Guideline Implementation: Energy-Generating Devices, Part 2dLasers 1.3

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1 CONTINUING EDUCATION Guideline Implementation: Energy-Generating Devices, Part 2dLasers BYRON L. BURLINGAME, MS, BSN, RN, CNOR Continuing Education Contact Hours indicates that continuing education (CE) contact hours are available for this activity. Earn the CE contact hours by reading this article, reviewing the purpose/goal and objectives, and completing the online Examination and Learner Evaluation at A score of 70% correct on the examination is required for credit. Participants receive feedback on incorrect answers. Each applicant who successfully completes this program can immediately print a certificate of completion. Event: #17512 Session: #0001 Fee: For current pricing, please go to: The contact hours for this article expire April 30, Pricing is subject to change. Purpose/Goal To provide the learner with knowledge specific to implementing recommendations for the use of lasers from the AORN Guideline for safe use of energy-generating devices. Accreditation AORN is accredited with distinction as a provider of continuing nursing education by the American Nurses Credentialing Center s Commission on Accreditation. Approvals This program meets criteria for CNOR and CRNFA recertification, as well as other CE requirements. AORN is provider-approved by the California Board of Registered Nursing, Provider Number CEP Check with your state board of nursing for acceptance of this activity for relicensure. Conflict-of-Interest Disclosures Byron L. Burlingame, MS, BSN, RN, CNOR, has no declared affiliation that could be perceived as posing a potential conflict of interest in the publication of this article. The behavioral objectives for this program were created by Liz Cowperthwaite, BA, senior managing editor, and Kristi Van Anderson, BSN, RN, CNOR, clinical editor, with consultation from Susan Bakewell, MS, RN-BC, director, Perioperative Education. Ms Cowperthwaite, Ms Van Anderson, and Ms Bakewell have no declared affiliations that could be perceived as posing potential conflicts of interest in the publication of this article. Objectives 1. Identify the components of a laser safety program. 2. Describe the staffing roles specific to the use of lasers in the perioperative setting. 3. Discuss the precautions to take to mitigate risk of injury from the use of lasers. 4. Identify items that should be documented related to the use of lasers. Sponsorship or Commercial Support No sponsorship or commercial support was received for this article. Disclaimer AORN recognizes these activities as CE for RNs. This recognition does not imply that AORN or the American Nurses Credentialing Center approves or endorses products mentioned in the activity. ª AORN, Inc, j AORN Journal

2 Guideline Implementation: Energy-Generating Devices, Part 2dLasers BYRON L. BURLINGAME, MS, BSN, RN, CNOR ABSTRACT Lasers have been used in the OR for many years and are essential tools in many different types of procedures. However, laser beams that come into contact with unintended targets directly or via reflection can cause injury to patients or personnel or pose other hazards, such as fires. The new AORN Guideline for safe use of energy-generating devices provides guidance on the use of all energygenerating devices in the OR. This article focuses on key points of the guideline that address the safe use of lasers. These include the components of the laser safety program, the responsibilities of the personnel in roles specific to use of a laser, laser safety measures, and documentation of laser use. Perioperative RNs should review the complete guideline for additional information and for guidance when writing and updating policies and procedures. AORN J 105 (April 2017) ª AORN, Inc, Key words: laser, laser safety officer, laser safety, laser operator, laser user. Health care providers have used lasers in the OR for more than 50 years and for many different types of procedures involving the skin, genitalia, and internal organs. The precision afforded by use of the laser in surgery can result in reduced trauma to surrounding tissue and faster healing of wounds. 1 However, these valuable instruments have the potential to cause injury to patients or personnel if staff members do not follow proper safety precautions. 1,2 Prevention of injury is the responsibility of every member of the perioperative team, but the specific responsibilities differ based on the role the person performs in the OR. There are also personnel involved in prevention of laser injuries who may not be a part of the perioperative team, including the laser safety officer, the laser safety specialist, and the laser operator. 3 The AORN Guideline for safe use of energy-generating devices, 3 published in September of 2016, combines the previous Guideline for electrosurgery and Guideline for laser safety. AORN guidelines provide guidance for the care of perioperative patients and are based on an evaluation of the strength and quality of the available evidence for a specific subject. The guidelines apply to inpatient and ambulatory settings and are adaptable to all areas where operative and other invasive procedures may be performed. The sections of the energy-generating devices guideline that pertain to electrosurgery were presented in a March 2017 AORN Journal article 4 and will not be covered in this article. Topics related to the use of lasers that are addressed in the guideline include the components of the laser safety program, staffing requirements, the responsibilities of the personnel in roles specific to use of lasers, and laser safety measures to be taken during use. This article elaborates on key takeaways from the guideline document; however, perioperative RNs should review the complete guideline for additional information and for guidance when writing and updating policies and procedures. ª AORN, Inc, AORN Journal j 393

