Laser Safety in the Cosmetic Practice: Understanding State Trends

As a continuation of last month's article which took a broad stroke at understanding the entities involved and the tasks to be undertaken to build a reproducible and responsible laser safety compliant office program, this article will attempt at looking at the roles that individual state's take and how each cosmetic laser office setting might best be prepared to meet existing or approaching compliance issues.

The federal government plays a very valuable role of providing up to date laser safety guidelines for the healthcare environment that all facilities should consider when developing their safety programs. OSHA is a federal entity that has used these guidelines to develop regulations that help these laser facilities ensure that everyone that works with these devices are informed and can participate in their own safety. Some states have or are in the process of enacting specific laser safety regulations, based on the federal guidelines that require these facilities to not only follow these laser safety rules, but may also require registration of equipment, facilities, operators, or Medical Laser Safety Officers for each facility. If a state does not specifically reflect laser safety regulations, any facility with medical lasers is expected to follow the existing and most current federal standards on Laser Safety in Healthcare Facilities (Current revision ANSI Z136.3; 3-2005)

The Federal Laser Safety Standards and OSHA Regulations continue to revise standards to embrace new laser and light based facilities such as medical spas. What are in major flux are questions such as these: Who may operate these devices? Should there be delineation between more aggressive and less aggressive procedures? Must the laser operator be a physician? What training will be required of the physician for operating and supervising the operation of these devices and how will this process be documented? What "Physician Extenders" (PEs are Physician Assistants, Registered Nurses, Advanced Nurse Practitioners, Aestheticians, Cosmeticians) may operate these devices? What training will be required of these laser operators? What should be the level of supervision of PEs? What is the physician liability?

These are a few of the questions that are facing each state as they continue to deal with increasing pressure from reports of patient injuries, reports of unlicensed and improperly supervised and trained cosmetic laser spa personnel, pressure from those in the industry desiring help ensure the safety of both patients and staff, pressure from existing profit centers protecting their positions, but also pressure media attention of both the excitement of new technology being marketed as well as deserved attention to poor outcomes and injury from some of these procedures.

Therefore, the state medical boards are being asked to react to a perceived need for more regulation and oversight. Some states have reacted quickly with what information was available at the time, sometimes resulting in confusing rules that may actually increase the level of irresponsible cosmetic business practices. Some states await the outcome of other states or more standardized controls. Some states have provided position statements that may temporarily act as a compass to all constituents and the public that they might know the direction of the board before actual regulations are recommended. Many states are in the process of due diligence on the subject.

Throughout the Internet and on various well intentioned information sources, many have attempted to provide simple straight forward data bases that categorize the states into groups such as:

  • Only physicians may operate these lasers
  • PA and/or ANP and/or RN and/or Aesthetician and/or Cosmetologist may operate these devices with on site supervision
  • PA and/or ANP and/or RN and/or Aesthetician and/or Cosmetologist may operate these devices with off site supervision
  • Level of supervision of laser operator not defined
  • A few years ago, this type of information was perhaps helpful for manufacturers and those interested in looking into establishing a cosmetic laser service business to begin the process of their own investigation. However, today, as one might access a variety of these databases, the result would probably be conflicting reports and information. States will often be defined quite differently from one database to another. The reason is probably two fold. As this process is evolving very quickly, the age of the database and the frequency that it is updated is imperative. Also, if the actual research is not performed, the interpretation of the data can be quite different from one author to another. Unless the actually supporting documents are available to enable the reader to see possible explanations and details about education, training, delegation, and supervision, policy and standard operating procedure documentation, the intent of the state's regulation is often lost when trying to place into a short form category.

    Once a state regulatory body or medical board begins the process of responsibly looking at all of the issues involved, the basic philosophy and intent of those involved will begin to form and will become evident. By following the process of many states that have identified the purpose and roll of these devices in the healthcare environment market, certain common threads tend to emerge.

    Most interesting today is to follow the work of state task forces that are carefully looking at these issues. The future concepts for defining medical spas, competency based training, and concepts of treatment difficulty may well be found in the notes of these well represented task forces.

    Some of the common denominators that seem to be emerging are:

    • Ablative lasers should be treated differently that non ablative lasers; physician only operating ablative devices
    • A properly trained physician level must be involved in a supervisory role.
    • Delegation of supervision of the use of these lasers could involve advanced practice licensed healthcare professionals (PA, ANP, possibly RN)
    • Depending on the level of training and education of the laser operator, and also depending on the integrity of the process documentation, supervision will be assessed as on site or off site.
    • Off site supervision requires supervising physician to be immediately available
    • Specific levels of training for supervising physician, delegate supervisor, and laser operators are specific and must be documented.

    Other common inclusions are:

  • Supervising physician must make initial patient evaluation
  • Required training courses must be approved by the medical board
  • IPL and radiofrequency devices included in Medical Board or legislative rulings
  • Laser Safety Audits should be performed internally for each facility
  • Patient documentation, laser safety policies, and standard operating procedures or standing orders should be in place
  • A meaningful and measurable QA program documentation is required
  • The Common Ground

    A very positive movement in this process is the evidence that many states going through the process of fact gathering are communicating with each other. In some states, we see the medical boards and the state regulating bodies also communicating to ensure that the proper goals are identified and outcomes are measurable and responsible. As these measurable and responsible outcomes are identified, we also see that supporting healthcare boards are then responding to help further identify the appropriate roles of non physician healthcare professionals (PA, ANP, RN) as well as aesthetician and cosmetology associated boards.

