FOOD AND DRUG ADMINISTRATION

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CENTER FOR DEVICES AND RADIOLOGICAL HEALTH

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RADIOLOGICAL HEALTH PROGRAM

STAKEHOLDER MEETING

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MONDAY,

OCTOBER 31, 2005

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The Meeting convened at 8:30 a.m. in the Montgomery Ballroom of the
Hilton Hotel, 620 Perry Parkway, Gaithersburg, Maryland, Mr. John
McCrohan and Mr. David Leslie presiding.

I-N-D-E-X

Welcome and CDRH Introductions 3

Mr. John McCrohan

Conference Orientation 7

Mr. David Leslie

An Historical Perspective 16

Mr. John McCrohan

CDRH Radiological Health Plan Overview 24

Mr. John McCrohan

Presentations

National Electrical Manufacturers Association 76

Mr. Robert Britain

American Association of Physicists in Medicine 86

Dr. E. Russell Ritenour

Consumer Electronics Association 92

Ms. Virginia Williams

American Society for Radiological Technologists 103

Ms. Christine Lung

American College of Cardiology and the Society 109

for Cardiovascular Angiography and Intervention

Dr. Charles Chambers

American College of Radiology 136

Ms. Pam Wilcox

American Society for Therapeutic Radiology 146

Oncology - Dr. Geoffrey Ibbott

Conference of Radiation Control Program 152

Directors - Mr. Thomas Kerr

State of Maryland - Ms. Renee Fizer 139

State of Washington - Ms. Ellen Haars 179

Open Public Comment 200

View of Term \"Collaboration\" 226

P-R-O-C-E-E-D-I-N-G-S

8:33 a.m.

DEPUTY DIRECTOR McCROHAN: Good morning. If everybody could take their
seats, we will get our couple of days together started.

My name is John McCrohan and I\'m the Deputy Director of the Office of
Communication, Education and Radiation Programs at the Center for
Devices and Radiological Health at FDA and I want to welcome you to this
Radiological Health Stakeholders meeting.

I\'m glad to see we have such a large and diverse group in attendance. I
think that\'s a reflection of the diversity and actually the vitality of
the Rad Health community. I think it\'s also emblematic of the diversity
and complexity of the problems that we collectively face as we work to
minimize unnecessary exposure to the American people.

A lot has changed over the years certainly since I began in the business
30 years ago and I think that it\'s important to understand all of the
things that have changed. These changes have affected not only our
organizations individually and collectively but also the environment in
which we operate. At CDRH, we\'ve been thinking for some time about how
we ought to respond to these changes and we\'ve developed a radiological
health program plan for CDRH which I\'ll be discussing in a little bit.

What became clear to us during our deliberations is that we can\'t
afford to operate alone. We seriously believe we need to work together
with all of you in order to effectively and efficiently address the Rad
health problems that we all face. That\'s why we\'ve convened this
meeting so that we can all come together to share our views on important
Rad health issues, to hear what we are all doing, to address the
problems that we face and to learn what actions would be most effective
in mitigating these problems.

I expect that we\'re going to have a very stimulating and interesting
two days. As you\'ll see from the agenda, there\'s a lot of information
to share today during a variety of presentations both this morning and
this afternoon. We also plan to spend a significant amount of time in
small group discussion sessions tomorrow so that you\'ll have a chance
to be involved in more specific conversations about the issues.

By the end of the meeting, I expect we\'ll have a broader and more
common understanding of the problems that we face and a shared view of
the priority of those problems and that\'s particularly critical for us.
We\'ll have a common understanding I think of the important actions that
are going on to address the problems that we face and a shared view of
what yet needs to be done. Most importantly, we\'ll have identified
opportunities to collaborate in taking actions to address those
problems. I hope we all leave here with a renewed commitment to work
together. I certainly expect myself to learn a lot of things that I
don\'t know and I suspect that may be true of a number of you and I hope
you all help me in that by taking this opportunity to share your views
on the issues.

I expect that we\'ll meet people that we don\'t know yet and I hope
you\'re going to take this opportunity to network with those folks on
the breaks and during lunch because I think those contacts are going to
be crucial in addressing the problems that we face related to
unnecessary exposure. We certainly don\'t expect to finish the
conversation at this meeting. In fact, we hope that this meeting will be
the beginning rather than the end of a rich, on-going conversation and a
source of continuing collaboration.

Now, I want to get us started by introducing David Leslie who is going
to guide us through the process of the next couple of days and then
I\'ll be back up here in a moment. David.

FACILITATOR LESLIE: Thank you, John. Good morning everybody. I\'m David
Leslie. As John said, my job is facilitator for the next couple days or
resident border collie, however you like that. And what may turn out to
be true is for you speakers when the blower comes on, we may wind up
I\'ll just hand you my lavalier mike and you can talk from wherever you
want if that comes on regularly. We\'ll work that as we go.

There are a couple of things as we get started in this two days, if
you\'ll allow, I\'d like to kick off just because they\'ll just make the
days a little easier. First, let me tell you what we were intending with
this meeting and the agenda you have in front of you. This whole thing
as we thought about it was to invite as many of you all as could and
wanted to come to get in the same room to think out loud together about
radiological health issues and looking forward. That was the fundamental
underpinning of this.

The other piece was to allow for public comment which you\'ll see on the
agenda. So if there are things that need to be said and things that need
to be captured we get all that done.

Another piece of this is you will note you don\'t have in front of you
copies of presentations and the like because part of our intention here
is that all presentations and those things will be available
electronically on the web within, I\'m not sure exactly when, but soon.
So we made a decision not to see if you could take down a whole forest
and make a lot of presentations.

We\'ve built in two distinct phases to this meeting. Today is a wide
range of presentations which we hope will be educational for everybody
in this room. You\'ll know some of the things you\'re going to hear.
You\'ll understand and appreciate some of the points of view that
you\'ll hear. But my guess is you\'ll find some other things where
you\'ll go \"Ah-ha. I didn\'t know that. I didn\'t know they thought
about that in this way.\" So we\'re hoping just to enrich the discussion
field with all the things you\'re going to hear today.

Tomorrow is a very different day. Tomorrow is having uploaded all of
this today to give you an opportunity in some specific areas of the
program that CDRH sees moving forward to get in a smaller settings and
literally talk about what your views of the issues are, the things you
think need to be made priority and how we can move this forward.

Our final part of the plan is for you to be able to leave here tomorrow
afternoon having seen what comes out of those groups tomorrow. In other
words, our plan really is for the facilitators and discussion leaders
tomorrow to be able to interact with groups all day long and before you
leave here tomorrow afternoon say, \"These are the themes that came out
of each of these groups in these topics\" so that you\'ll actually know
what you and your colleagues thought at least at a high level about all
this going forward. Then the rest will be available on the web.

Everybody got an agenda. Did you manage to get one coming in? Okay. A
couple things. It is straightforward. Let me highlight a couple of
things. We\'ll try to start at 8:30 a.m. right on the nose just because
it\'s courteous to be prompt.

We\'ll be out of here this afternoon around 4:15 p.m., 4:30 p.m. I\'m
hoping that many of you would be interested in joining us out around the
bar for rather much a no-host, meet and greet to say hello to each other
and hang around and visit a little bit at the end of the day. If that
works for you, fine. We\'d love to have you. If it doesn\'t, so be it.
But it\'s not something we have formally on the agenda. It\'s just
we\'re trying to be opportunistic about that.

This afternoon we\'ll have the public comment period from 3:15 p.m. to
4:15 p.m. Now let me say a word or two about that. In the announcement
for the meeting in the planning that went on, I believe there was a
request for those of you who wanted to make a public comment to either
provide something in ahead of time or certainly your name and I think
that has been done by some. When we get to that period, I\'ll certainly
want those folks to queue up first and let that happen. But if there are
others of you who would want to make some kind of comment, I will
certainly make time to do that without any difficulty. We\'ll work that
in terms of how many people there are who would like to talk against the
time we have allotted for that because there is certainly the
opportunity to submit things for inclusion later whether it gets said or
not because that\'s an important part of this and we\'re perfectly fine
with that. So we\'ll do that at the end of the day.

Tomorrow morning we will convene in here and then launch out into the
session on the three particular topic areas. I\'ll talk about all that
later and we\'ll work that.

Look at your agenda for 3:15 p.m. tomorrow afternoon. What I\'m hoping
to be able to do with that period is by tomorrow at 3:15 p.m. you will
have heard a wide range of presentations all day today. You will have
opportunity to participate in three separate groups all day tomorrow
listening to your colleagues about these various topics. I\'m hoping to
come back in at 3:15 p.m. tomorrow and John and I will be up in front of
the room and just hear what you think about all of this, your reaction
to what you\'ve heard, the things you think are smart, the things you
think we should be doing, whatever your reactions are and whatever
discussion points you would think appropriate to have considered by all
of us, have an opportunity to have a very gently structured discussion
about those kinds of things as we move forward, then get the themes from
the breakout groups, wind up with closing remarks and we\'ll be on the
road. So that\'s sort of the scheme. There\'s plenty of time in there
for breaks. There\'s plenty of time for lunch. I\'ll talk about those in
a minute.

One of the things to note is that we have full transcription today and I
think again tomorrow though we won\'t spend all of tomorrow of course in
this room. Now the implication of that is this. When you have a
question, we\'re going to ask if you would please to go to one of the
microphones and when you speak at least initially on one of these if
you\'d be so kind as to say your name and your organizational
affiliation so that our transcriber can get that early on. Some he has
in front of him but not all. So that will be very helpful as we work the
process and then all of that winds on the web.

Let me hit a few housekeeping items. Breaks and food. You\'ve seen the
break area out there. That stays pretty much the same and I think if
we\'re lucky cookies appear in the afternoon, you know those no-sugar,
low fat, not bad for you, those kind. But I think they show up later in
the day. Eat them if you look.

For food, lunch, there\'s a couple of things to say. One is I\'m told
they do a very good buffet here in the hotel and I think that runs
\$14.95. There are, I haven\'t gotten my directions right here, close by
in the little shopping area there are lots of restaurants and I think we
have a sheet out on one of the tables that list some restaurants if you
have some preferences. I\'m even told there\'s a Starbucks within
striking distance.

Okay. Restrooms if you haven\'t found them already, there\'s two right
here down the hall toward the main door and then there\'s another set on
around the corner in the direction of the breakout rooms. This is the
Montgomery Ballroom. It will be our main meeting room. We have three
breakouts for tomorrow called the Gaithersburg, Frederick and Darnestown
and they\'re literally, I\'ll go into it more tomorrow, down to the
registration desk and then just straight down the hall. All three of
those are just lined up. They won\'t be hard to find.

If you need any kind of assistance, if you need anything in the course
of two days, please do one of two things. The desk that did registration
this morning, go there. Ask those folks. They\'ll be happy to take care
of you or see me. We\'ll make sure something happens to take care of
whatever your needs may be.

If people need to get messages, this is interesting. Ten years ago, the
number I had to give out at the start of the meeting was always the
hotel phone number. Now we all have cell phones and the hotel message
traffic has dropped off a lot but I\'ll get to that in a second. If
somebody needs to get a hold of you and wants to call through the hotel,
the main hotel phone number is 301-977-8900. They could leave a message
for you there and either our registration folks or the front desk,
they\'ll handle that somehow or another and we can get that to you or
you can check to get that.

By the way, if you don\'t know, the hotel is wired for wireless internet
access without any kind of password. So if you have laptops, you can
easily get on the internet without any difficulty here.

My one last request is would you please check your cell phones, put them
on vibrate or off when we\'re in session and if you would if you need to
make cell phone calls, please do those outside of the room so it won\'t
be disruptive. This will happen after lunch too. We\'ll all come back
from lunch because we\'ve done our thing during lunch. That\'s all
right. We\'ll just work that.

That\'s the sum total of the administrative things that I had intended
to say this morning. I guess the one last thing. Speakers, it would help
us a lot if you\'ll work pretty close to the times we\'ve have allotted
to get through the presentations today because we have quite a few and
I\'m not sure what the window was. But if you can stick pretty close to
the times that we set out, that would be helpful to get through the day.

Anything you want to ask about any questions administratively what I\'ve
not covered you need to know? Anything? Going once, twice. Okay. With
that, John, let me turn it back to you and we\'re off and running.

DEPUTY DIRECTOR McCROHAN: This was the point in the program at which I
was going to be introducing Dr. Lillian Gill, the Senior Associate
Director of the Center for Devices on Radiological Health. However, I
got a message this morning that Dr. Gill came down sick over the weekend
and won\'t be with us today.

So I\'ll say a few words about the topics she was going to discuss and
then roll into my presentation. I\'ll be Dr. Gill for awhile and then
I\'ll be back to being myself and I hope you will indulge me because
I\'m not doubt going to be repeating myself or herself as we go.

As we go back historically, it seemed fitting to talk a little bit about
the waterfront if you will that the Center for Devices and Radiological
Health covers. You can see a range of products and devices, the
distinction being some of these things are electronic products that emit
electronic product radiation, some of them while emitting electronic
product radiation are also medical devices. We have authority under two
different laws to regulate these products and their manufacturers. There
is a therapy ultrasound system in the upper left, a cargo screening
system there in the middle, a television, a cell phone such as David was
talking about there a moment ago, laser light show projector, medical
laser and a radiation therapy treating planning system simulated here.

We have to cover a lot of ground. That could be attested to by former
senior officials from the Center, like John Villforth over on my right
who was the Director of the Bureau of Radiological Health and later for
the Center of Devices and Radiological Health and was my boss\'s boss\'s
boss, I think, when I started 30 years ago. We did our best to deal with
all of the problems and issues and concerns about all of the products
that were within our purview and I think at the time when it was the
Bureau of Radiological Health back in the 70s we actually did a pretty
sound job of covering this waterfront.

I think that the circumstances have changed. The world has changed. I
mentioned that in my introductory remarks and a number of things have
changed about the world that make it more difficult for us to cover this
waterfront with the degree of thoroughness that we would have in the
past and it leaves us in a situation where now we need to make much more
serious choices about where we put our energies, what kinds of products
we address, what kind of problems we address with those products, what
kind of approaches we take to addressing those problems with those
products and so forth. And I think that that is certainly one of the
driving forces behind our desire to have this meeting.

Amongst the various things that have changed over time since the
beginning of the program are things with respect to what we call the
product environment. Markets are now global. Companies are selling in
this global environment and therefore are subject to all of the
pressures associated with that.

And principal among those pressures are the requirement to meet
standards that themselves are global or at least standards which exist
in various countries around the world as well as our own. Back when we
started, it\'s fair to say that the standards that were in place and
important to manufacturers were the standards that we at CDRH had
developed, the Mandatory FDA Performance Standards, that dealt with what
went on in terms of manufacturing largely in this country. That has
certainly changed.

At the same time, I think it\'s fair to say that manufacturing processes
have advanced. There are a lot of things that have happened over the
decades in terms of the development of quality systems and so forth
which have led to better manufacturing processes. As I\'ve said, we have
these effective consensus standards in place, principally International
Electrotechnical Commission standards, that deal with a lot of the
products that we regulate and deal with those products as they\'re
manufactured and sold in Europe and in other parts of the world as well.
So the product environment has changed for lots of the products on that
waterfront that we deal with from a regulatory standpoint.

In addition, we think public health needs have changed. The product
problems that we saw in the past have largely been addressed. A couple
of examples of those might be the concerns which led to the initiation
of the program at FDA, concerns about the emission of radiation from
television sets. That problem has largely been dealt with and we\'re not
spending a lot of energy dealing with that today even though we still
have a mandatory performance standard for television sets.

This has translated into the consumer marketplace and I\'m here to say
this morning that I have done my part. I have bought my flat panel TV
which as a matter of design cannot emit radiation.  So I\'m protecting
my family and having a really big picture which is pretty cool. I think
we\'re seeing that there are technological changes which have resulted
in the problems of the past not being present today in addition to the
work that we have done to address those problems particularly back when
we were the Bureau of Radiological Health.

Another example might be microwave ovens. We have a mandatory Federal
performance standard for microwave ovens and we have in the recent past
not seen significant problems with that technology.

The shift of our concern has been to the medical arena which is
certainly where I\'ve spent almost my entire career. There were days in
the distant past when a medical x-ray exam involved, as we used to say,
a wall to wall x-ray beam where there wasn\'t any collimation, where
there wasn\'t any filtration and so on. We\'ve long since passed those
days and I think that the performance standards, the activities of the
various organizations, professional and manufacturer and so forth and
regulatory bodies such as outselves and the states have resulted in a
situation where those problems with products, those fundamental problems
of things emitting hazardous amounts of radiation or emitting radiation
in places that they weren\'t supposed to have been taken care of.

Today, however, I think it\'s clear that the issues that we face are
more related to product use and this takes us in CDRH and FDA out of our
regulatory arena. We regulate the manufacturing of products and the
performance of products, not their use with the exception of mammography
where I\'ve spent considerable amount of time over the last ten years.
That\'s essentially our only foray into the practice of medicine if you
will. But otherwise, we don\'t regulate product use.

But we see that the problems that represent public health risks today
are essentially problems that relate to product use. We\'ll go into that
in some depth later on.  So this is among the changes that have occurred
and in addition to that, we have had changes at what was the Bureau of
Radiological Health and is now the Center of Devices and Radiological
Health which has led to an appropriate focus that is more on medical
devices. Lots more medical devices, lots more possibilities for acute
injury, lots more public health risk there. But that has led to a
reduced emphasis and reduced staffing and so forth with radiological
health responsibilities.

We had a fairly sizable program back at the time when I started 30 years
ago.  We now have about 50 staff working on radiological health issues
and an additional 40 or so dealing specifically with MQSA and that\'s a
substantial reduction from what used to be the case. So we\'ve had
changes over time in the product environment and what we perceive to be
the public health needs and also our resources available to address
those needs.

What hasn\'t changed clearly is the mission that we have to protect the
public from hazardous or unnecessary electronic product radiations and
what hasn\'t changed is our commitment to that mission. What we\'ve had
to do is to refocus our efforts to address the public health problems
that we face today.

Looking into the future, we have developed a plan with the intent of
making ourselves adaptable to the changing standards environment, to
focus some of our energies on monitoring the risks posed by radiation
emitting products, be they devices or not, providing useful public
health information and training to the industry, to users, to the public
and to regulators ourselves and to the states, conduct research with
practical applications practically applied and then manage our program
internally in a way which maximizes its public health impact and that\'s
the structure of the plan that we had put together.

What we\'re asking today, what Lillian would have asked today is that we
stay connected, that we continue to collaborate whenever that\'s
possible and that we remain committed to advancing the radiation
protection, the protection of the public and public health.

If you\'ll pardon me for a minute, I\'ll become myself again. We\'re
almost on time. I\'m amazed.

I introduced myself and my position a moment ago when I was making my
opening remarks and alluded to the fact that I had been here for a long
time. It has been about 30 years and just so that you know where I\'m
coming from for purposes of our conversations later today and tomorrow
most of that time has been spent in the non-regulatory part of the
agency\'s operation and most of that time has been spent dealing with
ionizing radiation, in particular with the medical applications of
ionizing radiation. But we do have staff here who have spent
considerable periods of time dealing with the non-ionizing side, dealing
with the non-medical applications of ionizing radiation. As I mentioned,
a significant amount of my time over the last ten years or so had been
spent, until a recent job change, with the implementation of the
Mammography Quality Standards Act.

I mentioned the fact that I\'ve spent most of my time on the
non-regulatory side of the house because I think that\'s relevant to
where we\'re headed, particularly since I have some responsibility for
setting our course. And as I say, I think we will have more problems in
the future to deal with that relate to use. Since we deal with these
problems in a non-regulatory and rather educational fashion, I certainly
bring that experience to bear.

It\'s certainly our perspective that the public health problems and
issues that we deal with have changed over time but the mission
certainly remains the same and the Center, through its process of
planning over the last year or two, has refocused its radiological
health program. We\'re looking to begin with you the ongoing
conversation I mentioned and the collaboration or sets of collaborations
to move forward collectively to address what we perceive to be the
shared problems and, in fact, the priority problems where the priority
is based on public health risk.

