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Don Smith · 04-27-2007, 07:36 PM

“The truth is incontrovertible. Malice may attack it, ignorance may deride it, but in the end, there it is.” [Winston Churchill]

Here is the truth about “compatibility sheets” for HID/high pressure sunlamps.

THEY DO NOT EXIST!

Here is, verbatim, what FDA says about sunlamp compatibility.

A replacement lamp will be considered compatible with (or equivalent to) another (original) lamp if:

The replacement lamp will not cause any sunlamp product intended to use the original lamp to fail to comply with the standard or to become defective as defined by 21 CFR 1003.2 and;
The lamp is as effective, within + or – 10 percent, as the original lamp, in causing erythema and melanogenesis.

It should be noted that the above criteria apply to the sunlamp product exposure and maximum timer
interval which must appear on the product’s labeling. The manufacturer should use the following
procedure to establish conformance with criterion number 2 above:

Calculate the recommended maximum exposure time for a single original lamps (Y) using the CDRH August 21, 1986 guidance (Policy on Maximum Timer Interval and Exposure Schedule for Sunlamps Products).
Calculate the recommended maximum exposure time for a single replacement lamp (X) using the same method.
Compare the values. If the value for the replacement lamps (X) is within plus or minus 10 percent of the value of the original lamp (Y), the lamp would be considered compatible [X+Y±10%]

The distance(s) used for this comparison should represent the typical use-distance range in products using the original (Y) lamp.

You will note that this protocol is for "any sunlamp” and, therefore, it must be followed for replacement (Y) low pressure sunlamps and replacement HID/high pressure sunlamps.

When you get a new box of low pressure sunlamps, a “compatibility sheet” is included in the box (and/or can be downloaded from the vendors website) and this document is used to prove to an inspector that the “replacement” (Y) sunlamp you are using is compliant with the “original” (X) that came with the sunbed. Thus, if you are replacing the “original” (X) lamp that came installed in the sunbed (and is listed on the label) with a “replacement” (Y) lamp that has compatibility documentation you are compliant but if you don’t have this document an inspector can (and has) shut the sunbed down.

Now for some critical questions that cut to the heart of this issue.

Q1. Have you ever received a compatibility sheet with an order of HID/high pressure sunlamps like you do with an order of low pressure sunlamps? [Note: Don't hold your breath waiting for them because they don't exist!]

Q2. For a sunbed with (for instance) that came with a Cosmedico Ariana 400w HID/hp sunlamp (i.e., the “original” (X) sunlamp) and that is listed on the label, do you receive compatibility sheets proving that (for instance) a 400w Heraeus or Phillips sunlamp (i.e., the “replacement” (Y) sunlamp) is compliant with the Ariana?

The “bottom line” folks, is that there are no compatibility sheets available for replacement HID/high pressure sunlamps and so if an inspector asks for one, you are out of luck. That’s why the only “safe” thing to do (today) is to use the HID/hp sunlamp listed on the label of the sunbed.

Next, John says (incorrectly) that I am “wrong” when I say that “there is NO SUCH THING as "FDA quartz" (i.e., closed quartz) vs "Non-FDA quartz" *(i.e., open quartz)” because he “confuses” the necessity to make “Area 1” and “Area 2” calculations with a requirement for a specified “quartz” to be used in HID/hp lamps and/or a specific “glass” to be used in low pressure sunlamps. IF the lamp (HID/hp or LP) meets the Area 1 and Area 2 requirements, they are compliant and if they do not, they cannot be sold in the USA and it has nothing to do with the composition of the quartz or glass.

[A challenge to John. If you can find me any reference to “FDA quartz” or “closed quartz” in the regulations, I will send you an autographed picture suitable for framing. If you can’t, I expect you to have the balls to say so here in this forum.]

