• DUKE UNIVERSITY DUKE UNIVERSITY MEDICAL CENTER

Sponsored Links

  •   
  • FileName: laser_policy.pdf [preview-online]
    • Abstract: The Duke University laser safety policy is based on the recommendations of ANSI Z136.1 and the ... MSDS available for staff review and in general ensure compliance with applicable Duke policies ...

Download the ebook

DUKE UNIVERSITY
DUKE UNIVERSITY MEDICAL CENTER
Laser Safety Policy
Date Rev: 10/2008
CONTENTS
SECTION PAGE
1. Laser Safety Program Elements ………………………………………………………... 1
1.1 Abbreviations Used ……………………………………………………………………. 1
1.2 Purpose …………………………………………………………………………….….. 1
1.3 Roles and Responsibilities …………………………………………………………... 2
1.3.1 Laser Safety Program Oversight Organizational Chart ………………………… 2
1.3.2 Laser Safety Committees ……………………………………………………………. 2
1.3.3 Radiation Safety Officer …………………………………………………………….. 2
1.3.4 Laser Safety Manager ……………………………………………………………….. 3
1.3.5 Principal Laser User …………………………………………………………………. 3
1.3.6 Laser Operators ……………………………………………………………………… 4
1.3.7 Escalated Enforcement Policy ………………………………………………………. 5
2. Laser Classification ……………………………………………………………………... 7
2.1 Class 1 …………………………………………………………………………………. 7
2.2 Class 2 …………………………………………………………………………………. 7
2.3 Class 3a ………………………………………………………………………………... 7
2.4 Class 3b ………………………………………………………………………………... 7
2.5 Class 4 …………………………………………………………………………………. 8
2.6 Embedded Lasers ……………………………………………………………………… 8
2.7 IEC Classification Scheme ……………………………………………………………. 8
3. Laser Acquisition, Transfer, and Disposal …………………………………………….. 9
4. Laser Hazard Control Measures ……………………………………………………….. 10
4.1 Controls for Class 1, 2, and 3a Lasers ………………………………………………… 10
4.2 Controls for Class 3b and Class 4 Lasers ……………………………………………... 10
4.2.1 Posting ………………………………………………………………………………. 10
4.2.2 Authorization ………………………………………………………………………... 10
4.2.3 Beam Stop …………………………………………………………………………… 10
4.2.4 Eye Protection ……………………………………………………………………….. 11
4.2.5 Light Containment …………………………………………………………………... 11
4.3 Additional Controls for Class 4 Lasers ………………………………………………... 12
4.3.1 Rapid Egress and Emergency Access ……………………………………………….. 12
4.3.2 Laser Activation Warning Systems and Entry Controls …………………………….. 12
4.3.3 Key Switches ………………………………………………………………………... 12
4.4 Temporary Control Areas ……………………………………………………………... 12
4.5 Special Requirements for Invisible Beam Lasers ……………………………………... 13
4.5.1 Infrared Lasers ………………………………………………………………………. 13
4.5.2 Ultraviolet Lasers ……………………………………………………………………. 13
4.6 Substitution of Alternate Control Measures …………………………………………... 13
5. Laser Safety Training …………………………………………………………………… 14
5.1 Initial Laser Safety Training …………………………………………………………... 14
5.2 Visitors ………………………………………………………………………………… 14
5.3 Laser-specific Training ………………………………………………………………... 14
5.4 Update Training ……………………………………………………………………….. 14
6. Laser Related Non-Beam Hazards & Control Measures ……………………………... 15
6.1 Electrical Hazards ……………………………………………………………………... 15
6.2 Laser Dyes …………………………………………………………………………….. 15
6.3 Compressed Gases and Cryogenics …………………………………………………… 15
6.4 Laser Generated Air Contaminants (LGAC) ………………………………………….. 16
6.5 Plasma Emissions ……………………………………………………………………... 16
6.6 UV and Visible-Radiation …………………………………………………………….. 16
6.7 Explosion Hazards …………………………………………………………………….. 16
6.8 Ionizing Radiation (X-rays) …………………………………………………………… 16
7. Medical Surveillance …………………………………………………………………….. 17
8. Laser Accidents ………………………………………………………………………….. 18
8.1 Immediate Response and General Procedures ………………………………………… 18
8.1.1 General Laser Accident Reporting ………………………………………………….. 18
8.1.2 Known or Suspected Laser Overexposure …………………………………………... 18
8.2 Laser Accidents in Duke University Hospital ………………………………………… 18
8.2.1 Occurrence Reports ………………………………………………………………….. 18
