Lasers & the Operating Room
A Surgical Laser Program that WORKS.
We've taken a lot of the leg work out of this for you by providing to you a policy and procedure for the use of lasers in the operating room. Read it, get it tune with it, customize it where appropriate and enjoy implementing such a program that will withstand the toughest of any regulatory surveying team. The Joint Commission, AAAHC, AAAASF, and Medicare will love what you have done, here it is:
THE SAFE USE OF LASERS IN THE OPERATING ROOM
This policy is based on ANSI 136.3, 2005 recommended standards.
POLICY: To ensure the proper and safe use of this facilities medical laser equipment and to credential physicians and staff for use of lasers in this facility.
PURPOSE: To provide for patient and personnel safety during laser procedures
To provide for optimum and effective use of the laser
To provide for the proper care of the laser and related equipment.
a. Appointment and Responsibilities of the Medical Director
An individual shall be appointed by the governing body of this surgery center that shall add the functions of this protocol to their normal routine of Medical Directorship responsibilities and be held accountable for the overall compliance of the laser safety program for this surgical center.
b. Authority – The MEDICAL DIRECTOR shall have the authority to suspend, restrict or terminate the operation of the Health Care Laser System (HCLS) if they deem that a hazardous condition exists. They will additionally notify the operating physician of such hazard. The MEDICAL DIRECTOR may delegate this authority to the dedicated Laser Assistants operating the equipment.
c. Delegation of Authority – it is understood that the responsibilities of the MEDICAL DIRECTOR in enforcing the written laser safety policies and procedures, and monitoring the laser treatment controlled area for safety during procedures, are duly delegated to the dedicated Laser Assistants who may be operating the laser equipment while the MEDICAL DIRECTOR is not actually in the treatment room.
d. Appointment of an Ad-Hoc Laser Safety Committee – The MEDICAL DIRECTOR may, from time to time, on an as-needed basis, form a Laser Safety Committee comprised of members of the physician staff and employees for collaboratively addressing specific laser safety program issues. The MEDICAL DIRECTOR may disband such temporary committees when its purpose has been met.
e. Laser Safety Officer Credentialing Standards.
i. The MEDICAL DIRECTOR shall be an individual with the training, self-study and resources deemed appropriate by the governing body to administer the Laser Safety Program. Their background may include, but should not be limited to, nurses, biomedical engineers, or environmental health and safety officers, who have obtained appropriate training to manage the Laser Safety Program.
ii. Training shall include:
1. General laser and energy concepts (physics), tissue interactions and laser safety.
2. Hands-on orientation to the surgery center’s specific lasers
3. Laser Safety Program management including familiarity with A.N.S.I. Z136.3 recommended standards for the Safe Use of Lasers in Health Care Facilities.
The facility will recognize individuals certified by the National Council on Laser Excellence (and the administering Board of Laser Safety of the LIA) as Certified Medical Laser Safety Officer, as having met these requirements:
f. Duties of the MEDICAL DIRECTOR:
i. The MEDICAL DIRECTOR shall manage and administer the overall laser safety program of this facility, based upon their informed judgment of the potential laser hazards and control measures which they choose to implement to protect against these hazards, utilizing the ANSI Z136.3 recommended standards as a guideline.
ii. Establish written laser safety policies and procedures, working collaboratively with the physician staff and facility management where needed.
iii. Approve the HCLS installation, use and operation, including the suitability of the facilities for safe operation.
iv. The MEDICAL DIRECTOR has the authority to allow deviation from these written policies and procedures on a specific per case basis when circumstances indicate that this may better serve or facilitate the patient’s treatment without compromising safety, and to re-evaluate and modify safety policies and procedures as needed to effectively manage the laser safety program on an ongoing basis.
v. Work collaboratively with the physician credentialing mechanism to ensure that physicians are properly credentialed in the use of the facilities laser equipment, and to keep a current list of authorized physician users for the purpose of authorizing the scheduling of laser cases.
vi. Ensure that proper safety training is provided to all staff working in the presence of the HCLS.
vii. Ensure that proper safety and operational training is provided to the dedicated Laser Assistants, and to approve the credentialing of such assistants.
