Friday, June 17, 2011

An Update on Laser and Who May Operate a Laser

There is one area of aesthetic medicine that seems to be misunderstood and the subject of a lot of misinformation. Lasers and other light sources have been the subject of a lot of debate since the early 1990’s when the aesthetic use of laser began with the introduction of the CO2 laser. There also seems to be waves of misunderstanding regarding these devices and it appears that we are in another such wave. The development of new lasers and light-based devices that are non-ablative seem to have brought this issue to the forefront again.

The questions that we are frequently asked revolve around who can operate a laser. Before we address that issue, it is prudent to address the more global issue: Who can own and operate a laser?

Most (if not virtually all) efficacious aesthetic lasers are federally classified medical devices. They are classified such that they must be owned and operated by a physician since they are classified as medical devices. Yes, there are some devices that are classified as medical but are available to other professionals (some LED). These devices are the exception to this principle. Most of the devices must be acquired by a physician and the physician is then free to delegate the use of the device to some in his or her office. Others should only be utilized by the physician.

One of the confusing issues is the dichotomy of state and federal law. Generally speaking, federal law takes precedence over state law on a particular subject matter if both state and the federal government have regulated such area. An exception to this general principle is whenever the state law is more strict. Again, it is federal law that classifies the devices and state laws have varying additional regulations about who and under what circumstances may utilize such devices.

The question of who can acquire a laser is clearer than who may operate it and under what circumstances. The moment a physician allows someone else to perform the treatments, a whole litany of issues arise. The first issue would be what is the non-physician treating? There may be a difference between light based hair removal and treating a medical condition. It is clear that only a physician or appropriate allied health provider can make a medical diagnosis. This cannot be delegated by a physician. For example, someone operating a laser or light device cannot assess that a patient has acne and then treat them for acne under an established protocol.
Accordingly, it would be prudent to have the physician make a medical diagnosis prior to treatment. In any case, it is better protocol to allow the physician to see that patient prior to treatment.

The second issue would be where the procedure can be performed. Whenever the location of treatment is anywhere other than the physician’s office, there will be scrutiny of the relationship between the physician sand the owner or tenant of the other location. This is a complicated issue and it will vary from state to state. There are medical supervisory issues as well as delegation issues and fee splitting issues of state and federal law.
The third issue would be who is performing the treatment. The ability of someone other than a physician to operate a laser is based upon the concept that physicians are free to delegate the treatment plan to non-physicians to provide better and faster care to patients. Such concepts were developed long before the aesthetic use of light devices and in limited situations; they have not been modified to reflect delegation of light-based treatments.
Historically, physicians began delegating laser to existing office personnel. Some states began enacting legislation that limited a physician’s ability to do this. Again, this varies from state to state so we can only discuss general concepts. It would be prudent for a physician to delegate to medical personnel. The further you get away from medical personnel, the more risk there is to being noncompliant. Estheticians are not medical personnel and although some have “para” medical esthetician training, they are not considered medical personnel and their licensure is governed by a state board of cosmetology. It can be argued that non-medical staff can perform purely aesthetic procedures such as laser hair removal or tattoo removal. In such cases, bear in mind that the devices being utilized are still federally classified as medical devices and the use (and ownership) may be limited by that concept. Consideration should also be given to the location of the treatment and the best case scenario would be in the office of the physician that acquired the device.
The fourth issue would be under what circumstances the procedure is being performed. The safest location would be within the office of the physician that acquired the device. Removing the procedure from that office triggers the issues stated above. The availability of the acquiring physician to be present during treatment is also a significant issue. However, it should be noted that a medical procedure should always be performed in a medical facility. I should not have to state this, but a spa is not a medical facility. A non-physician owned “medical spa” is also not a medical facility.
Another issue that relates to the circumstances surrounding a treatment is where the after care is being administered. This is medical regardless of the procedure since the issues are frequently burning, hypo or hyper pigmentation and general wound healing. Non-medical personnel may make an initial review and listen to the patient’s concerns. The minute that there is any irregularity or subjective complaint from the patient, a physician or appropriate medical provider should be brought in to manage the patient care. There may be other idiosyncratic reactions and these would be classified as medical too.
Written protocols are another circumstances issue. Any physician should have clear and written protocols for each type of procedure being performed within his or her office or outside of it if the physician is allowing such treatments to be performed under his or her license. The absence of written protocols will be very damaging in any lawsuit brought by a patient or governmental compliance audit.
Such protocols should be thorough and clear. Procedures should be implemented to regulate adherence to the protocols as well. The fact is that many of the issues discussed in this article and others that relate to the topic are subjective and within a “gray” area of the law. This is done purposely by legislatures as the technology always leads the law. The law reacts to technology and tries to anticipate future changes. Since much of the regulatory and liability claims are subjective, the written protocols are critical as I have seen that the mere existence of them has terminated investigations.
It should also be noted that I have seen abuses of these concepts in the devices being utilized to treat fat or cellulite. There is misconception that these are not medical devices and I have seen them in far too many spas. The original device FDA cleared in the United States was Endermolgie in 1996. It is acceptable as a non medical device as long as the claims being made regarding the results are in FDA compliance. However, the newer generation products also contain a light-based component and most of these devices are federally classified as medical devices.
A final note that should also go without stating is that many laser companies will sell anyone a laser. I have been known to say that they would sell a laser to my dog Stoli if he ponied up the money! I have also heard too many times that the laser company has a letter from an attorney or the FDA allowing the sale to a non-physician. After 17 years of doing this, I am still waiting to see this mystery letter.

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