FDA Hearing on UV FDA 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

Michael Zanolli MDMichael Zanolli MDDisclosuresDisclosures

PhysicianPhysician DermatologistDermatologist President, The Photomedicine SocietyPresident, The Photomedicine Society Author: Phototherapy Treatment Manual 2nd Author: Phototherapy Treatment Manual 2nd

ed.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

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 Used to treat symptoms or side effects of

internal disease.internal disease. Application of UV light as a therapeutic option Application of UV light as a therapeutic option

to treat disease fulfills the definition of the to treat disease fulfills the definition of the practice of medicine in the State of Tennessee, practice of medicine in the State of Tennessee, because it requires an examination and because it requires an examination and diagnosis of a patient followed by diagnosis of a patient followed by determination of a treatment or remedy.determination of a treatment or remedy.

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

Categories of Diseases Being Categories 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)

Types of UV treatment to Types of UV treatment to treat medical diseases and treat medical diseases and

conditions 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)

Differences in Medical UV Differences in Medical UV light devices and Tanning light devices and Tanning

BedsBeds WavelengthWavelength

• >90% of medical application of UVB in N.A. since 2006 >90% of medical application of UVB in N.A. since 2006 is narrow band UVis narrow 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 melanoma Main 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 Tanning Bed lamps have variable percentages of UVB and UVA and UVA

– 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

Differences in Medical UV Differences in Medical UV light devices and Tanning light devices and Tanning

BedsBeds DosimetryDosimetry

• Dose in either mj/cm2 (UVB) or J/cm2 (PUVA or UVA-Dose in either mj/cm2 (UVB) or J/cm2 (PUVA or UVA-1) for medical.1) for medical.

• Exposure is rated on a range of time in minutes for Exposure is rated on a range of time in minutes for tanning beds.tanning 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 Proper measurement of the fluence of lamps needs to have a photometer which is matched to the to have a photometer which is matched to the wavelength output of the lamps being tested.wavelength output of the lamps being tested.

Differences in Medical UV Differences in Medical UV light devices and Tanning light devices and Tanning

BedsBeds 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.

Emission spectraEmission spectra

Narrow-band UVBNarrow-band UVB

Phillips TL01Phillips TL01Broad-band UVBBroad-band UVB

Phillips TL12Phillips TL12

Low Pressure LampLow Pressure Lamp

High Pressure LampHigh Pressure Lamp

Tanning Bed DevicesTanning Bed Devices

Designed to produce a tanDesigned to produce a tan Variables includeVariables include

• Lamp output Lamp 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 result End result • Common feature of all tanning bed lampsCommon feature of all tanning bed lamps

What evidence do we have to be What evidence do we have to be able to estimate the amount of able to estimate the amount of

UVA delivered in tanning salons?UVA delivered in tanning salons?

Tanning facility use: Are we exceeding Food Tanning facility use: Are we exceeding Food and Drug Administration limits?and 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 A detailed study of 62 tanning facilities in North CarolinaNorth Carolina

Critical reviewCritical review

A state employed regulator visited each siteA state employed regulator visited each site Surveyed what type of establishment offered Surveyed what type of establishment offered

tanning as a servicetanning as a service Reviewed records of patrons kept by the Reviewed records of patrons kept by the

facilityfacility Collected data on compliance with FDA Collected data on compliance with FDA

exposure schedulesexposure schedules Measurements of tanning bed UV outputMeasurements of tanning bed UV output

Critical reviewCritical review

ResultsResults• 95% of patrons exceeded recommendations 95% of patrons exceeded recommendations

of the FDA for exposure times and doseof the FDA for exposure times and dose• UV output of tanning bedsUV output of tanning beds

– mean UVA = 192 W/m2 mean 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

Relative comparisons to Relative comparisons to gauge the energygauge the energy

Average UVA output at noon in summer in Average 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 in Average 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 A flux of UVB at 0.35 W/m2 is equal to a UV index of 14 (now 11+)index of 14 (now 11+)

SummarySummary Ultraviolet light is used to Ultraviolet light is used to

treat skin disease and treat skin disease and symptoms of disease.symptoms of disease.

Physicians are trained to Physicians are trained to be aware of known acute be aware of known acute and long term side effects.and long term side effects.

More specific wavelengths More specific wavelengths of UV and lowest dose is of UV and lowest dose is used to treat disease.used to treat disease.

Measurement of the actual Measurement of the actual dose used and cumulative dose used and cumulative dose is part of medical dose is part of medical therapy.therapy.

Tanning salons are not Tanning salons are not medical facilities and should medical facilities and should not treat disease.not treat disease.

Patrons of tanning facilities Patrons of tanning facilities are not examined as part of are not examined as part of their service.their service.

Tanning is using higher and Tanning is using higher and higher doses of UVA to higher doses of UVA to produce the end results.produce the end results.

Cannot compare the time Cannot compare the time between devices because of between devices because of the variables involved. the variables involved. Dosage is not measured or Dosage is not measured or required.required.

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 Special controls and/or premarket approval may be inadequate for the safety of the public.be 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 Require a national registry which could be used to

gather data on this cohort of individuals. gather data on this cohort of individuals.

Effects of chronic excessive Effects of chronic excessive UVA exposure through UVA exposure through

window glasswindow glass