12-10-2002, 11:37 PM | #1 (permalink) |
Join Date: Jun 30 2001
Posts: 26
Rep Power: 0 | Thanks for inviting me to moderate this forum, Michael. Although I have been an active, freelance journalist for 25 years, my experience and savvy "online" is woefully limited, and as such would ask the indulgence of future participants herein. As most of you know, I was able to secure Howard Cyr's freedom, albeit temporarily, from his mad scientist’s dungeon at OST, to be the Keynote Speaker at Tancun 2002. The information imparted during his talk was well received by those in attendance, and his exposure to this level of the indoor tanning industry was, as he has stated, "an important step in the right direction". My 7 years in the US military and 20 years of industry involvement and advocacy has allowed me to gain unique insight as to how government both views the private sector, and interacts with it. In contrast to regions overseas, we have achieved significant improvement in the relationship between the business and regulators over the past 8 years in this country, a trend that I am committed to foster and promulgate with the aid of a group of associates and Dr. Cyr’s team. That having been said, a certain amount of vigilance set forth against possible aggression is always warranted, which, to my way of thinking, is best effectuated by manner of political expression. As AEGIS spends most of its day working to list numerous non-tanning medical devices at ODE, I feel quite confident we can answer most, if not all, questions sent our way in this forum. Anyone wishing to contact me directly on that note should feel free to call (727) 578-4060, here in Saint Petersburg, FL. My extension can be reached by dialing "1", and then "2", once in the automated answering system. I look forward to corresponding with you individually, or en masse, as time and subject matter LOD permit. Bob Wagner President AEGIS, Inc. |
12-11-2002, 10:27 AM | #5 (permalink) |
Join Date: Nov 13 2001 Location: MI
Posts: 861
Rep Power: 23 | Quote: ________________________________________ ______________ We perform dozens of spectral analyses of tanning beds / lamps each week according to IEC recommendations (FDA doesn't have such, yet...); ________________________________________ ______________ What did Howard say about standardizing on 200 J/m² per MED, and about agreeing to a uniform single lamp irradiance test protocol? |
12-11-2002, 06:47 PM | #6 (permalink) |
Join Date: Jun 30 2001
Posts: 26
Rep Power: 0 | Steve: Howard has deferred the standardized lamp / equipment testing protocol issue to Sharon Miller, who seems to be leaning toward the existing IEC guidelines. He and I discussed the fact that the vast majority of lamps and equipment have been properly and adequately tested with single-grating (versus double-)monochromaters over the years, which speaks in favor of continuing to use those systems. One needs to remember that we are talking about Class I Cosmetic devices that do not require 510(k) clearance. The 200 J/m2 threshold is actually 210, and reflects a more real-world dosage than FDA's earlier 156 figure. Howard agrees with this, which in my mind means that he would agree to have testing conducted in this country to that end, once Sharon gets around to writing the standard proposals. |
12-12-2002, 02:03 PM | #7 (permalink) |
Join Date: Nov 13 2001 Location: MI
Posts: 861
Rep Power: 23 | Bob, Last I knew Sharon was leaning toward 200 (and 100 for SED) and so was CIE/IEC. She's also considering 180 to better harmonize with units of EPA/NOAA UV Index units. As you know, Model 7.0 MED/hr meter doesn't use diffraction gratings, and some of the latest spectroradiometers are using prizms now. Whatever.. we all need to know what the "final" J/m² Eeff per MED turn out to "be" - the sooner the better so only one hymn book is needed. Are you SURE IEC uses 210 in Europe? In Australia they seem to want a different MED for each skin type as basis for determining Te, rather than multiples of type 2 MEDs. Also, the existing FDA submission forms (at least the ones I've seen) don't show MEDs output at all. They uW or mW or W per cm² or m² of weighted irradiance broken down in various UVB and UVA bandwidth ranges. The Euro breakdowns are different from US ones... and UVB stops at 315nm over there. You can convert all that gibberish to MEDs, but it's extremely confusing at the best. |
12-12-2002, 05:26 PM | #8 (permalink) |
Join Date: Jun 30 2001
Posts: 26
Rep Power: 0 | Steve: You are the technical titan! My colleagues in Germany who use the MSS-2040 spectrometer to test sunlamps and equipment currently set their software threshold at 200 Jm2, which is in the written standard. WG 16, on the other hand is aware of the fact that the summarized annual average (real world estimate) is somewhere around the 210 level. 200 is an easier value to remember and harmonize on in Te extrapolation using weighted NMSCAC, so I expect that is where we'll be once Sharon and Janusz have had a chance to sit down and bang out their props. As for MED's, I'm not sure whether both FDA and IEC are really interested in relating individual and / or annual limits according to those terms, primarily due to the fact that the definition of what an MED is, exactly, is proving difficult to get concensus on. This is especially true when one gets a peek inside Janusz' project, where skin sensitivity levels are being proven to have less and less relationship to the traditional "Fitzpatrick" monikers. (Surprise! - Read my article in this month's IST) As such, for the sake of administrative expedience, I am of the beleif that they will remain with the mathematically safer, more understandable values of mw/M2. This is mostly based on the US/EU divergence on the UVB/UVA barrier. Why that is, no one seems to know. Oh well, Vivre la Difference! |
12-12-2002, 07:00 PM | #9 (permalink) |
Join Date: Nov 13 2001 Location: MI
Posts: 861
Rep Power: 23 | Quote: ________________________________________ ______________ and harmonize on in Te extrapolation using weighted NMSCAC ________________________________________ ______________ Bob - pleeeze when you deal with these folks encourage staying with EAS not NMSCAS !! Because: 1. It was developed with FS lab lamps on hairless mice. 2. It contains the "C" word. 3. It can't be accurately replicated on broadband IF meters, and is split into two regions with an absolute cutoff between them. Salon owners can't afford spectroradiometers... not even yours! 4. It underweights UVR less than 297 nm despite the fact those wavelengths cause erythema big-time. 5. It is a "political" action spectrum more so than a human science based one. |
12-16-2002, 12:56 AM | #10 (permalink) |
Join Date: Nov 13 2001 Location: MI
Posts: 861
Rep Power: 23 | EAS will remain primary. NMSC a.s. is secondary, according to this from FDA: ________________________________________ ______________ Steve, I have 2 of your meters, one that is S/N 00080 and the other 00061. Both are set at 210 J/m2, I think, in which case I should 'adjust' the readings 5% upward? (In which case we have pretty darn good agreement!) So, I don't need to ship it back to you, right? We base all of our calculations on one MED being 200 J/m2-eff as weighted with the CIE a.s. for erythema. How do your meters provide a 'weighted' output? Do you use a filter or some electronic means to manipulate the detector readig? Regarding the NMSC action spectrum; in my opinion, if we adopt it, it will be used in addition to the EAS. IEC has decided to use the EAS to establish the timer setting and exposure schedule and use the NMSC a.s. to classify the 'appliances' and to determine the recommended annual dose. It has not been decided yet if the NMSC a.s. will be used in addition to the EAS to categorize the bare lamps. Regards and Happy Holidays! Sharon ________________________________________ ______________ ps: Sharon - hope you don't mind that I posted this.. I won't anymore if not appropriate to do so, but it was very relevant to the issue at hand. |
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