We have the goals that are related to our plan of aligning our current
efforts to the current and evolving public health needs allowing for
more targeted regulation and we\'ll get into that in some depth
momentarily, to expand our focus on the patient and the consumer because
we see the use problems as the most significant public health problems
and that\'s where both the impact of those problems fall and where some
of the solutions to those problems may lie. And we see ourselves as
increasing information dissemination and education. We\'ll talk about
that in some depth momentarily and trying to, as best we can, improve
coordination across the community an example of which is the meeting
that we\'re hosting today.

This is our mission, to protect the public from hazard risks and
unnecessary radiation exposures and we see needing to do that by
maintaining awareness of the radiation emitting products and their
manufacturers. We still retain that responsibility and that suite of
products and manufacturers changes. Manufacturers certainly change if
not from day to day at least from month to month and the products change
themselves as new technology introduces new applications of radiation
for a variety of purposes.

We need to understand the emission of those products and the risks that
they pose and provide public health guidance and direction as it relates
to those products and their emissions. We need to certainly encourage
manufacturers to comply with the appropriate standards. We are, after
all, a regulatory body and we intend to pursue enforcement actions as
necessary. We believe that there are opportunities to achieve our public
health mission without needing to do a lot of the latter.

In terms of the program plan which you may have had an opportunity to
see on our webpage, it\'s been up there since late spring or early
summer, we divided the plan into these five areas and I\'ll talk about
those in a little bit in some detail. But in terms of standards again, I
think we see ourselves as needing to adapt to a changing standards
environment and to work to acknowledge and work with the national and
international voluntary consensus standards that have been developed.

In the monitoring area, as we\'ve labeled it, we\'re talking about
paying attention to monitoring, overseeing radiation emitting products
and their manufacturers and then taking appropriate regulatory action,
if that\'s called for, based on the risk proposed by the products. So
our degree of our monitoring, the intensity of our monitoring, have to
be based on the public health risk posed by the particular products.

We also recognize that rather than simply monitoring products and their
manufacturer, we also need to monitor product use. How are the various
products that we\'re responsible for being used? By whom are they being
used? In what circumstances are they being used? What are the radiation
exposures attendant to that use? Where are the concerns with respect to
that exposure? What can we do to address those concerns? Who are the
actors? What are their behaviors? What do we need to do to affect that
behavior? What leverage do we have? What incentives and disincentives
exist in the system or what can we create to change the behavior of
individuals to reduce unnecessary radiation exposure?

In terms of education, which is going to be a significant element of
changing that behavior, we need to be looking at all of the
stakeholders. We need to be providing more information and guidance to
the industry so that it can comply with the requirements but also to
users, to the public and to regulators like ourselves and the states. We
need to be able to collaborate in providing training for all of those
stakeholder groups. I think there are a lot of resources in this room
that will help us accomplish that particular aspect of the mission.

In terms of research, we need to make sure that the research that we do
within the Center is directed at specific radiation risks and has
practical applications in practical settings and finally an internal
piece, we need to manage the program internally as a single cohesive set
of activities. In recent years, it has become somewhat fractionated. But
there have been some changes which I\'ll talk briefly about that are
going to lead to a more coherent program going down the road.

I want to talk briefly about each of the components of the plan as
we\'ve outlined them and give you an idea of what our thinking is to
date. We have goals with respect to the standards area of using
performance standards that are on the one hand enforceable and on the
other hand appropriate to today\'s technology.

As some of you may appreciate but certainly not as fully and deeply as
Dr. Tom Shope who is responsible for this activity, it\'s difficult to
amend an FDA mandatory performance standard. Our most recent effort came
to fruition last spring I believe with the amendment of the x-ray
performance standard which focused mainly on fluoroscopy systems and Tom
was instrumental in getting that completed. But it took a tremendous,
not to say Herculean, effort over quite a number of years to do that.

I think we need to find ways to be able to increase our reliance on
these voluntary consensus standards, be they national or international,
so that we can leverage the efforts that are being invested both by
ourselves, who have a significant play in this area, but also by the
manufacturers and others in developing these consensus standards and
bring that work and that effort to bear through our mandatory standards
schema. That\'s going to mean establishing some process to assure
conformance with mandatory standards and to encourage performance with
consensus standards as appropriate.

It\'s our intention in this area to increase our participation in the
development of international and national consensus standards focused on
what we see as dose intensive equipment, those things which present the
greatest risk to public health because they represent either the highest
exposure or exposures to large segments of the population. We have, for
some years now, been actively involved in the development of both
national and international consensus standards and we continue to want
to play that role and to actually increase our participation but in a
focused way, putting our energy behind those standards which as I say
relate to dose intensive equipment.

We also want to take steps to allow conformance to consensus standards
by guidance and follow that by adopting consensus standards by
reference. An example of this, and the paradigm for this approach, is in
the laser area where some years ago we issued a guidance which has come
to be known as Laser Notice 50 which told laser manufacturers that it
was okay with us if they certified conformance to the IEC laser standard
in lieu of certifying conformance to the FDA mandatory standard.

We\'d been involved in the development of the IEC laser standard. We
were comfortable with the standard. To the extent that we had some
discomfort, there are some exceptions in that guidance that says that
it\'s fine to certify conformance with respect to these aspects of the
standards but there are some exceptions where you need to conform to the
FDA standards. It was an attempt on our part to, as I say, leverage the
energy that was put into the development of the consensus standard and
to harmonize our standards with those international standards to help
the laser manufacturers deal with the more complicated world in which
they were selling product across the globe and it would be convenient or
beneficial to them to be able to deal with a single standard.

So we took that step in the guidance to move in that direction and we
indicated in that guidance that we intended to take the next step and
adopt the IEC standard for lasers by reference. We are in fact in the
process of working through that and we\'ll have something published
along that line shortly I hope.

There is opportunity to do something similar in computed tomography, for
example, where the FDA standard is currently couched in terms of a dose
metric which was relevant to the single slice scanners of yesteryear but
is less relevant, one would say, to the multi-slice spiral scanners of
today. At the same time, we have an International Electrotechnical
Commission standard which has a dose metric which is more appropriate
for today\'s modern CT scanners. So we have an opportunity by guidance
to say to manufacturers that it\'s fine with us if they certify in terms
of the IEC dose metric rather than the older FDA dose metric.

That\'s one example. There are certainly other examples in ultrasound,
potentially in other diagnostic x-ray areas and we\'re going to be
working for and looking to opportunities to use these consensus
standards appropriately within the context of the FDA\'s regulatory
standards and regulatory requirements. Again, we\'re going to base that
action, that activity, the priority that we give to the publication of
these various guidances and so forth, on the risk posed by the product.

In the monitoring area, we certainly have the need to maintain awareness
as I said of the radiation emitting products and their manufacturers,
and to assess the electronic product emissions and the conditions of
use. Again I would stress the conditions of use as something which
hasn\'t gotten as much of attention in the past as perhaps it needs to
now. We need as well to understand the effects of those emissions and
the exposure risks. In terms of our intentions in this area, as we
discussed in our plan, we\'re talking about requiring only essential
manufacturing reporting.  In the past, and even today, Manufacturers are
required to submit lots of reports to us which we don\'t have the staff
to evaluate in the way that they were in the past and so we\'re going
to, through guidance, provide exemptions to certain manufacturers from
the various reporting requirements and again base these exemptions on
the risk of the underlying product.

We\'re talking about moving from routine testing in the field or in the
lab of units of product, to for-cause testing, when there is a
particular problem identified, but more particularly to manufacturer
inspections such that we can go look at the manufacturer\'s quality
systems, what is it that\'s built into the design and manufacturing of
that product that assures its quality and so on.

The manufacturing inspection component is not something that has been
really significant in the past where we have really depended on testing
substantial numbers of products in the field. In the x-ray area, for
example, our history is to test about 1,500 x-ray systems a year at the
point of installation. That represents maybe something approaching ten
percent, probably less than that, of the units installed and the basis
of our oversight of the manufacturers and their associated assemblers
has been these series of field tests. We feel now that we can get a
better bang for our buck if we move to our manufacturers\' inspections.

Part of this step is going to be getting away from routine radiation
measurements in the field. In particular, eliminating the measurement of
dose in the Mammography Quality Standards Act inspections is one example
of stepping back from that direct primary measurement role that we\'ve
had in the past. Similarly, we will be phasing out the routine
laboratory and field testing of diagnostic and cabinet x-ray systems,
lasers, sun lamps, TVs, microwave oven products and so forth.

As a consequence of no longer having a program which involves the
routine measurement of lots of units of product in the field, we\'re
planning, over some period of time, to phase out our instrument
calibration function in favor of simply maintaining instrumentation
expertise and measurement capabilities so that we can go and do the
for-cause inspections and tests. Now we provide instrument calibration
services to the FDA field which does, as I mentioned, in the x-ray area
700 or 800 field tests a year and we provide instrument calibration
services to states who do an additional 700 or 800 field tests a year
under what are called partnership agreements with us. Now, over some
period of time which is yet to be determined, we feel it prudent to
phase out that calibration service in favor of maintaining our expertise
in instrumentation and our measurement capabilities. Again, this is all
related to trying to put our resources where they will do the most good
rather than to continue to do what we\'ve tried to do historically.

Also in monitoring, going back to where we think the root of most of the
problems are, it will be no surprise that we want to emphasize the
assessment of use and the exposures associated with that use. Here
again, we\'re talking about harvesting data that\'s gathered by others,
by third parties if you will, rather than by doing direct measurements
ourselves. Certainly this could involve adverse event reports, reports
of burns associated with fluoroscopy imaging for example, but it could
also involve exposure and dose data associated with other kinds of
medical applications, reports with respect to exposures from consumer
products and so on.

One of the things that I think is clear is that we no longer have the
capability to effectively sample and monitor what\'s going on in the
country in terms of medical exposure. I would assert that, while we have
over the past had a program called The Nationwide Evaluation of X-Ray
Trends to monitor exposures in the medical imaging area, that program,
which has gone on for some decades and has been very fruitful and has
been the basis for similar but I think superior programs in Europe,
isn\'t really adequate today to produce for us all a picture of what
exposures are like in this country for patients involved in medical
imaging procedures as those medical imaging procedures evolve very
rapidly. So we don\'t have a way of getting a good, accurate, timely
picture of what exposures are in this country. So to some extent, I
think it\'s fair to say we\'re sort of flying blind.

I think that there are efforts underway on the part of a number of
organizations in this room to help address that particular issue. But
it\'s certainly our view and it reflects back to what I said about the
Mammography Quality Standards Act, we need to be look at ways which we
can gather and compile and analyze and display information collected by
others rather than feeling like we have to collect that information
directly ourselves.

In the MQSA arena, as an example, and it\'s certainly an extreme
example, dose has been measured in MQSA inspections for ten years. There
have been conservatively 100,000 inspections done, a 100,000 inspections
over ten years and we have found problems with dose in maybe one or two
instances. Let me just go further and say that this is in a situation
where at the same time the facilities that we regulate are required
under the regulations to have a medical physicist measure the dose
annually and the facilities are required to be recertified every three
years and have their accrediting body measure the dose tri-annually. So
we have a belt-and-suspenders-and-I\'m-not-sure-what system where we
were measuring and measuring and measuring and there was really no
problem to be dealt with. We have amply demonstrated that fact.

But I think it goes to the point that there are circumstances in which
we, as the FDA, don\'t need to be directly measuring the exposure to the
exposed population when there are others who can make that measurement
and from whom we can gather collected information so that we have and
you have a picture of what\'s going on across the country. That\'s a
goal that we should be looking toward.

In terms of education, we certainly have a goal of a public that able to
make informed choices about exposure in the medical, occupational,
consumer settings, users who are able to minimize their own exposures
and those of the people that they expose, manufacturers who are
sensitive to radiation risk issues and able to respond effectively to
their customers and regulators and state and federal radiation control
programs that can effectively assist users in minimizing exposure and
risk.  This is an area I think which needs considerable attention given
the belief that we have that the problems that we face as a public
health matter are largely problems of use.

It\'s our intention in this area to invest in the web as an educational
tool and we\'re currently in the process of redesigning our radiological
health portion of the CDRH webpage. But it\'s also going to call on us
to create new web content to address priority issues be that guidance or
a better display of data that we have or data that we may harvest from
third parties as I was talking about a moment ago. We need to be able to
keep that content current and up-to-date and focused on what we consider
to be the priority problems so that it\'s available to those folks who
are in a position to exercise leverage with respect to changing behavior
to address those problems.

We also look to create a coordinated education program and to partner
with a number of you, I hope, to disseminate information and create
training opportunities. I think it\'s fair to say at least from my point
of view and from what I\'ve heard, that it would certainly be preferable
from the perspective of a manufacturer, let\'s say, to have an inspector
visiting their facility who was relatively well informed and relatively
smart about the topic. It certainly precludes, or makes less likely, the
inspector doing something, I wouldn\'t want to say stupid, but let's say
inappropriate.

I think that similarly for facilities that are being visited by
regulatory bodies it also is important for those regulators to be
appropriately trained and educated and, I think, to the extent that
we\'re looking at the medical realm, that includes being conversant with
and having some understanding of or some acquaintance with the clinical
applications for which the machines are being, used rather than simply
focusing on the machine itself. I think we have a certainly have a
challenge to meet going forward in that regard.

In terms of research, which is an internal activity of the center, we
want to have a research program that is pointed at the high priority
radiological health activities, obviously conducted in accordance with
the highest scientific standards as it certainly is and publicized in
the scientific literature and in other appropriate media. But I think
the key thing is to get that research focused on the high priority
radiological health activities and that means getting our radiological
health program people involved more directly in the selection of what
research is done in the center and engaging the various managers at the
various levels and assessing that value of that research as it goes
forward in terms of the overall program.

Finally, we have a goal of delineating the management structure more
clearly within the Center and getting it to operate more as a single
program as opposed to a whole series of stove pipes which I think had
become the problem as resources drained away leaving behind pockets of
activities developed across the Center. We\'re establishing various
teams and so forth to help direct the activities of the radiological
health program within the Center. But it also involves implementing a
communication strategy to promote our program and to deal with our
stakeholders as we are at this session over the next couple of days.

Having given you a rundown on the plan that we have, I think it\'s
important to focus on some of the challenges that we face. I think for
us it seems that there will be a challenge involved in staying aware of
new technologies and new bioeffects information. Certainly there is a
lot of evolution going on in the various technologies that emit
radiation and it\'s going to be challenging to stay up on that to
maintain some degree of not just awareness but some depth of
understanding of the technologies as they evolve.

I think that in terms of the bioeffects information there are often
things going on that are important in that area, the BEIR 7 Report being
a recent example, where there can be impact on how we perceive the risks
that we face as that bioeffects information evolves and develops.

It\'s also going to be challenging for us to make the decisions that we
need to make, the science based decisions that we need to make, in light
of what may be the current public opinion about a particular issue. I
think we need to go where the risk is. We\'ve said that repeatedly.

But at the same time, the reality is that we need to deal with issues
involving perceived risk. If we have a public that perceives that a risk
is posed by a certain product we\'re going to be dragged in that
direction. We\'re going to be required to deal with that particular. I
think we have to try as hard as we can to give that issue the attention
it deserves, that is to say to try to convince people that the risk
associated with that product is whatever it is. Perhaps it\'s minimal.
Perhaps it\'s nonexistent.

We need to be able to try to deal with that and not get too many of our
resources committed where we don\'t think a significant risk exists. But
we are inevitably, I think, going to have to commit some resources to
those kinds of areas. We see it time and again where we get dragged in a
particular direction by the perceptions of the public.

I think that goes to the next point of the challenge of communicating
risks to a variety of audiences. I don\'t think we have as a community
necessarily done as effective a job as we would like over the years in
communicating risks. I think we have a public out there who has
perceptions about risks associated with radiation which are not entirely
congruent with what we may individually or collectively see as the
reality of those risks. And as a consequence, people make decisions
which don\'t seem to us to be reasonable.

I think that we need as a community to educate the consumers whether
it\'s through the web or through other mechanisms about the risk or, as
I said, the lack of risk posed by products and the radiation that those
products produce. One product can have the potential to produce some
immediate acute injury if it\'s used even in a typical situation but
certainly if it\'s used in an atypical situation where there\'s more
exposure than might usually be the case. Fluoroscopy is an example of
that, laser certainly are an example, skin burns being the outcome.

On the other hand, another product may have the potential to produce a
delayed injury either from a typical exposure or from an unusual
exposure that may not appear for months or years. CT might be an
example, as are other medical imaging techniques, and potentially,
depending on the technology, security screening systems where the
outcome might be cancer down the road.

Yet another product could be perceived to pose a significant risk when
in fact from our best scientific judgment that risk is if any exists
minimal.

It seems to us that the users of products, doctors in the case of
medical imaging systems for example, need to both know what the risks
are and be able to communicate those risks that result from the range of
exposures to be expected from the products that they\'re using. There is
certainly in the medical area, I think, a significant amount of data in
the recent literature which suggests that that\'s not typically the
case. People who use products that emit radiation are typically not
really well versed in what amount of radiation that particular product
emits and what the consequences might be.  And for other, I think the
consumers need to be aware that there can be immediate risks, there can
be delayed risks, and they have to be able to make a judgment about
whether they should accept those risks or some alternative.

Screening technology is an interesting example. We go through airports
now as many of you did coming here. There are various ways that you\'re
being screened today. If we were in a foreign country, if you were
overseas, there are other technologies that have been implemented using
x-ray to screen personnel and you\'re faced with a choice. Do you want
to go through the personnel security screening system or in this
country, do you want to be sent downtown to the hospital and have a
fluoroscopic examination or would you rather have the strip search?
There are privacy issues which are going to have to be balanced against
the exposure. That means you\'re going to have to know something about
what the exposure issues are. You\'re put in positions where you have to
make judgments where I think today people have relatively limited
information upon which to base those judgments.

It\'s going to be challenging for us to change the behavior of
individuals in order to reduce exposures. We\'re all driven by different
imperatives. Certainly I think, for example, in the medical area when
you\'re doing medical imaging exam, the first priority is to get the
clinical information that you need out of that exam to do whatever the
task is with respect to that patient and deal with that patient\'s
medical issues.

But I think that it also needs to be fairly high up on people\'s minds
what the consequences of the exposures might be. People need to be
thinking not just that the risk is minimal given the benefit I\'m going
to get from this particular exam but what the cumulative exposures are,
not just to that individual, but to the population of individuals,
whether we\'re creating more risks in the future, more cancers in the
future, than we need to. We need to be mindful of what the exposures are
that are being delivered and so forth and there are other examples.
We\'ll talk about a couple of those as we go forward.

In terms of changing people\'s behavior, I think we have to ask
ourselves is it sufficient to give them more information. Is it dose
display for a fluoroscopy system the answer or is it something else? Is
the National Dose Registry an answer for the medical arena or is it
something else? Is it combination of these things? It\'s certainly not
clear to me at this point what the answer is.

In addition, we have a situation in which people are making decisions
which we may think, from a public health standpoint, are inappropriate
and it\'s outside of our control. We have asymptomatic individuals for
example asking for a whole body CT screening exam. They certainly have
perhaps a legitimate concern about figuring out whether they\'re well or
not. They may not have enough understanding about either what the risks
are or what the consequences may be when certain inconsequential
findings appear on that CT that have to be followed up on because now I
found something that isn\'t entirely normal.

We have expectant mothers who have an interest their developing fetus
and when we have the issue of fetal keepsake videography. Again people
putting themselves in a position to be exposed for a variety of reasons
which we may or may not think are entirely appropriate. So how are we
going to address and effectively change the behavior of those
individuals when that\'s appropriate?

I think perhaps the biggest challenge that we have is prioritizing our
efforts over what is after all a very broad range of products and issues
that we might potentially have to deal with. Just as an example, here
are some of the products that we have to come to grips with as a Center.