3 Burlingame April 2017, Vol. 105, No. 4 print & web 4C=FPO Figure 1. Key takeaways from the AORN Guideline for safe use of energy-generating devices. Key takeaways from the AORN Guideline for safe use of energy-generating devices 3 that are addressed in this article include the following: A laser safety program should be established for all owned, leased, or borrowed laser equipment in any location where lasers are used. Staffing roles specific to use of lasers should be delineated and filled whenever lasers are used. Perioperative personnel should take precautions to mitigate the risk for injury associated with the use of lasers. Laser use should be documented (Figure 1). The following scenario highlights these points and other aspects of the AORN guideline. Each key takeaway is then discussed in more detail. SCENARIO An otolaryngology surgeon requested privileges to perform laser surgeries at the Sunrise Ambulatory Surgery Center. This presented a challenge to the RN manager and the other perioperative personnel because laser procedures had never been performed at Sunrise, and the center did not have a laser device. After reviewing the options for obtaining the laser device (eg, purchasing, leasing, renting from a third party with delivery before each use), the facility administrators determined that the laser device would be leased and housed in the facility. The RN manager consulted the AORN Guideline for safe use of energy-generating devices 3 and regulatory documents 5 to determine the safety precautions to integrate into staff education and the facility s policies and procedures. While reviewing the evidence, she discovered that a laser safety program is required for all types of lasers, including leased lasers, and that the evidence supports developing the program by forming a multidisciplinary laser safety committee. She presented this information to the administrative team members, who decided that the multidisciplinary committee would be composed of the surgeon, a biomedical engineer, an RN circulator, a surgical technologist, representatives from the anesthesia and sterile processing departments, and a quality consultant. The first action the committee performed was to create an education appraisal tool based on the education requirements stated in the AORN guideline and the regulatory documents. 5 They performed an appraisal of the staff members knowledge of laser safety and determined that an educational program would be required. The biomedical engineer contacted the laser manufacturer and arranged for an educational program to be delivered to personnel. The multidisciplinary committee next determined who would perform the roles described in the guiding documents. The biomedical engineer volunteered to be the laser safety officer because he had previously received the training necessary to fulfill this position at another facility where he had worked. The committee also determined that the biomedical engineer would participate in an in-depth education program offered by the laser manufacturer to gain competence on the use of the particular laser device selected so he would meet the 394 j AORN Journal

4 April 2017, Vol. 105, No. 4 Guideline Implementation: Energy-Generating Devices, Part 2dLasers requirements to perform the laser operator role. As the laser safety officer, the biomedical engineer arranged for the RN circulator and surgical technologist, who frequently work with the otolaryngology surgeon, to attend another class offered by the laser manufacturer on the safety precautions to be taken during operation of the laser. The committee determined that the laser safety specialist role would not be required because there would only be one laser device in the facility, and it would only be used in one area. Next, the committee reviewed the laser manufacturer s instructions for use and determined which precautions to take to prevent injury to the patient and the personnel in the room. The committee incorporated these precautions into the laser policies and procedures. The committee determined which types of laser signs, eye protection, and window shielding were recommended and then placed a purchase order for the recommended safety supplies. The shielding ordered was specially sized to fit the window above the scrub sink and the window in the door leading into the OR. The RN circulator confirmed with the laser safety officer that the signs met the recommendations of ANSI Z136.3, the standard for safe use of lasers from the American National Standards Institute, 5 and the manufacturer s instructions for use. The final action the committee took was to establish the laser quality program, which states that the laser safety officer will perform laser safety audits every six