JOHN @ URI

Don, isn't it true you get paid by Tan America to test all their equipment?

Maybe you should disclose that info also.

Brian to my knowledge does not install ISO units or Retro kits. He just happens to have more in the field experience than anyone out there. He services many units on the east coast.

The ISO Retro kit is compatible with the unit. It is listed with the FDA. And the lamps are FDA compliant. If you can change the lamps in the unit yourself, then you can easily put one of these retro kits in your unit.

Don Smith

Here is what I said last July:

Here's my suggestion. Ask the ISO "agent" to provide IN WRITING the data showing that installing the ISO retrofit kit will not (a) cause the salon owner to become the "manufacturer of record" for the unit; (b) cause Tan America's product liability and warranty coverage to be voided; and, (c) cause their salon liability insurance to become null and void. If they won't do that...... Caveat Emptor.

In addition, please ask for a "compatibility letter" for the HID/hp sunlamp in the retrofit kit being installed by anyone other than the original manufacturer (Tan America). I think you will find that NONE OF THE 3RD PARTY INSTALLERS can provide you with you one! The reason I add this "caution" is that one state has been asking for them on inspections and others are expected to follow suit in the near future.

BE PREPARED. If you have allowed a third party to install a retrofit kit in your TA Matrix, I suggest that you go to the installer and request a compatibility sheet for the HID/hp sunlamps that they provided (buit don't expect to get one!).

Don Smith

John:

I hadn't read your post when I made mine.

As you already know, we provide spectroradiometric testing/consulting services for most of the reputable sunlamp/sunbed companies in the industry (there are some that we refuse to work for!). We also provide spectroradiometric testing/consulting services for universities, research organizations and sunscreen testing laboratories. Our objective is to conduct "just enough" testing each year to defray the cost of running the Non-Ionizing Radiation Research Institute (NIRRI), an organization gathering the data we believe will be required in the regulatory battles that lie ahead, for instance, in the attempt later this year by the dermatology community to force FDA to adopt the 0.3 W/m^2 MEIL (Maximum Erythemal Irradiance Levels) that will go into effect in Europe on July 23, 2007. [Note: An article we wrote explaining why the 0.3 W/m^2 MEIL must be fought here in the USA will be published in the June, 2007 issue of Looking Fit magazine.]

So, John, if your company would be willing to underwrite the costs ($60,000 - $80,000 per year) of operating NIRRI, we will be more than happy to stop providing testing/consulting services. [FYI, neither my wife Pat and I have ever received any compensation from NIRRI.]

Now, will you be kind enough to answer a few questions for me?

1. Do you provide "compatibility sheets" for the salons for which you install the ISO retrofit kit utilizing Hereaus HID/hp sunlamps?

2. Can you provide these mandatory compatibility sheets?

3. Do you warn your clients - in writing - that installing the ISO retrofit kit may: (a) cause the salon owner to become the "manufacturer of record" for the unit; (b) cause Tan America's product liability and warranty coverage to be voided; and, (c) cause their salon liability insurance to become null and void?

I eagerly await answers to these questions.

JOHN @ URI

1) Heraeus does not make the lamp for the ISO retro Kit. ISO Italia does.

2) Yes, the lamps are FDA Quartz & are compliant with the unit.

3) Most of the units that TA installed are already out of warranty. TA isn't supporting these units any more. I have people calling me day in & out for parts, because TA doesn't have them.

Don, no one said you had to stop testing units. I just think you should disclose that you get paid for work you perform for TA. You are always saying they are the greatest.

Don Smith

That was a masterful "non answer" John. Now how about answering my questions.

My Question 1. Do you provide "compatibility sheets" for the salons for which you install the ISO retrofit kit utilizing Hereaus HID/hp sunlamps?

John's Non-Response 1) Heraeus does not make the lamp for the ISO retro Kit. ISO Italia does.

NEW QUESTION: Do you provide a "compatibility sheet" for the ISO Italia HID/hp sunlamp for use in the Tan America Matrix? [Note: As I am sure that you know, ISO Italia DOES NOT manufacture the HID/hp lamp; rather, they are "private labeled" with the ISO etching by the manufacturer.]

My Question 2. Can you provide these mandatory compatibility sheets?

John's Non-Response 2: Yes, the lamps are FDA Quartz & are compliant with the unit.

NEW QUESTION 2: Please e-mail (reyksmith@aol.com) me a copy of the "compatibility sheet" for the ISO Italia "private label" HID/hp sunlamp that is included in the Matrix retrofit kit. It must be SPECIFIC for the Tan America Matrix. [Note: In case you don't know, there is NO SUCH THING as "FDA quartz" (i.e., closed quartz) vs "Non-FDA quartz" *(i.e., open quartz).]

My Question 3. Do you warn your clients - in writing - that installing the ISO retrofit kit may: (a) cause the salon owner to become the "manufacturer of record" for the unit; (b) cause Tan America's product liability and warranty coverage to be voided; and, (c) cause their salon liability insurance to become null and void?

John's Non-Response 3) Most of the units that TA installed are already out of warranty. TA isn't supporting these units any more. I have people calling me day in & out for parts, because TA doesn't have them.

NEW QUESTION 3: Never mind the "double speak" - answer my question. Do you warn your clients - in writing - that installing the ISO retrofit kit may: (a) cause the salon owner to become the "manufacturer of record" for the unit; (b) cause Tan America's product liability and warranty coverage to be voided; and, (c) cause their salon liability insurance to become null and void?


Note: Don't expect John to provide honest and complete answers to my questions because doing so could put him and his company in a "difficult" situation if there is a legal action by an unhappy retrofit client down the road. However, don't despair because I will provide "chapter and verse" of the INSANE situation regarding the lack of compatibility sheets for replacement HID/hp lamps and the lack of "traceability" of absorption filters in a later post.

My goal is not to sell products (like John); rather it is to (a) "educate and inform" my peers about this "out of control" situation and how to protect themselves, and, (b) bring pressure to bear on FDA to resolve this festering issue. More later but now I have to go work a double shift.

JOHN @ URI

engfant

Don needs some happy smoke me thinks.

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JOHN @ URI

Don,

You are also wrong
Ask Cosmedico, ask Philips, Ask Heraeus, Ask Radium.

There is a difference. Non-FDA quartz has too much UVC in it. (UVC to UVB ratio is .003 by FDA regulations of UV emitting lamps) FDA Qaurtz does not allow UVC. There are additives added to the quartz to make it block all the UVC & a bit of UVB.

Yeah, there is no actual term of FDA quartz, however if you test the lamps that are "open" quartz you will see that they don't meet the requirments of the FDA. If any manufacturer is stupid enough to put UVC producing lamps in thier units, then so be it.

Don Smith

“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]

MATT A

I edited the above post Dons only to enlarge the font because I thought I was going to blow a vein from squinting. So for the record all I did was increase the size of the font.

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