Illinois Administrative Code › Title 32 - ENERGY › Part 315 - STANDARDS FOR PROTECTION AGAINST LASER RADIATION › Appendix A - Sample Standard Operating Procedures

Current through Register Vol. 48, No. 28, July 12, 2024
Standard Operating Procedures (SOPs) are governed by
				institutional policy and are developed, modified and maintained in accordance
				with the needs of individual facilities. Information relative to safety
				incorporated into these SOPs is gathered from a wide range of resources,
				including, but not limited to, the laser system manufacturer or distributor.
				This Appendix A contains examples of SOPs for issues associated with the use of
				laser systems. It is recognized that the safety needs of installations with
				multiple laser systems may be different from those facilities with a single
				laser system. The samples that follow cannot cover all situations or
				procedures; they are only intended as models that should be used to accommodate
				specific requirements. Typically, the Laser Safety Officer shall have the
				responsibility to see that SOPs are followed.
It is reasonable to expect that the manufacturer of the laser
				system shall supply safety information that can serve as the cornerstone for
				the generation of the SOPs. It is incumbent upon the operator to demand the
				information from the manufacturer. The availability of safety related
				information is facilitated by the FDA requirement that the manufacturer of
				laser products provide the user with adequate instructions for the safe
				operation and maintenance of all laser products.
SAMPLE 1: Controlled Access to the Laser
				Room
Purpose:
To define the area in which control
				measures shall be applied and to describe the control measures necessary in
				order to maintain a safe environment for use of the laser system.
Policy:
Class 3b and Class 4 lasers shall be
				operated in areas where traffic flow and compliance with all safety procedures
				can be monitored.
Procedure:
1) Appropriate warning signs shall be posted at eye
				level on all doors that access a room where a laser is to be operated. These
				signs shall state all required information and shall be removed when the laser
				is not in use.
2) Safety goggles labeled with the appropriate
				wavelength and optical density shall be available at the entry where each door
				sign is posted.
3) Glass windows shall be covered with shades or
				filters of appropriate optical density whenever a fiberoptic laser system is
				operational.
4) All safety procedures shall be followed during
				service, maintenance and demonstrations.
5) No one shall be allowed into a laser room unless
				properly authorized and protected.
6) The laser shall not be activated when it is
				necessary to open the door, if the controlled area extends to the
				doorway.
7) Laser keys shall be kept in a secured area and
				signed out only by those authorized to do so.
SAMPLE 2: Ocular Safety
Purpose:
To prevent ocular injuries to personnel
				working with Class 3b and Class 4 lasers.
Policy:
Within the controlled area, all personnel
				shall adhere to appropriate eye protection procedures during all laser
				applications.
NOTE: Under some conditions, the controlled area may include
				the entire room in which the laser procedure is performed. Under those
				conditions, the ocular safety procedures listed in this Sample 2 apply to the
				entire room. In health care facilities, ocular safety procedures shall also
				apply to the patient receiving laser treatment.
All personnel involved in maintenance and demonstrations of
				laser systems shall follow all ocular safety procedures whenever a laser is in
				operation in the facility.
Procedure:
1) Appropriate eyewear shall be worn by everyone in
				the controlled area while the laser is in operation. Appropriate eyewear
				consists of glasses or goggles of sufficient optical density to prevent ocular
				damage at the laser wavelength in use. Exception to this is the operator
				looking through an attached microscope with a lens that has the appropriate
				optical density for the laser in use.
2) Prior to use, the operator and ancillary
				personnel shall be responsible for selecting and examining eyewear for comfort,
				proper fit, and presence of labels describing both wavelength and proper
				optical density.
3) If eyewear is damaged, it shall not be worn and a
				report shall be made to the laser safety officer.
4) Contact lenses are not acceptable as protective
				eyewear. Prescription lens wearers shall use appropriate laser safety
				eyewear.
5) All goggles shall have side shields to protect
				from peripheral injury and impact.
6) Any articulated arm that is not shuttered shall
				be capped when not connected to the hand piece or the operating
				microscope.
7) The laser system shall be placed in standby mode
				when delivery optics are moved away from the target.
8) In health care facilities, patients shall be
				fitted with appropriately labeled eyewear, or have their eyes covered with wet
				cloth pads or towels. Metal or dry materials shall be placed on the patient's
				face or eyes only when indicated.
SAMPLE 3: Handling of Laser Fiber Delivery Systems in
				Health Care Facilities
Purpose:
To promote safe and proper handling of
				laser fiber delivery systems and to limit the potential for fiber breakage,
				damage and reduced efficiency during clinical laser procedures.
Policy:
Personnel handling laser fibers shall
				assure compliance with all safety procedures and shall consider the fiber an
				extension of the laser system, governed by applicable standards and
				regulations.
Procedure:
1) Appropriate eye safety filters shall be used with
				endo/microscopes.
2) Laser room windows shall be covered completely
				with appropriate filters, if necessary.
3) Fibers and associated equipment shall be
				positioned to allow for safe traffic patterns in the room.
