Summary: use of class 3b and class 4 lasers and intense pulsed light sources for cosmetic procedures in non-medical settings

Ano de publicação: 2008

INTRODUCTION:

Body image has always preoccupied people across time and cultures. Today, the search for beauty can be fulfilled with high-power technologies that are relatively easy to use, such as Class 3b and Class 4 lasers and intense pulsed light (IPL) sources. Lasers are devices that amplify light, emitting it in a narrow, coherent optical beam; the beam produced is near-monochromatic, the particles all move in the same direction, and the waves are in phase with one another. Intense pulsed light is based on different physical and technological principles. Unlike lasers, IPL sources emit polychromatic light (non-coherent, between 500 and 1,200 nm), and selected wavelengths are obtained by means of filters. These technologies are used for various cosmetic purposes and applications, including some that clearly come under activities reserved to physicians, while others fall into the grey areas surrounding medicine. Based on the definitions of the different fields of medical activity and on the laws and regulations governing the practice of medicine, this report has limited its scope to examining laser and IPL procedures that do not require medical diagnosis and that may be performed in Québec by operators other than physicians or health professionals, without medical supervision. This report does not purport to determine what does and does not lie within the scope of medicine. Rather, it focuses on the risks inherent in these technologies and on the qualifications required to use them, by taking hair removal as a base case and by dealing more briefly with skin resurfacing and tattoo removal, without ruling on the field of activity to which these practices belong.

RESEARCH METHODS:

Medline (National Library of Medicine) via PubMed and the Cochrane Library were searched. The grey literature was also examined to take into account the contextual aspects that prompted the request for this report, especially the legal and regulatory provisions framing the use of lasers and IPL by non-physician operators in various countries and regions. In addition, local experts were consulted to validate the contextual evidence and the applicability of the ensuing recommendations.

These experts are key actors in the following organizations:

Association des dermatologistes du Québec; Collège des médecins du Québec; Comité sectoriel de la main-d’œuvre des services de soins personnels [sector committee on personal services workers]; Ministère de l’Éducation, du Loisir et du Sport; Ministère de l’Emploi et de la Solidarité sociale; and Ministère de la Santé et des Services sociaux.

CONCLUSION:

Analysis of the scientific and contextual evidence leads to these findings: Class 3b and Class 4 lasers and IPL sources are high-power technologies entailing risks for operators and their customers. The use of these technologies leads to adverse effects that, although minor and transient for the most part, may in some cases be serious; however, scientific evidence does not allow us to determine their frequency or severity, or to link them with the types of professionals using them. Some cosmetic procedures may overlap with activities reserved to physicians when these. procedures are applied to areas of the skin with an underlying medical condition or with the risk of complications requiring medical expertise. Current Canadian safety standards regulate the sale and importation of these devices and their use in health-care facilities, and the safe use of lasers is governed by laws and regulations intended to protect workers’ health and safety in all work settings. However, Québec has no law or regulation to protect the health and safety of the public undergoing laser or IPL procedures in non-medical settings. The use of Class 3b and Class 4 lasers and IPL sources is widespread in beauty care centres, but the specific types of devices used are not known. There is no professional order regulating the practice of estheticians or other types of personnel working in the personal services sector and likely to use laser or IPL devices, and the Office des professions du Québec has already denied the application by the Association des électrolystes du Québec to establish a professional order. The Comité sectoriel de la main-d’œuvre des services de soins personnels and the Ministère de l’Éducation, du Loisir et du Sport have already developed their own non-mandatory vocational training programs in laser hair removal, but these programs do not cover other cosmetic laser applications or the use of IPL. The Act respecting Workforce Vocational Training and Qualification (R.S.Q., c. F-5) could fill this regulatory gap in part by standardizing the required occupational skills, establishing vocational training and qualification programs, and determining occupational eligibility requirements for laser or IPL operators working in non-medical settings. In light of these findings, this report is not able to rule either on the safety of laser or IPL procedures by non-physician operators working without medical supervision or on the scope of activities that could be authorized to them in the Québec context. However, given that these technologies present hazards and may lead to adverse effects that are potentially serious when used for cosmetic procedures, and given that there is a serious possibility of interference with the field of medicine, AETMIS has reached the following conclusions, which define the major issues to be dealt with: The boundary between the procedures restricted to the field of medicine and the cosmetic procedures that may be performed by non-physician operators must be clearly established.

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