8.2.2 Follow-up Procedures by the Laser Safety Manager ………………………………... 19
9. Standard Operating Procedure (SOP) …………………………………………………. 21
10. Resources ……………………………………………………………………………….. 22
10.1 Glossary ……………………………………………………………………………… 22
10.2 SOP Template ………………………………………………………………………... 22
11. References ………………………………………………………………………………. 23
APPENDIX A – Use of Lasers Outside the Clinical or Laboratory Setting ………….... 24
APPENDIX B – Summary of Laser Hazard Classification Schemes …………………... 27
APPENDIX C – Additional Considerations for Outdoor Laser Use …………………… 28
APPENDIX D – Protective Eyewear for Ultrashort Pulsed Lasers ……………………. 29
1. Laser Safety Program Elements
1.1 Abbreviations Used
ANSI Z136.1 – American National Standards Institute Z136.1-2000 (or latest version thereof)
Standard for the Safe Use of Lasers
ANSI Z136.3 – American National Standards Institute Z136.3-2005 (or latest version thereof) Safe
Use of Lasers in Health Care Facilities
CFR – Code of Federal Regulations
CW – Continuous wave laser (laser operating with continuous output for more than 0.25 seconds)
DU – Duke University
DUMC – Duke University Medical Center
GCFI – Ground Fault Interruption Circuit
IEC – International Electrotechnical Commission. This group establishes standards for the safe use
of lasers that are similar to the ANSI Z136 series of standards and which, like the ANSI standards,
are recognized by the various U.S. government agencies regulating laser use in this country
IR – Infrared light (> 760 nm wavelength)
LO – Laser Operator
LSC – Laser Safety Committee.
LSM – Laser Safety Manager
MPE – Maximum Permissible Exposure, i.e. the laser radiation level to which a person can be
exposed without hazardous effect or adverse biological changes in the eye or skin.
MSDS – Material Safety Data Sheet
OESO – Duke Occupational and Environmental Safety Office
OSHA – Occupational Safety and Health Administration
PLU – Principal Laser User
RSO – Radiation Safety Officer and Director of the OESO Radiation Safety Division
SOP – Standard Operating Procedure
UV – Ultraviolet light (100 – 400 nm wavelength)
1.2 Purpose
The Duke University laser safety policy is based on the recommendations of ANSI Z136.1 and the
applicable federal and state regulations. The laser safety program’s primary objective is to ensure
that no laser radiation in excess of the MPE reaches the human eye or skin. This program is also
intended to ensure adequate protection against laser-related non-beam hazards.
1
1.3 Roles and Responsibilities
1.3 .1 Laser Safety Program Oversight Organizational Chart
Duke University Administration
Duke MC Administration
Director (RSO) Chair &
Radiation Safety Division MC/Univ RSC
Laser Safety Manager (LSM) Chair &
Radiation Safety Division MC/Univ
Laser Safety Committee
Operational Unit Policy Making Unit
Policy implementation/Safety Oversight Advisory role to RSO/LSM
1.3 .2 Laser Safety Committees (LSC)
While the two institutional Radiation Safety Committees are ultimately responsible for laser safety
oversight, two LSCs, one for Clinical Use and another for Research Use, directly oversee the laser
safety programs at Duke. Each LSC is a subcommittee of the corresponding Radiation Safety
Committee (see the Radiation Safety Manual for Duke University and Duke University Medical
Center). Each LSC consists of the Committee Chairman, the LSM, laser users, management
representatives, persons knowledgeable in laser safety and/or laser technology, and others as
needed. The LSCs’ responsibilities include:
(a) Establish and maintain internal policies/procedures to ensure they comply with applicable
regulations and standards.
(b) Resolve conflicts or issues identified by the LSM, laser users, or other parties.
(c) Perform annual program reviews.
(d) Maintain an awareness of all applicable new or revised laser safety standards.
