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Indoor tanning injuries: an evaluation of FDA adverse event reporting data
John C Dowdy1, Robert M Sayre, James G Shepherd
1Rapid Precision Testing Laboratory, Cordova, TN 38016, USA. rptlDowdy@aol.com
Background/Aims:
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.
Methods/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.
Insights
The Food and Drug Administration's (FDA) guidance effectively prevents indoor tanning injuries. Standardizing professional training and incorporating FDA policies into performance standards can further enhance safety and reduce UV-related harm.
Area of Science:
- Medical Device Regulation
- Public Health
- Dermatology
Background:
- Indoor tanning devices were regulated as medical devices by the FDA starting in 1979.
- FDA established scheduled doses in 1985 to minimize sunburn risk during tanning.
- Adverse event databases (MAUDE/MDR) track medical device-related injuries, offering insights into UV exposure harm.
Purpose of the Study:
- To analyze medical device-associated injury reports related to indoor tanning.
- To understand the causes and trends of UV-related tanning injuries.
- To evaluate the effectiveness of FDA guidance in preventing tanning injuries.
Main Methods:
- Compiled 142 injury and malfunction records from 1985-2006 from FDA databases (MAUDE/MDR).
- Analyzed reported injuries, distinguishing between UV exposure-related incidents and non-injury malfunctions.
- Examined trends in UV-related injuries over time, correlating with regulatory changes.
Main Results:
- Approximately 50% of reported injuries stemmed from UV exposure, with fewer than one hospitalization per year.
- User or operator noncompliance with FDA sunlamp guidance contributed to at least 36% of UV-related injuries.
- UV injuries significantly decreased after 1996, likely due to changes in mandatory reporting, with a steady decline from 1997-2006.
Conclusions:
- FDA guidance demonstrates efficacy in preventing indoor tanning injuries.
- Recommendations include integrating FDA guidance into enforceable performance standards.
- Standardization and accreditation of tanning industry professional training programs are advised, potentially through bodies like ANSI or ISO/IEC.
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