Lasers have transformed the way medical procedures are done. Cosmetic procedures, vision correction, teeth whitening, surgery and tattoo removal have all benefited from the use of a specialized laser.
Medical device lasers are regulated by the FDA, and some states have additional regulations on healthcare laser systems (HCLS), such as licensing, registration and training. It is the manufacturer’s responsibility to comply with FDA regulations for production of HCLS, and it is the responsibility of the LSO to comply with state regulations for registration, licensing, installation and operation of the individual device.
Health Care Laser System (HCLS) are often used as medical devices in hospitals, surgery centers, dental offices, veterinarian offices, salons, and spas. The HCLS apparatus includes the following components:
Use of HCLS outside of hospitals is common, especially in the case of private practice medical offices, veterinarian offices, dental offices, salons, and spas.
Needless to say, where lasers are in use on humans and animals, laser safety is of paramount importance. Therefore, procedural controls must be adhered to during use of Class 3B and Class 4 laser systems (to be determined by the LSO) such as:
Respiratory protection (respirators, breathing filter masks, etc.) are part of the personal protective equipment for laser operator during medical procedures. They are intended to limit the inhalation of bacteria, viruses, gasses, and vapors.
It should be noted that the current state of PPE for inhalation prevention is limited and does not completely protect the user. Surgical masks are not sufficient because they are only design to contain nasal and oral contaminants that may originate from the surgeon themselves. Only respirators and breathing filter masks may partially protect the laser user, but they must be used in conjunction with the exhaust ventilation system. Such equipment must comply with OSHA respiratory protection standards.
Lasers are capable of emitting secondary radiation which is not part of the primary beam radiation. For example, charge tubes on gas lasers can emit ultraviolet radiation that may exceed the NPE. Note that ultraviolet radiation can sometimes cause cataracts. Charge tubes and diode pump lamps should be shielded by the manufacturer. Additionally, when the primary beam interacts with bone tissue, the light can be scattered and reflected, causing a bright spot at the point of incidence. This light can be extremely bright and require goggles for viewing. Bone interaction with laser light can also cause plasma radiation.
It is extremely important to properly label each laser system with warnings according to the laser class.