Performance Standards for Sunlamps Amanda Grimm, MSHSRA April 10, 2013 Presented to NCSCP
BACKGROUND
What are performance standards? Included in the Federal Food, Drug & Cosmetics Act Performance standards control emissions for radiation emitting medical devices Standards may include: Requirement to attach warning signs and labels Requirement to include the provision of instructions for the installation, operation, and use of such products
Specific performance standards Ionizing radiation emitting products Diagnostic x-ray systems, Computed tomography (CT) equipment, Television receivers Microwave and radio frequency emitting products Microwave ovens Light emitting products Sunlamps, lasers Sonic, infrasonic, ultrasonic radiation emitting products Ultrasonic emitting products
Performance Standards for Sunlamps Initial performance standards published in 1985 Amendments issued in 2002, 2004, and 2010
Sunlamp Standards Allowable radiation emissions Labeling Warning statement on the label Recommended exposure Affixed to the product Timer system with maximum timer interval Timers must have a +/- 10% accuracy Termination capability Panic Button Protective eyewear requirement User instructions on proper operation and determining correct exposure time for skin type
RECENT ACTIVITIES
TAN Act Included in the Food and Drug Administration Amendments Act of 2007 (FDAAA) Requires FDA to determine: If current labels provide consumers with sufficient information on the associated risks If a revised label will better convey the associated risks OR No label can communicate the risks
Current Label DANGER - Ultraviolet radiation. Follow instructions. Avoid overexposure. As with natural sunlight, overexposure can cause eye and skin injury and allergic reactions. Repeated exposure may cause premature aging of the skin and skin cancer. WEAR PROTECTIVE EYEWEAR; FAILURE TO MAY RESULT IN SEVERE BURNS OR LONG- TERM INJURY TO THE EYES. Medications or cosmetics may increase your sensitivity to the ultraviolet radiation. Consult physician before using sunlamp if you are using medications or have a history of skin problems or believe yourself especially sensitive to sunlight. If you do not tan in the sun, you are unlikely to tan from the use of this product.
DANGER Ultraviolet Radiation Alternative Label Avoid overexposure-- It may cause severe burns Read instructions carefully Ultraviolet Radiation causes: Skin Cancer Injury to the Eyes and Skin Skin Aging WEAR PROTECTIVE EYEWEAR TO PREVENT EYE INJURY Certain medicines or cosmetics can increase your sensitivity to ultraviolet radiation Consult your physician before tanning
Label Focus Groups FDA convened a number of focus groups to evaluate current and alternative labeling Focus groups concluded: Updating labeling may communicate the associated risks Positioning the label away from other labels will emphasis the importance of the warning
Proposed Changes to Performance Standards Update warning labels to follow focus group recommendations Including placement and format Revise maximum timer interval and maximum exposure schedules based on current science Provide clarification for manufacturers and individuals who are responsible for replacing all UV bulbs in the device Uniform grading and lamp codes to ensure proper installation
Updated Standards: Coming soon FDA has been reviewing the science to amend sunlamp performance standards HHS review in progress Next step-- Office of Management and Budget (OMB)
AADA ACTIVITIES
AADA Activity OMB review is public AADA Comment Letter in support of revised standards to ensure patient safety Continued communication with FDA on reclassification of tanning beds
Questions? Amanda Grimm, MSHSRA agrimm@aad.org