Finally, John stated that “My source inside the FDA says that HP lamps are not high on their enforcement list because they are always used in conjunction with filter glass, and filter glass….oh wait, maybe filter glass is one of those things that you ALSO need a compatibility sheet for, like ballasts and sockets and reflectors? The source also says that they have got much bigger radiological fish to fry (as far as spending their limited resources), such as lasers, X-rays, cell phones, etc. than to worry about trying to figure out how to determine whether somebody got overexposed from getting MED’s from the pool, playground or beach, or from the Electric Beach tanning salon in Hometown USA. Of course, I can’t tell you who that source is, because they’re the same source who told me that they try to avoid you like the plague due to your frequent off-the-wall-mad-scientist-the-sky-is-falling Chicken Little impersonation, and because of how you usurp all the public’s allotted time anytime there’s a TPRSCC forum and refuse to let anybody with a different, more moderate, opinion be heard.”

First of all, you can be excused for not understanding what takes place at Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC not TRRSCC) meetings and/or FDA/Industry meetings since you have never attended one. No one in the industry “usurps” the time at TEPRSSC meetings because the deck is stacked against us. FDA personnel take all the time they want to make their case and each industry person making a “rebuttal” is given 6 – 8 minutes to respond. It is true that I have testified on behalf of the industry at several FDA and TEPRSSC meetings and since my testimony has been instrumental in stopping some onerous changes to the regulations, I take great pride in those efforts. In the case of the FDA/Industry meeting, FDA personnel "invite" people to speak who have something to contribute to the meeting. Since I have been invited to speak at every meeting, they must have respected what I had to say.

However, I don’t believe for a minute that an FDA official would EVER make a comment like this about ANYONE in an industry that they have jurisdiction over because they are far too professional to stoop that low. Therefore, either publicly identify the individual who made this statement so that I can confront them (and their superior) directly or I will be forced to assume that you made up this scurilous lie for the specific purpose of damaging my name and reputation.

In closing, I certainly hope that you ran the statement “ISO Italia and any of its authorized distributors, including URI, stand behind the legality of these retrofit lamp/reflector kits.” by the appropriate legal counsel before you "broadcast" it.

“It is as fatal as it is cowardly to ignore the facts because they are not to our liking.” [John Tyndall]