months, and the audits will include an examination of all laser-related equipment and safety devices (eg, eyewear, warning signs, inspection-tracking indicators), verification that all personnel maintain competency in laser safety, and observation of all laser procedures to ensure compliance with the written policies and procedures. The laser safety officer met with the medical staff credentialing office personnel, and they determined that the surgeon had completed the necessary education and had completed the number of procedures required in the bylaws to gain laser privileges. They notified the surgeon of the decision, and he scheduled the first surgery after confirming with the laser safety officer that all of the safety supplies had arrived and the personnel had received the required education. The first procedure was to be performed on a 45-year-old woman who had been diagnosed with nodules on her vocal cords. Before beginning the procedure, the laser safety officer placed the shielding on the windows, verified that the RN circulator had placed the correct sign on the door, and confirmed that the safety goggles were available outside the room. During the counting procedure, the RN circulator and surgical technologist confirmed that the matte-finished, laser-safe instruments were ready to use on the sterile field. The surgical technologist then assembled the sterile laser components, and the laser safety officer helped him attach the components to the laser. The laser safety officer announced that they were going to test the laser and confirmed that everyone was wearing the correct eye protection and that the shielding was in place over the windows. The laser safety officer and the surgical technologist then tested the laser as described in the manufacturer s instructions for use. The RN circulator brought the patient into the OR and, after the patient was anesthetized, covered the patient s eyes with wet eye protection pads and confirmed with the anesthesia professional that he had used a laser-resistant endotracheal tube inflated with methylene blueetinted saline. After the entire team was present in the OR, the RN circulator called for a time out and performed a fire risk assessment. This procedure was determined to be in the category of high risk of fire because of the presence of an ignition source (ie, the laser), the oxygen-enriched environment, and because the surgery would take place above the patient s xiphoid process. As a part of the interventions required for a high risk of fire, the anesthesia professional stated that he would administer the lowest possible oxygen concentration the patient could tolerate. He also asked the surgeon to alert him before using the laser so he could turn off the oxygen temporarily if the patient would tolerate it. The surgical technologist confirmed that there was normal saline on the sterile field for use as a fire extinguishing agent if necessary. The RN circulator confirmed that the fire extinguisher for a carbon dioxide laser was available and then placed the laser foot pedal near the surgeon s feet. The laser safety officer confirmed with the surgeon that they would use the lowest power setting to begin the procedure and that the power may be increased if necessary. During the procedure, the RN circulator documented that carbon dioxide laser #1 was used for 30 seconds starting at 8:15 AM. She also documented the safety measures the team implemented during laser use (eg, covering the patient s eyes with wet pads, type of eye protection used). After the surgeon removed the laser fibers from the patient, the surgical technologist examined the fibers and found them to be intact. He notified the rest of the team of his findings. The procedure was completed without any complications or negative outcomes. KEY TAKEAWAYS DISCUSSION The key takeaways from the AORN Guideline for safe use of energy-generating devices 3 address components of the laser AORN Journal j 395

5 Burlingame April 2017, Vol. 105, No. 4 safety program, staffing roles, interventions to mitigate the risk of injury, and documentation requirements. These takeaways do not cover the entire guideline. Rather, they help the reader focus on important or new information that should be implemented into perioperative practice. Laser Safety Program Professional expert panels recommend that health care facilities have a laser safety program 6,7 to guide staff members who are involved in procedures for which lasers are used. A multidisciplinary laser safety committee should develop the laser safety program to allow input from personnel who will participate actively in the procedures and from personnel with expertise beyond clinical end users. 7 The committee may consist of administrators, the laser safety officer, a biomedical or clinical engineer, a physician representative from each specialty group that uses lasers, anesthesia professionals, perioperative services administrators, a perioperative educator, medical staff education or credentialing personnel, quality department personnel, and the laser safety specialist (eg, nurse, surgical technologist). The laser safety committee is responsible for developing and enforcing laser-related policies and procedures. 