1.3.3. Radiation Safety Officer (RSO)
The RSO has the responsibility to establish, monitor, and enforce control of laser hazards and is
responsible to the Radiation Safety Committee and LSC for the laser safety program’s
management and administration. The RSO designates the LSM.
2
1.3.4 Laser Safety Manager (LSM)
The LSM is designated by the RSO. The LSM’s responsibilities include:
(a) Administer the day-to-day operation of the Laser Safety Program.
(b) Maintain a current inventory of Class 3b and 4 lasers.
(c) Function as liaison between PLUs and the LSCs.
(d) Accompany outside inspectors/regulators on laser safety inspections.
(e) Perform laser hazard analyses and audits; ensure, by follow up and additional audits as
necessary, that all laser safety deficiencies are addressed and resolved.
(f) Make recommendations to improve laser safety.
(g) Restrict or terminate use of lasers that present an imminent danger or excessive hazard.
(h) Ensure the availability of proper laser safety training.
(i) Make recommendations for selection of proper personnel protective equipment.
(j) Investigate laser accidents and near misses.
(k) Update laser safety policy and procedures as needed.
(l) Review, approve, and maintain a copy on file of all laser SOPs.
(m) Review, approve, and maintain a copy on file of all Non-Clinical Laser Laboratory Pre-
Operational Checklists; coordinate with the responsible PLU to ensure compliance prior to
approval.
(n) Review, approve, and maintain a copy on file of all Non-Clinical Laser Laboratory
Authorizations; coordinate with the responsible PLU to ensure compliance prior to
approval.
(o) Ensure maintenance of laser user’s most recent laser safety training records until that user
is no longer involved with laser use at Duke.
(p) Provide periodic reports on the status of laser safety to the LSC and RSO, and promptly
inform the RSO of any serious laser safety concerns.
1.3.5 Principal Laser User (PLU)
Every class 3b or 4 laser system on site must be assigned to a PLU. If no PLU has been formally
identified for a particular laser/laser system, the Departmental Chairman may designate a PLU, and
inform the LSM of the designation. The PLU’s responsibilities include:
(a) Planning and implementation of all safety measures required for safe laser operation for all
lasers under their control, and prior to introducing additional laser equipment to their area.
(b) Complete a Laser Registration Form for each Class 3b or 4 laser and send the form(s) to the
LSM.
(c) Prior to non-clinical use of a Class 3b or 4 laser, complete and obtain the LSM’s approval
signature on a Laser Laboratory Pre-Operational Checklist. This checklist is available on
the OESO Laser Safety Web Site.
3
(d) For every non-clinical area using class 3b and 4 lasers under the PLU’s control, complete
and submit to the LSM a Non-Clinical Laser Laboratory Authorization form (available on
the OESO web site). Coordinate with the LSM to obtain approval of the Non-Clinical
Laser Laboratory Authorization before operating a Class 3b or 4 lasers for non-clinical
applications. Resubmit each Non-Clinical Laser Laboratory Authorization to the LSM for
renewal every four years, or upon major changes (e.g. room relocation, different laser
types, etc.) to the laser laboratory.
(e) Post a written SOP (as described in section 9 of this Policy) in a location readily available
to laser operators, for all unenclosed Class 3b and 4 lasers; ensure compliance with the
SOP. Provide a current copy of the SOP to the LSM and obtain LSM approval for the SOP
before operation of the laser.
(f) Supervise the safe use of lasers in the laser environment.
(g) Ensure that all lasers under his/her control are properly classified and labeled.
(h) Establish and maintain a current list of those personnel approved to operate specific types
of Class 3b or 4 lasers under their supervision and provide a copy of the list to the LSM.
(i) Complete the applicable OESO Laser Safety course at the interval specified in this Manual.
(j) Immediately notify OESO in the event of a suspected overexposure to the output beam
from a Class 3b or 4 laser.
(k) Ensure that safety controls are not disabled, removed, or modified without written
authorization from the PLU, and notify the LSM immediately of any changes in the status
of safety controls.
(l) Notify the LSM of any OEM lasers (i.e. lasers that do not comply with all requirements of
the Federal Laser Product Performance Standard, e.g., warning labels, interlock shutter, etc.
because they are designed for incorporation into larger devices) that the PLU is using in an
open beam configuration.