And to use a couple of examples, we routinely get reports dealing with
mercury vapor lamps. These are light sources which are typically used in
gymnasia in schools for example but they\'re also using in street
lighting and security lighting and so forth. If one of these lamps gets
broken and is not of the self-extinguishing type, then it can result in
exposure to people who are close enough to that lamp. For example, we
got a report a few weeks ago of such an exposure in Tennessee where
about 100 people in a gymnasium for a 9/11 event were exposed to the
ultraviolet radiation from a broken mercury vapor lamp, about 18 of them
requiring hospital treatment for the skin and eye burns irritation that
resulted.

Here\'s a situation where we get two or three of these kinds of reports
over a year. What level of effort do we put into that particular arena?
There are as I said self-extinguishing lamps which in principle school
systems and others ought to put into fixtures where they need lighting
and where that lighting can be fairly proximate to human beings and
where the human beings can be there for perhaps a significant period of
time. Those lamps happen to be more expensive than the ones that don\'t
self-extinguish. How much effort, energy, do we put into this? How do we
encourage school systems and so forth to try to address this kind of a
problem?

As I said, we get several of these every year and we\'re currently
making a modest investment in an outreach campaign to educate the users
of these lamps and the hazards posed and encourage them to use the
self-extinguishing lamps. That\'s being done through the web and through
other mechanisms and this problem may be mitigated somewhat by existing
newly revised building codes which get into this issue more directly.

In the security screening area, there are a variety of x-ray screening
systems and technologies that are in use today, so-called cabinet x-ray
systems such as you put your carry-on baggage through at the airport.
FDA has a mandatory performance standard to insure that products are
designed to prevent leakage from the systems. But these security systems
are being put into more locations for more purposes and I think the
potential for that downstream is greater.

The checked baggage that you may have brought you to the airport was put
through a baggage screening system which may well have been hard to
distinguish from a computed tomography system, a system which involves
more radiation than a conventional baggage system. But again, NIOSH has
been out to the airports doing studies for TSA, the Transportation
Security Administration, and is paying attention to the exposures to the
workers in this regard and so far, there are no major problems I think
it\'s fair to say.

But the screening technologies are likely to change over time. Their
applications are likely to increase. Is this something we need to be
paying attention to? Well, we have to the extent of being involved in
the development of the national consensus standard under the American
National Standards Institute for the personnel screening systems, those
that are intended to screen human beings for security purposes using
x-ray and we\'re currently involved in a similar standards development
effort with respect to baggage systems and so forth.

We\'re also working with other Federal agencies to look at the questions
that agencies ought to address if they\'re considering implementing or
deploying some of these technologies so that we are asking the right
questions and all asking the same questions using the same sort of
approaches to get the answers about whether or not it\'s reasonable to
make the balance between the exposures that may be involved and the
security benefits that may accrue.

I think it\'s true to say that the public who may be exposed in these
circumstances ought to be educated more to the hazards as well as the
security benefits and so I think that there are a variety of things that
need to be done and we\'re working in this area largely in terms of
developing in this case national consensus standards.

In terms of another non-ionizing source, there are problems that have
come to light with respect to high powered green laser pointers over the
past year. As we began to worry about those problems, we began to see
reports in the literature of aircraft being illuminated by the green
laser pointers and the potential problem here isn\'t limited to
aircraft. There have been no reports of actual injuries or accidents but
certainly those are possible and certainly if you were to be \"lased\"
while driving your car there\'s certainly the potential for flash
blindness or distraction that would be sufficient to cause an accident.

We have addressed this problem by educating consumers through the
website through an article in the magazine *FDA Consumer*, through a web
newsletter that\'s called *FDA and You* which is directed at secondary
level schools and by conducting a variety of press interviews about the
hazards of the green laser pointers. We\'ve identified manufacturers of
the illegal and noncompliant products, those that are too powerful to
comply with the laser standard and we\'ve taken regulatory action
against them.

But it\'s interesting to note that while this has gotten considerable
press so far as I know there were no actual reports of injury to date.
So the question remains in terms of what priority ought this kind of
problem to be given, what approach ought we to be taking to this
particular kind of problem as we move forward.

Finally in the medical arena, CT procedures we would all agree
contribute the greatest dose to the public of any medical x-ray
procedure. There have been certainly articles to that point in the
literature in recent years. In fact, a few years ago, there was an
article in the peer review literature which talked about concerns with
respect to technique selection in pediatric CT which got picked up by
that famous radiological health journal, *USA Today*, and made quite a
little splash for a while. I think it\'s fair to say that it was a
wake-up call to the medical imaging community.

I don\'t think anyone understood what was happening and what the
consequences were of using adult techniques when examining pediatric
patients on a CT unit. The fact is that those pediatric patients were,
as I\'ve heard, given doses that were perhaps three to five times what
they might have needed in order to get the clinical information that was
being desired.

Of course, when it involves children, it\'s easy to get people energized
and I think the community certainly got energized. There was
considerable discussion. There was guidance put out. There were
educational activities and so forth to help mitigate the problem.

But I would ask whether or not we can be sure that those activities were
effective. What mechanism do we have to know today what exposure
techniques are being used on pediatric patients or on adult patients for
that matter? What do we know about what the typical exposures are for
various kinds of CT exams for pediatrics and for adults? Again, I think
we do the things which make sense in terms of trying to change behavior
but I think it\'s fair to say that the behavior may still be going on
and don\'t know if we don\'t have a good picture of what\'s happening
exposure-wise in the United States. In addition to problems with
inappropriate technique which was what is going on here, children being
exposed using adult techniques and therefore getting more exposure than
was necessary there are other problems.

I think it\'s fair to say the computed tomography may not always be used
in a fully appropriate way.  I think there are lots of pressures not
simply from medical legal concerns but also from consumer themselves to
have a CT exam of some particular kind in some situation, to have a CT
exam for their child who has fallen down and hit their head or has pain
in their belly and there may be pressures to use CT in situations where
the physicians and scientists looking at this practice would argue its
not particularly appropriate way to to evaluate this situation.

It\'s clear that various groups have developed criteria for when a CT
exam is indicated, but it\'s less clear at least to me how effective
those criteria have been, how often they\'re followed, how well they\'re
followed, again going back to the question of, do we know what\'s going
on. How good a picture do we have of what exposures and technique and so
forth are like in the medical arena in this country?

I would say that CT is just one facet of a broader problem and it
applies rather obviously to CT but I think it applies to fluoroscopy and
other medical imaging as well and I think the challenge that all of you
in that area know about is that assuring that the right patient gets the
right exam at the right time for the right reasons and the right
technique and so forth and it\'s easy to say but how we act to make that
happen on a routine basis is a different question. I think that we need
to look at the question of how do we address the users of CT systems and
how do we affect their behavior in terms of these issues about technique
as well as appropriateness of exams.

It won\'t pop up here because I didn\'t think about it while I was
putting my slides together but if you notice hiding down in the lower
right-hand corner from your perspective is medical accelerators. I point
that out because historically CDRH has not done much in the way of
activities within the radiation therapy sphere. I think, and again it\'s
my ill-informed perspective, that that\'s because historically most
radiation therapy was isotope based and because it wasn\'t a machine
emitting the radiation, it wasn\'t our business. It was NRC\'s business
or the agreement states\' business. And I think it was certainly my
perception that the medical physics was all over this, if you will.
There was lots of support and attention being given to radiation
therapy.

I mention this simply to ask the question that since more and more
therapy is being done with machines today, is there any issue? Are we
assured and, if so, how are we assured that the kinds of quality
assurance procedures that are associated with isotope based therapy are
actually being done with respect to machine based therapy using linear
accelerates? From my perspective not having much background in that
area, it's simply a question, but I think it fleshes out to some extent
the range of issues that we have to deal with.

So I bring us back to the structure of the plan that we put together to
make the point that while I think it\'s clear to us where we ought to be
putting our energy that we ought to be putting some energy as I
described in the area of standards, that we ought to be as a Center
focusing on monitoring, that we ought to investing in education and so
forth. It\'s less clear what the balance across those areas should be.
It\'s less clear how those areas ought to be brought to bear, how work
in standards or monitoring or education ought to be brought to bear on a
particular problem because I would think that the mix of effort would be
different depending on the product, depending on the problem, depending
on who we think has the leverage to affect whatever the situation is
that\'s potentially leading to unnecessary exposure.

So it\'s one thing for us to say we want to do things in standards and
monitoring and education for example. It\'s a different thing to say
what the balance should be and how that balance should be changed or
should be different perhaps as products change and as new technologies
become available. I think that\'s what I\'m certainly hoping that we\'ll
get out of the discussions that we\'re going to have over the next two
days.

So I would ask you that over the next two days that you participate,
that you express your views, that you listen to all of the things that
you\'re going to hear and there\'s going to be a lot of that, that you
look for opportunities to collaborate with one another including with us
and that you leave with a commitment to continue the work that we\'ve
begun here as I certainly think that there\'s a lot of work left to be
done. With that, I will stop and ask if there are any questions. We have
ten minutes before break.

FACILITATOR LESLIE: If you have questions if you would please make your
way to the mike and as you start please say who you are and your
organization so our transcriber has it. Sir?

MR. BRITAIN: Bob Britain with NEMA. John, are they actually using x-rays
to screen people in airports?

DEPUTY DIRECTOR McCROHAN: Not in this country. However, there are
countries in this world where that is being done and there are
circumstances overseas where that\'s being done. So I think it\'s fair
to say that the potential exists. I\'m not aware of any systems that are
actually deployed, certainly not at airports in this country. I\'m
looking at Jill. I think there have been deployments of x-ray security
screening systems in prisons and we\'ve had conversations with folks in
the Bureau of Prisons about that.

I think that with respect to the security screening systems,
particularly personnel security screening systems, we worked on the
standards with ANSI and others who participated in that effort. So with
the anticipation that this could be an issue, we wanted to get in front
of it. But I think there are lots of circumstances that you can imagine
in which someone would want to deploy some sort of security screening
technology that might involve x-rays, so not necessarily today\'s
problem but something that we\'ve been looking at. Yes?

MR. McCORMICK: Yes sir. I\'m Luke McCormick with U.S. Customs and Border
Protection and we do have a few of those back-scattered x-ray machines
deployed. They are a secondary system that we use. It\'s after we have
somebody that we have targeted as a problem that might to be diverted to
secondary. On the whole if I remember right, I think there were an
average of two scans a month last year. So that\'s not a main issue.

But one of the issues that we are coming up to see is where the security
screening systems are going to. Presently we\'re using three and four
megavolt linear accelerators. But some of the newer systems that have
been proposed go all the way up to 15 MeV lin acc and we\'re starting to
look at active neutron interrogation of cargo and 14 MeV neutrons and 14
MeV x-rays we\'re starting to look at problems of activation products or
are there real issues in this? From our previous studies, we have not
seen activation products at the pulse fast neutron analysis system that
we\'ve been testing but this is something that the public is very
concerned about.

DEPUTY DIRECTOR McCROHAN: Is that largely for cargo purposes at this
point?

MR. McCORMICK: Yes. That\'s strictly for cargo. In fact right now with
the pulse neutron system, the dose to a stowaway should one actually get
that far down the system is only about 8 millirem.

FACILITATOR LESLIE: Good. Thank you. Other questions? Please. One of the
things we\'re hoping here is agreeing with everything John says is not
necessarily a goal. But understanding what the thrust and intent of the
program was clearly our intention with all this. Please.

MR. LEIDHOLT: Ed Leidholt, U.S. Department of Veterans Affairs. Question
or perhaps it will be addressed later. Would you care to address what
you intend for the NEXT program?

DEPUTY DIRECTOR McCROHAN: Let me just say something briefly. It\'s
certainly my expectation that that program may well continue, but I
think that, and this is my view, a program which on an annual basis
looks at 300 or 400 facilities in this country and the exposures
attendant to one exam is going to give us the kind of picture it\'s been
giving us historically which is a very episodic picture. It\'s been very
useful. It\'s been a program, I think, that\'s created a lot of the
interest that exists in Europe and so forth. I simply ask the question
whether or not it\'s providing us all of the information we ought to
have about the range of exams particularly the different kinds of CT
procedures for example that we might be interested in where the
exposures are fairly high.

I think there\'s still a role. The advantage NEXT has I think is that
it\'s a set of measurements made with a very tightly controlled
procedure with a phantom that drives the unit the way a patient would
and so forth. So it\'s very good data. I think the problem is just, if
you will, the sampling frame. So I think that there\'s a role for much
more, if you want to look at this way, poorer data, less well controlled
data, to give us some sense of what\'s going on in between both in time
and in terms of imaging space if you will.

FACILITATOR LESLIE: Okay. A couple more?

MS. APPLEGATE: I actually have a comment if it\'s all right. I\'m
Kimberly Applegate. I represent the American Academy of Pediatrics and
I\'m a pediatric radiologist. I thank you very much for the comments
particularly focused on CT and perhaps reprioritizing the issues to look
at children\'s dose. I\'ll say though that if you look at this when you
look at your list of challenges, one of the things that I think isn\'t
mentioned that is very important is the driver of economics and medical
reimbursement where CT is very profitable compared to some of the other
things that we do that may be alternatives imaging in children.

DEPUTY DIRECTOR McCROHAN: Let me just respond by saying that I think
that there really is some development in that area and it\'s certainly
impression that the third party payers are getting more interested
particularly in the higher costs medical imaging procedures and I think
there are issues being brought to bear there in terms of quality and
what kind of assurances facilities might be able to provide that they
are doing a quality service and so forth for the third party payer\'s
money. So we may be getting to a little bit of a nexus here that would
be very helpful.

MR. BALTER: Steven Balter representing the Society for Interventional
Radiology. I also happen to have a hat in the IEC and answering to
several questions here, we have a project between IEC and NEMA called
DICAM Dose where looking forward a year or two, all imaging systems that
are capable of writing DICAM images in principle will be able to
generate structured reports. You may have more data than you can deal
with. Thank you.

DEPUTY DIRECTOR McCROHAN: That\'s better than having not enough.

MR. BALTER: That\'s right.

MR. VILLFORTH: I\'m John Villforth. I\'m unemployed.

DEPUTY DIRECTOR McCROHAN: I think you worked long enough, John.

MR. VILLFORTH: I wanted to compliment you and the staff for putting this
together. It was an excellent overview and it was very helpful to
introduce it and get us thinking about the different areas.

I felt there was one area that was missing as far as CDRH was concerned
and that is the non-machine, non-electronic product area. You do have at
least one FTE devoted to what to do about emergency planning, Federal
guidelines for emergency activities and so forth. Since this is a CDRH
discussion today to look at all of the areas, I would hope somewhere
that that gets put on the table because I think its\' incredibly
important as to whether the Department and whether the FDA and then more
specifically whether CDRH is going to play a role in this or not. We\'re
hearing so much about what can happen with weapons of mass destruction
particularly the radiological type and if something does happen,
certainly FDA is going to have some concern or some involvement as it
relates to the products that FDA regulates.

And then secondarily, the leadership question in the Federal Government.
If I could back to a few years ago in 1979 when the Three Mile Island
accident occurred, one of the things that impressed me tremendously was
the leadership that then Secretary Joe Califano expressed to the Federal
Government and that is that the issue around Three Mile Island is there
was a real issue because it wasn\'t known at the time was a public
health issue and that the public health, that is the Department, needs
to take a bigger role as opposed to the role of the Department of
Energy, the Nuclear Regulatory Commission, FEMA and everybody else.

My personal feeling is that it can\'t go away and I don\'t know where
this might fit in to your agenda but it ought to be considered in terms
of where CDRH goes in the future. Thank you.

DEPUTY DIRECTOR McCROHAN: I think an interesting historical anecdote, as
you know, John, was the response of the Center to in terms of looking
for what exposures might exist around Three Mile Island. Part of that
response was to take some cards that had thermoluminescent dosimeters in
them and nail them to every telephone pole we could find. What\'s ironic
is that those cards were designed for evaluating mammography systems. So
we adapt.

But I do think that your point is well taken in the sense that we really
don\'t have a lot of resource in that area.  It\'s one of the things
that had Lillian been here she would have spoken to since she\'s the
senior person in the Center responsible for coordinating
counterterrorism and urgency response activities. But we do have one
person working on this and we certainly hope that in the face of some
potential if he doesn\'t get hit by a truck because we\'re pretty thin.
But thank you for bringing that up.

FACILITATOR LESLIE: Are there other questions?

DEPUTY DIRECTOR McCROHAN: Maybe where\'s the coffee?

FACILITATOR LESLIE: Oh, they are letting you off easy. I\'m surprised.
Okay. A couple of quick administrative announcements before we head off
to break.  One is if messages come in for you to the hotel phone number
and the like and wind up out at the front desk what I\'m going to ask
that the registration table do is just keep those out on the
registration table. So if you\'re expecting anything, cycle by and see
if there\'s one for you.

Should something come in however that\'s in the category of an emergency
and we need to get to you quickly they\'ll wander around the room or
even interrupt and we\'ll find out where you are because we don\'t have
actual seating for who\'s sitting where. I would like to do that if I
can.

The second thing is just a quick check. Do we have enough chairs? Those
of you who are sitting, is that by choice or do we not have enough
chairs for you? We\'re okay on that? Temperature in the room okay? Light
okay? I know that\'s a dangerous question always to ask. Ball park.
Dying? How are you? It\'s a little too high. Not all the way to meat
locker but a little colder.

DEPUTY DIRECTOR McCROHAN: I thought it was only too hot up here.

FACILITATOR LESLIE: I\'ll see if I can\'t make that. Okay. Let us then
to break. We convene at 10:30 a.m. We will start the presentations. Bob,
you\'re up first. We will get you queued up and ready to go.

(Whereupon, the foregoing matter went off the record at 10:05 a.m. and
went back on the record at 10:32 a.m.)

FACILITATOR LESLIE: Okay. All right. Are you ready to go? So you said
you wanted it cooled off a little bit. So we\'ve done that. But as
Charles up here a minute ago said to me having asked for a little bit
cooler and gotten this he\'s not dare going to ask me for water. Wise
man. In any event, now that we know that they bought the biggest and the
best AC unit that could be bought on the planet, what I expect to do now
is try to cool it off when we go away for lunch or when we go away for
breaks and what I have to calibrate is how long to leave it on. I think
it will get us through until lunch, but we\'ll see.

Let\'s get into the presentations. We have a series of those for you and
Bob Britain from the National Electrical Manufacturers Association is
going to start that off. I think we\'ve anticipated about 15 minutes
each presentation. So, presenter, if you are through in less than 15
minutes, that\'s a little elbow room for questions. If you start running
over that, I\'ll start dancing around and the like because what I\'d
like to do is get through the morning\'s presentations before we break
for lunch and not have them jump over into the afternoon. Bob, are you
ready? Bob Britain, you\'re on.

MR. BRITAIN: Ladies and gentlemen, if it is a privilege to be the lead
off, I would have hoped that it would have been John Villforth. So maybe
it isn\'t necessarily a privilege.

A little bit about me. John and I started this program. He preceded me
by about a year and a half with this. It was called the Center of
Radiological Health then which later became the Bureau of Radiological
Health under FDA. So I spent 23 years with the Bureau and FDA and
leaving that going to NEMA and spending, I\'m in my 20th year now at
NEMA. All these years have been involved with radiological health. I\'m
privileged to say that. I\'m passionate about radiological health
technology, the industry and the government regulators.

What\'s a NEMA? It\'s a trade association and it\'s the largest trade
association representing the U.S. electro industry. Electro industry
means most anything electrical is covered, lights, lighting, electrical
motors and even medical equipment. So we have a medical products
department that covers anything from x-ray machines, CT, radiation
therapy, nuclear medicine and medical imaging informatics.

NEMA historically has been known for its standards, known world wide for
its electrical standards. We have electrical standards for just about
every imaging modality and these standards work their way up to the IEC
level where we\'re very happy to turn them over to IEC committees who
work to establish to an IEC standard. So between IEC 62B and 62C, all
imaging modalities and linear accelerators are indeed covered.