7 The laser safety committee should update the policies and procedures on a regular basis to provide the best evidence-based guidance to assist personnel in providing safe patient care. The committee should define the educational requirements for personnel to gain competence in each of the roles and include the educational requirements the surgeon must complete to gain privileges to operate the laser device. Personnel can gain competence by various methods, including attending educational offerings presented by the laser manufacturer or a formal program offered by an independent consultant or educational company. The laser safety committee should define the safety interventions that staff members must perform during procedures for which lasers are used. These safety interventions are intended to protect patients and personnel from injury caused by direct or indirect exposure to laser beams. Injuries may include burns to the skin and damage to the eyes. 3 The committee should ensure that the program establishes the responsibilities for the roles each person will fill when directly or indirectly involved in procedures for which lasers are used. Finally, the committee should ensure that the laser safety program defines the parameters of a laser quality program, establishing the extent and frequency of audits of the patient records and the process, as illustrated in the scenario. The primary responsibility of the laser safety committee is to develop and modify the laser program, but they also have other responsibilities. In the scenario, the laser safety committee selected and purchased such appropriate safety tools as eye protection and window shields. The committee also defined the responsibilities of each role and determined who would perform the roles and the education required for those roles. Staffing Roles The roles described in the laser safety program include that of the laser safety officer, laser safety specialist, laser user, and the laser operator. The laser safety officer is responsible for administering many aspects of the laser safety program, including coordinating education and confirming credentialing. Additional responsibilities illustrated in the scenario include verifying that protective equipment is available and ensuring that staff members have posted the correct warning signs. The laser safety specialist is an optional role that may be described as being an assistant to the laser safety officer. This person must be capable of filling in for the laser safety officer in his or her absence or if the laser safety officer is occupied in another location. This role is only necessary when there are lasers simultaneously in use in various areas. The laser user is the person who manipulates the active component of the laser and applies the beam to the patient. The medical staff office or its equivalent must grant this person privileges to perform this role. 8,9 This role is traditionally filled by a physician or a nurse practitioner who possesses the necessary educational experience and the required credentials as determined by the medical staff privileging office of each facility. A laser operator is required for every procedure. The person may be a nurse or, as illustrated in the scenario, another person who has gained the competency to perform the role (eg, surgical technologist, employee of the company owning the laser device, biomedical engineer). This role cannot be filled by the RN circulator because the RN circulator has duties that may pull him or her away from the laser, leaving it unattended, which is a safety risk. The defined roles may overlap, or responsibility may be delegated to another person. This is illustrated in the scenario by the laser safety officer also serving as the laser operator and by the laser safety officer delegating the task of ensuring the presence of the eye protection to the RN circulator. During the procedure, the laser user manipulated the hand piece, and the laser operator stayed with the laser at all times. 396 j AORN Journal

6 April 2017, Vol. 105, No. 4 Guideline Implementation: Energy-Generating Devices, Part 2dLasers Resources for Implementation Guideline implementation topics: laser safety. AORN, Inc. -topics/equipment-and-product-safety/laser-safety. Accessed February 17, AORN Syntegrity. Accessed February 17, ORNurseLink. Accessed February 17, Perioperative Competency Verification Tools and Job Descriptions [USB drive]. Denver, CO: AORN, Inc; sku=man577&dept_id=1. Accessed February 17, Policy and Procedure Templates [USB drive]. Denver, CO: AORN, Inc; Aorntitles.asp?pageno=7. Accessed February 17, Editor s note: Syntegrity is a registered trademark and ORNurseLink is a trademark of AORN, Inc, Denver, CO. The staff members who perform the various roles may differ from one facility to another and may differ from one procedure to the next. The licensure or the educational background of the person fulfilling the roles is not the main qualification; the key is having the competence to perform the role. In the scenario, the biomedical engineer filled both the role of laser safety officer and laser operator because he had received the education and training necessary to fulfill both roles. Mitigating Risk of Injury There is a risk of injury to patients and personnel when lasers are used. Injuries have been reported involving eyes, skin, and respiratory systems. 