The following safety problems and possible solutions regarding tanning equipment are identified for manufacturers of tanning booths or other similar equipment that provides whole body exposure for tanning purposes. Some of these recommendations may be in addition to the requirements of the Sunlamp Product Performance Standards.
User Positioning. The intensity of the radiation to which a user is exposed usually depends upon the distance the user is from the lamp. The intensity of the radiation at contact can be as much as five times higher than that at a distance of 12 inches. Serious burns can occur if the proper exposure distance is not maintained. Installing hand rails, markings on the floor or other suitable physical aids are possible solutions.
Timer Error. The ultraviolet radiation intensity usually found inside a tanning booth is relatively high when compared to the sun or the intensities associated with smaller home portable sunlamps. Because of this, allowable exposure times are shorter. Therefore, more accurate control of exposure duration is necessary to decrease the risk of overexposure and injury. A timer having an accuracy of + or - 10 percent of any selected timer interval is sufficiently accurate.
Protective Eyewear. Exposure of a person’s eyes to ultraviolet radiation may result in eye damage; however, persons being exposed need to see well enough to maintain their balance and to locate the door and the exit quickly and safely should it be necessary. It is important that protective eyewear be provided that protects from ultraviolet radiation and allows adequate vision.
Temperature Control. Operation of sunlamps can increase the temperature in an enclosed area. A large increase in temperature might cause fainting and subsequent injury. Units which keep the temperature below 100 degrees Fahrenheit (38 degrees Celsius) would not be cause for concern.
Electrical Safety. If potential electrical hazards in the unit are not controlled, users, operators and service personnel could be seriously injured. Elevated temperatures cause perspiration which enhances the possibility or severity of an electric shock. Even without perspiration, the skin may come into contact with the interior surfaces which house lamps and ballasts that carry large amount of current. There is a potential for electric shock without proper circuit design and insulation. In addition, there are potential hazards to operators and service personnel. Changing lamps, turning on the device, etc., can be a hazard if the device is not grounded properly and if ground fault protectors are not included. There also is the possibility of a fire due to circuit overloads, wire shorting and flammable material being used. Electrical hazards will be minimized in booths that conform to currently recognized electrical standards for such equipment.
Mechanical Construction. The collapse of a booth might cause electrical shock, fire or direct physical injury. This can be prevented by designing the booth to have had enough strength and rigidity to resist the stress of use and to withstand the impact of a falling person.
Protection from Lamps. A person can be cut and seriously injured by falling into or bumping against bare sunlamps. This could be prevented by use of physical barriers around the lamps, such as heavy grid wires or ultraviolet transmitting plastics, which are sturdy enough to withstand the impact of a falling person.
Access and Support. Rapid entrance into or exit from the booth is essential in emergencies. This can be assured by use of doors which open outwardly and are opened easily from both inside and outside of the booth. The potential for injuries from falls can be reduced by use of hand rails and floors which provide adequate traction for wet or dry bare feet.
Radiation Control. Because the FDA considers sunlamp products and ultraviolet lamps to be both electronic products and medical devices, these products and their manufacturers are subject to both the Radiation Control for Health and Safety Act of 1968 (transferred to Chapter V of the Federal Food, Drug and Cosmetic Act in 1991) and the Medical Device Amendments of 1976 (which amended the Food, Drug and Cosmetic Act). Ultraviolet lamps and accessory equipment have been proposed for classification into Class II. Instructions for preparation of a pre-market notification to the Food and Drug Administration and registering a firm as a medical device manufacturer may be found in 21 CFR 801 (Labeling), 21 CFR 803 (Medical Device Reporting), 21 CFR 807 (Establishment Registration and Device Listing for Manufacturers of Devices) and 21 CFR 808 (Exemptions from Federal Preemption of State and Local Medical Device Requirements).
A manufacturer of a sunlamp or sunlamp product is any person engaged in the business of manufacturing, assembling or importing a sunlamp or sunlamp product designated to incorporate one or more ultraviolet lamps and intended for irradiation of any part of the living body, by ultraviolet radiation with wavelengths in air between 200 nm and 400 nm, to induce skin tanning. Manufacturers are required, under Part 1002 of the regulations for the enforcement of the Radiation Control for Health and Safety Act of 1968, to submit an initial report and model change reports for new or modified product models. These reports must be submitted prior to the introduction of a product into commerce and must be prepared in accordance with the “Reporting Guide for Initial Reports and Model Change Reports on Sunlamps and Sunlamp Products.”
The Sunlamp Product Performance Standard, 21 CFR 1040.20, located in the regulations for the enforcement of the Act, initially became effective on May 7, 1980. All sunlamps and sunlamp products manufactured or offered for entry into the United States on or after May 7, 1980, are subject to the code. For products such as tanning booths or beds, the Center also issued equipment recommendations. In addition to the standard, these recommendations also had to be met prior to introducing a product into commerce.
The standard was amended to include many of the equipment recommendations and better address certain safety issues in September 1985. The amended version took effect on Sept. 8, 1986; all sunlamps and sunlamp products made or submitted for entry into the United States on or after this effective date had to comply with the amended standard. Failure to certify products as required in the code or to provide required reports or to maintain the required records are violations of Section 538, Chapter V, FDDCA (Section 360B, RCHSA) and may result in the imposition of the penalties, specified in Section 539 (Section 360C, RCHSA).
The reporting and recordkeeping requirements are set forth in Part 1002. In brief, manufacturers, importers and assemblers are required to submit:
1. An initial report for each product family which:
- a. Identifies models within the reported model family and their intended uses.
- b. Describes the nature of radiation emissions associated with those products and the performance and safety characteristics affecting such emissions.
- c. Details manufacturer design, quality control, and testing standards and procedures with respect to product radiation and safety.
2. Model change reports for each new or different model family.
3. Annual reports which summarize the contents of records maintained by the manufacturer.
Initial and model change reports must be filed prior to the introduction of sunlamps and sunlamp products into commerce. They are to include sufficient information to enable the determination of whether a manufacturer has correctly certified his products as being in compliance with the performance standard.
Annual reports should be submitted by Sept. 1 of each year and should cover the 12-month period beginning on July 1 of the previous year and ending on June 30 of that year. For aid in submitting the information required in the initial and model change reports, consult the Guide for Preparing Annual Reports. The use of these reporting guidelines is mandatory.
Since the product is also a medical device, manufacturers should be aware of the provisions of the Medical Device Amendments of 1976. Among these provisions are requirements for establishment registration and pre-market notification. Also, section 807.87, paragraph (f) of the regulations requests information on substantial equivalence of the device to similar devices already in commercial distribution.
Cosmetic Standards
In addition, those companies which produce sunscreens, lotions and moisturizers, etc., are subject to 21 CFR part 352, titled “Sunscreen Drug Products for Over-the-Counter Human Use.”