The most recent and now quickly becoming the most famous standard we
ever developed or had part in developing was the DICAM standard which is
the Diagnostic Imaging Communication and Medicine standard. This
standard is supported by 24 working groups unless we\'ve gotten another
one recently. And the standard is presently up to about 3,000 pages.
This addresses all aspects of imaging, how to move images electronically
over the wires, to archive them, to bring them back for viewing.

We try and stay close to our partners so to speak with the American
College of Radiology and for example the American College of Cardiology,
the Radiological Society of North America. We work very closely with the
National Cancer Institute and soon we will be working much closer with
the National Institute of Biomedical Imaging and Biomaterials.

What have we done historically with you guys, with FDA, I should say?
Way back in \`67 and \`68 we provided testimony for the Radiation
Control for Health and Safety Act which was published in 1968. We\'ve
interacted with BRH on the x-ray standard going back to the early 1970s
and with TEPRSSC and we\'ve interacted with TEPRSSC, spelled with two
s\'s instead in two c\'s, Technical Electronic Product Radiation Safety
Standards Committee, that always has been a mouthful, on the sunlamp
standard and the mercury vapor lamp standards where we provided some
information and testimony to TEPRSSC.

NEMA had a major role in reclassifying MRI from Class 3 to Class 2 and
that happened almost immediately after I went to NEMA in 1985. That was
one of my goals. Then we\'ve had a major role in developing ultrasound
510(K) guidance and even now we hope periodic meetings with CDRH staff
and of course it\'s the topic of intense interest like CT dose and
fluoro dose and other issues regarding fluoroscopes.

So just a brief mention, in NEMA\'s product scope there are products
within your scope that are not in our medical program. But just to let
you know that NEMA does have some review and some activity with sun
lamps and mercury vapor lamps and even arc welding machines which I
think could fall under the Radiation Control for the Health and Safety
Act because they do produce intense ultraviolet light and they are on
circuit.

So these are the general comments. I hope I\'m staying to the structure
that was given to us by the CDRH folks. Here are the general comments. I
want to just proceed all of this in that we don\'t have any magical
fixes for you guys. So please don\'t expect any. Obviously we\'re in
total support of the general direction you\'re heading, the concept of
FDA RAD health program to focus the FDA resources where it\'s needed the
most on the highest priority risks and where the questions are needed to
be answered with the highest priority.

And we agree on the major program areas. The use of international
standards, NEMA has supported IEC and ISO standards for years. So we
have absolutely no problem in moving in that direction for CDRH.

Efficient monitoring, obviously. You probably are getting too much data
in now that you don\'t know how to handle. So if we can make that more
efficient, I think that\'s a good road to go.

Focused education, absolutely necessary. I\'ll talk a little bit about
that later.

And research based on high priority questions, obviously we support all
of these, all the directions you\'re taking.

So let\'s tease these out. On standards, I think we\'ve all learned by
now that FDA standards are just too expensive to develop and maintain
and at least in the medical area and the imaging area, the technology is
changing so rapidly and we\'ve see this in CT. It\'s just too difficult
to maintain the FDA X-Ray Standard to keep up these technologies.
Referring IEC standards is very tempting to industry and I think it\'s
probably very tempting to FDA also and especially tempting to us because
like I said before, all imaging modalities are covered by IEC standards
in 62B.

Now one note of caution in that I know you\'re going to adopt a
reference or whatever these standards and so FDA and industry should
take a careful look at each of these standards that you\'re thinking
about adopting because sometimes at the IEC they\'re developed with some
sort of flexibility built into them and you have to be careful that
they\'re not so flexible that both FDA and industry could find itself in
an uncomfortable position when start to enforce these standards. So we
need to look at each of the standards very carefully.

You have talked about a legislative change, some sort of legislation
that would allow you to adopt. I think in your original document the
word was adopt not so much reference but adopt. I think knowing the
lawyers and the legal people, in FDA the Chief Counsel Office, I think
they would be very careful about allowing anyone to adopt something
without going through the routine administrative process of comment or
publish proposal and comment and then publish final. So we need to take
a look at that.

Monitoring. We need to make monitoring more efficient. We absolutely
agree with you that only requiring the most essential information is
where you ought to go. We\'re going to suggest eliminating assembly
reports which are called 2579 Reports for replacement components and not
for new installations. Keep them for new installations but when each of
those. Installations needs some replacement components perhaps where you
have required 2579s every time you replace an x-ray tube, I don\'t think
is necessary to have this paperwork coming forward.

We\'re going to suggest exempting x-ray equipment from any reports
except CT and fluoro where I think you have the most interest and
that\'s where the interest in the dose is. So we are suggesting that we
keep those but eliminate the annual reports for the other x-ray
equipment.

Now we certainly agree on shifting from the product testing to quality
systems audits and inspections. I mean we\'ve always come from that
direction. We\'re on record of not supporting type testing. The testing
you do isn\'t necessarily type testing but it\'s giving the hint to
other countries that type testing is okay and we don\'t like that. Type
testing is expensive. It\'s happening in Korea and China and any hint of
having the kind of type testing by a government especially FDA as okay
to us is damaging. So we agree with you. Quality systems is the way to
go. Most modern countries are going in that direction.

And I think that probably what you\'re getting at by giving up testing
would be the microwave oven, door slams and the TVs which don\'t even
have shunt regulator tubes anymore. But they still have screens, cathode
ray tubes.

This is something that we have become quite interested in recently.
There\'s a definite need for credible consumer/patient education and
what we\'re seeing especially with medical imaging, diagnostic imaging,
is that the public is being educated through the press. All we\'re
seeing these days in the *New York Times*, *Wall Street Journal*,
*Chicago Tribune*, the stories on imaging are coming forth and they\'re
coming forth unbalanced. Most of them are negative and there\'s no
balance. If the journalists were dealing with these issues with a sense
of a balance, the good with the bad or when they\'re talking about
utilization/over-utilization, they could be talking about some of things
that diagnostic imaging really saves, gets you out of the hospital two
weeks earlier rather than surgery, whatever. Yes, we need education.

As a matter of fact, the coverage in the press was so, I have to be
careful here. We felt the need to develop our own website so we could
actually balance the picture of medical imaging. It\'s a great website.
I think you would enjoy going into it. So please visit
medicalimaging.org.

Research. Yes, we agree.  Research based on highest priority questions
obviously. That\'s the only way to go when your resources are so
stretched and, yes, there should be an oversight committee. So that\'s
short and sweet. We just plainly agree with you on your suggestions.

How can NEMA and CDRH work together? Well, we talked with some of our
manufacturers and we think one of the contributions we can make is
develop a list of relevant IEC standards that FDA could take a look at
and that we could actually certify to.

Education. We are willing to work with FDA to develop whatever papers or
brochures you feel necessary to help you with your website. As a matter
of fact, I\'ve talked with our public relations program and suggested
that we even develop a section our medicalimaging.org for consumer and
patients and hopefully that would jive with yours. I understand you\'re
wanting to develop one too.

The problem with websites is making them known and making them available
and that\'s a bigger job. It\'s easier to do such a great job on a
website but then people don\'t just show up and click on it. You have to
make them.

And finally, we believe your plan is sound. It needs to be implemented.
I think these two days you\'re going to get a whole lot of good ideas.
We\'re ready to work with you. Thank you very much.

FACILITATOR LESLIE: Thank you. Give Bob a hand. Next up, American
Association of Physicists in Medicine, Dr. Ritenour. One of the things I
think you\'re going find from these today is you may very well is
occasionally the case, you\'ll see lots of agreement about that\'s a
perfectly good direction to go. The question always gets down to so how
do we do that and how do we do that together and that is what I hope we
begin to stimulate the discussion around over these next two days. Sir,
the floor is yours.

DR. RITENOUR: Thank you and thank you for the opportunity of commenting.
I think many of you are quite familiar with the AAPM but I\'m still
going to go through the description of who we are and what we do. I\'m
Russell Ritenour, currently President Elect.

The mission of the AAPM is to advance the practice of physics in
medicine and biology. We are into research and development,
dissemination of technical information, educational and professional
development, we spend quite a bit of time on that because our members
are board certified and have to maintain their certification, and
attempt to promote the IS quality medical physics services for patients.
We are in charge of radiation safety during radiological procedures and
many of our members through their individual research have improved many
types of imaging.

We also contribute to the development of therapeutic techniques such as
prostate implants, stereotactic radiosurgery, multileaf collimators,
tomotherapy and all of that sort of thing too. So medical physicists
collaborate with radiation oncologists to design treatment and insure
safety. The AAPM represents over 5,000 members.

So in terms of commenting on what the FDA is doing and planning and
thinking about I think we\'re in pretty good agreement with the things
that were mentioned in the RAD health plan overview just before the
break and I think my comments will bear that out. We do agree that you
need to concentrate of high risk areas such as interventional fluoro
where there\'s a risk of skin injury, computed tomography where there is
probably a significant contribution to population dose.

We\'re concerned about use of radiation and radiation producing machines
by unqualified individuals. Radiologists have a great deal of didactic
training in radiation safety and that training is reinforced through the
board exams that they take and we\'re concerned about individuals who
don\'t do things to keep radiation doses as low as possible.

We believe that quality assurance programs should be designed by medical
physicists and quality control programs too mainly because equipment
changes and new modalities are introduced so rapidly. It\'s very
difficult for anyone to be prescriptive about how to do these things.
Medical physicists are there at the forefront sometimes inventing these
changes but at least having to deal with them as soon as anyone does. So
we think that we\'re in unique position to oversee quality assurance and
quality control.

We also strongly support evidence-based regulation. One good example of
this is the IEC program that was mentioned earlier that could gather a
lot of data from DICAM headers.  The AAPM and the ACR also have a joint
program to look at the DICAM headers of computer tomography, computer
radiography and CT to store and transmit to a central location
information on patient technique factors, indices of patient dose and
that kind of data can certainly be the basis for what is the variation
across the country and what are people actually doing which certainly
plays a role in evidence-based regulation.

We do encourage the FDA to place more reliance upon the data that
medical physicists take in mammography. That was mentioned this morning
as well. Medical physicists have very strict requirements as to how to
be approved to do mammography and how they have to survey a number of
units under qualified individuals and do a number of units in a year to
maintain that certification and that kind of data is probably a very
effective way for the FDA to monitor what\'s going on in mammography, a
very cost effective way and people effective way.

In terms of education, I think we can have a real impact in
collaboration programs with the FDA. The AAPM currently provides
hundreds of hours of educational programs at its annual meeting which
occurs in the summer at various locations around the country and at the
Radiological Society of North America in the late fall. Some of that
material, some of those classroom type presentations, didactic
presentations would be of benefit.

But we also work specifically with groups such as CDRH and the
Conference for Radiation Control Program directors to provide special
educational programs at their meetings. Furthermore, the American
Association of Physicists in Medicine has chapters throughout the
country.  So in terms of hand-ons training on equipment, there are some
opportunities we could discuss there to work with academic programs or
others willing to work with training people in specific locations given
the difficulty of travel and the expense of travel to national programs.

Also we have several programs in place through our website. For example,
there\'s the remotely directed continuing education which was put
together basically to serve our members\' needs to have continuing
education credits and to maintain certification but it\'s certainly an
appropriate way to glean information on current practices that would be
useful to the CDRH and the FDA.

Also the AAPM has recently made its task group reports available
electronically online to all radiation control program directors because
we see that as in everyone\'s best interest to disseminate that
information as quickly as possible on new findings and good summaries of
best practices and quality assurance and quality control. So we look
forward to working with the FDA quite a bit in areas of education
because I think we\'re well set up to do that. I will end my comments
there.

FACILITATOR LESLIE: Russ, Bob, both of you did a nice job helping us
stay on track. If you have a minute, are there questions? Okay. You\'re
both getting off easy. Okay. Next up, Consumer Electronics Association
with Ms. Virginia Williams. There you are. Great. We have everything
ready to go.

MS. WILLIAMS: Good morning everyone. Thank you to the FDA for inviting
us. My name is Virginia Williams. I work in technology and standards for
the Consumer Electronics Association or as many of you know as CEA.

This morning\'s presentation is very short and to the point. First, I
want to tell you a little bit about CEA for anyone that doesn\'t know.
You may think you know. It turns out we\'re probably more than you think
you know already, the CE industry and how it relates to radiological
health and then some interesting observations from our side of the
industry and possibly how we can work together going forward.

CEA is a full service trade association. So for those of you that are in
the association world, these are all very familiar activities. Our
mission is to grow the consumer electronics industry. That means in a
lot of cases innovation for new technologies and also to protect our
industry from outside forces as well.

We do standards, government policy, research, education, the kinds of
things that trade associations do. Our industry itself is very large and
we are probably one of the broadest industries represented here today.
We have over 2,000 members and every horizontal and vertical slice of
the industry that you can imagine, everything from manufacturers, our
core base of members, the traditional members back to the days when the
only consumer electronics there was was radio and these days everything
is solid state, chip makers, service providers.

One thing I\'ll say at this juncture, our industry is so wide that it
overlaps with a lot of other industries. So it\'s often difficult to
classify products or technologies. One of the areas that is most
overlapping in today\'s subject is microwave ovens and I want you to
know that for the most part that sector of our industry is represented
very heavily by AHAM. I don\'t know if AHAM is going to present today or
not. But they have reviewed these slides and they concur with our
recommendations.

In the area of technology and standards, my department inside CEA, we
are broken down by a number of different committees that write standards
or help other people write standards. R1 is the product safety committee
and for the most part, they are not actively writing new standards.

Any of you that are familiar with the standards\' worlds have heard the
expression, \"The nice thing about standards is you have so many of them
to choose from.\" Unfortunately, when you have so many you have none. So
we\'re not in the business of just making work or trying to create new
things just for the sake of new projects. Where there is an existing
standard, it\'s our first choice to use that.

There are other aspects of the industry in terms of conformity
assessment that are well established and we\'re very supportive of
organizations like UL and other nationally-recognized test laboratories
or OSHA calls them Nerdles. I think they\'re rethinking that term even
as we speak.

There are a couple of areas of our website that give you more
information about this and since we\'re time limited, I have some extra
slides. If these presentations are made available, you\'ll see at the
end more detail of each on the areas that our standards and our other
departments work in.

I would like to just pause briefly and recognize some of the people that
helped put this presentation together. As a trade association, we\'re
very member driven. Our R1 committee is chaired by JVC, Ted Marks, who
is with us today and under R1, one of the many work groups that we have
is radiological compliance and health and that\'s chaired by Wayne
Myrick of Sharp who is also very instrumental in helping compile
comments and as they say, herd cats.

These are some of the projects that we\'ve done recently that relate.
There are a number of others that probably don\'t relate to today\'s
topic that I could go into. Our area of involvement in safety again is
very wide. We\'ve done things from stability of TVs based on their form
factors to make sure that they\'re not a liability physically and
mechanically to tip over and fall on people.

We\'ve also done some work in audio health, the proper use of our
products. One of the things that is very difficult in the CE world is
constantly evolving technology. So as new things come out, there are new
things that people didn\'t think of and part of how we help the public
learn how to use these products is through the product literature that
accompanies them. There are also product warnings and marking right on
the products and more general campaigns that we work with other partners
to get the word out in educating the public on safety of our products.

This is another product area that we worked in, another initiative for
manufacturers not so much for consumers but for the industry itself to
help them know the proper ways to deal with radiation, x-rays and no
TVs. It\'s meant for mostly offshore manufacturers, some guidance for
them.

Most of the industry that we work with is very mature and very safe and
they\'ve been doing this for a long time. So it\'s not so much for 70
percent market share members that we worry about but the new guys, the
smaller companies that are coming into the market.

In the area of product safety, I mentioned that we don\'t develop new
standards where they are not needed. Our preference is to work in the
international level with a number of agencies. We provide financial
support.  We provide support for experts to attend these meetings, to
contribute and we facilitate comments from industry funneled through
these experts into these committees. We also lobby internally in the
U.S. with other agencies and with government agencies for adoption of
these standards where they\'re appropriate.

One of the things that we\'ve noticed in the international front in the
last few years is a hazards-based approach. It\'s a very systematic way
of analyzing risk and understanding what the hazard is and how to
mitigate against it, less prescriptive than in the old days. Part of a
movement in a broader sense of object-oriented or performance-based
standards setting.

By way of general comments, I think it\'s safe to say that our part of
industry is probably not the highest risk area. That\'s not to say that
we\'re not diligent but based on our track record, we think for the most
part that we\'re very pleased to see the CDRH and the FDA in general
look toward more progressive changes and automation and streamlining of
the methods and focusing on the things that are more important, less on
the things that are less important. Having established a good track
record, it\'s probably safe to say that the reporting that we\'re doing
now is probably a bit of an overkill.

In general, our comments are going to be mostly about the reporting and
monitoring process. In general in that area, we think that we can
implement some reduced reporting in the annual report to minimize that
and probably no need for a product report. The other area that we hear
the most comments about is the custom\'s form itself and how much
information is either contained on it or the guidance that goes with it
and how to interpret some of the areas that need to be filled in.

In minimizing the annual report, the declaration of responsible party is
probably sufficient and a master list of authorized manufacturers\'
names and their countries of origin or another method to identify the
contact person, again keeping it simple and finding a responsible party
in the U.S. which may or may not be the manufacturer.

We think that we could afford to do some relaxation of the reporting
rules for Class 1 products. Lasers, televisions and microwaves are
primarily the products that we\'re talking about and again microwave
ovens is also represented by AHAM.

I think probably I\'m not going to read this slide to you. On the
customs form, echoing the same sort of sentiments about the responsible
party, we think that this could be consolidated with just one box that
has the manufacturer\'s responsible party of record. We could amend the
instructions better to explain and interpret and allow import
declaration without reference to the Class 1 products not specifically
to the products but just to the party of record.

In generalized standards, we can probably help a little bit more with
the how to. I know a lot of agencies are struggling with this at the
moment, how to do two things, point to the standards in general, do you
synchronize with them, do you point to them as a reference document,
what if the standards contain options, how do you decide which of them
you\'re going to allow, what about country differences. So there are a
number of aspects that need to be considered in harmonizing the
standards.

The idea of relevancy and timeliness. As the standards evolve, how do
the regs evolve with them?

Of course, recognition of compliance marking. In an ideal world,
there\'s one mark that all countries recognize and the standards that
the mark represents even if they\'re country standards, are harmonized
one standard, one size fits all, to the extent possible and to the
extent that the standards exist.

By way of example, it seems like there has been some attempt to do that
but maybe not as smooth as it could be. An example is Laser Notice 50
which is only partially harmonized with the International Standards and
this is ironically one of those areas where partially harmonizing is
almost worse than no harmonizing at all. All that does is create an
additional alternative and more complexity to the problem. So we would
advocate full harmonization to the standard.

In the area of education, we have no issues there to report but we are
here to help and I have a feeling you\'re going to hear this from most
of the stakeholders as well. We have as I said product literature that
comes with the products, ways of marking the products, tags that go on
the products, a long history of knowing how to get the consumer\'s
attention appropriately.

And in addition to that, we have general awareness campaigns that we can
help launch whether it\'s through a print campaign or other means, on
the website. Many of you know that we put on the International CES every
year and there\'s a lot of opportunity for coverage and for visibility
to the retail channel. So a lot of training is done to the consumer
through the retail channel.

Maybe a little more detail on these same thoughts will come out later in
the workshop today and tomorrow. In general, we have a lot of
opportunities and ways that we can be supportive in standards, in direct
contribution of input for revisions that you\'re making in your program
and in getting to the consumer, getting messages out to the consumer
public.

One thing, it\'s always bad to end on sort of on a wagging-your-finger
note, but I have to be honest. One of the comments that we heard was
that we would prefer that you not cry wolf. If you want to make changes,
then we need to make changes. There have been a number of attempts over
the years that seem to have lost their momentum and probably more
execution and commitment to the execution phase would be in order.

If we have time, I have more detailed slides but otherwise, I\'ll take
questions.