viii. Ensure that the proper protective safety equipment, such as laser warning signs, safety eyewear, smoke evacuation equipment, etc., is available, in good condition and appropriate for the laser procedure being performed.
ix. In collaboration with the operating physicians and anesthesia, approve patient eye protection measures such as safety eyewear, opaque metal eye shields, corneal shields, moistened drapes or sponges as deemed appropriate.
x. Investigate all known or suspected accidents resulting from the operation of a laser, and initiate appropriate actions including compliance with the facilities’ incident reporting policy.
xi. Ensure that the laser equipment is properly maintained by qualified individuals including the facility biomedical engineering department, third party service agents, or the laser manufacturer.
xii. Ensure that both Laser Operating Manuals and Laser Service Manuals (complete with specific alignment and calibration information) are obtained for each laser in use within the facility.
xiii. Ensure that laser rental groups or any similar contract laser service that operate within this facility has supplied to the MEDICAL DIRECTOR documentation of appropriate training of their personnel and periodic maintenance of their equipment. The MEDICAL DIRECTOR will accept NCLE Laser Safety Officer or Laser Operator certifications as evidence of appropriate training. The MEDICAL DIRECTOR will supply such rental/contract service operators a copy of the facilities written laser safety policies and procedures and require their compliance while operating within the facility.
xiv. Conduct a comprehensive Laser Safety Audit/Inspection of the facilities Laser Safety Program, including physical inspection of all HCLS and protective safety equipment, on an annual basis. This may be performed directly by the MEDICAL DIRECTOR or may be delegated to consultants or organizations providing such Laser Safety Audits/Inspections.
xv. Become a member of the American Society for Laser Medicine and Surgery (ASLMS), in order to stay abreast of developments in the medical laser field, and to distribute such communications to hospital physicians and staff as deemed appropriate.
xvi. Maintain continuing education on an annual basis in the area of medical/surgical laser use or safety, such as the annual scientific meeting of the American Society for Laser Medicine & Surgery or other laser related programs or meetings.
II. Physician Credentialing Standards
a. Physicians wishing to utilize the various lasers of this facility must be properly trained in the use of such equipment and submit their credentials for approval. Approval will be for each type of laser individually. Such training shall include:
i. General laser and energy concepts (physics), tissue interactions and laser safety.
ii. Clinical considerations for the specific lasers and applications including indications, contraindications, procedural techniques, complications and management of complications.
iii. hands-on training with the specific type of laser
iv. Orientation to the operation and user options on the hospital’s specific laser system provided by the Laser Safety Officer or their designee.
Such training may be obtained through their residency program, formalized courses, or individualized study including individual review of the medical literature and work with the laser manufacturer or participation in a combination of study experiences that will meet these requirements. It may be evidenced by current credentialing of the applicant by other surgery centers or medical centers for the same type of lasers/applications.
b. Physicians will be approved for procedures only within their scope of medical practice.
c. The Chairman of the Governing Board will make the final recommendation on approval of the application.
d. A laser-credentialed physician shall be present for the first two cases.
e. Evidence of laser credentialing at another accredited medical facility will be sufficient for granting of laser privileges at this facility.
f. Once an initial approval for privileges of one laser type is granted, privileges for additional types of lasers may be obtained by making similar application and showing evidence of incremental training with the “new” type of laser.
III. Scheduling Procedure
a. The current list of qualified physicians to the Operating Room Coordinator shall serve as the basis for physician scheduling of laser use.
b. Scheduling will be on a first scheduled, first served basis, no blocked time will be given unless the physician has the volume to keep the schedule full with laser type procedures.
IV. Presence of the responsible Physician – The physician who has been credentialed for the laser use must remain in the treatment room at all times during laser use.
V. Selection of Laser Treatment Parameters, Modes of Operation and Equipment Configurations – It is the sole responsibility of the operating physician to select the laser parameters and equipment configuration by which the patient is treated. The physician shall request the parameters from the dedicated Laser Assistant who shall configure and set the laser equipment as requested. Any suggestions or recommendations by the Laser Assistant are to be for informational purposes only and the sole responsibility for the settings shall be the operating physician’s.
