Many regulatory and professional organizations provide recommendations and guidelines for laser safety. While the American National Standards Institute (ANSI) publishes consensus standards considered to be the standard in laser safety, these standards are recommended practices only. The positions of professional organizations are important to consider in addition to those of ANSI to ensure comprehensive safety standards for laser use are practiced.
A number of regulatory and professional organizations have promulgated and disseminated recommendations for safe laser use. Though there is considerable agreement among professional organizations and regulatory agencies regarding laser safety guidelines, variation among patients, facilities, and state laws ultimately affects how these rules are implemented.
The American National Standards Institute (ANSI) creates and publishes consensus standards for the conduct of business in almost all sectors, including medicine. This chapter will refer to the ANSI Z 136.3, the American National Standard for Safe Use of Lasers in Health Care Facilities, with specific attention to control measures, as it is widely regarded as the standard for laser use. It is important to clarify that these standards are recommended practices rather than rules subject to enforcement, and compliance is both voluntary and dependent on individual organization’s specifications.
In addition to the standards set forth by ANSI, medical organizations also set professional standards for their membership. The American Society for Laser Medicine and Surgery (ASLMS), with its multidisciplinary membership, including physicians and surgeons, nurses, and other health professionals, is an umbrella organization for all specialties whose clinical care involves lasers. In addition to formulating standards and guidelines for implementing safe and effective laser practices, ASLMS also makes recommendations to medical laser training programs regarding procedural skill for individuals operating lasers.
The American Academy of Dermatology (AAD), the primary professional organization for practicing dermatologists in the United States, encourages the safe practice of medicine and acknowledges that medical laser is subsumed under the practice of medicine. “The Academy endorses the concept that use of properly trained non-physician office personnel under appropriate supervision allows certain procedures to be performed safely and effectively.”2
The American Society for Dermatologic Surgery (ASDS), the main professional organization within dermatology for proceduralists, is committed to the development of safe in-office procedures. The ASDS maintains that medical laser use constitutes the practice of medicine, and that non-physicians should use lasers only when delegated do so by physicians who are appropriately supervising them.
Medical laser use is also subject to regulation by the relevant state and by the U.S. Food and Drug Administration (FDA). Laser devices, such as those used for medical application require clearance or premarket approval by the FDA Center for Devices and Radiological Health (CDRH) prior to distribution for commercial use in the United States. The Radiation Control for Health and Safety Act (RCHSA), a standard similar to that of ANSI, is intended to prevent unnecessary or inappropriate access to laser equipment, and to minimize exposure to collateral radiation. Additionally, RCHSA ensures the appropriate performance features and labels are provided by the manufacturer.2 With respect to laser devices, the FDA is responsible for classifying laser devices based on levels of laser emission. For medical use, lasers are defined as Class III and IV, which require the highest level of regulation for safe use.
Practice Guidelines
The first tenet to laser safety is the training of physicians, healthcare professionals, and personnel. The American Society for Laser Medicine and Surgery (ASLMS) outlines recommendations for training and credentialing, which are referenced by the ANSI standards. |
Procedural Skills
The ASLMS outlines recommendations for the safe use of laser technology, specifically training and credentialing benchmarks, to be used in conjunction with the ANSI Z 136.3 guidelines. Training and credentialing represent distinct issues for laser safety, especially given the escalating debate regarding laser use by non-physicians.
The ANSI Z 136.3 refers to the ASLMS policy “Standards of Training for Physicians for the Use of Lasers in Medicine and Surgery,” which was approved by the board of directors on April 3 of 2008, regarding the recommendation for appropriate training for laser privileges. The specific suggestions for training are as follows3:
The initial program should include clinical applications of various wavelengths in the particular specialty field and hands-on practical sessions with lasers and their appropriate surgical or therapeutic delivery systems. A minimum of 8–10 h is suggested by the ANSI standards. A further 40% of the time should be allocated to the practical sessions. However, more time may be required to complete the basic course contents. Usually, basic training is concentrated on one or more wavelengths. Subsequent programs covering different wavelengths or substantially different applications or delivery instruments may require more hours of training of which 50% of the time is allocated to hands-on sessions. A small faculty-student ratio in the range of 1 to 3-5 is optimal.
It is recommended that an applicant for privileges spend time after the basic training course in a clinical setting with an experienced operator (such programs are often called “preceptorship” training programs or “observation”) when appropriate and practical. Several brief visits or a more prolonged period suffices provided that a variety of cases is observed. It is valuable for the novice to perform the laser procedures with supervision by the expert, however, for a variety of reasons, such as hospital privileges, status of patients and insurance coverage of physicians, this is not always possible.
