Thursday, March 26, 2009

Medical Spa Regulations

 Updated 3/2017-- all links (except to my own posts) removed as many are no longer active and it's easier than checking each one.

As mentioned yesterday*, the “throw away” journal, MedEsthetics, has had a couple of nice articles recently.  I looked at the first one yesterday, Medical Lasers and the Law, and today will look at the second.  I am impressed with the Massachusetts Task Force and would love to see these same findings implemented in my state.

The second article looked at how state officials are struggling to address the need for appropriate regulations governing the use of laser and light technologies in medical practices, laser centers, and medical spas.  The article reviews how the Massachusetts Legislature asked their Board of Medicine to convene a task force to study and draft some standards and regulations.  They wanted these to cover not just the use of laser and intense pulsed light devices, but also microdermabrasion, chemical peels, soft tissue fillers, sclerotherapy, BOTOX injections, etc.
Massachusetts Medical Spa Task Force represented everyone:
      • Representatives from the Boards of Medicine, Nursing and Cosmetology
      • Two ranking members from the state Legislature (one from the House and one from the Senate) with experience in the public health sector
      • Four physicians – one internist, one plastic surgeon, and two dermatologists
      • One nurse
      • One registered electrologist
      • One consumer

The Medical Spa Task Force gather information from their state and others on current regulations, practices, and safety concerns.  They reviewed relevant national standards.
Representative from the Boards of Medicine, Nursing, Cosmetology and Electrology provided overviews of permitted practices and related education and training requirements.  Industry representatives provided input on the medical spa marketplace and the training of estheticians.  Finally, concerns related to patient safety were identified by a physician from a leading dermatological association and a 2007 survey of American Society for Dermatologic Surgery members, which reported a steady increase in complications caused by non-physicians performing aesthetic procedures over the past five years.

Three big questions were focused  on for the proposed regulations:
  • Who should perform medical spa services?
  • What services should be offered and how should they be regulated?
  • In what environment should these services be provided?

The Task Force developed a three-tier classification system which considered the level of risk, type of supervision needed, and training requirements.
Level I Procedures are noninvasive and demonstrate low risk.  LED therapy and microdermabrasion are examples of procedures at this level.  Since Level I procedures are not considered the practice of medicine, they are overseen solely by the Board of Cosmetology.
Level II Procedures represent a moderate level of risk and include nonablative and nonvaporizing lasers, intense pulsed light devices and radiofrequency devices.
Level III Procedures are the highest level of risk and include ablative and vaporizing devices, chemical peels, and the use of injectables.  Procedures performed using Level III devices can only be administered by a physician. 
Facilities providing Level II and III procedures would require a medical spa license.

Another goal of the Task Force was to look at the appropriate supervision of medical spa procedures.  Existing regulations often permit physicians to act as medical directors even when they know little about aesthetic procedures  and / or spend little time overseeing the spa personnel.  The Task Force proposed changes to put an end to this.
Medical directors and personnel providing medical spa services must meet certain licensure and training requirements. 
On-site supervision by a qualified healthcare provider would be required for Level II and III procedures.
While the medical director is not always required to be onsite to oversee delegated procedures, he/she must be located within four hours of the medical spa and be present on-site 10% of the time each month for each site supervised.

After grappling with the issues of ownership, the Task Force determined that anyone can own a medical spa, but they must hire appropriate medical personnel for clinical supervision.  It was determined that the Department of Health would be responsible for licensing and inspection of medical spa facilities.  It was determined that individual licensing boards would have jurisdictions over appropriate practiced by their licensees.  It was determined that a separate advisory committee should be created to provide future oversight in this constantly changing field of medical aesthetics.
The article indicated that the participants in the Task Force hope their findings will be introduced as a formal bill in the Massachusetts stat legislature sometime this year.

*Medical Lasers and the Law (March 25, 2009)

Medical Spa Regulations;   MedEsthetics, Mar/April 2009, pp 14-16; Andrea Nadai, MHP
Arkansas Medical Board:  Arkansas Medical Practices Acts & Regulations (pdf file) – page 57, Regulation No. 22, Laser Surgery Guidelines

No comments: