FDA Hearing on UV Tanning Devices

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FDA Hearing on UV Tanning Devices

  1. 1. FDA Hearing on UVFDA Hearing on UV Tanning DevicesTanning Devices March 25th, 2010March 25th, 2010 Gaithersburg, MDGaithersburg, MD Dr. Michael Zanolli representingDr. Michael Zanolli representing The Photomedicine SocietyThe Photomedicine Society
  2. 2. Michael Zanolli MDMichael Zanolli MD DisclosuresDisclosures PhysicianPhysician DermatologistDermatologist President, The Photomedicine SocietyPresident, The Photomedicine Society Author: Phototherapy Treatment Manual 2nd ed.Author: Phototherapy Treatment Manual 2nd ed. Member, American Academy of DermatologyMember, American Academy of Dermatology Board of Trustees, TN Medical AssociationBoard of Trustees, TN Medical Association Board of Medical Examiners, State of TNBoard of Medical Examiners, State of TN
  3. 3. Medical Uses of UV lightMedical Uses of UV light Used to treat skin diseases.Used to treat skin diseases. Used to treat symptoms or side effects of internalUsed to treat symptoms or side effects of internal disease.disease. Application of UV light as a therapeutic option to treatApplication of UV light as a therapeutic option to treat disease fulfills the definition of the practice ofdisease fulfills the definition of the practice of medicine in the State of Tennessee, because itmedicine in the State of Tennessee, because it requires an examination and diagnosis of a patientrequires an examination and diagnosis of a patient followed by determination of a treatment or remedy.followed by determination of a treatment or remedy.
  4. 4. Snapshot of a Solo PracticeSnapshot of a Solo Practice Phototherapy utilization in my private officePhototherapy utilization in my private office February, 2010February, 2010 54 active phototherapy patients54 active phototherapy patients
  5. 5. Categories of Diseases BeingCategories of Diseases Being TreatedTreated Psoriasis (32)Psoriasis (32) Vitiligo (6)Vitiligo (6) Dermatitis (5)Dermatitis (5) Pityriasis Lichenoides (2)Pityriasis Lichenoides (2) Grover’s Disease (2)Grover’s Disease (2) Morphea (1)Morphea (1) Generalized Pruritus (1)Generalized Pruritus (1) Lichen Planus (1)Lichen Planus (1) Erythema Annulare Centrificum (1)Erythema Annulare Centrificum (1) Granuloma Annulare (1)Granuloma Annulare (1) Alopecia (1)Alopecia (1) Cutaneous T cell Lymphoma stage 1a (1)Cutaneous T cell Lymphoma stage 1a (1)
  6. 6. Types of UV treatment to treatTypes of UV treatment to treat medical diseases and conditionsmedical diseases and conditions Narrow Band UVB (311-313 nm)Narrow Band UVB (311-313 nm) PUVA (Psoralen plus UVA light)PUVA (Psoralen plus UVA light) Broad Band UVB (spectrum 290-340)Broad Band UVB (spectrum 290-340) Laser produced UV at 308 nmLaser produced UV at 308 nm UVA-1 (340-400 nm)UVA-1 (340-400 nm)
  7. 7. Differences in Medical UV lightDifferences in Medical UV light devices and Tanning Bedsdevices and Tanning Beds WavelengthWavelength • >90% of medical application of UVB in N.A. since 2006 is>90% of medical application of UVB in N.A. since 2006 is narrow band UVnarrow band UV – Sale of new units in 2009 was >98% NBUVBSale of new units in 2009 was >98% NBUVB • Still some PUVA but declined steadily since 1998Still some PUVA but declined steadily since 1998 – Main reason: Association with increased risk of melanomaMain reason: Association with increased risk of melanoma when > 250 treatments in fair skinned patients.when > 250 treatments in fair skinned patients. • Tanning Bed lamps have variable percentages of UVB andTanning Bed lamps have variable percentages of UVB and UVAUVA – 0.7% UVB to 8.5% UVB (5% UVB very common)0.7% UVB to 8.5% UVB (5% UVB very common) – Some more recent tanning bed lamps all UVASome more recent tanning bed lamps all UVA – Hundreds of lamps availableHundreds of lamps available
  8. 8. Differences in Medical UV lightDifferences in Medical UV light devices and Tanning Bedsdevices and Tanning Beds DosimetryDosimetry • Dose in either mj/cm2 (UVB) or J/cm2 (PUVA or UVA-1) forDose in either mj/cm2 (UVB) or J/cm2 (PUVA or UVA-1) for medical.medical. • Exposure is rated on a range of time in minutes for tanningExposure is rated on a range of time in minutes for tanning beds.beds. – Dependant upon the lamp usedDependant upon the lamp used – The number of lamps in a tanning bedThe number of lamps in a tanning bed – Dependant upon the ballast used to provide the currentDependant upon the ballast used to provide the current – Low/high pressure lampsLow/high pressure lamps – Reflectance materials in the tubeReflectance materials in the tube • Proper measurement of the fluence of lamps needs to haveProper measurement of the fluence of lamps needs to have a photometer which is matched to the wavelength output ofa photometer which is matched to the wavelength output of the lamps being tested.the lamps being tested.
  9. 9. Differences in Medical UV lightDifferences in Medical UV light devices and Tanning Bedsdevices and Tanning Beds Informed consentInformed consent • Prior to treatment course in a medical setting.Prior to treatment course in a medical setting. Cumulative dosage monitoringCumulative dosage monitoring • Easily calculated on the treatment flow sheet.Easily calculated on the treatment flow sheet. Ongoing medical examinations and monitoringOngoing medical examinations and monitoring • Documented in a medical office.Documented in a medical office.