FACILITATOR LESLIE: Questions?

MS. WILLIAMS: Thank you. That\'s no.

FACILITATOR LESLIE: There probably will be plenty of time for questions
at breaks and lunches and the like. I suspect this will come later in
the day. Thank you very much.

MS. WILLIAMS: Thank you.

FACILITATOR LESLIE: Okay. Next up, Ms. Christine Lung from the American
Society for Radiological Technologists.

MS. LUNG: Good morning. ASRT is very glad to be invited to participate
in this FDA workshop because this is the first time we\'ve ever been
asked to participate. We are basically, I guess, the new kids on the
block when it comes to regulations.

But in this overview, I want to frame this as more of an introduction to
ASRT for you. I want to give you a little bit of the background, the
role of radiologic technologists, some of the ways RTs and CDRH can
interact together, some of the issues facing our workforce and
radiologic technologists\' needs as device endusers.  As you all know,
technologists follow the equipment and having the opportunity to comment
when it comes to this aspect of imaging is very important to us.

ASRT is the largest allied health association in the world. Right now,
we have a little over 120,000 members making up 48 percent of all
registered RTs. This figure does not include the number of imaging
technologists out there are either not registered or not licensed by
states. We have no way of capturing that number but we know that
there\'s a lot more people out there doing medical imaging than what we
really know to be true.

We represent diagnostic and therapeutic technologists performing in more
13 imaging and therapy modalities including radiation safety officers
and quality inspectors and ASRT\'s role is to provide radiologic
technologists with the knowledge, resources and the support they need to
deliver quality patient care.

As I said, the clinical role of RTs is to provide direct patient care.
With health care resources being stretched further and further, RTs are
spending more and more time with the patients that they are either
treating or imaging. We are using imaging equipment to emit ionizing and
non-ionizing radiation for diagnostic imaging as well as therapeutic
purposes. Our role in the clinical site is really to reduce and minimize
radiation exposure to patients as well as to the workers, radiologic
technologists and the public.

Radiologic technology as I said has not been directly involved with FDA
or CDRH until MQSA came along. The technologist\'s standards put in
place by MQSA has helped us elevate the stature of our profession and be
recognized more as a profession and more involved in patient care.

RTs are the equipment endusers. Our patients are the beneficiaries of
that use. But when it comes down to actually putting the hands on the
equipment, we\'re the folks and a lot of times we\'re not only just the
enduser. We\'re the repair person, the designers of where it may go and
we do a lot of input into how patient through-put goes on in
departments.

We play a large role in educating patients. Since we have probably the
largest amount of patient interaction in the imaging sites, we do a
patient education work there and we also are branching into more of a
research role in assessing the clinical efficacy of new imaging
equipment and devices.

Since we are an old profession but relatively new when it comes to be
out there in the public\'s forefront, we\'re finding out that there\'s a
general lack of public awareness about the imaging technology
professions. Not many people know who RTs are. They assume that
radiologic technologists are nurses or sometimes even physicians.

We really haven\'t been out there in the forefront and as a result of
this lack of public awareness, we have also a lack of consistent and
uniform professional standards. We still have states out there that have
no education or certification requirements for persons who perform
medical imaging, plant and deliver radiation therapy.

We also are seeing a difficulty with RT education not keeping pace with
the emerging technologies. One facet of that that we\'re dealing with
right now is fusion imaging, the combination of PET and CT for example.
We have a number of technologists that are CT certified and a number of
nuclear medicine technologists who are PET certified. However, when it
comes to fusing those two distinct modalities together, you run into a
personnel issue. They may be one but not the other.

We are currently coming out of a relative work force shortage. Three
years ago, the American Hospital Association reported that radiologic
technology\'s vacancies in hospitals was eighteen and a half percent,
higher than that of nursing.

We also are running into more and more workplace injuries because of
lack of ergonomic design controls when it comes to equipment as well as
patient lifting. So that is really an important issue to us right now.
We\'re having a shortage in the work force and we certainly want to keep
them healthy.

One way that ASRT can assist as endusers of devices is that we want to
work with manufacturers in developing user education tools. As I
mentioned, PET/CT has been a little bit of a speed bump for us. We
really need to know what\'s going on in the manufacturing area so that
by the time equipment hits the hospitals we have technologists that are
educated and can fully utilize that equipment.

We want to assist in the ergonomic design of equipment including patient
assistive devices. We realize that ergonomics is playing more and more
of a role in the delivery of health care and with Americans tending to
become a little bit wider as they are now, getting patients into CTs,
MRs and under C arms is becoming more and more of an issue. So we
certainly want to make sure that we can get patients imaged and treated.

Also we want to provide input on methods and techniques to reduce
radiation does to patient. This is really the most paramount we have on
our list. Patients are relatively uneducated when it comes to the amount
of radiation that they receive in medical imaging. We want to make sure
that we can balance and provide some equilibrium for them when it comes
to the medical necessity of the exam versus the radiation safety
aspects.

Just a brief thank you. We really appreciate the opportunity to be here
as well as we look forward to working with everyone when it comes to
providing safe and effective patient care and we certainly appreciate
the opportunity FDA and CDRH have given us to be here today.

FACILITATOR LESLIE: Okay. Dr. Charles Chambers representing the American
College of Cardiology and the Society for Cardiovascular Angiography and
Intervention. You\'re on.

DR. CHAMBERS: Good morning and thank you for having me here this
morning. As mentioned my name is Charlie Chambers. I\'m from Penn State
Hershey Medical Center. I\'ve been Director of the Cath out there for
ten years and Director of Nuclear Cardiology for about 15 years.

I\'m here representing the American College of Cardiology and the
Society for Cardiovascular Angiography and Interventions. The American
College of Cardiology as most of you are aware is approximately 31,000
members, all aspects and basis of non-invasive imaging.

The Society for Cardiovascular Angiography and Intervention is a more
specialized group of individuals where I serve as Board of Trustee for
that group. I\'ve been Chairman of the Laboratory Performance Standards
Committee for about three years. That group is 3,400 and is involved in
both invasive and interventional procedures.

You can tell an interventional cardiologist when he can\'t find a button
to push. Thank you. I\'d like to again thank the group of CDRH and the
FDA for having cardiology here today. I think what\'s important to
emphasize is that cardiologists as a group, the American College of
Cardiology, represents invasive, interventional, electrophysiologist,
nuclear, but also cardiologist in training and as a group when we
practice, we\'re actively representing the nurses and laboratory support
personnel.

It\'s important to keep in mind and I think part of my role here today
is to emphasize that we as a practicing cardiology group are routinely
exposed to radiation ourselves and our patients and they rely on the
cardiologist\'s judgment from the initial office visit into and
including the procedure and more importantly, we are actively involved
in these patients we see back in follow-up. We encourage the FDA and the
CDRH to include all physician specialists that use ionizing radiation in
their proposals and we\'re again thankful for the opportunity to speak
here today.

My comments today will be initially a few general comments and then
specifically as requested to address monitoring, standards and
education. First of all, as I\'m sure most in the audience are aware,
there\'s a significant variation between diagnostic and interventional
procedures. Having performed over 10,000 diagnostic procedures and over
3,000 interventional procedures in my 20 year career, there certainly is
a variation in those avenues and it\'s essential that those be separated
with respect to standards.

The FDA from our standpoint, it\'s important when they put together
standards to work to establish policy to talk with other organizations.
OSHA is seeking to determine whether regulations in the workplace,
ionizer regulations, should be modified. It\'s important that these
regulations be coordinated with the FDA proposals.

We want to avoid any potential conflicting or burdensome regulations in
the catheterization laboratory.

Though the NRC has not been involved in ionizing regulation, it\'s
important that they be involved if appropriate as well as any state or
regulatory bodies.

With specific comments with respect to standards, the ACC and the SCAI
are interested in the reference of the CDRH with respect to the
challenges in enforcement of these regulations. We\'re very interested
in how this program first into the FDA\'s June 2005 final rule on
Performance Standards for Diagnostic X-Ray Equipment.

With respect to the comments on the CDRH plan on the global concept,
several issues have to be addressed. In particular, the NCRP and ICRP,
the coordination of the various groups need to be addressed and the FDA
should be encouraged as it does today with incorporating the various
organizations to be encouraged to engage manufacturers in these
discussions.

I think the first presentation this morning addressed some of the CDRH
programs and particularly the better classification of monitoring. What
the ACC and the SCAI are concerned about with the respect to the CDRH
monitoring section is to specifically define what they mean by
monitoring and I think John did a good approach with this earlier in the
morning. But what we are concerned about is it\'s essential to include
cardiology in this monitoring process.

There are various stakeholders in all areas of this incorporating data
and particularly with cardiology with the ability to take these patients
from before the procedure, follow them through the procedure and with
follow-up we offer a unique perspective in the opportunity to see these
patients long term. And with respect to monitoring if life long
cumulative dose and things like that are involved, I think the
cardiology group offers a unique opportunity for this.

Along those lines, the ACC and SCIA have several data collection
vehicles, the SCIA with the Heart Rhythm Society and the Society for
Interventional Radiology and NCC are working with the National Cancer
Institute to field retrospective and prospective studies on operator
radiation exposure in the catheterization laboratory.

A specific monitoring tool that the ACC offers to its 31,000 members and
over 2,000 cardiocatheterization laboratories is the NCDR. The NCDR
actually has three separate monitoring groups. It has the PCI where
approximately 650 cath labs participate where they have over two million
records of interventional procedures performed. It also has a database
for implantable cardiodefibrillators and also is working on a carotid
stenting registry that is now in place.

In 2003 with efforts from several people here in the audience, an SCAI
nema-phantom was established for image quality assessment in the
cardiocatheterization laboratory and we have that as an imaging quality
assessment tool that\'s being put into place. But again, the ACC, NCDR
and the imaging phantom registry are voluntary proposals.

We as a group were very interested in the educational component proposed
by the CDRH, particularly the website issues. One of the earlier
speakers talked about the limitations of websites, the importance of the
ability of people to know what\'s there and to access it. With the
31,000 members of the American College of Cardiology as well as the SCI
database, there\'s a large number of access ability from our members to
the various websites.

We have very active websites in both the ACC and SCAI. The ability to
link these websites to a proposal with the CDRH I think offers a unique
opportunity for both programs to implement particularly in the
educational opportunities.

Over the years, the ACC has in conjunction with SCAI and other
organizations has put together several documents in the area of
radiation safety. Additionally with respect to the board examinations,
we now have approximately 5,000 interventional cardiologists that are
board certified in interventional cardiology. That board examination
includes approximately 30 percent of the questions on imaging and
radiation safety.

The documents that have been put forth by our society are listed here.
In 1998, our first major publication from ACC. It was a general overview
of radiation safety and an introduction of the IR principle.

With respect to training in cardiology, we have our document published
in 1999 and an overall standard for the cardiocatheterization labs.
Again with some participants here in the audience, we are very pleased
with the position statement that was published just last year, \"A
Clinical Competence Statement on Physician Knowledge to Optimize Patient
Safety,\" which has been an excellent tool for the cardiology community.

And most recently in the area of CT imaging which we encourage all
groups to be actively participating in, we published our clinical
competence statement. That was endorsed by the Society of CT.

Again, I would like to thank the FDA and the CDRH for having us here
today. It\'s my pleasure to represent the ACC and the 31,000 members as
well as the Society of Cardiovascular Angiography and Interventional. We
feel we offer a unique, broad-based, patient follow-up opportunity to
work with this group and we encourage this to be achieved and we look
forward to any opportunity to work with all. Thank you for your time.

FACILITATOR LESLIE: Thank you, Charles. So first, thank you speakers for
staying with the schedule. Now I don\'t know whether we twisted your
arms and threatened bodily harm if you didn\'t stay on schedule or not
but we\'ve wound up a little ahead of schedule. So thank you very much.

I would actually like to take advantage of this being a little ahead of
schedule and if you will allow a little period of open mike and if there
are things that ought to get said, read into the record here, points of
view, you are stakeholders in this radiological health business and
there may be some of you that aren\'t scheduled to present that actually
would like an opportunity to say something, to raise up an issue or
something that we might not ought to overlook. So I would actually like
to take a minute here and allow anybody that would like to speak an
opportunity to do that. We\'ll still probably break a little early for
lunch but it\'s an opportunity I\'d rather not pass up.

Frankly, that includes the folks from CDRH. If there are things that any
of you would wish to say, I\'d say you ought to feel free to step to the
mike and have that say as well because this is a community of
stakeholders and we all have a point of view in this and we all have a
role to play.

So anybody\'s point of view on this is worthy of hearing. So let me say
anybody that would like to speak either asking a question or make a
statement please raise your hand or a head to the microphone.  This was
intended to be an interactive exercise. You\'re on. Just say your name
again and say where you\'re from.

MR. McCORMICK: I\'m Luke McCormick with U.S. Customs and Border
Protection.

FACILITATOR LESLIE: Thank you.

MR. McCORMICK: And what I want to do is reemphasize what I\'ve heard
from a number of people here already. Make sure that any regulations you
put out there are in conformity with the Nuclear Regulatory Commission,
OSHA as well as all the other little regulatory agencies. Especially
when you get into a nationwide program, it is amazing how many
conflicting regulations there are in the Federal Government alone. When
we start adding in individual states, it\'s a mess.

FACILITATOR LESLIE: Wonderful. Thank you. Others? Tom, are you coming
around?

MR. SHOPE: Yes, nobody else is.

FACILITATOR LESLIE: Okay. Cool. I was told you weren\'t a shy group.
I\'m a little surprised here.

MR. SHOPE: I wanted to make a comment and then maybe \--

FACILITATOR LESLIE: Tom, identify yourself please.

MR. SHOPE: Okay. I\'m Tom Shope with the Center for Devices and
Radiological Health. One thing I wanted to just mention. There\'s top of
regulation and I just want to make sure people understand, are aware and
are thinking about the kinds of regulations, the kind of regulatory
authority that FDA has and our authority to regulate comes through the
Congressional legislation that gives us a charge or a mission or an
authority to do regulations and those currently with the exception of
mammography which addresses the whole clinical practice of mammography
gives us the authority to regulate the performance of electronic
products that emit radiation and we can regulate the manufacturers and
establish standards for which manufacturers have to conform and certify
their products.

We also have the medical device amendments to the Food, Drug and
Cosmetic Act that also gives us the authority to regulate the
manufacturers by acting as gatekeepers to what can be marketed in the
U.S. that\'s illegal to market products that haven\'t been either
approved or cleared by FDA depending on the class of the product.

We don\'t have the authority to do anything else in terms of
regulations. So I wanted to get that out there. We\'re not an authority
to regulate the practice of medicine, how products are used. We could if
Congress passed another legislation that gave us some of these
authorities and equipped us to do those kinds of things. But we\'re not
at that stage. So the thought that FDA is going to regulate occupational
exposures, what technologies can do, the kinds of monitoring that
physicians might have to do of their patients, all those things are
outside our realm of responsibility currently.

So that was my little comment to put in perspective what we can do from
a regulatory standpoint. It can always if Congress changes something.

The second point I wanted to make was to ask a question and perhaps get
people to think about, our current process for establishing mandatory
performance standards which is the notice and comment rulemaking
procedures as laid out in the administrative procedures. In Europe, they
don\'t quite have that involved process to take an international
standard and have it apply and be mandatory in the European countries.
They have a method whereby they can through the CENLEC procedures which
is basically a committee procedure.

If a international consensus standard is approved and thought to be
effective for use, it doesn\'t have to go through notice and comment
rulemaking. So the point I wanted to pose is what is the opinion,
reaction, thoughts of the group as to suppose Congress where to give the
secretary the authority not to establish a mandatory performance
standard by notice and comment rulemaking but the authority to recognize
an international or national consensus standard developed by a consensus
group in an open process recognize that standard and by that recognition
require conformance with that standard for any product of that type sold
in the U.S. It would not be the notice and comment rulemaking that gets
into the environmental assessment, the regulatory assessment, the
federalism assessment, all the assessments that are tied up currently in
the notice and comment rulemaking, the whole cost benefit analysis stuff
that is required when the Federal Government does a regulation. But if
you\'re dealing with an international consensus standard that\'s been
developed in a consensus process by the industry, interested
professional groups, the regulatory groups of the various countries and
voted on by the national committees of the countries, perhaps there is a
simpler process that we might use to adopt a regulatory approach to
requiring conformance to international standards but that don\'t have
the bottleneck that we currently have speaking from some firsthand
experience recently.

We\'re not going to talk about this in any more greater detail today but
I wanted to take the opportunity to pose that question to get people to
think about how acceptable would that approach be. Would industry be
willing to deal with that? Would the consumers think that\'s
appropriate?  Would they want to always have this notice and comment
rulemaking process rather than relying on an international consensus
standard? Food for thought hopefully.

FACILITATOR LESLIE: Good. So that\'s rhetorical but for tomorrow, Tom
has either seeded the clouds or chummed the water depending on which
image you have and the like. Okay. Other comments? Anybody else? This is
a good time to get provocative if you want to put an idea on the table.
The whole intention of the day. Wait sir. One and then you\'re next.
Please. Before you start, then what we\'ll do is if we finish you all
saying anything early, we\'ll adjust lunch a little bit. Otherwise,
we\'ll stay on schedule. Sir, who you are and where you\'re from first.

MR. MATHER: Rich Mather, Toshiba American Medical Systems. I just had a
quick comment on Bob\'s thought about the website and the education for
the general public. It\'s certainly disturbing and definitely a problem
that the public gets all their radiological information from the press
and via us. It think it\'s a great idea once we get it out there to make
it available and seen.

My only concern and maybe a trick that we have to get to do it is that I
think there\'s a general public mistrust of the government especially
when it comes to radiological issues and whether they would believe it
coming from a government body and how do we address that. I think
there\'s a more trust of the press than there is of the government in
general. So it would be good to get it out there but also to get it into
a position that it\'s believable and they feel they can trust what they
read. Just a comment.

FACILITATOR LESLIE: Cool. Thank you very much. Sir, you\'re next and
then Bob, you.

MR. MORTON: I\'m Bob Morton. I represent my own company, Quality and
Regulatory Services and I consult for medical device manufacturers and
have done so for the last 12 years. But I used to work at the Bureau of
Radiological Health/Center for Devices and Radiological Health.

So I have a comment specifically at this time about these international
standards. Bob Britain was right. It\'s tempting to just latch onto
these but I served on a committee developing the international standards
for IEC for radiation therapy equipment and it\'s not an easy process.
 It takes years. It doesn\'t keep up with technology and the application
of that to get the CE mark is very variable. It depends on who you hire
to get your CE mark as to what clauses of the standards they think
applies to your device.

So it\'s not even uniform to get a CE mark for the same kind of device
for two manufacturers if they use two different certifying bodies. The
first thing is when they say I comply with IEC 601-1, the Electro Safety
Standard, it\'s impossible that they comply with all clauses. They
don\'t make a device that has the need to comply with all clauses. So
that\'s already wrong. They can\'t do it. But we say we do it. The
manufacturers say they do it.

So to just shift over to an international standard is just pulling the
wool over the consumers\' eyes in my opinion because the consumer thinks
the government is actually looking out for them and this perceived risk
aspect, they think there\'s somebody protecting them from radiation and
if you shift over to some international selectivity measure, they\'re
not going to have that protection.

Lastly, what is the criteria for this risk base? Is it like the traffic
light approach? Three deaths at an intersection and we can have a
traffic light? How do you decide risk?

I\'m also involved with companies in reporting adverse events to medical
device reports, AROs and the like and I also know what\'s not reported.
So I don\'t think you know what the risks are by looking at those and I
also don\'t believe that the MDR reports are analyzed today to look for
risk because I know what the reports are that go in for some
manufacturers and there should have been FDA action based on what was
written. So I don\'t think you know the risk and I would hesitate a
great deal to go to IEC standards for the new method of regulating this
industry. Thank you.

FACILITATOR LESLIE: Good. Thank you. You know if these questions were
easy, we wouldn\'t have to get us all together. But these points of view
need to be heard. John.