4) The fiber shall be examined for breaks or damage
				of the distal tip, the proximal connector and the catheter sheath. Fiber shall
				be calibrated in accordance with manufacturer's directions. If deficiencies or
				damage are noted, another fiber shall be obtained.
5) Do not use clamps or other instruments to secure
				fiber in the operative site.
6) Always use coaxial cooling that is appropriate to
				the procedure. Never use gas to purge a fiber in the intrauterine
				cavity.
7) Never operate the laser unless the aiming beam
				(if used) and the tip of the fiber beyond the end of the endoscope are both
				visible.
8) Monitor the fiber for distortion of the beam,
				decreased power transmission and accumulation of debris on the tip.
9) Never reuse a disposable fiber without
				manufacturer's directions.
10) Always put the laser in standby when not aimed
				at a target.
SAMPLE 4: Non-Beam Hazards in Health Care
				Facilities
Purpose:
To recognize and effectively deal with a
				variety of potential non-beam hazards that may be present during laser
				procedures.
Policy:
Non-beam hazards are the purview of safety
				and industrial hygiene personnel, who will effect the appropriate hazard
				evaluation and control.
Procedure:
I. Fire
1) Never use alcohol in the operative field. Fibers
				may be rinsed in hydrogen peroxide or saline intraoperatively.
2) Never place a hot fiber directly on paper drapes.
				Wait until tip is cool before contact is made with flammable material.
3) Use fire-retardant drapes, damp packs or pads.
				Fill pelvic cavity with Ringer's, saline or other appropriate solution during
				surgery.
4) Put laser system in standby mode when procedure
				is interrupted or terminated.
5) Avoid high levels of oxygen in the operative
				field.
6) Avoid laser beam exposure of the sheaths of
				flexible fiber endoscopes, since many of the sheaths are flammable.
II. Plume Management
1) Remove laser generated airborne contaminants from
				the laser target area to reduce the transmission of potentially hazardous
				particles.
2) Position smoke evacuator in the operating room
				whenever a plume is anticipated.
3) Check operation of the plume management system
				prior to the beginning of a procedure.
4) Check the plume filter monitor and, if needed,
				install a clean filter.
5) In-line filters with minimum 0.3 µm
				filtration shall be placed between wall suction and the fluid canister
				for:
a) Suction line not connected to evacuator
b) Procedures producing minimal plume
c) Failure of evacuator before or during
				operation
6) Distal collection port shall be no more than 2 cm
				from impact site when practical.
7) All tubing, connectors, adaptors and wands will
				be changed between patients and disposed of according to biohazard
				procedures.
III. Electrical Shock
1) During service or maintenance, precautions shall
				be taken against electrical shock that may be fatal.
2) Medical lasers shall be installed and operated
				in conformity with the National Electrical Code.
SAMPLE 5: Work Practices for Optical Fiber Communications
				Systems (OFCS)
Purpose:
To recognize and effectively deal with a
				variety of potential hazards that may be present when working on an
				OFCS.
Policy:
Engineering controls shall not take the
				place of good work practices. Good work practices are essential to operating,
				servicing and maintaining OFCS, especially with higher power systems that
				utilize Class 3b and Class 4 lasers.
Procedure:
The following presents some basic
				guidelines when working on any OFCS.
1) Trained Personnel. Only authorized, trained
				personnel shall be permitted to install or perform service on OFCS containing
				Class 3b or Class 4 lasers.
2) Unterminated Fibers
a) Do not view the end of a fiber with unprotected
				eye. Fiber should only be viewed with an indirect image converter or with a
				filtered optical instrument or optical density (OD) sufficient to reduce the
				exposure to levels below the appropriate MPE.
b) Always cover the ends of unterminated fibers with
				a splice protector, tape or end caps.
3) Splicing. Splicing on ribbon cables, fixed array
				cables or OFCS containing Class 3b or Class 4 lasers shall be de-energized or
				viewing systems incorporating personal protection shall be employed.
4) Installation and Testing. The laser source shall
				be first to be disconnected and last to be connected when installing and/or
				testing an OFCS.
5) Modifications. No modifications shall be made to
				the OFCS or associated equipment without management or supervision
				authorizations. Such modifications may alter the service group classification
				of the OFCS.
6) Labels. Any damaged or missing optical safety
				labels shall be reported immediately to the supervisor.
7) Other Hazards
a) Use of protective guards or shields shall be used
				during splicing and cleaving operation to prevent direct injury from small
				lengths or particles of fiber. Proper disposal of fiber pieces avoids
				subsequent embedding in clothing or skin.
b) Optical photocuring may present a UV or light
				source hazard. Protective filter lenses of the appropriate optical density
				shall be worn if viewing of the light source is probable.
AGENCY NOTE: Reproduced with permission from the American
				  National Standard Z136.1 -2000 (or American National Standards Z136.2 -1997 or
				  Z136.3 -1996, as applicable). Copyright Laser Institute of America, Orlando,
				  Florida. The complete standard may be obtained by contacting the Laser
				  Institute of America, P.O. Box 781029, Orlando FL 32878-1029, telephone:
				  407-380-1553, fax: 407-380-5588, e-mail:
				  lia@laserinstitute.org.