(m) Ensure the safe and responsible disposition of their unneeded, but potentially hazardous,
class 3b or 4 lasers and laser components. See chapter 3 for a list of appropriate disposal
options.
1.3.6 Laser Operator (LO)
Only a PLU or an LO may operate a Class 3b or 4 laser. Each LO must work under the
supervision of a PLU. LO responsibilities include:
(a) Complete the applicable OESO Laser Safety course, before operating a Class 3b or 4 laser
and again at the interval specified in this Policy manual.
(b) Use lasers safely.
(c) Comply with established policy, SOPs and other procedural requirements.
(d) Promptly report to the PLU any malfunctions, problems, accidents, or injuries, which may
have an impact on safety.
(e) Do not disable, remove, or modify any safety control systems without prior written
approval from the PLU.
4
1.3.7 Escalated Enforcement Policy
(a) Purpose
This section specifies the actions of the Radiation Safety Officer (RSO) and the Research
Use Laser Safety Committee to correct specific items of non-compliance, ensuring that
laser users work with the RSO and the Committee to maintain safety and compliance. This
enforcement policy does not apply to patient care areas. Instead, for these areas, the RSO
will work with the Division Director or Departmental Chair to resolve any uncorrected
compliance issues.
(b) Enforcement Process
i. Radiation Safety staff will provide the PLU with written notification of any items of non-
compliance discovered in that PLU's area of responsibility. If appropriate, Radiation
Safety staff may request a written response from the PLU regarding corrective measures
for any items of non-compliance discovered during routine laser laboratory audits. Any
such written response shall be provided by the PLU to the auditor on or before the date
specified in the written notification.
ii. Documented compliance issues should be resolved between the PLU and the RSO or
his/her designee.
iii. If routine Radiation Safety staff surveys show a repeat violation (i.e. same item cited on
last inspection) or other pattern of multiple violations, the PLU must, within one week of
notification, send the Radiation Safety Officer a brief written explanation of:
what caused the item(s) of non-compliance,
steps taken to date by the PLU to correct the item(s),
further steps to be taken by the PLU, and
measures the PLU took or will take to prevent recurrence.
iv. If the PLU has not achieved compliance to the Radiation Safety Officer's satisfaction
within one week of notification, the Radiation Safety Officer and the PLU will discuss
the matter with the PLU's Departmental Chair or Faculty Dean, or other representative of
the Institutional Administration as appropriate.
v. If satisfactory resolution still cannot be obtained, the matter will be escalated to the
Research Use Laser Safety Committee and, if necessary, senior Institutional
Administration.
(c) Enforcement Options
i. Radiation Safety Intervention
The RSO is authorized to immediately order the termination or limitation of any
procedure or other laboratory activity that in his/her professional opinion constitutes an
immediate danger to life, health, property, or the environment. The RSO is also
authorized to order the termination or limitation of any procedure or laboratory activity of
a PLU who willfully violates the Duke Laser Safety Policy. Such intervention may
include, but is not necessarily limited to, the suspension of laser use, the withholding of
pending deliveries of lasers and the disabling of lasers (e.g. by confiscation of the laser
5
on/off switch key). The RSO will notify the PLU, the chair of the Research Use Laser
Safety Committee and appropriate senior management.
ii. Restriction and Revocation
The Chairman of the Research Use Laser Safety Committee may, upon the RSO's
recommendation, restrict the authority of a PLU as a result of repeated or serious
violations of Duke University/Medical Center policy. Radiation Safety staff must
immediately notify the PLU, the PLU's Departmental Chair or Faculty Dean, and the
appropriate Institutional Administrators of any restriction and of the reason for that
restriction.
Such restriction remains in effect until review by the Research Use Laser Safety
Committee either reinstates, modifies, or revokes the restricted privileges by a
majority vote.
6
2. Laser Classification
All lasers and laser systems in the U.S. are categorized into one of several hazard 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). See Appendix B for a summary of the classification schemes of these three
organizations. The manufacturer provides the classification for most lasers. For custom-built and
modified lasers, the LSM can assist with classification.
2.1 Class 1
• Do not emit harmful levels of radiation during normal operation.
• Also includes higher class lasers completely enclosed and interlocked to prevent beam
access, allowing a Class 1 laser system designation; any time the higher class laser is
accessible (e.g. during alignment or servicing), the higher laser class controls must be
observed.