VI. Dedicated Laser Assistants (if the volume of cases supports the additional full time equivalent, otherwise the surgeon will function in this capacity in addition to the surgeon’s duties for the case. Management will have the final word on the hiring of such position as to be designated for this laser assistant role solely.)
a. A dedicated laser assistant shall be assigned to set up and operate the laser equipment, and monitor the laser treatment controlled area for safety during the procedure. From the time the laser key switch is activated, to the time it is turned off, the laser assistant shall have no other duties except for direct operation of the laser control panel and to monitor the room for compliance with safety policies & procedures.
VII. Laser Assistant Credentialing Standards
a. Nurses/Technicians who have been selected to operate the laser equipment during surgical procedures shall be properly trained in laser safety, operation of the specific laser units and the facilities specific laser safety policies and procedures. Credentialing of such assistants is through approval of the MEDICAL DIRECTOR. Laser assistants may be RN’s; PA’s; Surgical Technicians or other individuals deemed qualified by the MEDICAL DIRECTOR. The MEDICAL DIRECTOR shall maintain a current list of credentialed Laser Assistants with the Operating Room Coordinator for the purpose of coordinating schedules for laser cases.
b. Training shall include:
i. General laser and energy concepts (physics), tissue interactions and laser safety.
ii. hands-on training with the facilities specific laser(s)
iii. Instruction in the facilities’ written laser safety policies and procedures.
Such training may be obtained from the manufacturer or another credentialed laser assistant or the MEDICAL DIRECTOR, formalized courses, or individualized study including individual home study programs, in any combination that meets these three requirements. The facility will recognize individuals certified by the National Council on Laser Excellence as Certified Laser Operators/Surgical or Certified Medical Laser Safety Officer as having met these requirements.
c. Another credentialed assistant, or the Laser Safety Officer, shall be present for the first two cases.
d. Once an initial approval for one laser type is granted, approval for additional types of lasers may obtained by incremental instruction in the operation of the additional Laser system(s) as determined by the MEDICAL DIRECTOR.
VIII. Maintenance of Laser Log for each case – The use of a laser log shall be at the sole discretion of the MEDICAL DIRECTOR as they may from time to time require. This laser log shall be maintained by the dedicated Laser Assistant according to the parameters on the printed form. The MEDICAL DIRECTOR may change, add or eliminate information or this log, as they deem appropriate. The use of a laser log does not preclude or replace the need for patient charting as required by law, and such a Laser Log is not a requirement of ANSI 136.3.
IX. Laser Safety/Operational Checklists – An abbreviated checklist for proper laser setup, operation and safety shall be utilized by the dedicated laser assistant for each laser case. The checklist shall be as determined by the MEDICAL DIRECTOR, and may be altered by the MEDICAL DIRECTOR on an as needed basis.
X. Laser Treatment Controlled Area, Nominal Hazard Zones and use of Laser Safety Eyewear.
a. The Laser Treatment Controlled Area (LTCA) shall be the entire treatment room. Control measures to maintain laser safety shall include:
i. Appropriate warning signs will be posted on each entrance to the room, and removed when the laser cases are not being conducted. These signs shall meet ANSI recommendations and include the appropriate laser wavelength(s) so that staff will know which eyewear is appropriate.
ii. Be supervised by the dedicated Laser Assistant assigned to the case to monitor the room for compliance with laser safety policies and procedures. Such supervision is required only when the laser key is in the active “on” position.
iii. Laser Safety Eyewear, appropriate for the laser in use, shall be made available to personnel upon entrance to the room, regardless of where the Nominal Hazard Zone is declared. All safety eyewear shall be labeled according to the wavelength and Optical Density (except patient metal eye shields, which provide protection against all laser wavelengths) The default policy will be for the entire room to be deemed the Nominal Hazard Zone (NHZ) for all laser cases, so that personnel will need to wear their eyewear upon entry. The MEDICAL DIRECTOR does have flexibility in contracting this NHZ for certain cases as explained elsewhere in this safety policy, at which time the glasses will need to be worn only when in the NHZ and not the entire room.
iv. Laser Safety Eyewear will be without defect, and will be removed from service if defects are noted in the frames, the filter material or optical coatings.