1,2 Injuries to the skin and the respiratory system are usually burns, with the degree varying based on exposure time. The type of damage to eyes depends on the location receiving the beam and may include retinal burns, ocular burns, or macular holes. 1 These injuries are caused by the laser beam coming into contact with tissue that is not the intended target. The beam may contact the unintended target either directly or by being reflected off a shiny surface. Health care personnel can perform many interventions to prevent these injuries. In the scenario, the RN circulator took proper safety precautions, including covering the eyes of the patient with moist pads to prevent eye injuries and conducting a fire risk assessment as part of the time out. She verified the use of a laser-resistant endotracheal tube with the balloon inflated What Else Is in the Guideline? Read the AORN Guideline for safe use of energygenerating devices 1 to learn what the evidence says about the following topics: What is the full scope of responsibility of the laser safety officer? (Recommendation IV.b.1.) What education and training should the laser operator have? (Recommendation IV.b.3.) What is the required labeling for safety eyewear? (Recommendation V.b.1.) What procedures should be in place to prevent accidental activation or misdirection of the laser beam? (Recommendation V.d.) What precautions should be taken during endoscopic procedures using a laser? (V.j.) What area represents the nominal hazard zone? (Glossary) Reference 1. Guideline for safe use of energy-generating devices. In: Guidelines for Perioperative Practice. Denver, CO: AORN, Inc; 2017: with methylene blueetinted saline. This is important because the balloon on these tubes is not laser resistant. The anesthesia professional inflated the endotracheal tube with saline because the saline helps to decrease the potential of rupture if the balloon is contacted by the laser, and he used the blue tinting because it enables the rupture to be more noticeable. In the scenario, the surgical technologist used matte-finished instruments to prevent the laser beam from being reflected onto an unintended target, possibly causing injury or a fire. Personnel also posted signs and donned appropriate eye protection. The surgical team performed these actions to protect the personnel directly involved in the procedure, and those around them, from injury related to the use of lasers. Documentation The recommendations for documentation of use of lasers, as described in the scenario, include the type (eg, carbon dioxide) and identification of device (eg, serial or biomedical number) of the laser used, patient safety measures implemented during use of lasers (eg, type of eyewear, eye shields used on the patient), and the times during which the surgeon activated and deactivated the laser. Documenting laser power settings is no longer a recommendation in this guideline, but the RN circulator should document this if it is a requirement of the accrediting or regulatory body. AORN Journal j 397

7 Burlingame April 2017, Vol. 105, No. 4 CONCLUSION Safe use of lasers in the OR requires input from members of a multidisciplinary committee including all members of the surgical team and personnel from other departments, such as biomedical engineering and risk management or a quality consultant. The multidisciplinary committee should use the AORN Guideline for safe use of energy generating devices, 3 which is based on current research, as the foundation on which to create policies and procedures that guide the processes to protect patients and perioperative personnel from harm and promote optimal efficacy in the use of lasers. Perioperative personnel should review the entire guideline and use it as a resource when developing or revising policies and procedures to ensure that the facility is using the best evidence-based practices for the use of lasers. The guideline also provides the foundation for educational programs that personnel should develop to meet requirements for mastering competency. References 1. Pierce JS, Lacey SE, Lippert JF, Lopez R, Franke JE, Colvard MD. An assessment of the occupational hazards related to medical lasers. J Occup Environ Med. 2011;53(11): Althunayan AM, Elkoushy MA, Elhilali MM, Andonian S. Adverse events resulting from lasers used in urology. J Endourol. 2014; 28(2): Guideline for safe use of energy-generating devices. In: Guidelines for Perioperative Practice. Denver, CO: AORN, Inc; 2017: Eder SP. Guideline implementation: energy-generating devices, part 1delectrosurgery. AORN J. 2017;105(3): US Department of Labor: Occupational Safety and Health Administration. Personal protective equipment. 29 CFR x table=standards&p_id= Accessed February 20, ANSI Z136.3: Safe use of lasers in health care. In: ANSI Z136 Standards. Orlando, FL: Laser Institute of America; ANSI Z136.1: Safe use of lasers. In: ANSI Z136 Standards. Orlando, FL: Laser Institute of America; Centers for Medicare & Medicaid Services. State Operations Manual Appendix L - Guidance for Surveyors: Ambulatory Surgical Centers. Rev Manuals/Downloads/som107ap_l_ambulatory.pdf. Revised April 1, Accessed February 3, Centers for Medicare & Medicaid Services. State Operations Manual Appendix A - Survey Protocol, Regulations and Interpretive Guidelines for Hospitals. Rev Guidance/Guidance/Manuals/Downloads/som107ap_a_hospitals.pdf. Revised November 20, Accessed February 3, Byron L. Burlingame, MS, BSN, RN, CNOR, is a senior perioperative practice specialist in the Nursing Department at AORN, Inc, Denver, CO. Mr Burlingame has no declared affiliation that could be perceived as posing a potential conflict of interest in the publication of this article. 398 j AORN Journal