• Can be used without restriction in the manner intended by the manufacturer and without
special operator training or qualification.
2.2 Class 2
• Emit accessible laser light in the visible wavelength region.
• Capable of creating eye damage through chronic exposure.
• In general, the human eye will blink within 0.25 second when exposed to Class 2 laser
light; this blink reflex provides adequate protection.
• Can be used without restriction in the manner intended by the manufacturer and without
special operator training or qualification.
2.3 Class 3a
• Normally not hazardous when viewed momentarily with the unaided eye, but may pose
severe eye hazards when viewed through collecting optics (e.g., microscopes and
binoculars).
• Power levels 1-5 milliwatt (mW).
• Same controls as Class 1 and Class 2 lasers for normal operations; if viewed through
optical instruments (e.g., binoculars, telescopes, or microscopes), contact the LSM for a
hazard review.
2.4 Class 3b
• Will cause injury upon direct viewing of the beam and specular reflections.
• Power output 5-500 mW for CW or less than 0.03 joule (J) for a pulsed system (i.e. pulse
width less than 0.25 second).
• Must implement specific control measures covered in this chapter.
7
2.5 Class 4
• Includes all laser systems with power levels greater than 500 mW CW or greater than 0.03
J for a pulsed system.
• Pose eye hazards, skin hazards, and fire hazards. Viewing the beam or specular reflections
or exposure to diffuse reflections can cause eye and skin injuries.
• All control measures explained in this document must be implemented.
2.6 Embedded Lasers
Lasers are often embedded in laser products or systems with a lower hazard class. When the laser
system is used as intended, the controls for the system's class apply. When the system is opened
(e.g. for service or alignment) and the embedded laser beam is accessible, a temporary control area
must be established. The controls for the temporary control area must be based on the
classification of the embedded laser. The user and LSM must determine adequate controls.
Confirmation of a system classification is the responsibility of the LSM, and therefore necessitates
registering the system. An abbreviated SOP may be required, as in the case of such commercially
available enclosed laser systems as a laser scanning confocal microscope.
2.7 IEC Classification Scheme
The IEC has established a hazard classification scheme similar to that described in this section, but
with some minor differences. Laser products encountered at Duke may be labeled using this
alternate system. Laser systems bearing the IEC 1M, 2M, or 3R classification require the same
control measures as Class 3a lasers. See Appendix B [Summary of Laser Hazard Classification
Schemes] for further information regarding these laser classification schemes
8
3. Laser Acquisition, Transfer, and Disposal
Notify the LSM of any decision to purchase, fabricate, or otherwise acquire a Class 3b or Class 4
laser. The LSM will review with the user the hazards of the proposed operation and make
recommendations regarding the specific safety requirements that pertain to the proposed use,
including requirements for SOPs, laser control areas, training, and personnel protective equipment.
Also notify the LSM of any class 3b or 4 laser or laser system relocated, transferred to another
PLU or institution, or sent offsite as surplus equipment.
Laser users have an obligation to ensure safe and responsible disposition of their unneeded, but
potentially hazardous, class 3b or 4 lasers and laser components. Appropriate means of laser
disposal include:
• Donate the laser to an organization (e.g. school, industrial company, hospital) with a need
for such a device. The donor should ensure that the donated laser system complies with all
applicable product safety standards, such as the Federal Laser Product Performance
Standard, and is provided with adequate safety instructions for operations and maintenance.
The donor should also verify that the receiving organization has a viable laser safety
program.
• Return the laser to the manufacturer, or to a vendor specializing in re-selling used laser
equipment.
• Eliminate the possibility of activating the laser by removing all means by which it can be
electrically activated. Once this has happened the laser could then be discarded.
• Destroy the laser.
The last two methods also require proper disposal of any hazardous materials found inside the laser
components, such as mercury switches, oils, dyes, etc. Users should contact the LSM if they need
further information or assistance with proper disposal.
9
4. Laser Hazard Control Measures
4.1 Controls for Class 1, 2, and 3a Lasers
Class 1, 2, and 3a laser beams may not be intentionally directed at a law enforcement
officer or the head or face of another person, except for:
- law enforcement purposes by police, or
- medical use by authorized medical personnel.