v. The room will be occupied only by those personnel who have had documented training or orientation to laser safety. If a person who has not had such documented safety training is required to be in the room, then the laser assistant may provide a quick verbal orientation to laser safety and use of protective equipment such as eyewear appropriate to the laser case, and document this orientation in the laser log or in the patients chart.
vi. All window openings into the laser treatment room (when the NHZ has been declared the entire room) shall be covered with opaque flame-retardant material to block viewing of the laser light from the outside. Such coverings will not be necessary for the Carbon Dioxide Laser since that wavelength will not pass through the glass.
b. Nominal Hazard Zone shall by default include the entire Laser Treatment Controlled Area (laser treatment room) so that laser safety eyewear must be worn by all personnel within the room when the laser is active.
c. Nominal Hazard Zone may be made smaller than the entire treatment room, as determined by the MEDICAL DIRECTOR (and this authority delegated to the dedicated Laser Assistant) on a case-by-case basis utilizing the following criteria. The MEDICAL DIRECTOR or the dedicated laser assistant may convert the NHZ back to the entire treatment room at any time if they become uncomfortable with the situation or environment of the laser use.
i. Carbon Dioxide Laser used in Laparoscopy. – The NHZ may be declared totally within the body cavity that is endoscopically accessed so that no personnel in the room are required to wear laser safety eyewear. This is contingent upon the dedicated Laser Assistant being present at the control panel of the laser at all times that the key is “on”, and ensuring that the laser is placed in the standby mode when the laparoscopic laser delivery device is outside of the body cavity. If the physician is not utilizing video for viewing through the endoscope and is looking directly through the optics of the laparoscope, the glass in these optics provides sufficient eye protection and no further protective eyewear is required. The laser assistant and physician will require the use of glasses only when test firing the laser outside of the patient’s body cavity in which case the NHZ will be considered three feet in the direction of laser output for the purposes of the test firing. (others in the room need not wear glasses)
ii. Carbon Dioxide Laser used with the focusing handpiece (125mm or shorter focal length lens). – The NHZ may be declared the surgical table so that only those personnel standing at the surgical table are required to wear laser safety eyewear. Since the NHZ has been contracted to an area smaller than the entire room, an additional laser warning sign will be posted on an IV pole or other conspicuous manner at the table to remind personnel entering the field to wear their protective eyewear. This is contingent upon the dedicated Laser Assistant being present at the control panel of the laser at all times that the key is “on”, and ensuring that the laser is placed in the standby mode when it is not actually being used, and to closely monitor personnel entering the field at the table to ensure that they are wearing the protective eyewear.
iii. Holmium:Yag Laser – used endoscopically in urology or other endoscopic procedures. – The NHZ may be declared totally within the body cavity that is endoscopically accessed so that no personnel in the room are required to wear laser safety eyewear. This is contingent upon the dedicated Laser Assistant being present at the control panel of the laser at all times that the key is “on”, and ensuring that the laser is placed in the standby mode when the laser fiber is outside of the body cavity. If the physician is not utilizing video for viewing through the endoscope and is looking directly through the optics of the laparoscope, then Ho:Yag laser safety eyewear or endoscopic filter will be required for viewing. If the physician is viewing entirely through video attached to the endoscope, then no additional protective eyewear is required.
iv. Diode Laser – used endoscopically in urology. – The NHZ may be declared totally within the body cavity that is endoscopically accessed so that no personnel in the room are required to wear laser safety eyewear. This is contingent upon the dedicated Laser Assistant being present at the control panel of the laser at all times that the key is “on”, and ensuring that the laser is placed in the standby mode when the laser fiber is outside of the body cavity. If the physician is not utilizing video for viewing through the endoscope and is looking directly through the optics of the laparoscope, then Diode laser safety eyewear or endoscopic filter will be required for viewing. If the physician is viewing entirely through video attached to the endoscope, then no additional protective eyewear is required.