MR. VILLFORTH: John Villforth. I\'m going to need a little help on this
from some of the old timers like Bob. But as I recall, the Radiation
Control for Health and Safety Act\'s primary intention for regulating
these products that were described here is through the Federal Mandatory
Performance Standard of which you heard a lot about today and which I
think it\'s been agreed has a lot of problems in getting those current
and the enforcement activity that goes with it.

There is another provision of the Act and that is the defect provision.
Basically it says in the absence, I\'m paraphrasing and that\'s why I
need Bob\'s help, of a mandatory Federal performance standard if there
was a product or a class of products in which there is problem, I don\'t
know how to define that and these aren\'t the words of the Act, but
there is something like that that is of concern, the FDA can come in and
regulate that product as defective and require refunding of the money to
the consumer, replacement or repair. I think those are the three Rs that
were listed in the Act.

So on the one hand as we go about discussing this is that recommended
approach of the Act of mandatory Federal performance standards. But
there\'s something else in there which is not very clear and it probably
depends to a large extent on the role of general counsel as to how much
they\'re going to support something versus how much something is a minor
discrepancy with some international or whatever kind of standard before
you take action.

But there is a hammer in that Act that should not go unconsidered and
that needs to perhaps get on the table to get resolution to the people
who are involved with the standard setting to get resolution on the part
of FDA CDRH as to what extent might that be used and how extensive
should it be. Is it left to the judgment of the people who see a defect
as to what a defect is I think it is or what I call as a defect that\'s
a defect or whether in fact there can be some clarification, just to put
that other point for consideration?

FACILITATOR LESLIE: Good. Thank you, John.

MS. APPLEGATE: Kimberly Applegate again. From an enduser perspective, I
would just like to raise a different issue which is that I understand
regulations are quite complex for getting things on to the market. But
as an enduser, I\'m concerned about a lack of regulation of use of the
equipment particularly the higher radiation emitters and in particular I
think it would be interesting to address the oversight and this is just
a check and a balance concept that we all understand given our
government that there is no check and balance or very little check and
balance outside of the community hospital setting. If you look at where
these devices are being used and where the growth is, it is not in the
community hospital setting where there is committee oversight by
professionals, but it\'s outside of that in specialty hospitals and in
outpatient setting.

FACILITATOR LESLIE: Great. Thank you.

MR. MYRICK: Wayne Myrick from Sharp Electronics. I just have a general
comment and a question. There\'s a group known as TEPRSSC that
represents a lot of the stakeholders as spoken this morning. The
question would be what role will they play in developing the plan and
implementing the plan.

FACILITATOR LESLIE: Okay. Thank you. John, let me look to you. Is that a
question that comes out of tomorrow or is that a question you actually
have a view on you would want to talk to at the moment? It\'s really
TEPRSSC\'s role going forward.

DEPUTY DIRECTOR McCROHAN: I don\'t know if that\'s going to be come out
of tomorrow\'s discussions. One of the things that I would say is that
it\'s clear if we take any actions to alter any of the mandatory
performance standards, any of our regulations, we have a legislative
obligation to consult with TEPRSSC. So it\'s natural that they would be
involved in some of the processes that we\'ve been talking about vis á
vis the standards this morning.

In recent years, we\'ve tended to broaden their role and we\'ve used
them if you will as a sounding board and we\'ve had conversations with
TEPRSSC in areas that weren\'t really regulatory. How should we approach
various things and so on? We haven\'t met with them really recently.
There\'s not to my knowledge another meeting scheduled as yet but we
certainly would expect to bring them up to speed on where we are and
where we plan to head and use them in that consultative role even
outside the area of regulations per se.

FACILITATOR LESLIE: Okay. Bob.

MR. BRITAIN: Bob Britain with NEMA. I just want to say a few things
about the IEC standards or the ISO standards which are International
Standards and I\'m not going to completely disagree with Bob wherever
you are, Bob. But I just don\'t think you can throw them out. We just
have to make them better, probably have to do a better job on the
committee work if Bob is seeing that sometimes these don\'t work
properly.

The world cannot exist without these international standards. A group
like NEMA has to look globally. Most of our manufacturers are global
manufacturers. We cannot have countries like China and Korea and Japan
and Europe coming up with different standards. So where do you start?
You have to start from IEC or International Standards and then they
trickle down.

The other thing, Bob was talking about the CE mark and CENLAC and CEN
these standards, yes they\'re taken from ISO and IEC and most of the
time they\'re mirror images. Sometimes there are a few changes but
they\'re voluntary standards. They\'re not regulatory standards.

In Europe, you are required, a device manufacturer is required, to meet
essential requirements as part of their law. And you can do so by either
saying that you will meet standards that are directed to the certain
essential requirements or you can describe how you can meet the
essential requirements without actually meeting a CEN or CENLAC
standard. I just wanted to clarify that for the record.

FACILITATOR LESLIE: Good. Thank you, Bob. Okay. I don\'t see anybody
else standing up. Let\'s take this opportunity and go to lunch. Now as
we do that, here\'s a couple of points. (1) We will have the room open
and there will be somebody here. However, I would carry your phones with
you. I do a little looking after your stuff. I don\'t know that it\'s
not safe but I\'m not prepared to guarantee that I\'m going to sit on
top of everybody\'s laptop for an hour and a half. So just know that.

Secondly, I would like to reconvene at 1:15 p.m. That\'s what your
agenda says for the start time. When we get back, tell me whether the
amount of time it takes to actually get fed is about right because then
we\'ll know what to adjust if anything tomorrow for the lunch.
Otherwise, we\'ll cool it off a little bit between now and 1:15 p.m. So
we\'ll reconvene at 1:15 p.m. Thank you very much for the morning.

(Whereupon, at 11:52 a.m., the above-entitled matter recessed to
reconvene at 1:14 p.m. the same day.)

A-F-T-E-R-N-O-O-N S-E-S-S-I-O-N

1:14 p.m.

FACILITATOR LESLIE: All right. Are we ready to go? Two quick things if I
might as we begin this afternoon. First of all, does the amount of time
we\'ve allotted for lunch seem about right or did you wind up with time
on your hands you wished we would have been back in session? Is it about
right? Too long? Too short? It\'s okay. All right. Good.

Second thing is check your cell phone please. Get them on vibrate or off
or something. You know after lunch we all forget to do that, me
included. Okay.

The afternoon looks like this. We have a series of presentations, then a
break, public comment period. If we wind up with extra time, look for me
to do open mike again and allow those who have something to provide us
that prepares us to better discuss the issues tomorrow, we\'d like to
hear from that. We\'ll wrap up the afternoon with a few words about how
I\'d like tomorrow to go and then we\'re off. With a little luck, many
of you will stay and have something with us at the bar and say hello to
people you haven\'t yet met because this is a wonderful opportunity to
put names and faces together and see old friends and make some new ones.

With that, let me get into the agenda. The American College of
Radiology, Pam Wilcox. You\'re on.

MS. WILCOX: Thank you. It\'s a pleasure to be here. Again as with the
other speakers, I want to thank the FDA and CDRH for inviting us to
participate. I think this is an exciting initiative and the ACR is very
supportive of these proposed changes from CDRH.

I\'m the head of the Department of Quality and Safety for the American
College of Radiology and so I\'m going to primarily focus on what we do
within that area of the organization. But just to give you a little bit
of background about who we are for those of you who don\'t know, there
are over 30,000 members in the ACR. It includes radiologists, radiation
oncologists, medical physicists, nuclear medicine physicians and
interventional radiologists. There is more than one interventional
radiologists.

This is the mission statement of the ACR. I think it\'s key to thinking
about what we\'re doing and how we can collaborate as a community of
radiology and with the FDA and CDRH. Our primary focus is advancing the
science of radiology, improving the quality of patient care, providing
continuing education for radiology and allied health professions and
conducting research for the future of radiology. All of these go very
nicely with the proposals that we\'ve been hearing about all day.

First of all, we have practice guidelines and technical standards. These
are very different than what we were talking about in the context of
standards this morning. They\'re really more looking at specific
training skills and techniques.  They don\'t focus as much on dose.
Although we do have a practice guideline that\'s in physics for the
reference values and we\'ll talk a little bit more about that later.

There are educational tools designed to assist practitioners in
providing appropriate radiological care for patients. There are over 160
of them now and we go through a consensus building process and then they
are approved by our council at the annual meeting. However, they are not
intended to establish a legal standard of care but rather to be
educational pieces.

We have accreditation programs in all of these modalities. As was
mentioned earlier under the Mammography Quality Standards Act, the ACR
is the national accrediting body. There are a number of states that also
accredit within their borders. We accredit 12,975 units in the country
currently. So these numbers are unit numbers.

We also have programs in stereotactic breast biopsy and breast
ultrasound and biopsy. CT is a relatively new program and we\'ll talk a
little bit more about some exciting data that\'s going to be coming out
of that program now that it\'s reached its three year anniversary. MRI.
Nuclear medicine.  The PET program again is also relatively new but may
fit well with some of the things we want to do here.

We have appropriateness criteria. I was pleased to hear John say right
exam for the right reason, done the right way, with the right dose.
Right now, appropriateness criteria is doing the right exam for the
right reason. Given a set of clinical conditions, what is the right
exam, the most appropriate exam to be done for that patient? It\'s to
enable referring providers as well as payers to make the appropriate
decision about imaging. We are in the process of looking at dose and
linking dose to the appropriateness criteria, too. So there will be even
a stronger educational tool going forward.

Other products that are in the Department of Quality and Safety include
quality control manuals in mammographies, stereotactic breast biopsy,
MRI and the ever popular barium enema. They\'re already asleep.

We also have a program called RADPEER which is a peer review program for
radiologists. As they\'re doing interpretation, they pull out old cases
from the jacket and they score according to whether they agree with the
diagnosis that was made or whether it was a miss. And it\'s a quality
improvement program. We collect data. It\'s all deidentified but we
provide benchmark reports back to the facilities.

BIRADS, anyone in mammography or breast cancer is probably familiar with
this lexicon that was originally developed in the very early 90s by the
ACR and now includes not just mammography but MRI and breast ultrasound.

We also have a white paper on MRI safety. One of the things I\'d like to
hear a little bit about is is there any role for the CDRH in MRI. No,
it\'s not radiation but is there something that we should be looking
forward to given the safety issues in MRI?

I want to talk a little bit about our new initiatives because I think
these are some things that will be very much interesting to this group
in going forward in collaboration with the CDRH is very viable and would
be very exciting. I mentioned earlier that from CT accreditation we have
dose data. We have data from over 820 units collected through the
accreditation process over the last three years and the dose data is
compared against the reference values, so the adult head at 60, adult
abdomen at 35 and pediatric abdomen at 25. We had a meeting just last
week to look at this data. We\'re going to be doing some further
analysis and expect to get a paper out early next year to really get the
word out about how to reduce dose and optimize image quality. That\'s
what this is really all about. We\'d like to work with CDRH on
disseminating this information going forward.

We have another new initiative that we\'ll be kicking off right after
the first of the year. It\'s a dose reduction program and again, we\'ll
be inviting CDRH to appoint someone to participate in this committee. It
will be an effort to educate radiologists and radiologic technologists
about ways to achieve diagnostic quality images with the lowest dose
possible. We are all familiar ALARA but ALARA often, I think, motivates
people to do optimal image quality when acceptable diagnostic quality
doesn\'t necessarily mean the same thing and we may be able to reduce
significantly more.

We need to educate referring physicians and Dr. Applegate talked about
the issues with pediatrics. We really need to get the word out to the
referring physicians about dose issues and to the public as John was
speaking about this morning, choosing the right exam for the right
reason with the lose possible radiation exposure. Again, as I mentioned
earlier, we\'re going to be linking dose to the appropriateness criteria
as part of this initiative. We really need to get the message out what
diagnostic quality is versus optimal image quality.

Another new initiative is what we\'re calling National Radiology Data
Registry or NRDR. And NRDR will be an umbrella registry that will
include modality registries, for instance a PET registry and that\'s
been mandated by Medicare.  There will be a registry for carotid
stenting as well.

Then under GRID which stands for General Radiology Information Database,
we will be looking at performance outcomes as well as adverse events,
contrast reactions, things like that. RADPEER that I mentioned will also
fit under this registry and then the Dose Registry that Dr. Ritenour
talked about this morning in terms of collecting dose from CT will also
be a part of this data collection. So as time goes on, we\'ll have a
really rich database that will allow us to mine it for real benchmarks
and educational materials back to facilities as well as on a more
universal basis through publication.

So having said all that, I think there are lots of opportunities for
collaboration. Sharing data as part of the monitoring initiative of the
CDRH can be done through projects like the CT Dose Collection
Initiative. Coordinating dissemination of new data and guidance,
educational programs through the CDRH, again I think there is a lot of
information that radiology and oncology radiology has to share but we
need to find multiple avenues to get the information out there.

Clearly, we can reach the radiologists and the medical physicists in our
community. But how do we reach the other physicians who are using
imaging? How do we reach patients and payers? I think looking to CDRH to
help coordinate that as well as facilitating international cooperation.
We heard about consensus standards this morning. That\'s going to be a
key element going forward.

I was pleased to hear John talk about the use of consensus standards
rather than mandatory standards. Because as we all know, the way
technology is evolving so rapidly if we have mandatory standards the
unintended consequences could certainly be to limit technology going
forward. So with that, I will finish.

FACILITATOR LESLIE: Any questions? John.

DEPUTY DIRECTOR McCROHAN: I\'m John McCrohan. One of your slides, Pam,
talked about the CT dose collection and the reference values and I\'m
struck by the fact that at least at the moment there are in CT reference
values for the adult head, the adult abdomen and pediatric abdomen. I
guess my question is for you and for others and perhaps for conversation
tomorrow is that a picture of what\'s going on in CT. Does that have
sufficient granularity? Are there enough reference values for the
purposes that we have collectively in mind? Is it sufficient a sense,
let\'s say, of what the national average is for CT or whatever of the
head, the chest, the abdomen irrespective of the procedure that\'s being
done in that area?

You mentioned a number of things where if you\'re going to do a stent
placement, you might do a procedure one way. If you were going to do a
general diagnostic survey, you might do something else. So in theory,
how far ought we to go in terms of trying to make our picture of what
exposures and doses are richer using CT as an example of those three
things where we ought to be or are we hoping to go further with that?

FACILITATOR LESLIE: John, I think in terms of the dose registry
beginning with CT it\'s going to be key. The concept as I understand it,
and I\'ll ask Dr. Ritenour to speak or maybe even Jeff may be able to
speak to this more since this is an AAPM ACR project, it\'s my
understanding that the idea is you take an exam and you will be able to
through software automatically upload to this registry what your dose is
for a given exam. I think that\'s the kind of data that we\'re really
going to need.

Head and abdomen are important. The reference values come from Europe.
But as we were talking about last week at our meeting, you\'re doing a
liver and how many times do you go through the same body part to do an
abdomen? So what\'s the real effect of dose as opposed to these
particular reference values? I think we can get there.

How we will achieve participation in the dose registry is another issue.
That\'s one that worries me a little bit. In an environment where most
imagers including the technologists as well as the physicians are
overtaxed, time is of the essence. How do we make sure that we get out
what we really want to get out without adding to the burden?

FACILITATOR LESLIE: Good. Thank you, Pam. Next, Dr. Geoffrey Ibbot,
American Society for Therapeutic Radiology Oncology. We have you ready
to go. Great. You\'re on.

DR. IBBOT: Great. Thank you. Yes, I\'m Geoff Ibbot. I\'m a medical
physicist at M.D. Anderson Cancer Center in Houston. I work in the
Radiation Oncology Department there.  And I\'m here on behalf of the
American Society for Therapeutic Radiation Oncology, ASTRO, to talk to
you about ASTRO\'s position and interests on some of the things we\'ve
been hearing about today.

ASTRO is the largest radiation oncology society in the world. Virtually,
all radiation oncologists in the U.S. are members but there are many
international members as well. So all together, there are 8,500 of us
including medical physicists, radiobiologists who play a very important
role in radiation oncology and also oncology nurses who come to ASTRO
for educational opportunities.

And you\'ll hear some similarities between this presentation and Pam\'s
a moment ago because radiation oncology and radiology work very closely
together and have many of the same interests. And of course, ASTRO\'s
principal interest is advancing patient care by providing access to
radiation oncology and assuring the best possible treatment.

Now I was interested to hear the comments about patient education
because one of the issues for radiation oncology is misconceptions on
the part of patients, members of the public, even referring physicians
who don\'t always understand how radiation can be beneficial when they
believe all these statements. So public education is certainly an issue
for ASTRO.

In terms of regulations, again ASTRO\'s primary goal is ensuring that
patients who need radiation therapy can get it. So while regulations
have a very important role in assuring consistency and quality, we have
to be careful that they don\'t inhibit access to procedures and to the
development of new techniques.

So listed here are the agencies you\'re all familiar with that already
play some role in regulating radiation oncology, the NRC of course,
especially for radioactive sources, the FDA. While the MQSA doesn\'t
affect radiation oncology directly, that is a source of referrals. So
good mammography is important. OSHA regulations play a part.

IAEA standards haven\'t been mentioned this morning, I don\'t believe,
and play a role in radiation oncology even in the U.S. even though they
principally apply outside the U.S. A number of American physicists and
physicians contribute to the development of those standards. So they
have a way of working back into our own standards here.

NCRP provides important guidance to the practice of radiation oncology
and the design of facilities. We\'ve already talked about the state
agencies and of course, institutions have their own internal regulations
all of which contribute to regulations affecting radiation oncology.

Now in terms of standards, we mentioned IEC standards several times
today. Certainly, they can play an important role. But I do agree with
Bob Morton that we have to take leadership to make sure that they are
current and relevant particularly if we\'re going to consider adopting
those or referencing IEC standards in the U.S. which putting my IEC hat
on I think would be a great idea.

I want to mention IHE and particularly IHE-RO, the Radiation Oncology
version of Integrating the Health Care Enterprise. This is an important
and very exciting development in our field that will enable radiation
oncology equipment and practitioners to communicate, transfer data
effectively and seamlessly. This is critical of course all through
medicine but very much so in radiation oncology which is probably the
most technical and most quantitative field of medicine I\'m familiar
with. So we deal with large amounts of data and transporting those data
accurately is critical.

Some of the issues and concerns for ASTRO are monitoring. Monitoring is
important but as already has been said, it will be most effective if
it\'s consistent among agencies and if areas of duplication can be
eliminated.

Regulations should be targeted to the need and require being updated
regularly. To keep them focused on new equipment and new procedures.

We certainly need information about adverse events, equipment problems
but also successful methods of treatment which must be disseminated. We
have good techniques for distributing scientific information. We don\'t
do so well about adverse events partly because of the threat of
litigation and partly because we don\'t have a uniform, straightforward
way of reporting adverse events, equipment problems in particular.

Quality of procedures must be maintained and regulations must not be
allowed to inhibit or adversely affect the quality of those procedures.

Finally, with regard to public education, we\'re certainly supportive of
CDRH plans to coordinate education in this area and to enhance existing
training opportunities while developing new ones.

I want to point out ASTRO\'s educational programs in this area. ASTRO
has a number of activities going on including our Train-The-Trainer
courses which is a very effective way of disseminating information and
expertise rapidly. Radiation incident management course that is
available and may be suitable for adoption in other areas and the
radiation emergency planning training prepared by ASTRO which also might
be appropriate for other groups. I will end there. Thank you very much.

FACILITATOR LESLIE: Thank you. Any questions for Geoff? Okay. Great.
Thank you. Tom Kerr up next, the Conference of Radiation Control Program
Directors. Sir, are you ready? All right.

MR. KERR: Good afternoon, everybody. It\'s good to be here. If I seem
just a little down, it\'s not because of lunch. It\'s because this
morning I got the call that I\'ve been passed over again as a Supreme
Court nominee.

