The subject of lamp compatibility, substantial equivalency and recommended relamping procedures poses several concerns for responsible salon owners and operators who are trying to conduct business within the guidelines established by the FDA, local authorities and the original equipment manufacturers. The following is a brief overview that should be reviewed by all your employees.

It generally is agreed that tanning lamps should be replaced when their output drops below 65 percent to 70 percent of the level when they were new. In operating time, this is generally between 700 and 1,000 hours, although some longer maintenance models may last as long as 1,500 hours with proper care.

When approaching this procedure, the obvious first question is, what can be used for replacement? The physical dimensions of a lamp obviously could preclude its use in certain units. A 72-inch lamp obviously will not fit into a unit designed to use 59-inch lamps. And the voltage requirements of a lamp must match the tanning unit's output. However, there are other factors that might make a lamp good for one tanning bed and incorrect for another.

One basic factor is the connector type. Tanning lamps are available in either Recessed Double Contact (RDC) or Bi-pin configurations. The bi-pin lamp has two pins protruding in a side by side arrangement on each end; the RDC type of lamp has two contacts on each end housed in a plastic post. The two types are not interchangeable.

Also, distinctly different types of lamps, including standard low-pressure, RUVA and VHO lamps are not interchangeable. Different lamp types have individual operating requirements determined by their particular design. For example, RUVA lamps have a reflecting panel built into the lamp itself, eliminating the need for external reflectors in the tanning unit. This means there is a distinct front and back to the lamp, as the reflective panel must face toward the tanner. Tanning units that use this type of lamp generally place them closer together than do those using traditional lamps.

Both RUVA and VHO lamps also generate more heat than normal low-pressure lamps, making a more powerful cooling system within the tanning unit necessary. To summarize, lamps of any design should be used only in equipment that is designed for them.

Recent revisions to the FDA regulations bearing on tanning products fortunately take much of the guesswork out of choosing replacement lamps. To be compliant, a replacement lamp must be + or - 10 percent of the erythemegenic and melanogenic output of the original lamp. It does not attend to the maintenance value or type of tan given by the original lamp. Since the procedures and testing necessary to satisfy the regulations are beyond the capabilities of almost any salon, primary determination of whether a replacement lamp is compatible is the responsibility of the lamp manufacturer.

Once the compatibility is established, the FDA requires the lamp manufacturer to print somewhere on the lamp or its packaging the specific lamp models that the new lamp is designed to replace. If the labeling doesn't say that the lamp is a direct replacement for a specific lamp, odds are it is not. It is important to remember that just because a lamp physically may fit into a tanning unit, it is not necessarily designed for use in that until.

Salon owners should be aware than an FDA inspector or state regulator may visit their salon without notice. If the original lamp or an FDA compatible lamp is not being used in the tanning unit, they may prevent the salon owner from using the equipment unit it is in compliance.

Additionally, lamp manufacturers are required to file appropriate paperwork with the FDA for its replacement lamp products. Salon owners should have all the necessary paperwork on hand to show that the lamps are compatible.

The following has been excerpted from an FDA-published document, Sunlamp Products Performance Standard, and is presented as general information for the suntanning device owner or operator:

The Sunlamp Product Performance Standard, 21 CFR 1040.20, applies to (1) any sunlamp product "designed to incorporate one or more ultraviolet lamps and intended for irradiation of any part of the living human body, by ultraviolet radiation with wavelengths in air between 180 and 320 nanometers, to induce skin tanning," and (2) any ultraviolet lamp "which produces radiation in the wavelength interval of 180 to 320 nanometers in air and is intended for use in any sunlamp product." The standard requires the elimination of unnecessary UVC radiation (180 through 260 nanometers) from sunlamp products, that sunlamp products have a timer that limits the duration of UV emission to 10 minutes or less with manual recycling provisions, and that protective eyewear be provided with sunlamp products. The hazards due to chronic exposure to UVB radiation, and the use of photosensitizers that interact primarily with UVA radiation are addressed in the form of warning labels on sunlamp products and user information accompanying the product. The conventional RS (reflector spot) sunlamp, the bi-pin fluorescent type sunlamp and the bare quartz sunlamp, examples of the products for which the sunlamp standard originally was developed, emit a relatively high percentage of UVB radiation (8 percent to 58 percent). Sunlamp product manufacturers recently have developed sunlamps for which the ratio of UVA to UVB emissions have been adjusted so that only a relatively small quantity of UVB (two percent or less) is emitted compared to the much higher quantity of UVA radiation and there is no measurable UVC radiation below 260 nanometers. These sunlamps require a much longer exposure to cause erythema and/or tanning and the acute hazard of severe sunburn appears to be reduced greatly. Consequently, the question has been raised concerning which sunlamp products are subject to the Sunlamp Product Performance Standard, 21 CFR 1040.20.

The position of the Bureau of Radiological Health is that the performance standard (21 CFR 1040.20) applies to all sunlamp products (including UVA sunlamp products) or ultraviolet lamps intended for skin tanning which emit ultraviolet radiation with wavelengths in air between 180 and 320 nanometers. Recommended initial exposure intervals for skin tanning products that emit 2 percent or less of UVB radiation are often in excess of one-half hour duration. Since these lengthy exposure intervals do not appear to pose severe erythema problems, the bureau will be amendable to variance requests for an extension of the maximum timer interval (21 CFR 1040.20(c)(20) and modification of the wording of warning labels (21 CFR 1040.20(d) to achieve the same degree of safety and freedom from hazard intended by the standard. Also, the Bureau will consider amendments to the sunlamp standard to eliminate the need for variances for sunlamp products which emit a low percentage of UVB radiation. Since sunlamp products which emit 2 percent or less of UVB radiation were not considered in formulating the standard and variances from certain requirements may be appropriate, the Bureau of Radiological Health will not take enforcement action against such products for failure to comply if manufactured prior to Oct. 7, 1980. This will allow adequate time for these products to be designed and manufactured in compliance with the standard and for variance applications to be submitted and acted on. However, this policy will not apply to conventional UVB sunlamp products, e.g., the RS sunlamp, bi-pin fluorescent type sunlamp and the quartz sunlamp.

Manufacturers should note that sunlamp products which emit only UVA radiation and, thus, are not subject to the performance standard for sunlamp products, are still subject to the FDA requirements applicable to medical devices (under the Medical Device Amendments of 1976) and to the defect provisions of the Radiation Control for Health and Safety Act of 1968 (21 CFR 1003). The equipment recommendations for tanning booths issued by the Bureau of Radiological Health on Nov. 16, 1979, should be considered in any design or testing program for these products. While such items as the 10 minute limit for the timer may not be appropriate, the maximum timer error of + or - 10 percent is still important as is the wearing of appropriate UVA protective eyewear by tanners.