v. 532nm and 810nm Opthalmic Diode lasers when used through the indirect laser ophthalmoscope, or intra-ocular probes for intraocular use – The NHZ may be declared the procedure table so that only those personnel working at or directly around the procedural table are required to wear laser safety eyewear. Since the NHZ has been contracted to an area smaller than the entire room, an additional laser warning sign will be posted on an IV pole or other conspicuous manner at the table to remind personnel entering the field to wear their protective eyewear. This is contingent upon the dedicated Laser Assistant being present at the control panel of the laser at all times that the key is “on”, and ensuring that the laser is placed in the standby mode when it is not actually being used, and to closely monitor personnel entering the field at the table to ensure that they are wearing the protective eyewear, and to closely monitor the physician user to ensure that the output of the indirect ophthalmoscope is directed solely towards the patient when the laser is in the ready mode, or similarly ensure that the laser is in the standby mode if an intra-ocular probe (fiber) is not contained within the eye.
d. Patient Eye Protection – patient’s eyes will be protected for all laser cases, as determined collaboratively by the MEDICAL DIRECTOR, operating physician and anesthesiologist. Such protection may take the form of laser safety eyewear, protective metal eye shields made for laser safety, or moistened sponges, drapes or towels as deemed appropriate. The method of eye protection shall be charted in the patient’s chart.
i. Laser procedures performed within the bony orbit of the eye (i.e. blepharplasty) shall require the use of protective corneal shields specifically made for laser eye protection.
ii. Laser safety eyewear, as used by personnel, may be used by the patient during cases involving only local anesthesia, if the laser use is not directly on or around the face, in which case protection that is more thorough should be provided.
e. Testing of automatic safety shutters – On equipment that incorporates automatic safety shutters to protect the operating physician’s eyes during laser use (i.e. certain diode and KTP lasers, or others), the Laser Assistant shall test the shutter mechanism for proper operation prior to use by the physician.
f. No person who is controlling the output end of the laser device shall point the device (even when the laser is in standby or not firing) in the direction of anyone’s face. This is to be rigidly enforced by the Laser Assistant, recognizing the fact that laser safety eyewear does not guarantee eye protection from a direct impact of the laser through the glasses.
g. Suspected Personnel Eye Injuries – in the event of a suspected eye injury a report will be made immediately to the Laser Safety Officer, and a hospital incident report completed per hospital policies. An eye examination will be required upon a suspected eye injury, although routine or baseline eye examinations are not required of any personnel.
XI. Laser Safety Training for all peri-operative personnel – All personnel who may have the occasion to work within a laser treatment room (LTCA) shall be provided with basic laser safety instruction. This will include at a minimum the knowledge of matching appropriate laser safety eyewear by wavelength with the posted laser warning signs, the types of hazards that laser may present, and awareness of the functions of the facilities Laser Safety Officer and dedicated laser assistants. Such basic safety training will be incorporated into employee orientation training. Sign-in sheets for laser inservices will be acceptable documentation of such training, or any formal certificate of laser training that includes safety.
XII. Secure storage of laser keys – The key to each laser shall be stored separately from the laser in a secure location, and only qualified personnel shall have access to this key.
XIII. Footpedal safety – because of the possibility of confusing footpedals between the laser and other surgical equipment during cases, the laser footpedal shall be kept on a separate side of the surgeon (either right or left from) from footpedals for other equipment such as electrosurgery or microscopes. Only the physician directing the output of the laser to the treatment site shall operate the laser footpedal.
XIV. Smoke Evacuation – whenever a laser plume is generated from the use of the laser, adequate smoke evacuation will be utilized to capture the emitted laser plume. The evacuator collector tip will be held as close as practical so the site of plume emission – generally within about 2 inches – in order to collect all of the plume as it is generated. When the smoke generation is minimal or generated within a cavity such as vaginal speculum or microlaryngoscope, small bore, suction may be provided in lieu of or in addition to the large bore suction.
a. When using the small bore suction tubing, from regular wall suction, a smoke filter shall be placed between the fluid collection bottle and the wall suction source to preclude damage to the suction system.
b. All suction tubing and filters are to be treated as contaminated material and disposed of properly.
c. Viral protection masks – Surgical masks that provide viral level filtration shall NOT be required during laser cases, and smoke evacuation will be utilized as the sole control measure for eliminating the laser plume. These viral masks will be made available on the laser supply cart for personnel who wish to use them.
d. Laser procedures performed under fluid do not generate a laser plume and smoke evacuation will not be necessary (i.e. Ho: Yag laser lithotripsy, Indigo diode cystoscopy, etc.)
