Accepted by the Board on April 27, 2006

On June 2, 2005, the Iowa Board of Medical Examiners, at the request of the Iowa Medical Society, voted to establish a special committee to study the use of lasers, intense pulsed light devices and radio-frequency devices in the treatment of medical conditions. Iowa Medical Society’s Resolution 05-03 Legislation Limiting Use of Lasers, Intense Pulsed Light Devices,Radiofrequency Devices, Pulsed Light Devices, and Hair Removal Lasers is as follows:

The Iowa Medical Society encourages the Iowa Board of Medical Examiners (BME) to develop a statement of policy on the appropriate use of lasers, intense pulsed light devices, radiofrequency devices, and pulsed light devices to guide investigation and regulation in this area and once this policy is established, the Iowa Medical Society shall communicate the BME policy decision to the physician community.

Committee Membership: The Board appointed an ad hoc committee of M.D.s and D.O.s (hereinafter referred to as “physicians”) with expertise and/or interest in the use of lasers and associated devices1 in the practice of medicine and Board staff. The Committee included:

• Allen Zagoren, D.O., Medical Director, Wound Healing Center of Iowa, Des Moines;
• Benjamin Van Raalte, M.D., Plastic Surgeon, Davenport;
• Marta Van Beek, M.D., M.P.H., Assistant Professor, UIHC Department of Dermatology, Iowa City;
• Christopher Haupert, M.D., Retinologist, West Des Moines;
• Duane Jolivette, M.D., Family Physician, Des Moines;
• Ann Mowery, Executive Director, Iowa Board of Medical Examiners; and
• Kent Nebel, Legal Director, Iowa Board of Medical Examiners.

Special Committee Meeting: On September 29, 2005, the Committee met at the Board’s office in Des Moines, Iowa. All Committee members were present and many other interested parties testified before the Committee, including representatives from the Iowa Medical Society, Iowa Board of Physical Therapy Examiners, Iowa Physical Therapy Association, Iowa Chiropractic Society, Iowa Board of Nursing, Iowa Physician Assistant Society, Iowa Board of Cosmetology
Examiners, Iowa Optometric Association, and other cosmetology and ermatology providers.

The Committee discussed lasers and associated devices—the technology involved, Federal and State regulation, medical uses and risks, responsibilities of physician and non-physician healthcare providers, training requirements, physician delegation and supervision, complications and emergencies, and how best to regulate the use of these devices in Iowa.

Definitions: For the purposes of this report, lasers, intense pulsed light devices and radiofrequency devices include all light-based or radio-frequency emitting devices that are used to alter living tissue. Living tissue includes but is not limited to: epidermis, dermis, melanocytes / melanophages, vasculature, hair bulb, extracellular protein (collagen, elastin), connective tissue (muscle, tendons, fat), neural tissue and bone.

The following definitions were used:

Laser: A laser is a precisely focused light beam that can be used to treat tissues by heating targeted cells. (MedlinePlus Medical Encyclopedia) A laser can deliver only one wavelength of light at a time. The wavelength determines the color of the light. Longer wavelengths (red) penetrate deeper into the tissue without affecting tissue closer to the surface. Shorter wavelengths (green) are used to treat more superficial targets and avoid damaging deeper tissue. (MDLaserDerm.com) Lasers were first developed in 1964 for industrial uses, such as precise cutting of metals and plastics. Industrial lasers were adapted for medical use. In the early 1980’s medical lasers were developed to deliver specific wavelengths of light to treat different medical conditions. (American Society for Laser Medicine and Surgery, Inc.)

Intense Pulsed Light Devices: An intense pulsed light device can deliver hundreds or thousands of wavelengths (colors) of light at the same time. The wavelengths can be customized to reach specific target cells. Intense pulsed light can reach different depths of tissue at the same time. Pulsed light can be delivered in pulses or bursts of light varying from 1 to 5 pulses at a time. The “duration” of each pulse and the “delay” in time between pulses can be modified. Longer pulse durations are generally better for treating larger targets and shorter pulse durations are used for treating smaller structures. Intense pulsed light devices often have a wide variety of settings allowing the user to vary the wavelengths and the duration of the pulses delivered to the target cells. (MDLaserDerm.com)

Radio-Frequency Devices: Radio-frequency is a form of electro-magnetic energy similar to microwaves. Radio-frequency devices pass radio frequency electricity through tissue to heat up target cells. The radio frequency can be modified to reach different target cells.

Risks Associated with the Use of Medical Lasers and Associated Devices: The Committee determined the following risks have been associated with the use of these devices:

• Burns. First-, second-, and third-degree burns can result in pain, infection, bleeding, nerve damage, and scarring.

