength and optical

density will be provided prior to all authorized personnel prior to entering room.

• Only personnel essential to the laser procedure will be allowed in room during

laser procedures.

• Laser will not be activated when door to room is open.

Other:

5. SPECIFIC OPERATING PROCEDURES

A. Preoperative

• Post laser warning signs

• Laser barriers and window coverings put in place (if applicable)

• Distribute PPE (eyewear and other)

• Plug laser into electrical outlet

• Attach foot pedal, assemble additional accessories / attachments for procedure

(micro manipulator, endoscope, headpiece, etc.)

• Turn laser on with key

________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

_____________________________________________________________ _____________________________________________________________ _____________________________________________________________ _____________________________________________________________

________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

Other:

B. Intraoperative

• Patient protections in place (wet towels, eye shields, rectal pack, etc.)

• Operative site draped with wet towels or sponges, remoistened as necessary

• Select appropriate power and mode

• Position laser control panel and foot pedal

• Connect laser attachments as needed

• Only diffuse reflective materials or instruments with low reflectance will be used

in or near laser beam path. Laser will not be directed at reflective materials.

• Laser stays in STANDBY when not in use

Other:

C. Post-operative

• Turn laser off

• Remove warning signs, protective barriers

• Clean and store laser and accessories/attachments

• Return key to secure location

Other:

D. Personnel Protection Equipment

I.Laser Eye Protection

• All individuals (staff and patient) will wear appropriate laser protective

eyewear when in the laser treatment control area.

• Eyewear will be labeled with optical density and wavelength attenuated.

• Eyewear will be inspected prior to each use. Damaged eyewear will be

removed from service.

________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

• Lens covers with appropriate filtering lenses will be used during direct vision

through scopes.

• Patients:

a) Awake for procedure will be provided laser specific

goggles/glasses.

b) Under general anesthesia will be provided wet eye pads or

laser specific eye shields (as appropriate).

c) Undergoing laser treatments on or around eyelids will be

provided corneal eye shields.

II.Other PPE

• Windows and entryways will be shielded by appropriate laser

barriers/curtains. Flame retardant or wet drapes will be used in operative

field. Flame retardant opaque window coverings will be used where

appropriate (except for CO2 lasers).

• When necessary, appropriate skin protection measures will be used.

Other:

6. SERVICE AND MAINTENANCE PROCEDURES

• All service and maintenance of lasers/laser systems will be performed in accordance

with the manufacturer’s guidelines by trained Bio-Medical staff and/or vendor service

staff only.

• The appropriate Notice laser warning sign will be posted at all entryways to room

/area prior to beginning of service and removed upon completion.

• Safety interlocks will not be permanently disabled.

• Malfunctions will be immediately reported to Bio-Medical staff and/or vendor service

staff and laser removed from service.

________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

Other: ________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

7. EMERGENCY PROCEDURES

A. Fire (In or Out of Operative Field)

• Turn combustible gases and laser off.

• Remove burning materials from operative site.

• Attempt to extinguish fire within operative field by dousing with water or saline

solution. Use fire extinguisher for burning materials away from operative area.

• Follow standard fire protocols for all other fire situations.

B. Other

• Laser emergency shutoff procedures will be initiated under these

conditions:

o Shutter failure

o Water leakage from laser console

o Water leakage from water hoses (significant)

o Electrical hazard alarms on isolated transformer

o Unexplained, abnormal operation

o Inappropriate or unsafe use

Other:

Please return completed form to Radiation Safety at [email protected]. For

questions, contact Radiation Safety at 843-792-4244.

**********************************************************************************************************

FOR RSO USE ONLY:

Date Received: ______________ Reviewed by: __________________________

________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

mailto:[email protected]

APPENDIX E – Laser Safety Checklist

Source: Recommended practices for laser safety in perioperative practice setting. In: Perioperative Standards and Recommended Practices. Denver, CO: AORN, Inc.; 2011:125‐141.

Laser Safety Checklist This laser safety checklist is intended as a reference for medical personnel involved in laser surgical procedures. The checklist reviews common safety measures to implement during the use of laser systems.

Preoperative

☐ Laser area warning signs are posted at all entrances of procedure room. ☐ Window covers or laser barrier curtains are deployed. ☐ Appropriate laser protective eyewear is in good condition and available for

personnel and patient (if applicable). ☐ Respiratory protection is available (i.e. fit tested N95 or high filtration surgical

mask). ☐ Smoke evacuator has clean filter and is operational. ☐ Fire extinguisher is readily available. ☐ Electrical cords and outlets inspected for damage. ☐ Laser self-tested and calibrated if needed. ☐ CO2 laser test fired to check for alignment. Intraoperative

☐ Flammable prep solutions are dry before laser use. ☐ Eye protection is worn by all (including patient) in procedure room during laser use. ☐ Basin of water is available and wet towels or drapes and sponges are in place at

procedure site (if applicable). ☐ Anodized, dull, non-reflective, or matte finished instruments are used near beam

path. ☐ Laser foot petal accessible only when laser is in use. ☐ Laser is in standby when not in use. ☐ Lowest possible O2 concentration that maintains patient’s O2 saturation is used. ☐ Laser resistant endotracheal tubes are used for airway or aerodigestive tract

procedures. ☐ Laser resistant endotracheal cuffs are inflated with saline and dye. Postoperative

☐ Laser key returned to secure storage. ☐ Laser, smoke evacuator, and accessories are properly cleaned and stored. ☐ Laser protective eyewear is cleaned, inspected for damage, and stored properly.

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