XV. Aiming beam alignment – the aiming beam and the surgical beam from the carbon dioxide or Er:Yag lasers will be checked by the laser assistant before each case to ensure alignment by test firing of the laser onto a moistened tongue depressor. This alignment will be further confirmed by the operating physician before laser use on the patient. The laser will not be utilized if the aiming beam and surgical beams are not coincident. Testing of the alignment should occur with the delivery device used for the procedure where possible (i.e. laparoscope, microscope, etc).
XVI. Lack of Aiming beam on fiberoptically delivered lasers – When the aiming beam cannot be seen emitting from the fiber when the laser is placed in the ready mode (both lasers with separate aiming beam lasers and those that use low power versions of the same laser for aiming. This applies to Diode lasers, the Ho:Yag, Nd:Yag, KTP, and others) then the laser will not be test fired until the equipment has been checked by service personnel. This is to preclude damage to the laser from alignment problems.
XVII. Use of low reflectance instruments. Metal surgical instruments may be anodized to reduce their reflectance of laser light and should be considered when the operating physician deems appropriate. They are not a requirement for all laser use however and most surgical procedures may be safely performed with standard instruments. Care shall be taken to avoid directly firing onto metal instruments. Special low reflectance instruments shall be used during microlaryngoscopy cases with the CO2 laser.
XVIII. Protection of rigid and flexible endoscopes – Both rigid (i.e. cystoscopes, arthroscopes, hystersocopes) and flexible (i.e. bronchoscopes, gastroscopes, colonoscopes) endoscopes may be damaged by firing the laser fiber when it is within the channel of the endoscope or in close proximity to the optics of the endoscope.
a. Flexible endoscopies – the laser shall not be placed in the ready mode until the fiber is sufficiently advanced from the channel of the endoscope – approximately 1.5 cm. This is to be determined either by marking the proximal end of the fiber where it enters the endoscope with the correct positioning so that the laser assistant can see visually that the fiber tip is sufficiently advanced; or by looking at the video screen with the fiber tip sufficiently advanced prior to use in the patient, so that the fiber tip positioning may be visually determined by its position on the video screen.
b. Rigid endoscopies - the laser shall not be placed in the ready mode until the fiber is sufficiently advanced past the distal optic of the rigid endoscope by approximately 1.5 cm. This is to be determined either by marking the proximal end of the fiber where it enters the endoscope with the correct positioning so that the laser assistant can see visually that the fiber tip is sufficiently advanced; or by looking at the video screen with the fiber tip sufficiently advanced prior to use in the patient, so that the fiber tip positioning may be visually determined by its position on the video screen.
i. Arthroscopies – the laser fiber is generally inserted separately from the rigid arthroscopic telescope. Care will be taken by the operating physician to avoid placing the laser fiber tip in close proximity to the telescope optic during the procedure, to avoid damage to the endoscope.
XIX. Fire Protection – the MEDICAL DIRECTOR will ensure that the following fire safety precautions are taken during laser cases:
a. Fire Extinguishers – the dedicated Laser Assistants will be made aware of the location of nearby fire extinguishers that are required by NFPA regulations.
b. A container of water (any non-flammable fluid) will be available during all laser cases for immediate dousing of flames if needed (irrigating solutions on the backstand will suffice).
c. The dedicated Laser Assistant will place the laser in the standby mode when it is not actively being used to treat the patient. The Laser Assistant will verbally notify the operating physician each time the laser is placed in the “ready” mode, and is able to be fired.
d. Any sponges or dry materials directly in the surgical field will be moistened (blood, saline, water or any nonflammable and nontoxic fluid may be used). This applies primarily to the Carbon Dioxide Laser but can apply to other lasers if used in open cases with dry materials present. Sponge counts will be made after CO2 laser cases that count the number of sponges and examine each one to ensure that it is intact and has not been cut into smaller pieces by the laser. Surgical control techniques with laser delivery systems offer control in situations where packing with moistened materials is not feasible. Appropriate backstops or guards should be used during some laser cases where it is appropriate. Laser use under fluid presents no fire hazard while the laser output is under the fluid (i.e. cystoscopy).