    The common ground is becoming evident. Regardless whether it is the physician, the device manufacturer, or the consumer patient; the common goal is the same. The true goal of all of these efforts is to help ensure the safety of staff and patients when working with and near these devices as well to help ensure that patients are not injured and may have a reasonable expectation of satisfactory outcomes.

    Education, Training, and Appropriate Supervision

    Whether the industry is to be regulated or not, these three issues will help make for a healthy and expanding cosmetic light based market.

    The very nature of these devices lays critical ground for education. Although we are still experiencing the infancy of understanding the benefits of what light is able to do, we are also in the midst of an expansion of new knowledge of the nature of light and it's interaction with biological tissue. Unlike the early days of laser surgery in the 1980s and 90s, we no longer depend simply on the wavelength or band width of emissions with adjusting power outputs. This is truly developing into a science of photobiology as we witness the knowledge expansion and recognize the importance of other light output variables. In the early development of general laser medicine we knew little about the impact of spot size on the depth of tissue penetration, the relationship of time and the energy delivered with the size of the target, pulsing frequency and the prevention of pulse stacking, or the profile of a laser pulse and its impact on reproducible outcomes. With the advent of tissue modeling we can now more specifically anticipate and identify intended chromophores or targets thus using all of these variables to target tissue specifically and improve outcomes.

    It quickly becomes evident that unbiased and up to date education of light mechanics and tissue interaction is a logical step for any group or individual to take before stepping into this marketplace. It is the responsible thing to do not only for the future patient base, but for the business as well. Many versions of biological light interaction can be found. It will vary on who is telling the story, what agendas are behind the story, and certainly when the information was last updated. Again, this identical scenario was seen with the advent of surgical lasers. The story is repeating itself with cosmetic lasers, except the technology and our general knowledge base has progressed much further.

    For an initial investor of the technology, it only makes sense to become educated into the aspects what we know TODAY about light and tissue. The key is to access that information from a source that is providing that education to you for the purpose of providing you with the most up to date, factual and unbiased program possible. Only then can one even reasonably make decisions about equipment choices and help ensure that the unbiased laser and light based safety information is available to provide a service vested in the expected patient outcomes and to operate a safe and compliant laser safety program. Then, comes the training required to best utilize the equipment that is chosen to have the safest and best possible outcomes.

    A real concept for the future will be the consideration of a National Certification for all levels of cosmetic light based device applications. With this type of certification, the educational and training component will be not biased by turf or manufacturer, but will be based on real and current science based training. Cooperative efforts between states, medical boards, healthcare boards, aesthetic & cosmetology licensing boards, and organizations such as the ASLMS (American Society for Lasers in Medicine and Surgery) will most probably play vital roles in this development.

    Supervision of non physician laser operators by a responsible physician that has both the education and training to not only anticipate outcomes but also address and possibly prevent adverse events is the responsible thing to do.

    Example Players

    There are many states making great strides to help the industry ensure public safety with cosmetic laser providers. Here are three state efforts highlighted:

    Georgia: Although not funded yet, the expected "Georgia Cosmetic Laser Services Act" may look similar to what we may find as a comprehensive program in the future. The bill describes a dual level of required competencies based on level of responsibility, licensure, experience, and successful completion of approved laser and light based training programs. This ruling is a combined work from both the state government and state medical board. www.ors.dhr.georgia.gov

    Texas: The state medical board program from Texas "Laser Rule 193.11" was developed to work in conjunction with Texas State Laser Regulations, which are based on the Federal Laser Safety Guidelines for Healthcare Facilities. This program specifies the hours of education and training required for both physicians and delegated laser operators. Also specified are to whom properly trained physicians may delegate the tasks to, and depending on the level of training and licensure of the operator, what level of supervision is required. The Texas ruling also specifies the need for appropriate laser safety policies and procedures, as well as the use of standing orders. Laser safety program audits are also recommended. Many of these issues and suggestions are components of the Federal Laser Safety Guidelines recommended for all facilities utilizing medical lasers, the ANSI Standards for laser healthcare safety. This laser ruling is generally accepted as a goal for all state cosmetic laser facilities and users in Texas; however, officially, the ruling is on hold for further review. http://www.dshs.state.tx.lus/radiation/laser.shtm

    Massachusetts: The state of Massachusetts has a Medical Spa Task Force sponsored by the Massachusetts Board of Registration in Medicine. The work provided by this program has been quite impressive and will be presented to the state legislation later this year. This task force is working through some of the fundamental questions such as thedefinition of a "Medical Spa", competency based training and education of all levels of practitioners, the appropriate supervision required, differentiating the level of intensity of specific procedures, and a variety of ideas on how to best involve the appropriate licensing and medical boards and professional organizations that will need to be involved in the development process. http://www.massmedboard.org/public/med_spa.shtm