Wednesday, March 25, 2009

Medical Lasers and the Law

 Updated 3/2017-- all links (except to my own posts) removed as many are no longer active and it's easier than checking each one.

The “throw away” journal, MedEsthetics, has had a couple of nice articles recently.  I will look at one today and the second tomorrow.

The first one on the laws governing the use of lasers in a medical practice.   Lasers:  Aesthetic or Medical?  This one discusses and answers the question:  Who can own and operate a laser?
The Food and Drug Administration regulates all medical lasers.  Most efficacious aesthetic lasers are classified as medical devices and , as such, must be owned (or leased) by a physician.  Yes, some medical devices are legally available to other professional, but these are exceptions.
The article points out that the question of who can own a laser is more clear than who can legally operate one.  They point out that a physician can legally delegate the operation of some lasers or light devices to others.  If the physician does delegate, he/she raises a whole litany of other issues.
What is the non-physician treating?  There may be a difference between using a light-based device for hair removal and treating a medical condition.  The law is clear that only a physician or an appropriate allied health provider can make a medical diagnosis.  Diagnosis cannot be delegated by a physician.
This article also covers the “misconception that devices used to treat fat  or cellulite are not medical devices.”    The Endermologie was the original device cleared by the FDA for cellulite reduction.  It is safe to utilize it as a nonmedical device as long as one is careful with the claims made for its effectiveness. 
However, newer generation products that contain light-based components are federally classified as medical devices.
The article continues to discuss the question “Who is performing the treatment?”  This quickly can become a quagmire as the physician gets further away from medical personnel.  Estheticians are not considered medical personnel.  Estheticians are governed by a state board of cosmetology and not by the state medical board. 
While it can be argued that nonmedical staff can perform purely aesthetic procedures, such as laser hair removal or tattoo removal, bear in mind that the devices being utilized are still federally classified as medical devices and their use (and ownership) may be limited by that concept.
Another issue where care is needed is “post-procedure care.”   It should be well known by now that any of the lasers or light devices can cause problems – burns, pigmentation problems, etc.  If a nonmedical personnel is doing the treatment, it must be remembered that she/he can not make the medical diagnosis of the problem (ie burn). 
Nonmedical personnel may make an initial review and listen to the patient’s concerns, but the minute there is any irregularity or subjective complaint from the patient, a physician or appropriate medical provider should be brought in to manage patient care.
I love the last line of this article:
“Owning a laser does not give you the legal right to use it.”

It is important to check your own state’s laws.  It is also prudent to have good written protocols and to utilize medical personnel rather than simple training a “lay person” to save money.
Here  are my state’s guidelines (Regulation No 22, Laser Surgery Guidelines):
Pursuant to Ark. Code Ann. 17-95-202, the practice of medicine involves the use of surgery for the diagnosing and treatment of human disease, ailment, injury, deformity, or other physical conditions.  Surgery is further defined by this Board as any procedure in which human tissue is cut, altered, or otherwise infiltrated by mechanical means, to include the use of lasers.  The Board further finds that the use of medical lasers on human beings, for therapeutic or cosmetic purposes, constitutes the practice of medicine.
Under appropriate circumstances, that being the performing of minor procedures, a physician may delegate certain procedures and services to appropriately trained non-physician office personnel.  The physician, when delegating these minor procedures, must comply with the following protocol:
  • The physician must personally diagnose the condition of the patient and prescribe the treatment and procedure to be performed.
  • The physician may delegate the performance of certain tasks in the treatment only to trained non-physician personnel skilled in that procedure.
  • The physician must make himself available to respond to the patient should there be any complications from the minor procedure.
  • The physician should ensure and document patient records that adequately describe the condition of the patient and the procedure performed, and who performed said procedure.
A physician who does not comply with the above stated protocol when performing minor procedures will be considered as exhibiting gross negligence, subjecting the physician to a disciplinary hearing before the Board, pursuant to the Medical Practices Act and the Rules and Regulations of the Board.
History:  Adopted June 5, 1998; Amended June 2, 2005

Lasers:  Aesthetic or Medical?;   MedEsthetics, Jan/Feb 2009, pp16-19; Padraic B Deighan, MBA, JD, PhD
Arkansas Medical Board:  Arkansas Medical Practices Acts & Regulations (pdf file) – page 57, Regulation No. 22, Laser Surgery Guidelines

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