e. Flame retardant drapes will be used for surgical laser cases, or regular drapes may be moistened in the area around the surgical field or area where the laser handpiece or fiber is placed on the drapes.
f. Laser Ignition of intestinal gases – methane gas (flatus) from a patient is combustible, and peri-anal procedures with laser may present a fire hazard. Appropriate methods to control this potential hazard will be taken to include bowel preps, suction and irrigation, or covering of the anus with a wet sponge at the discretion of the operating physician. Deep packing of the anus with wet sponges up past the internal anal sphincter is to be discouraged because of the likelihood of spreading virus from perianal areas deeper into the anus, which may create medical complications that have adverse medical consequences. The operating physician may choose the appropriate method of protection, including the deep anal packing when so indicated.
g. Flammable preps – the use of flammable preps is not precluded when using the laser, but appropriate precautions will be taken such as airing out drapes to prevent collection of combustible fumes underneath. Prepped areas should be dried before using the laser directly within that area. Special emphasis should be placed on hairlines such as facial or pubic hair that can retain prep solutions (including flammable hairspray) in the hairline. When utilizing the laser in these areas the hairline will be protected with a moistened towel held over the hairline, or by utilizing a water soluble lubricant such as K-Y jelly to provide a barrier between the hair and area of laser use.
h. Vaporization of Polymethylmethacrylate (PMMA) – Use of the CO2 laser to remove polymethylmethacrylate from within bone is a useful technique during joint revisions. PMMA produces toxic fumes when vaporized and is highly flammable, so that appropriate smoke evacuation and fire precaution techniques will be utilized.
i. Smoke evacuation – in addition to the use of the large bore, high flow smoke evacuation, which filters out particulate matter, additional tubing will be connected from the output vent of the smoke evacuator and led to the negative pressure air vent in the treatment room (vented to the outside – not to another room).
ii. Fire precautions – irrigating solution will be used intermittently to cool the area when the PMMA is being vaporized from the bone, and a container of solution will be immediately available in the sterile field to douse any flame that might be created.
i. Airway Laser Procedures – the following specific precautions will be taken to preclude and manage airway fires during laser use. This is an issue primarily with the CO2 laser used for microlaryngoscopy but to some degree can be an issue with Ho:Yag or Nd:Yag lasers during flexible bronchoscopy, or any case where a laser is used in or around the patient’s airway:
i. Anesthesia must minimize concentrations of FIO2 and N2O as much as possible when performing airway laser procedures. As low, an FIO2 as can be administered without compromising the patient’s respiratory status is to be used. Patient O2 saturation levels shall be monitored. Compressed air, Nitrogen, or Helium, at the discretion of the Anesthesiologist, is to be used as the balance gas rather than increasing the percentage of N2O for the balance.
ii. Explosive anesthetic agents such as Cyclopropane will not be used during laser airway cases.
iii. An emergency tracheotomy kit/tray will be made available in the treatment room for all laser airway cases for use in the event of an emergency. The kit need not be opened unless it is required.
iv. In the event a fire has occurred the first priority will be to re-establish the patient’s airway and ventilation, including the use of emergency tracheotomy if required. The laser procedure is then terminated and all efforts will be made to assess and manage the injury to the patient.
v. CO2 Laser Microlaryngoscopy:
1. The patient’s entire face/head, including lips and teeth shall be totally protected by packing with wet towels or coverings
2. Standard PVC endotracheal tubes (ET tubes) shall not be used.
3. Alternative airways/ventilation that may be used, as determined by the operating physician and anesthesiologist, include:
a. Commercially available laser resistant endotracheal tubes, used according to manufacturer’s recommendations. When used, the following procedures will apply:
i. After intubation, inflate the cuff with sterile water to which a small amount of dye solution has been added.
ii. After the cuff is inflated with dyed fluid, pack off the cuff for additional protection with sponges/cottonoids that have been moistened.