In addition to training recommendations for physicians, ANSI also suggests standards for general laser safety and training programs, with specific attention to nurses and other non-medical personnel. The following summarizes this position3:
Laser safety training for perioperative nursing and support personnel must be compatible with that taught to physicians. A smoothly functioning laser team depends on this, and every effort must be made to eliminate any discrepancies in training materials. Content of this program should stress overall understanding of operation characteristics of equipment, biologic and physical properties of the laser tissue interaction, potential hazards associated with laser use, and procedures and equipment required to ensure a safe laser environment.
ANSI maintains that training in laser safety practices for physicians and non-physicians should be distinguished from training of methods and techniques of laser procedures.
Though the need for operators to be trained in laser use is universally accepted, the process of credentialing physician and/or non-physician operators as competent in laser use is more subject to debate and interpretation. Often strict and multiple criteria bus be simultaneously met to satisfy credentialing rules. In its paper entitled “Procedural Skills for Using Lasers in General Surgery,” which was approved on April 6, 2006 by the ASLMS board of directors, the criteria for granting laser privileges are summarized4:
A.The physician (attending) must be a diplomat of or be admissible to a specialty Board such as the American Board of Surgery; Orthopedics; Otolaryngology; Ophthalmology; Urology; Dermatology; Plastic Surgery; Cardiovascular Surgery; Neurosurgery; or other medical specialty.
B.The physician must first have been granted appropriate privileges by the facility through the designated certification and facility process. The physician must have privileges to perform requested procedures in the absence of laser use.
C.The physician must have been trained to use laser(s) in a recognized and approved residency program or must have obtained training through an appropriate CME course.
D.Physicians using a laser adapted to an operating microscope or other optical device must demonstrate proficiency in the use of the optical equipment in addition to the laser technology. The physician must already have hospital privileges for the use of these instruments in the performance of procedures with conventional techniques.
E.The user of the laser must be cognizant of the safety hazards of lasers. This knowledge must be obtained either through a residency program or an appropriate CME course. Proof of this training must be supplied in writing to the Laser Usage Committee at the time privileges are requested.
F.Initial approval or use of laser will be provisional until the physician has demonstrated the ability to use lasers to a member of the Medical Staff who has been designated by the facility as being qualified and must have achieved the required standards as previously listed. The criteria for recertification shall be set forth and a yearly review of cases and their outcomes shall be performed.
G.If the applicant requests the use of the laser for investigational purposes, the request must receive approval by the facility’s Clinical Investigation Committee (IRB/CIC) as is required for all other research purposes. An appropriate investigational protocol and informed consent process must be in place.
H.Residents involved in the use of lasers may not perform procedures with these instruments until such time as they have attended an in-depth training program or an appropriate CME course recognized to be adequate by the Laser Usage Committee. In addition, residents must be supervised by a laser-certified attending physician during actual utilization of laser technology at all times.
Similarly, ASLMS outlines physician qualifications for proficiency in laser techniques in its policy statement entitled “Procedural Skill and Technique Proficiency for Laser Medicine and Surgery in Dermatology.” Approved on November 2, 2005, by the board of directors, the following requirements are relevant to laser use in dermatology5:
Possession of an appropriate medical degree or its equivalent. Candidates must be a Doctor of Medicine (MD) or Doctor of Osteopathy (DO) and complete an ACGME accredited residency in their specialty areas.
Must possess primary specialty certification from the American Board of Dermatology.
For a specified period of time (5 years) there will be a practice category for eligibility. Specific criteria for qualifying under this category will be determined and approved by an independent certifying body. Suggested requirements for this category may include the following:
(a)Completion of at least 150 h of Category 1 CME including laser safety and physics. At least 20 h of the 150 h must entail hands on workshops proctored by an experienced physician in laser medicine and surgery and a minimum of 50 h in programming approved by the American Society for Laser Medicine and Surgery (ASLMS), American Academy of Dermatology (AAD) or the American Society for Dermatological Surgery (ASDS).
(b)Submission of 100 cases with a minimum of 15 sets of before and after photos or videotapes representative of at least four of the nine management areas.
(c)Mastery of Standards of Training must be demonstrated by obtaining a passing grade on an examination the content of which will be determined by an independent certifying body.
(d)Letters of recommendation attesting to character from at least three practicing physicians in the same specialty.
It is the widely accepted belief of the aforementioned organizations that a necessary precondition for patient safety is the proper training and credentialing of healthcare professionals. As such, despite differences in details, there is minimal, significant variation in the standards by which physicians are assessed with regard to their competence to utilize medical laser devices. Discrepancies arise when considering credentialing of alternative allied health providers, which will be addressed later in this chapter in the section on delegation and regulation by the state.
Administrative Controls
Administrative controls are essential for the safe operation of lasers within a healthcare facility. These control measures minimize the potential for hazards to operator and patient during laser use. A Laser Safety Officer (LSO) is appointed to ensure the appropriate standards are followed. |
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