8 EXAMINATION Continuing Education: Guideline Implementation: Energy-Generating Devices, Part 2dLasers PURPOSE/GOAL To provide the learner with knowledge specific to implementing recommendations for the use of lasers from the AORN Guideline for safe use of energy-generating devices. OBJECTIVES 1. Identify the components of a laser safety program. 2. Describe the staffing roles specific to the use of lasers in the perioperative setting. 3. Discuss the precautions to take to mitigate risk of injury from the use of lasers. 4. Identify items that should be documented related to the use of lasers. The Examination and Learner Evaluation are printed here for your convenience. To receive continuing education credit, you must complete the online Examination and Learner Evaluation at QUESTIONS 1. A laser safety program is only required when lasers are purchased for use in the facility. a. true b. false 2. To set up the laser safety program, the multidisciplinary laser safety committee determines 1. what education is needed for surgical personnel. 2. which precautions are needed to prevent injury to patients and personnel. 3. when safety audits will be performed. 4. who will perform the roles specific to laser use. a. 1 and 2 b. 3 and 4 c. 1, 3, and 4 d. 1, 2, 3, and 4 3. The person who administers many aspects of the laser safety program, including coordinating education and confirming credentialing, is a. the laser operator. b. the laser safety officer. c. the laser safety specialist. d. the laser user. 4. The role is optional unless there are lasers simultaneously in use in various areas. a. the laser operator b. the laser safety officer c. the laser safety specialist d. the laser user 5. The person who manipulates the active component of the laser and applies the beam to the patient is a. the laser operator. b. the laser safety officer. c. the laser safety specialist. d. the laser user. 6. The RN circulator should also perform the laser operator role. a. true b. false 7. Injuries that can be caused by the laser beam coming into contact with tissue that is not the intended target include 1. macular holes. 2. capacitive coupling injuries. 3. respiratory system burns. 4. retinal burns. a. 1 and 2 b. 3 and 4 c. 1, 3, and 4 d. 1, 2, 3, and 4 AORN Journal j 399

9 Burlingame April 2017, Vol. 105, No Precautions to take when a laser device will be used include 1. conducting a fire-risk assessment as part of the time out. 2. covering the patient s eyes with moist pads. 3. ensuring that reflective instruments are available for use. 4. using a laser-resistant endotracheal tube with the balloon inflated with methylene blueetinted saline. a. 1 and 3 b. 2 and 4 c. 1, 2, and 4 d. 1, 2, 3, and 4 9. Documentation of laser use should include the 1. laser type. 2. patient safety measures implemented. 3. serial or biomedical number. 4. times the laser was activated and deactivated. a. 1 and 2 b. 3 and 4 c. 2, 3, and 4 d. 1, 2, 3, and Laser power settings only need to be documented if this is a requirement of the accrediting or regulatory body. a. true b. false 400 j AORN Journal

10 LEARNER EVALUATION Continuing Education: Guideline Implementation: Energy-Generating Devices, Part 2dLasers This evaluation is used to determine the extent to which this continuing education program met your learning needs. The evaluation is printed here for your convenience. To receive continuing education credit, you must complete the online Examination and Learner Evaluation at Rate the items as described below. OBJECTIVES To what extent were the following objectives of this continuing education program achieved? 1. Identify the components of a laser safety program. 2. Describe the staffing roles specific to laser use in the perioperative setting. 3. Discuss the precautions to take to mitigate risk for injury from laser use. 4. Identify items that should be documented related to laser use. CONTENT 5. To what extent did this article increase your knowledge of the subject matter? 6. To what extent were your individual objectives met? 7. Will you be able to use the information from this article in your work setting? 1. Yes 2. No 8. Will you change your practice as a result of reading this article? (If yes, answer question #8A. If no, answer question #8B.) 8A. How will you change your practice? (Select all that apply) 1. I will provide education to my team regarding why change is needed. 2. I will work with management to change/implement a policy and procedure. 3. I will plan an informational meeting with physicians to seek their input and acceptance of the need for change. 4. I will implement change and evaluate the effect of the change at regular intervals until the change is incorporated as best practice. 5. Other: 8B. If you will not change your practice as a result of reading this article, why? (Select all that apply) 1. The content of the article is not relevant to my practice. 2. I do not have enough time to teach others about the purpose of the needed change. 3. I do not have management support to make a change. 4. Other: AORN Journal j 401