Anyway, I\'m the Executive Director of the Conference of Radiation
Control Program Directors. So I\'ll keep my day job for a little while I
guess and talk to you a little bit. I guess I\'m the first speaker other
than the FDA folks who actually works in a group that has some
regulatory authority of its members. So this will be maybe a slightly
different take on things. But CRCPD and CDRH have been working for many
years, over 30 years, together to further the cause of radiation
protection. We\'ll talk a little bit about that.

First off, we were established in 1968. It\'s a nonprofit organization
incorporated in Kentucky not for any particular reason but other than
the fact that the first executive director lived there. But it\'s a
really nice place to be incorporated out of. Our members, we have a
little less than 1,000 members. I don\'t think we\'re the largest group
of anything. You\'ve heard that a couple times today. But we only have
about 1,000 members but there are a lot of states. All the states are
represented as radiation control program directors and many of the state
officials and local officials as well as others that are interested in
radiation issues are member of CRCPD. So although it may be small, it\'s
really high quality folks.

Our purpose is important. We provide a common forum for the exchange of
information among state and local radiation control programs and keeping
the conversation going with the Federal Government on radiation
protection issues as well. That\'s a real important part of our overall
purpose because, and I heard this referred to once this morning at
least, it\'s one of the things that CRCPD does is tries to promote
consistency in addressing and resolving radiation protection issues.
That\'s a tough job when you have 50 states and a couple of territories
pulling in that many different directions. Also part of the mission is
to encourage high standards of quality and to provide leadership in
radiation safety and education. So we have many of the same goals that
CDRH does.

The ultimate goal is to keep the radiation exposure of the patient and
worker and general public to the lowest practical level while not
restricting the beneficial uses of radiation and radioactive materials
because CRCPD covers a lot more than just the issues that CDRH might be
interested in. A whole gambit of other issues.

This is what the org looks like. In particular, the two sections I would
like to refer you to are on your left there. We have councils underneath
our board of directors. We have the one that pays a lot of attention to
issues in this area. It\'s the Healing Arts Council. That\'s composed of
many different committees that look at all of these different issues and
produce guidance, white papers, analyses, comments on different
regulations and guidance that other groups put out. That\'s a real
important part of what we do is under the Healing Arts Council.

And if you have any questions on the Healing Arts Council, I happen to
have the Healing Arts Council chairperson in the room here and he knows
everything. That\'s John Winston from Pennsylvania. He knows everything
about that. Personally, I wouldn\'t like that. It would take all the
mystery out of life.

The second one that I want to point out for you is what\'s called the
Suggested State Regulations Council. This is one that\'s very important
because one of the major products that CRCPD works on is called the
Suggested State Regulations. This is a comprehensive compendium of
regulations that states can then take, change to their own
circumstances. These are developed through committee action and advisors
and resource persons work on these.

They go through an extensive review process, input from stakeholders and
so forth just like regular rulemakings do just about and they go through
that. They\'re produced. They are approved by the board for
dissemination for peer review. They go through peer review at the
federal agency level.

So when it comes out and it\'s ultimately approved, it\'s a pretty good
document. We look at the Federal regulations. We look at particular
things that are important to the states and those are incorporated into
the suggested state regulation. They address a lot of different issues,
pretty much the entire gambit of issues that you might find in radiation
control programs. That\'s one of our big ones. Those two I wanted to
point out in particular because those are real important products for
us.

One of the things that CDRH asked us was what issues needed to be
addressed and I figured that being a little bit later in the day that
the medical issues had been pretty much beaten to death and I think I\'m
right. We\'re not saying that those aren\'t important. I would refer to
you all of those that the states are indeed very interested in CT and
PET and fluoroscopy and all of the other medical things. But I thought
that by this time we\'ve pretty much talked about those and those are
issues and we all know that those are issues that need to be addressed.

So I wanted to mention a couple that I didn\'t think would be mentioned
quite so much by this time and that\'s some of the non ionizing
radiation technologies like lasers and tanning beds. States are
interested in those. We do have suggested state regulations regarding
those issues. So those should not be forgotten.

We also wanted to point out the non medical uses of ionizing radiation
and those were mentioned briefly this morning like people scanners at
prisons, baggage scanners and those kinds of things. Those are also
issues that are of concern to some states.

One that was brought up by another state regulator that\'s here today
and I\'ll refer this one to him if you have any questions is the
criteria for electronic signatories for diagnostic and therapeutic
procedure prescriptions. One of the things that we\'re seeing in several
states is that there\'s really no set criteria as to what\'s accepted
there. Many states require a written prescription. What does that mean
in the era of electronic signatures? Even our own suggested state
regulations talk about written prescriptions. So we all need to think
about those things as the technologies advance how do we incorporate
those kinds of requirements into regulations to allow the flexibility
that we\'re beginning to see in these areas.

A couple of other things. Many of the states are expressing some levels
of concern about the cutting back on calibration of equipment. That
remains an issue. I\'m not going to suggest any solutions here but that
is an issue that needs to be addressed. It needs to be very carefully
thought through and I know that we\'ve talked to some of these CDRH
folks and they are thinking that through.

Also the need for training that\'s similar to the level two x-ray
inspector training.  If that kind of training can continue, that would
be a very large plus from the states\' standpoint, from the inspectors\'
standpoint.

In particular, one of the things we wanted to comment on was under
monitoring on the plan is to encourage CDRH to continue harvesting data
from outside sources. For example, the NEXT data collection and
publishing may be that there needs to be some tweaks. It may need to be
other topics that are addressed in the same way. But the NEXT data is
viewed by the states as being extremely valuable and should continue in
some way.

Under education, we want to encourage CDRH to continue to provide that
kind of training in conjunction with our annual meeting, our annual
national Conference on Radiation Control as well as standalone forums.
We\'ve had a partnership for many years and this has been very
effective. So we would just like to encourage CDRH to continue to work
with us on that.

Also at our annual national conference, I would be remiss if I didn\'t
mention the fact that ACR, AAPM, Society of Nuclear Medicine, ASRT, all
work with us very closely to put on some really excellent training each
year and I would like to make sure I mention them as well. It adds
tremendous value to the national conference.

How we see ourselves as being able to help, CRCDP is a standard setting
organization. So we do develop, as I said earlier, the coordinated set
of suggested state regulations and the other guidance documents that go
with them and we would say we will continue to do that. We\'re willing
to continue to work with CDRH to improve that process.

Over the last couple of years, there\'s been some streamlining of that
process so that those suggested state regulations can go through more
quickly. They had been taking two, three, sometimes more years to do
that. But there is an abbreviated process that works very well on those.
So we would be more than happy to continue to work on those and make
that a very useful product for the states and the federal agencies.

We also assist in the collection and publishing of NEXT data and other
specialty surveys. You would be surprised, you might not be surprised,
how often I get called what are the states, how many states do this, how
many states do that, that kind of thing and would you ask the states if
they collect this kind of information. And every time, I\'m thinking
\"Wow. I have to go out to each state.\" They just get surveyed to
death, speaking from a state perspective as well. They just get surveyed
to death. So we need to make sure that surveys that we do are focused
and useful and aren\'t too burdensome from a state standpoint because
they like everybody else get too many surveys come at them from too many
different directions. But we do that. We do collect that information. We
publish the NEXT data and we\'d like to continue to do that sort of
thing.

And education, that\'s probably the longest part of our partnership with
CDRH, high quality training of state personnel. Generally, we do that in
conjunction with the national conference on radiation control. But there
are other ways that we might be able to deliver that more effectively.
Maybe we should look at regional models, smaller things, taking the
training to the place of use, those kinds of things. I think there are
some efficiencies that might be looked at in education that would be
beneficial for all. So we would be happy to continue to work with CDRH
on things like that.

I just wanted to point out one thing. Next week is National Radiation
Protection Professionals Week and that\'s partly in commemoration of the
discovery of x-rays on November 8, 1895. So this is the 110 anniversary.
We want to make sure that you all know that and celebrate that. This
year\'s slogan. So we want you to turn to your neighbor here. That\'s
all I have. But do remember that these folks work hard on your behalf
and on each other\'s behalf and show the appreciation next week in
particular. Thanks.

FACILITATOR LESLIE: Give him a hand. Thank you, Tom. John, did you have
a question?

MR. KERR: This is the hard part.

DEPUTY DIRECTOR McCROHAN: I\'m in the midst of this euphoria having
gotten through my presentations this morning. I had a couple of
questions and the first thing was could you comment in general on the
background of the folks in the state programs because I think it\'s
relevant for the conversation about training. We\'ve heard from the
medical societies today as well as the medical physicists and the
radiologic technologists and I\'m not sure that people have a good sense
of where the state radiation control program people would fit in that
spectrum in terms of the training they might already have had.

I noticed that there were a number of groups that talked about training
and what they might be able to do. You made the point about
regionalizing training opportunities as well as doing them at national
meetings and so forth. I\'m aware of the fact that we are certainly
doing at the Center much less direct training than we used to do. I
don\'t think it was entirely my fault. But I got to Center or the Bureau
at the time just about the time they stopped doing direct training. I
don\'t think it was anything about my arrival.

But we\'ve done relatively little of that over the years and I think
that there is a, or perceived to be, lack of opportunity for people in
the states and certainly for even people in FDA to get access to
appropriate training. So I guess the first question is where are people
starting from and what\'s your sense of what the opportunities are.

MR. KERR: Like any other group, they are probably pretty diverse,
probably more diverse than most of the societies here who have a lot of
doctors and nurses and things like that. I think most of the state
programs are having a lot of difficulty in recruiting. A lot of the
folks are straight out of college, have had some minimal training in
that regard. I don\'t think you\'re going to find a lot of health
physicists for instance because the states just don\'t compete with the
private sector in terms of funding.

I\'ll think you\'ll find a fairly good concentration of military-trained
folks for instance. I\'m a Navy reactor operator on a submarine. I\'m
kind of typical of who might come out, those kinds of things. But a lot
of times, I think it\'s true for a lot of states that the folks that are
coming in the door have very little background in the areas that they
will be working with and inspecting and the training that they get when
they come to the state is in many cases I think probably the extent of
the training they might have. So it\'s really important to have those
basic introductory kinds of training and ongoing training to improve the
quality of staff abilities.

DEPUTY DIRECTOR McCROHAN: I would just add to that. I think that in the
medical area I know that certainly some of the states personnel are
former radiologic technologists but that may not be broadly the case.

MR. KERR: Right.

DEPUTY DIRECTOR McCROHAN: I think that it\'s one thing to know the
physics if you will, however you get that training. I think it\'s
another thing to appreciate the clinical environment in which that
physics is operating, the machine and so forth. If we\'re talking about
use problems, then I think some of that more clinical training or at
least an understanding of that clinical environment and the applications
and so forth is important.

MR. KERR: I know speaking for myself like I said coming from a Navy
reactor background how to go fast and dive deep but the clinical stuff
is beyond me. I guess I could get into brachytherapy and get into the
dive deep part anyway.

DEPUTY DIRECTOR McCROHAN: Yes. The other question I had related to the
Nationwide Evaluation of X-ray Trends Program. You\'ve said and a number
of others have said on other occasions to me that NEXT is something
which the states consider to be very important and I know that they\'ve
been an indispensable part of that program in terms of their
participation in collecting the data. I know that the conference has
been a partner for a long time in terms of disseminating the data.

But the question I have really goes more to the question of how is that
data being used and applied. We have limited as it may be a picture of
what the chest exam has looked like every few years for a number of
years back, abdomen exams and so on and so forth. What I\'m not sure is
whether that data, that information, is being used by the states and
penetrating into the clinical facility and having some impact there or
if for all of these years we\'ve been running this program and producing
nice graphs that look good in publication but haven\'t been getting to
what we really wanted to do which is influencing behavior on the ground.
So I didn\'t know if you had any thoughts on that.

MR. KERR: I don\'t have a real good sense of that yet. I\'m new enough
to this field that there are other folks in the room that would be able
to address that much more, maybe John Winston or Don Flater from Iowa or
Renee Fizer from Maryland who I think is going to be up next. They might
be able to address that one a little bit more as to how exactly the
states use it and the utility of it. But I know that there are certainly
improvements that can be made in the process to make the collection more
timely, to make the dissemination more timely for instance. Are you
going to address that, John?

MR. WINSTON: Sure.

MR. KERR: You\'re not going to ask me a question, are you?

MR. WINSTON: No.

MR. KERR: You\'re not supposed to do that. You\'re not supposed to shoot
me in the back.

MR. WINSTON: No, I\'m just going to say I\'m John Winston from
Pennsylvania, Healing Arts Council Chair, and I don\'t have a clue.

MR. KERR: You don\'t have a clue.

FACILITATOR LESLIE: That\'s a straight answer, isn\'t it?

MR. WINSTON: I think to follow up on two of John\'s comments. First off,
like in Pennsylvania, our entry level positions, you can not qualify if
you\'re a registered technologist. But if you have so many years in
nuclear power or something like that, you qualify.  That\'s where the
training that CDRH has on x-ray really helps our inspectors because as
far as I know, there really aren\'t any other sources for that kind of
training, the hands-on training.

The other question with regard to the NEXT values, we use those as what
are called reference values in the states where we make recommendations.
There are states that actually set regulations which I don\'t
necessarily agree with but set regulations for maximum exposures for
certain projections. But I think most states do use those NEXT values
for facilities with keeping their exposures as low are reasonably
achievable.

MR. KERR: Thanks.

FACILITATOR LESLIE: Thanks. Cool. Next up we have two state
presentations, Maryland first and then the State of Washington. Renee
Fizer is going to do the Maryland pinch-hitting.

MS. FIZER: Good afternoon. First off, thanks to FDA for allowing us to
come and talk as a state program and, no, I am not Roland Fletcher. My
name is Renee Fizer. I am Division Chief of the Radiation Machines
Division at the Maryland Department of the Environment. I do apologize
to you all because this is also the first time I will see this
presentation today.

Just quickly a brief overview of our \-- Oh, he has all of these things
going. For those of you who know Roland, he usually sings his
presentation or has it in rhyme or has a joke throughout the whole thing
and I\'m not going to do any of that. The Radiological Health Program is
in the Department of the Environment. There are three administrations in
the Department of the Environment, Wastewater, and we are the \"R\" in
ARMA. Otherwise, it would be AMA. So we\'re hidden in an environmental
department.

What this means is that we have what\'s considered a split program,
meaning the licensing of the physicians, the RTs, the therapists, is all
done through a totally different department through a different set of
regulations. In Maryland, it\'s the Department of Health and Mental
Hygiene either through their Board of Physicians Quality Assurance,
through their Board of Dental Examiners, Chiropractic Board, what have
you. Our program strictly regulates the facilities that have x-ray
equipment.

We\'ve been an agreement state since 1971. We have, I\'m guessing on
this number, about 600 to 700 licenses at this point in time. We are now
implementing our general licensing program. The fees are in place. We
are putting together all the other stuff now to meet that requirement.
In the RAM program, there are three permit writers, four inspectors and
a division chief.

Radiation machines, we permit approximately 5,000 facilities that have
x-ray equipment. That\'s hospitals, mammo, industrial, research,
academic. About 12,000 tubes. I have one permit writer so I have two
other vacancies. I have six inspectors and there\'s me.

In order to meet our statutory requirements, we do work very hard to
have a cooperative working relationship with our Maryland stakeholders.
So we definitely applaud FDA for doing a venue of this type and
soliciting information about their changes upcoming.

Aside for registering the facilities with the equipment, we also have
what\'s called a third party inspector system, our inspector program. We
license medical physicists, other people who meet the education criteria
to perform state certifications for most of our Maryland facilities.

We also regulate and register all the service providers that do any work
in Maryland. Any company that installs equipment, performs maintenance
on equipment, removes equipment, sells chemistry for conventional
processing, they have to registered with our program and with our
private inspectors and service providers, we meet with them at least
once a year, the private inspectors twice a year. We send out
newsletters. We have a little flyers. We work very close with them and
they\'ve actually been of great value for us on making our program more
efficient and more realistic based on all the other cutbacks going on.

The last item about \-- I didn\'t realize it was blank. I\'m so sorry. I
have to look back here. And the last think is we do have annual fees
that we collect from Maryland stakeholders. These do go into a special
fund as opposed to a general fund. This year is our first year of having
to subsidize our entire program only on special funds and it will be
interesting to see what our senior management does in future years
because we\'re not going to be able to survive very long.

I have to be honest. I wasn\'t really sure what this slide meant. So
we\'re going on. The last thing that the staff does is we do respond to
emergency response drills, graded scenarios. We have two power plants
that we do the annual FEMA graded exercise. One is Calvert Cliffs and
the other one is in Pennsylvania. It\'s Peach Bottom. So our guys are on
call. We do do these things. We work with the counties, etc.

Issues and problems that we believe impact health and need to be
addressed. A lot of these things have already been discussed in a great
deal of detail. So I\'m just going to gloss some of those. Fluoro, the
high dose hitters, therapy, CT and thanks to the FDA we now deal with
dental CT. Thank you.

Operator qualifications and end use is a very large and again remember.
We\'re not a medical based program. So we\'re coming up some very
creative ways to try to deal with some of the operator enduser issues
and we\'d love some input on that. I added to this also some non,
perhaps, public issues but state staffing. It was just mentioned by Tom
Kerr and John McCrohan. I have vacancies I can\'t fill because we don\'t
pay enough. It\'s really hard.

The fee issue, like I mentioned the first year without general funds,
it\'s going to be tight. The education issues. I have a degree in
biology. I studied trees. I was a radiochemist at a public utility for
six years. Now I\'m in charge of a x-ray program. Most of my staff
either have engineering degrees or masters in public health or
environmental hygiene of some sort. We don\'t have any RTs on staff.
Again, we\'re more on the machine side of it but the training that the
FDA has provided in the past and we hope that they embellish on in the
future is vital to us being able to efficiently regulate the
stakeholders and provide them the guidance that they need on reducing
worker and patient dose.

Misadministrations, we\'ve been doing some work in Maryland and we\'d
love to have some eventual federal help with this. Ninety-five percent
of the reported external B-misadministrations are wrong patient. It\'s
just gross procedural breakdown. Sometimes when we\'re dealing with
these issues, we feel like we\'re working without a net. That\'s why we
would like some support perhaps in the future. We\'re working right now.
We have a plan for misadministrations. We\'re working with the
stakeholders to identify the issues and come up with some reasonable
responses to it.

The ESE, we\'ve already mentioned that. I also agree with John that
perhaps the NEXT data should not go into regulations. However, it is a
wonderful tool to have when you\'re troubleshooting a facility. It is
marvelous and unfortunately in Maryland, we don\'t have a quality
assurance program that\'s of any real value right now. We\'re now
getting into a position where we\'re getting ready to pursue and adopt
something and again those values every year that it comes out and the
information is updated is of great value to us to be able to take back
to our stakeholders and work with them on reducing worker and patient
dose.

There is a concern to make sure that the regulations should be
consistent whether federal or state and should not be nonexistent. One
thing with the fluoro, fluoro is not on this list because we just
recently put together a regulation package and it\'s basically a big
awareness campaign and we used CRCPD\'s H-22 Committee. It was a task
force on fluoroscopy. They developed some suggested state regs for
privileging of in-house of fluoro users. We worked for three years with
our Maryland stakeholders on appropriate language. Intent of the regs,
we implemented those. They were published in June and they actually
become effective on December 31. For the most part, they have been very
well received by our stakeholders because of the intent of the whole
process there.

It\'s already been talked about that the technology is quickly changing
and the State of Maryland would actually like to see one federal agency
with regards to ionizing radiation perhaps in control of other federal
agencies. It is a big issue for states. What goes on on Federal property
is what goes on on Federal property. But when the members of the general
public start getting involved, the Federal agencies aren\'t usually the
easiest way for them to communicate their concerns. They go to the state
agencies. So we get a lot of questions, comments when it\'s members of
the general public being involved in nonmedical use of ionizing
radiation and we would welcome the role of FDA perhaps of looking into
that.