  10. 10. Emission spectraEmission spectra Narrow-band UVBNarrow-band UVB Phillips TL01Phillips TL01 Broad-band UVBBroad-band UVB Phillips TL12Phillips TL12
  11. 11. QuickTime™ and a TIFF (LZW) decompressor are needed to see this picture.
  12. 12. Low Pressure LampLow Pressure Lamp
  13. 13. High Pressure LampHigh Pressure Lamp
  14. 14. Tanning Bed DevicesTanning Bed Devices Designed to produce a tanDesigned to produce a tan Variables includeVariables include • Lamp outputLamp output – Fluence or powerFluence or power – Essentially will determine the time (min)Essentially will determine the time (min) • Wavelength ratioWavelength ratio – UVB/UVAUVB/UVA • Avoidance of “sunburn” reactionAvoidance of “sunburn” reaction – UVB with a much higher UV indexUVB with a much higher UV index High UVA output and fluenceHigh UVA output and fluence • End resultEnd result • Common feature of all tanning bed lampsCommon feature of all tanning bed lamps
  15. 15. What evidence do we have to beWhat evidence do we have to be able to estimate the amount of UVAable to estimate the amount of UVA delivered in tanning salons?delivered in tanning salons? Tanning facility use: Are we exceeding Food andTanning facility use: Are we exceeding Food and Drug Administration limits?Drug Administration limits? • J Am Acad Dermatol 2003;49:655-61J Am Acad Dermatol 2003;49:655-61 A detailed study of 62 tanning facilities in NorthA detailed study of 62 tanning facilities in North CarolinaCarolina
  16. 16. Critical reviewCritical review A state employed regulator visited each siteA state employed regulator visited each site Surveyed what type of establishment offered tanningSurveyed what type of establishment offered tanning as a serviceas a service Reviewed records of patrons kept by the facilityReviewed records of patrons kept by the facility Collected data on compliance with FDA exposureCollected data on compliance with FDA exposure schedulesschedules Measurements of tanning bed UV outputMeasurements of tanning bed UV output
  17. 17. Critical reviewCritical review ResultsResults • 95% of patrons exceeded recommendations of the95% of patrons exceeded recommendations of the FDA for exposure times and doseFDA for exposure times and dose • UV output of tanning bedsUV output of tanning beds – mean UVA = 192 W/m2mean UVA = 192 W/m2 – range for UVA 17.7 - 674.0 W/m2range for UVA 17.7 - 674.0 W/m2 – mean UVB = 0.35 W/m2 (measured as 6MED/hr)mean UVB = 0.35 W/m2 (measured as 6MED/hr) – range for UVB 0.12 W/m2 - 0.82 W/m2range for UVB 0.12 W/m2 - 0.82 W/m2
  18. 18. Relative comparisons to gaugeRelative comparisons to gauge the energythe energy Average UVA output at noon in summer inAverage UVA output at noon in summer in Washington D.C.Washington D.C. • 48 W/m2 (compare to 192 W/m2)48 W/m2 (compare to 192 W/m2) • Photochem Photobiol 1998;68:63-70Photochem Photobiol 1998;68:63-70 Average UVB output at noon in summer inAverage UVB output at noon in summer in Washington D.C.Washington D.C. • 0.18 W/m2 (compare to 0.35W/m2)0.18 W/m2 (compare to 0.35W/m2) • Photochem Photobiol 1998;68:63-70Photochem Photobiol 1998;68:63-70 A flux of UVB at 0.35 W/m2 is equal to a UV index ofA flux of UVB at 0.35 W/m2 is equal to a UV index of 14 (now 11+)14 (now 11+)
  19. 19. SummarySummary Ultraviolet light is used toUltraviolet light is used to treat skin disease andtreat skin disease and symptoms of disease.symptoms of disease. Physicians are trained to bePhysicians are trained to be aware of known acute andaware of known acute and long term side effects.long term side effects. More specific wavelengths ofMore specific wavelengths of UV and lowest dose is usedUV and lowest dose is used to treat disease.to treat disease. Measurement of the actualMeasurement of the actual dose used and cumulativedose used and cumulative dose is part of medicaldose is part of medical therapy.therapy. Tanning salons are notTanning salons are not medical facilities and shouldmedical facilities and should not treat disease.not treat disease. Patrons of tanning facilitiesPatrons of tanning facilities are not examined as part ofare not examined as part of their service.their service. Tanning is using higher andTanning is using higher and higher doses of UVA tohigher doses of UVA to produce the end results.produce the end results. Cannot compare the timeCannot compare the time between devices because ofbetween devices because of the variables involved.the variables involved. Dosage is not measured orDosage is not measured or required.required.
  20. 20. RecommendationsRecommendations The Photomedicine Society recommends:The Photomedicine Society recommends: • Ban or reclassify tanning bed devicesBan or reclassify tanning bed devices – Special controls and/or premarket approval may beSpecial controls and/or premarket approval may be inadequate for the safety of the public.inadequate for the safety of the public. • If not bannedIf not banned – Require dosimetry on each deviceRequire dosimetry on each device – Informed consentInformed consent – Require a national registry which could be used to gatherRequire a national registry which could be used to gather data on this cohort of individuals.data on this cohort of individuals.
  21. 21. Effects of chronic excessive UVAEffects of chronic excessive UVA exposure through window glassexposure through window glass

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