Indoor tanning injuries: an evaluation of FDA adverse event reporting data.
OBJECTIVE
In 1979 the Food and Drug Administration (FDA) designated indoor tanning units would be regulated medical devices and that each must have an exposure timer. In 1985 FDA added a scheduled series of doses designed to allow tanning with little risk of concomitant sunburn. Subsequently FDA/CDRH maintained databases in which medical device associated injuries were reported. The databases, MAUDE and its predecessor MDR, are available online. While these records, in part, are not intended for evaluation of adverse event rates, analysis provides insight into the etiology of UV-related tanning injuries.


RESULTS
We compiled 142 records reported for 1985-2006 including 22% noninjury malfunctions. Of the reported injuries approximately 50% resulted from UV exposure, an average of <1/year resulted in hospitalization. At least 36% of the UV-related injuries were attributable to various (user/operator) noncompliance with FDA sunlamp guidance policies. During 1985-1995 there were six times more UV injuries than 1996-2006, presumably reflecting cessation of much mandatory reporting in 1996. Injury reports declined steady from 1997 to 2006.


CONCLUSIONS
FDA guidance appears most efficacious in injury prevention and we encourage its incorporation into the enforceable performance standard. We also advise that tanning industry professional training programs seek standardization/accreditation of their personnel certifications through recognized accreditation bodies such as ANSI or ISO/IEC.
Dowdy
John C
JC
Rapid Precision Testing Laboratory, Cordova, TN 38016, USA. rptlDowdy@aol.com
Sayre
Robert M
RM
Shepherd
James G
JG
D001505:Beauty Culture / Q000331:legislation & jurisprudence* / Q000592:standards*; D016208:Databases, Factual; D005260:Female; D006760:Hospitalization; D006801:Humans; D008297:Male; D017410:Practice Guidelines as Topic; D012189:Retrospective Studies; D055108:Sunbathing / Q000331:legislation & jurisprudence* / Q000592:standards*; D014466:Ultraviolet Rays / Q000009:adverse effects*; D014481:United States; D014486:United States Food and Drug Administration