iii. After intubation, tape the E.T. tube to the patient’s face/neck to maintain proper positioning, utilizing a minimum amount of tape, so that the E.T. tube may be rapidly pulled from the patient during an emergency.
iv. Maintain a pail of water on the floor beside the operating physician in which to throw a burning E.T. tube during an emergency.
v. At any sign that the tube cuff has burst (discoloration from the dye seen in the airway), the patient will be extubated and properly re-intubated before proceeding with any laser use if the cuff has been burst.
vi. At any indication of a fire in the airway, the operating physician will immediately disconnect the ventilation circuit from the E.T. tube while simultaneously and rapidly pulling the E.T. tube from the patient, throwing the tube into the pail of water, and alerting all personnel.
b. Norton Flexible Metal tubes – another alternative, where agreed upon by anesthesia and the operating physician, is the use of the all metal flexible endotracheal tubes, which are sized to fit the patient’s airway so that no external rubber cuff is placed on the tube. If a rubber cuff is utilized then it will be treated the same as the cuff in laser resistant tubes as described above.
c. Jet Ventilation is another alternative method of ventilation, provided that an all-metal cannula is used in place of the plastic cannulas so that no combustible materials are in the airway.
vi. Flexible bronchoscopy – with Ho:Yag, Nd:Yag or KTP lasers.
1. The laser will be placed in the “ready” mode only when the laser fiber has been sufficiently advanced from the channel of the bronchoscope (1-2cm), both to avoid damage to the endoscope and to prevent igniting the plastic/rubber materials in the bronchoscope.
2. The laser will not be used in the direct vicinity of the tip of the endotracheal tube. The laser (and hence tip of the bronchoscope) will be used only past the distal end of the ET tube, and the ET tube placed as high as practical in the airway when using the laser at or just past the carina. Alternatives to work at the carina or within the trachea will include not using an ET tube at all, or the use of a rigid laser bronchoscope in lieu of a flexible bronchoscope.
3. Proper cooling of the fiber tip will be provided through the laser fiber/catheter, such as compressed air or fluid drips, according to the manufacturer’s recommendation.
4. Enhanced cooling of the fiber/catheter tip will be provided when utilizing the laser in the area of metal mesh airway stents. Fluid drip is preferred but any aggressive method of tip cooling is acceptable, to prevent the laser fiber/catheter tip from igniting from the heat created in the mesh stent during vaporization.
5. Although this policy maintains that the type of endotracheal tube used during flexible bronchoscopies when using the laser past the mainstem bronchi is not the significant fire hazard it is with CO2 laser microlaryngoscopy, our policy will be to use only laser resistant tubes, flexible metal tubes, or no ET tubes, during flexible laser bronchoscopies, as determined by the operating physician and anesthesiologist.
XX. Laser Maintenance and Service – shall be performed by qualified personnel as determined by the MEDICAL DIRECTOR.
a. Qualified service personnel may include the manufacturer’s service technicians, third party service agents, or the hospital’s biomedical engineers. Such service personnel shall have documented laser safety training, and documented service training commensurate with the level of work they are performing on the laser. The facility shall accept NCLE Laser Certification as a repair technician as evidence of meeting this training requirement.
b. Periodic Maintenance, including calibration checks, shall be performed at six-month intervals. Written service reports shall be maintained by the facility.
 Reference ANSI Z136.3 Section 4.4 which states that the MEDICAL DIRECTOR may determine that some control measures in Section 4 are not required (cross references Section 126.96.36.199), particularly when a sterile field exists so that movement in and out of a confined NHZ is minimal or absent (Section 4.4.1).
 Reference ANSI Z136.3 Section 188.8.131.52.2, second paragraph “The MEDICAL DIRECTOR may determine that the use of protective eyewear during an endoscopic procedure is not required”.
 Reference ANSI Z136.3 Section 184.108.40.206.2, second paragraph “The MEDICAL DIRECTOR may determine that the use of protective eyewear during an endoscopic procedure is not required”.
 Laser plume: aMedical Director called Laser Generated Airborne Contaminants (LGAC), smoke, or laser smoke. It should be noted that plume generated from electrosurgical units contains the same contaminants and toxins as that produced by lasers.
 Nitrous Oxide supports combustion equally as well as oxygen