• Skin color changes. Various colors of skin react differently to the devices and use of the devices may result in temporary or permanent skin color changes.

• Allergic reactions to topical anesthetic. Topical anesthetic is used to reduce the discomfort of the treatment. At least one individual had an allergic reaction and died from methemoglobinemia after applying a topical anesthetic prior to treatment.

• Eye damage. Shining a laser in an individual’s eye can burn the retina causing permanent damage to one’s eyesight.

• Exacerbation of existing disease. These devices are contraindicated for some individuals, e.g., those with lupus, dermatomyositis, etc.

• Obscuring cancer. If the user of the device makes an improper diagnosis of a condition, e.g., melanoma, the patient may receive inadequate treatment for a life threatening condition.

• Fraud. Users may assert that treatment with one of these devices is effective when there is no scientific evidence showing such.

Uses of Medical Lasers and Associated Devices: The uses for these devices are expanding and will continue to do so. The devices are currently being used for less risky procedures as well as those with significant risk, e.g., dermatological conditions (hair removal, tattoo removal, skin surfacing); pain and inflammation as in arthritis; cosmetic surgery including liposuction; soft tissue repair as with wounds; heart disease; eye surgery; and repair of spinal cord injuries.

Representatives for the practices of physical therapy, chiropractics and cosmetology indicated that the use of lasers and associated devices is growing amongst the members of their professions for a variety of uses, including wound healing, pain relief, tissue repair, hair removal and skin resurfacing.

Federal Regulation on Medical Lasers and Associated Devices: The Federal government regulates product safety, e.g., laser product performance (29 CFR 100), eye protection (29 CFR 1910.132), and power generation (29 CFR 910.269). The Occupational Safety and Health Agency has developed laser safety policies and standards for the devices themselves. (OSHA Pub. 8-17) While the federal government regulates the devices and restricts the purchase of some of the devices to physicians, the government does not categorize the devices by safety levels nor does it regulate who may use which devices on patients.

State Regulation of Medical Lasers and Associated Devices: Most State regulation in existence today addresses the use of medical lasers and does not address the associated devices. Some of the State medical boards regulate medical lasers through statutes or regulation that establishes the use of medical lasers as the “practice of medicine” and limits their use to physicians or personnel under physician supervision. Many State medical boards have made an exception for laser hair removal and other minor procedures, permitting non-physician providers to use lasers for these less risky procedures without delegation or supervision of a physician. A few State medical boards distinguish who may use lasers based on the power of the laser. It is unclear how these states account for adjustable power settings on most lasers that allow the operator to adjust the setting depending upon its use. Criteria for what constitutes low risk procedures is also lacking. A number of State medical boards have established rules on delegation to non-physician providers, training requirements and physician supervision.

Status of Regulation of Medical Lasers and Associated Devices in Iowa: The only law and administrative rules in Iowa related to who may utilize these devices were initiated by the Iowa Board of Cosmetology Examiners for their licensees: estheticians, cosmetologists and electrologists. These licensees may only use certified laser products or intense pulsed light devices if their Iowa license is in good standing and the Cosmetology Board has approved their training and certification in the use of such devices. The training and certification must be specific to each procedure or device and must include a safety component which provides a thorough understanding of the procedures being performed, the fundamentals of non-beam hazards, management and employee responsibilities, and regulatory requirements. With the exception of hair removal, manicuring, and nail technology services, licensees may not perform any procedure in which human tissue is cut, shaped, vaporized, or otherwise structurally altered. Only cosmetologists who were initially licensed in Iowa before July 1, 2005, may utilize certified laser products or intense pulsed light devices. Electrologists may utilize such devices for hair removal only. Licensees receive a certification card for the use of such devices that must be conspicuously displayed at their primary site of practice.

Beginning May 1, 2006, estheticians, cosmetologists and electrologists must complete a minimum of one hour of continuing education in the area of each procedure or device utilized. Licensees must also obtain appropriate consent from clients prior to providing such services. The consent form must specify the nature and purpose of the procedure(s), list known risks, acknowledge that appropriate disclosure has been made and that questions have been atisfactorily answered, and include a signature of the client or a person with legal authority to consent for the client. Licensees must submit a report to their board within 30 days of any incident which resulted in physical injury requiring medical attention.

Training Requirements: The Committee concluded that all healthcare providers, physicians and non-physicians alike, who utilize medical lasers and associated devices, should have appropriate training and experience to perform the procedures safely. While training on each specific device to be used is essential, the Committee stated that training should be broader than what is offered by the devices’ manufacturer. At the minimum, the healthcare provider or person operating the device should have knowledge and understanding of:

• Anatomy, physiology and pathology related to the condition being treated and the body’s response to the device being used.