Class 3a laser beams must not be viewed with collecting optics (e.g. microscopes) unless
the optical system is specifically designed and constructed to prevent eye exposure
exceeding the applicable MPE.
Otherwise, no other specific laser safety requirements apply to Class 1, 2, and 3a lasers.
4.2 Controls for Class 3b and Class 4 Lasers
Class 3b and Class 4 lasers may be operated only in designated laser control areas, including
operative suites, patient treatment rooms and patient examination rooms, or in other laser control
areas approved by the LSM. The purpose of laser control areas is to confine laser hazards to well-
defined spaces that are under the control of the laser user, thereby preventing injury to those
visiting and working near the control area. All personnel authorized to enter a Class 3b or Class 4
laser controlled area shall be appropriately trained, and must follow all applicable administrative
and operational controls.
4.2.1 Posting
The area must be posted with appropriate warning signs that indicate the nature of the hazard. The
wording on the signs will be specified by the LSM and conform to the ANSI Z136.1 guidelines.
Such signs shall be posted at all entrances to the laser control area during the time a procedure
utilizing the active beam is in progress, and shall be removed when the procedure is completed. In
addition, an SOP approved by the LSM must be posted in a location readily available to laser
operators.
4.2.2 Authorization
Only personnel who have been authorized by the PLU may operate the laser. Personnel may be
authorized upon completing the applicable OESO laser safety training. The PLU may stipulate
additional authorization requirements. For Non-Clinical Applications, Class 3b and 4 lasers may
only be operated upon the LSM’s approval of the responsible PLU’s applicable Non-Clinical Laser
Laboratory Authorization.
4.2.3 Beam Stop
All laser beams, other than those applied to tissue for surgical or therapeutic purposes, must be
terminated at the end of their useful paths by a material that is non-reflective and (for class 4
lasers) fire resistant.
10
4.2.4 Eye Protection
Laser protective eyewear of adequate optical density and threshold limit for the beams under
manipulation must be provided and worn at any point where laser exposure could exceed the MPE.
This includes provision and use of M-rated eyewear in labs using unenclosed class 3b
or 4 laser systems capable of 700 nm), other than those applied to tissue for surgical or therapeutic
purposes, must be terminated by a highly absorbent, non-specular backstop. Note that many
surfaces that appear dull are excellent IR reflectors and would not be suitable for this purpose.
Class 4 IR laser beam terminators must be made of a fire-retardant material, or of a material which
has been treated to be fire-retardant.
4.5.2 Ultraviolet Lasers
UV radiation causes photochemical reaction in the eyes and the skin, as well as in materials that
are found in laboratories. The latter may cause hazardous by-products such as ozone and skin-
sensitizing agents. The direct beam and scattered radiation should be shielded to the practical
maximum extent to avoid such problems. The use of long-sleeved coats, gloves, and face
protectors is recommended. Some medications, including tetracycline, doxycycline, tricyclic
antidepressants, and methotrexate, can increase a person’s risk to UV radiation. Contact the LSM
for more information about this subject.
4.6 Substitution of Alternate Control Measures
Upon documented review by the LSM, the engineering control measures recommended by ANSI
Z136.1 for Class 3b and Class 4 lasers or laser systems may be replaced by administrative or other
alternate engineering controls that provide equivalent protection. Approvals of these controls are
subject to the same review procedure as described in this chapter.
13
5. Laser Safety Training
5.1 Initial Training
All employees who use Class 3b or Class 4 lasers must complete the appropriate OESO Laser
Safety course. Non-Medical laser users must complete the “Laser Safety – Non Clinical Use”
course. Healthcare laser users and those nursing and ancillary personnel working in operative or
treatment areas during healthcare laser use must complete the appropriate application-specific laser
safety course. All of these laser safety courses are available on-line on the OESO Web site or,
upon request, by classroom instruction through the LSM.
5.2 Visitors
Guests of DU/DUMC requesting to use or observe Class 3b or Class 4 lasers must contact the
LSM regarding the training requirement for non-Duke personnel. New employees and guests may
use lasers under the direct supervision of a PLU until completing the training requirement.
5.3 Laser-specific Training
Laser users are also responsible for knowing the safety requirements that apply to their specific
laser or laser syst


Use: 0.5596