04-27-2007, 07:36 PM	#49 (permalink)
Don Smith Join Date: Feb 25 2000 Location: Tucson, AZ Posts: 1,597 Rep Power: 10	Re: Matrix L33 Relamp kit “The truth is incontrovertible. Malice may attack it, ignorance may deride it, but in the end, there it is.” [Winston Churchill] Here is the truth about “compatibility sheets” for HID/high pressure sunlamps. THEY DO NOT EXIST! Here is, verbatim, what FDA says about sunlamp compatibility. A replacement lamp will be considered compatible with (or equivalent to) another (original) lamp if: The replacement lamp will not cause any sunlamp product intended to use the original lamp to fail to comply with the standard or to become defective as defined by 21 CFR 1003.2 and; The lamp is as effective, within + or – 10 percent, as the original lamp, in causing erythema and melanogenesis. It should be noted that the above criteria apply to the sunlamp product exposure and maximum timer interval which must appear on the product’s labeling. The manufacturer should use the following procedure to establish conformance with criterion number 2 above: Calculate the recommended maximum exposure time for a single original lamps (Y) using the CDRH August 21, 1986 guidance (Policy on Maximum Timer Interval and Exposure Schedule for Sunlamps Products). Calculate the recommended maximum exposure time for a single replacement lamp (X) using the same method. Compare the values. If the value for the replacement lamps (X) is within plus or minus 10 percent of the value of the original lamp (Y), the lamp would be considered compatible [X+Y±10%] The distance(s) used for this comparison should represent the typical use-distance range in products using the original (Y) lamp. You will note that this protocol is for "any sunlamp” and, therefore, it must be followed for replacement (Y) low pressure sunlamps and replacement HID/high pressure sunlamps. When you get a new box of low pressure sunlamps, a “compatibility sheet” is included in the box (and/or can be downloaded from the vendors website) and this document is used to prove to an inspector that the “replacement” (Y) sunlamp you are using is compliant with the “original” (X) that came with the sunbed. Thus, if you are replacing the “original” (X) lamp that came installed in the sunbed (and is listed on the label) with a “replacement” (Y) lamp that has compatibility documentation you are compliant but if you don’t have this document an inspector can (and has) shut the sunbed down. Now for some critical questions that cut to the heart of this issue. Q1. Have you ever received a compatibility sheet with an order of HID/high pressure sunlamps like you do with an order of low pressure sunlamps? [Note: Don't hold your breath waiting for them because they don't exist!] Q2. For a sunbed with (for instance) that came with a Cosmedico Ariana 400w HID/hp sunlamp (i.e., the “original” (X) sunlamp) and that is listed on the label, do you receive compatibility sheets proving that (for instance) a 400w Heraeus or Phillips sunlamp (i.e., the “replacement” (Y) sunlamp) is compliant with the Ariana? The “bottom line” folks, is that there are no compatibility sheets available for replacement HID/high pressure sunlamps and so if an inspector asks for one, you are out of luck. That’s why the only “safe” thing to do (today) is to use the HID/hp sunlamp listed on the label of the sunbed. Next, John says (incorrectly) that I am “wrong” when I say that “there is NO SUCH THING as "FDA quartz" (i.e., closed quartz) vs "Non-FDA quartz" (i.e., open quartz)” because he “confuses” the necessity to make “Area 1” and “Area 2” calculations with a requirement for a specified “quartz” to be used in HID/hp lamps and/or a specific “glass” to be used in low pressure sunlamps. IF the lamp (HID/hp or LP) meets the Area 1 and Area 2 requirements, they are compliant and if they do not, they cannot be sold in the* USA and it has nothing to do with the composition of the quartz or glass. [A challenge to John. If you can find me any reference to “FDA quartz” or “closed quartz” in the regulations, I will send you an autographed picture suitable for framing. If you can’t, I expect you to have the balls to say so here in this forum.] Finally, John stated that “My source inside the FDA says that HP lamps are not high on their enforcement list because they are always used in conjunction with filter glass, and filter glass….oh wait, maybe filter glass is one of those things that you ALSO need a compatibility sheet for, like ballasts and sockets and reflectors? The source also says that they have got much bigger radiological fish to fry (as far as spending their limited resources), such as lasers, X-rays, cell phones, etc. than to worry about trying to figure out how to determine whether somebody got overexposed from getting MED’s from the pool, playground or beach, or from the Electric Beach tanning salon in Hometown USA. Of course, I can’t tell you who that source is, because they’re the same source who told me that they try to avoid you like the plague due to your frequent off-the-wall-mad-scientist-the-sky-is-falling Chicken Little impersonation, and because of how you usurp all the public’s allotted time anytime there’s a TPRSCC forum and refuse to let anybody with a different, more moderate, opinion be heard.” First of all, you can be excused for not understanding what takes place at Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC not TRRSCC) meetings and/or FDA/Industry meetings since you have never attended one. No one in the industry “usurps” the time at TEPRSSC meetings because the deck is stacked against us. FDA personnel take all the time they want to make their case and each industry person making a “rebuttal” is given 6 – 8 minutes to respond. It is true that I have testified on behalf of the industry at several FDA and TEPRSSC meetings and since my testimony has been instrumental in stopping some onerous changes to the regulations, I take great pride in those efforts. In the case of the FDA/Industry meeting, FDA personnel "invite" people to speak who have something to contribute to the meeting. Since I have been invited to speak at every meeting, they must have respected what I had to say. However, I don’t believe for a minute that an FDA official would EVER make a comment like this about ANYONE in an industry that they have jurisdiction over because they are far too professional to stoop that low. Therefore, either publicly identify the individual who made this statement so that I can confront them (and their superior) directly or I will be forced to assume that you made up this scurilous lie for the specific purpose of damaging my name and reputation. In closing, I certainly hope that you ran the statement “ISO Italia and any of its authorized distributors, including URI, stand behind the legality of these retrofit lamp/reflector kits.” by the appropriate legal counsel before you "broadcast" it. “It is as fatal as it is cowardly to ignore the facts because they are not to our liking.” [John Tyndall] Last edited by MATT A; 04-27-2007 at 07:58 PM.