• Basic physics relevant to the device being used, including wavelength emitted and the chromophore targeted.

• Safety issues relevant to the device being used.

• Sedation and anesthesia utilized for such procedures, including risks associated with administration of topical anesthesia.

• Possible complications and the appropriate treatment or referral for treatment of the complications.

• How to properly evaluate various conditions and determine whether treatment by laser or an associated device is appropriate and whether it is appropriate for the knowledge and skill level of the healthcare provider intending to perform the care.

Physician Use of Lasers and Associated Devices: Physicians with the most in-depth preparation to use lasers and associated devices are usually those with residency training that included use of the devices. Those without preparation at this level should have substantial training beyond that of a manufacturer prior to using these devices and delegating their use to personnel. In addition to the above, training should cover appropriate patient selection (including proper diagnosis of the condition under treatment), preparation of the patient for treatment, use of the devices on patients, post-treatment care, care of complications, recordkeeping, and maintenance of the devices. The physician should keep documentation of this training.

Delegation of the Use of Lasers and Associated Devices to Non-Physician Personnel: The Committee recognized that physicians may delegate the use of these devices to non-physician personnel—both licensed and unlicensed personnel. The Committee concluded that physicians who delegate a procedure to a non-physician should be capable of performing the procedure themselves. Non-physician personnel should receive appropriate training and education that is documented. The physician, physician assistant or nurse practitioner delegating the use of these devices should be responsible for evaluating patients and making the diagnosis of the condition intended for treatment. The physician and any licensed personnel should carry adequate malpractice insurance to cover their use of the devices and that of those they supervise.

Supervision of Non-Physicians Who Use Lasers and Associated Devices: The Committee concluded that physicians who delegate the use of medical lasers and associated devices to nonphysician providers must provide appropriate supervision to these individuals when they use such devices. The level of physician supervision depends on the risks associated with the procedure and the training and experience of the non-physician provider. Greater direct physician supervision is required for higher risk procedures and for non-physician providers with less training and experience. For high-risk procedures, non-physician personnel must be properly trained and may carry out specifically designated procedures only under direct, on-site physician supervision. The supervising physician should utilize written protocols that describe the supervisory relationship for the performance of procedures with these devices and make certain that non-physician providers have read and fully understand the written protocols. The protocols should address what is expected of the non-physician in caring for patients before, during and after the procedures.

Complications and Emergencies: The written protocols established by physicians should delineate procedures for recognizing and responding to complications and emergencies that may occur with the use of medical lasers and associated devices. This is particularly important if the physician does not provide direct, on-site supervision of non-physician providers. It is important for physicians to remember that the ultimate responsibility for the procedures rests with the
physician.

Summary: The Committee concluded that the regulation of lasers and associated devices is a very complex issue, involving a broad range of changing technologies and significant scope of practice implications. However, unregulated widespread use of these devices is an increasing public safety concern. Concerns regarding safety risks for these devices vary significantly. In addition to safety risks, there are concerns regarding the efficacy of the ervices offered, including fraudulent practices. Choosing a qualified healthcare provider to provide medical treatment with lasers or associated devices is an important decision. The public should consider all of the issues discussed above before choosing a provider.

Regulatory Options for Iowa: The Committee discussed three possible regulatory options.

1. Legislation. The Cosmetology Board has worked with the medical profession in the past few years to address some of the concerns related to the use of lasers and associated devices by the cosmetology industry. The Committee would like to see even reater regulation affecting physicians, other professions and unlicensed personnel utilizing lasers and associated devices. A bill seeking such changes, introduced in 2005 on behalf of a number of physicians, was unsuccessful and probably foretells how challenging any future legislative attempts will be. The legislature and the public appear to be unaware of the significant safety concerns regarding the use of medical lasers and associated devices. In the past, access to such-services and the lucrative potential of owning and operating these devices appeared to outweigh safety concerns brought up by physicians. The Committee concluded that a statutory change, although ideal, will be the most difficult option to achieve.

2. Administrative Rules: While formal rulemaking would be the Committee’s second choice, such rules would be very difficult to enact given the significant scope of practice implications and opposition from several other professions. The interested parties who addressed the Committee made it clear that each profession is utilizing lasers for limited services and that they would strongly oppose any restriction or limitation on their use. A rules change would be very difficult at this time.

3. Policy Statement: Unlike a statutory or rules change, a policy statement cannot be enforced against violators. A policy statement is advisory in nature only. A policy statement may be the easiest and least contentious method for the Board to express its safety concerns and provide guidance to healthcare professionals and the public.

1 “Associated devices” will be used to refer to intense pulsed light devices and radio-frequency devices.