Consistency again with the state programs. For instance, there are at
least two other Federal agencies that have dose to general public
standards if there\'s going to be that type of thing. Again, we\'ve
already talked about the training. It\'s of great value and we look
forward to assisting FDA in whatever way possible to get that to be
something that occurs.

We hope that there is the U.S. Department of Health and Human Services
Administration buy-in on this change for FDA and CDRH. We realize that
perhaps radiation safety in the medical community and the industrial
environment isn\'t as a high visibility as homeland security issue.
However, we do believe that it has a much broader and complete impact on
national population dose issues.

And lastly, we understand that it does take a long time for the FDA to
change regulations. However, we do hope that they utilize guidance
document or the public health advisories. It\'s very hard for me to go
to senior management in a state agency and say this is a real big issue.
We need to look at this as a state agency. Unless I have quantifiable
data to say this is a big issue or unless there is perhaps something
from a Federal agency hopefully not an oversight agency but a Federal
agency saying this is a concern, it\'s very hard for me to go and try to
pursue changing regs or putting in place other processes if those items
are not there even if it\'s not a change in regs.

One other thing to the FDA, and of course they\'re aware of this, is
even though different states have different regulations, different
authorities, they have fees, they don\'t have fees, big programs, small
programs, a lot of states do have expertise and/or knowledge on a wide
range of topics and it\'s just waiting to be garnered. Of course, that
can be done through the CRCPD. We have great resources there on little
pet projects that we\'ve worked on that turn into wonderful blooming
flowers that can be harvested.

I have a comment about a previous comment about the 2579s to the
gentleman who had hoped that 2579s for replacement parts could be taken
away. My comment to FDA is please don\'t do that. We have a regulation
that any machine that has been previously owned and moved or refurbished
or any time a major component other than a tube has been replaced, it
has to be restate certified which is done through our program prior to
use on patients and we find that more often than not there are
violations, functional violations, with the machine, image receptor
issues, etc. on those machines and a lot of times the facilities don\'t
let us know when these happen. The way we do find those out is by
submittal of those 2579 forms. So it would be taking a tool away from
us.

Lastly, Maryland agrees with and offers support and assistance during
FDA\'s transition. This state perceives the benefit to our program as
well as to the general public for the proposed changes. Thank you.

FACILITATOR LESLIE: Thank you, Renee. Well done. Okay. Ellen Haars from
the State of Washington.

MS. HAARS: Good afternoon. I would like to thank the Food and Drug
Administration for the opportunity to address its Radiological Health
Program Plan. I also would like to compliment you for your organization
for seeking comments from stakeholders with different perspectives.

Today I\'d like to focus on who we are, the Washington X-Ray Program,
our perspective of what are the radiological health issues and you may
have heard them already but you\'re going to hear them one more time,
our perspective on the plan, our view of a partnership with FDA and the
states and proposed next steps.

My message will have five key themes and these can be grouped into three
major categories and those are training, guideline development and
technical assistance. You\'re going to hear that throughout my message.

First of all, a snapshot of the State of Washington X-Ray Control
Program. We have 58 registered radiation machine facilities. Fifty of
those are mammo facilities. Over half of the facilities are dental. We
have nine surveyors in the program, two certified MQSA surveyors and two
in training.

A very important part is that over half of our surveyors will retire
within the next five years. If you combine all the years of the staff,
it\'s 255 years with a range from eight years to 37 years with the
program.  So that\'s good because they like the program and they stay.
But it\'s not so good because they\'re going to be leaving to retire.

The program is 100 percent fee supported. We have to charge the fees to
cover the cost of the program. Of course, the registrants do not like
that and I can understand why.

I want to emphasize the fact that we have an aging workforce in our
program. We are looking at ways to reduce the weight of inspector
equipment, smarter ways of handling the equipment. A 40 pound phantom
presents a problem and finding qualified individuals to replace retirees
also must be addressed. We need FDA\'s assistance in training new and
current so that our workforce is well qualified to perform their job
duties.

The current problems can be grouped into training, guideline development
and technical assistance. Let\'s start with training. We want staff that
are up-to-date and are well qualified. How do you test a C-arm unit? We
need more information on CT systems and how to evaluate these systems
now that they are so sophisticated.

We need training tools to help surveyors know what to look, what it
means and what are the key findings. The state of course has a role in
it. We cannot just depend on FDA for that. Course patterned after the
FDA basic surveyors course is a good place to start.

Guideline development, another area of health issues. For example, give
us guidelines regarding the ever-increasing radiation doses to medical
patients due to the proliferation of high technical modalities. How much
radiation is too much for diagnostic imaging?

Technical assistance, this is another category that needs to be
addressed. Here are some examples of areas that we need assistance. The
department recently received a letter from two medical physicists in the
state reporting their data and observations concerning dose estimates
for patients receiving CT scans. They found the typical head dose
received in Washington State is higher than those published in the
European studies. I want to incorporate their letter into this
presentation because we want to work with FDA on how to proceed.

I was also asked to give my general reaction to the radiological health
plans. In these times of limited resources and demand for public
accountability, it is important that government agencies are
accountable, efficient, effective and doing the right thing. We support
your vision statement, the shift to product use and we ask you to
continue to provide technical assistance, share information and
coordinate the members of the radiological health community.

However, we have several areas of concern and ask that you consider our
suggestions.  Your evaluation and accountability tools are not clear.
Tools should be developed to demonstrate a performance review mechanism.
The citizens need to have a clear, concise view of how this government
program is working and whether the citizens are receiving value for
their tax dollar. State regulatory agencies have a key role in the
success of this program and your report says that. It is important
therefore to recognize that funding is always an issue with the program.
 We are 100 percent fee supported and we may need assistance.

Then the next category you asked me to talk about was examples of
partnership and here again, I\'m going to give examples in training,
guideline development and technical assistance. Your plan identified
five major program elements: standards, monitoring, education, research
and program. These elements are designed to protect the public from
hazardous and unnecessary radiation while insuring appropriate use of
radiation when necessary. We support your intention.

So how can we work together in training? In the next five years, over
half of our surveyors will retire. We need a mechanism to insure all
surveyors have adequate hands-on inspection training in the classroom
and in the field. We need training that\'s similar to the basic course
offered by FDA as well as on-going so that the current or existing staff
are up-to-date.

Guideline development, here states and FDA can work together in
collection of adverse events, dose and exposure data. The states can
collect the data as well as perhaps other parties and forward it to FDA
and in consultation with the states, analyze the data and make
recommendation and develop tools for sharing this information with
regulators, consumers and device operators.

Technical assistance is another area where we can work with FDA
assisting states and finding alternative survey tools or proposing other
ways of doing business. What about the reintroduction of the old FDA
high-low study or bringing back perhaps the modified but revisiting the
old DENT program. We are only able to visit DENT just every five years.
If we could have another tool in between which would not be equivalent
to an inspection but it would be a screening tool for facilities that
need to be looked at.

So what do we think should be the next step? Of course, I think we start
with sharing the results or the summary of this meeting and identify any
revisions to the plan. You should regularly share information about the
plan\'s status and the outcome of evaluation and accountability tools
with the stakeholders, perhaps have an annual meeting where we get
together just like we are doing today and lastly and most important is
communicate, communicate, communicate.  Don\'t just do it here. There is
another Washington. I had to say that.

So one more time, I had three key things but they all fit into the three
categories. We have an aging workforce with retirements pending. So we
need hands-on training for new hires.  We also need training for new
modalities, field compliance testing. We ask that you emphasize dose
reduction and improve image quality, produce culturally sensitive
information for users and consumers, form partnerships with states on
technical issues and have a performance review mechanism so that you can
tell where you are and are you making progress. That concludes my
presentation.

FACILITATOR LESLIE: Thank you, Ellen. Give her a hand. Any questions?
Great. Thank you. John, were you heading to the mike?

DEPUTY DIRECTOR McCROHAN: Yes.

FACILITATOR LESLIE: Okay. I guess you\'re not so fast.

MS. HAARS: You know they\'re waiting for break, don\'t you?

DEPUTY DIRECTOR McCROHAN: And they\'re all getting warm as I am. But I
did want to ask a couple of questions. I didn\'t want to let Renee
totally off the hook. But I guess that one of the things that would be
perhaps useful for you to clarify, two things. One is with respect to
the training. You mentioned a basic radiological health training which
back in John Goforth\'s day before my time we used to do in what was
then BRH and I think one of the things that perhaps this is less of a
question and more of a comment for discussion tomorrow is I think that
in the educational breakout sessions, one of the issues I would hope
would be discussed is how can we deal with the fact that we have a
regulatory community both state and I would say federal where the entry
level positions are attractive to people who don\'t come prepared with
the kinds of educational backgrounds that we might like.

MS. HAARS: It is unusual.

DEPUTY DIRECTOR McCROHAN: And then I think the consideration of given
today\'s problems what sort of education do we want to provide to those
people. Do we want it to be as it would have been in the old days if I
may very machine oriented or do we need it to be a training which would
prepare people better to provide oversight to facilities to assure that
the facilities are meeting their responsibilities to do quality control
and quality assurance and all of the things that I think everybody knows
they ought to be doing? But I think what may be missing in some respects
is the external agency looking and asking questions and so forth. From
my point of view, it may be less about machines and therefore less of a
physics orientation than used to be the case. But perhaps that\'s
something that could be talked about tomorrow.

You mentioned dental. Renee mentioned dental and you\'re entirely
welcome. We\'re happy to make your life more interesting by evidently
having not terribly long ago approved on the medical device side of our
house dental CT units that were I believe classified as though they were
panoramic x-ray units. Anyway, we\'ll talk about that I\'m sure at some
point.

MS. HAARS: You also approved a hand-held dental unit too.

DEPUTY DIRECTOR McCROHAN: We just want to do our best to make your lives
more and more interesting.

MS. HAARS: Thank you.

DEPUTY DIRECTOR McCROHAN: But I think one of the things that others in
the audience may not appreciate is the fact that I think you mentioned a
figure which I understand is fairly typical where the number of x-ray
tubes in Washington and I think in Maryland are about 50 percent dental
tubes and about 50 percent medical tubes.

MS. FIZER: Seventy percent dental.

DEPUTY DIRECTOR McCROHAN: Seventy percent dental. Okay. Those dentists.
Nobody here from the Dental Society I don\'t think. I think there\'s a
question probably in some people\'s minds about what\'s the relative
priority that ought to be given to dental versus medical when you think
about what\'s being exposed and the degree of exposure and so on and so
forth, notwithstanding that we\'ve complicated matters for you by
approving hand-held units and CT units which have probably changed the
picture a little bit at dental facilities. I\'ll let Renee come up and
berate me more immediately.

MS. FIZER: In response to the Maryland program as I mentioned, we do
have third party inspectors who do most of the medical equipment. My
inspectors predominantly inspect dental, veterinary and mammography
facilities. Our dental lobby, all of our requirements for dental
machines including the inspection, frequency and fees are in our
statute. They\'re not in regulation so that because of the issues in the
past with I guess concerns about the dental lobby and the effect on the
dentists.

But what we\'ve done since 1999 is we\'ve identified that in the dark
room because of the dose issues, we were finding \-- Let me back up.
I\'m sorry. Not very well prepared. We found that the as-found values
for most of the intraoral machines were above those of the NEXT data.
They were significantly above what the NEXT data had said the average
national ranges should be based on the KBP of the machine and the type
of films, the D-speed versus at that time it was only E-speed was the
only other option.

So we evaluated the profile of violations found and found that over 70
percent of the violations were in the dark room and they had to do with
the processing. A lot of the facilities weren\'t changing out chemistry.
They had disengaged their heater elements in the processors so to try to
prolong the life and the way they compensated for light films was
turning up the exposure times for the patients. So we identified a
statewide population dose issue even though we\'re talking about dental
here.

We decided especially since that\'s what our inspectors do are the dents
and the vets we would address this. So we spent two and a half to three
years working with our dental lobby, the Maryland State Dental
Association, and giving over 20 outreach presentations talking about
processor issues, dark room issues. Fog was another big thing. We sent
out flyers.

We put together a regulatory packet. We didn\'t change the regs.  We put
together a booklet that had all of the regulations that concerned the
dentists into one little thing because as most of you all know, the
suggested state regs or most of the state regs are 600 pages long if you
include all of them. So it\'s really hard to wiggle through those.

We worked with our dental lobby on putting together that packet and half
the page was the legalese and the other half was what it meant. We
wanted to put little Mr. Tooth things in there and gold stars but they
didn\'t like that. So we worked with them a whole bunch and we\'ve been
actually able to drop the as-found settings and right now, I\'m pulling
ten years of data. I\'m having to do it manually because we up until
three years ago didn\'t have an electronic system for reporting dental
inspection information. So I\'m pulling it file by file back from 1995.
Because what we\'re hoping to show is a drop-in population dose based on
the as-found conditions based on KBP and the type of film that was used
at the time of the inspection at the facility.

The other thing that we did was we identified some controversial topics.
We put together a little task force to look at premixed auto processor
chemicals.  We called together a couple of the manufacturers of film,
the auto processors, dental auto processors and the companies that
manufactured the auto processor fluids, the premixed fluids because we
have a minimum optimal density speed criteria in Maryland and we believe
that there were some of these premixed dental chemicals that when they
were fresh out of the bucket, they opened up a can, they could not meet
the processing requirements.

So we met with a couple of the large nationals of the film, the
equipment as well as the chemicals and discussed this. We also had the
Maryland State Dental Association involved as well as the Commonwealth
of Pennsylvania. New Jersey radiation programs were also involved on
this. And we discussed these issues and we brought up some things like
for instance there is no expiration date on the bottles of these
premixed chemicals for the facilities to use as an indicator of how old
it is, a lot of other issues as well with that.

But we\'re in the process of trying to address those. We\'d like to see
a drop in the population dose and I forgot what the original question
was now. But we\'re looking at things. Thank you.

DEPUTY DIRECTOR McCROHAN: I\'m sorry to keep you stuck up there. I think
it\'s just interesting to realize in the predigital age and frankly most
of the community out there is still in that age where we\'re talking
about film as the image receptor, there are lots of things that are not
related to the electronic product per se that affect the exposure to the
patient and as Renee said, certainly the film that\'s selected and the
chemistry and the processing of that film have an effect on the
exposure.

I think that now things are becoming more digital is an inclination to
think that those problems have gone away and in substances, that\'s
probably true. But I think additional, newer problems are coming in in
the sense that unlike when we have film as the image receptor and if you
make it totally black, the person reading the film is probably not going
to like it very much and send you back to do it over again.

With a digital image receptor if you use more radiation than you needed
to get the clinical image, you still get a very nice clinical image. In
fact, you might get a quieter, smoother image than you would otherwise
have gotten even though you might have used a dose that\'s far in excess
of what you would have needed to get the clinical information.

But just a comment. One other quick point. Renee mentioned
misadministration in therapy presumably with a machine based source and
we had left Geoff off the hook earlier and I wondered if he could
comment on whether or not in the machine based radiation therapy world
the comparable sorts of quality control procedures and so on and so
forth exist which are I think mandated in the isotope based therapy
world by the regulations at NRC and the agreement states. I don\'t know
where the states are in that and I don\'t believe there\'s any federal
agency with the authority to regulate use vis á vis therapy.

DR. IBBOT: I think that you\'re right that there is no federal agency at
the moment dealing with this. There are publications and recommendations
for groups such as the AAPM, the ACR and ASTRO giving recommendations
for quality assurance procedures that I think are every bit as thorough
and probably more extensive than the previous advice for isotope units.

Some states have adopted potions of these recommendations into
regulations. Some have gone much further with that than we would like
because some of these publications were intended strictly as
recommendations for departments, institutions to consider in developing
their own QA programs.  So there\'s a broad range of degrees to which
publications like that have been adopted into regulations but there is
certainly much more uniformity in the degree to which the QA
recommendations have been adopted into clinical practice and for the
most part, they are followed.

In fact, I will step to one side and put on my RPC hat and tell you that
on our visits to radiation therapy departments while we often find some
small aspect or other that we don\'t think is being addressed in a
quality assurance program, for the most part institutions we visit are
following the guidance of groups like AAPM quite closely.

FACILITATOR LESLIE: Good. Thank you, Geoff.

MR. WILLIAMSON: My name is Steve Williamson. I\'m the Section Chief of
X-Ray and Accelerators in the State of Pennsylvania. I just wanted to
reiterate and agree with Marilyn and Washington on some of the issues.
The State of Pennsylvania, the VRP is 100 funded. We also have an aging
inspector staff and they rely a lot on the \-- I had a lunch discussion
about a lot of this stuff as far as Level Two training as far as which
really adds to the inspector training. We really want to know what\'s
going to happen with that. Our Level Two agreement ends in 2007 with the
FDA.

Reiterate the 2579 forms that we use with all the vendors. We\'ve
currently started registering all the vendors in the State of
Pennsylvania that supply equipment in the State of Pennsylvania. That
more or less works as a triangle for our organization, the VRP, the
vendors and the registrants. We tie all that together into one thing to
know what equipment\'s coming into the state and being installed and new
equipment coming online, what the inspectors are faced with when they go
out to do inspections and also the vendors as far as providing a lot of
information back and forth.

The MQSA changes as far as the acceptability of survey equipment is
another big item for us. We\'re looking at new equipment to purchase in
Pennsylvania. We\'d like to have some guidance maybe from the FDA on
that as far as what is acceptable equipment, what they\'re going to
consider acceptable or if they\'re even going to give us any acceptable
criteria. Pretty much to tie in with a lot of new technology, the new
equipment and the new instrumentation, I think there needs to be a lot
of cooperative effort on that between the FDA and the states on a lot of
that to continue the programs we have.

FACILITATOR LESLIE: Cool. Thank you. It\'s already hot in here. So I
want to take a break. Two quick things. One is a couple of you in the
restaurant apparently got up and out of there without paying for lunch.
I can just envision you were in the middle of a conversation and just
got up and walked out. So if you would be kind enough to sort that with
the dining room manager.

Second thing is one of the things I want to make a little time to do
this afternoon is inquire about what you mean when you talk about
collaboration and partnership as we\'ve had this thing going forward.
I\'m really going to be interested to hear what you think collaboration
and working as partners ought to be, how high the bar should be set.

On one hand, your 16-year-old would say collaboration is just fine when
you hand them the car keys and don\'t ask where they\'re going. That
might not pass your test. There are those that would say collaboration
is that I will comply grudgingly with a Supreme Court decision. That\'s
probably not an answer either. There\'s another one that say I won\'t go
anywhere without you.

So I\'m really interested in hearing a variety of you talk about what
does collaboration mean, what does working together mean, from your
various positions as we go forward. I\'ll make a little time on the
agenda for that. Let\'s reconvene at 3:05 p.m. That will give you enough
time to get some coffee. I think there may be cookies. 3:05 p.m.

(Whereupon, the foregoing matter went off the record at 2:37 p.m. and
went back on the record at 3:07 p.m.)

FACILITATOR LESLIE: As they say, come on down. All right. If we could,
I\'d like to get started. Could I have your attention? We have three
things left on the agenda this afternoon. Two are already on your agenda
and one I\'ve taken the audacity to add. The first thing is the public
comment period which I want to begin here in just a few minutes. The
second is to inquire your views on the nature of collaboration as you
think it should be, could be, ought to be in this RAD Health Program and
the third piece is whatever words that I\'ll say that set up the day
tomorrow.

Now I have taken the liberty of moving the microphone from back there to
up here because I noticed that those of you who spoke were having to
speak with your back to half or more of the audience and I thought you
probably didn\'t like that anymore than the rest did. So we\'ve just for
this part moved it up here in front so you can at least speak to your
colleagues.

For public comment, let me get into the public comment. Let me just
decree that part of meeting open and in that regard, anyone who would
like to speak can certainly do so. This meeting was published in the
*Federal Register* so that anybody that would like to speak can actually
do so and two parts to that. One is if there are things that you\'d like
to say from the microphone that\'s fine. If they\'re either in addition
to that or separate from that, you\'re certainly welcome to submit to
John and his staff for inclusion in the record. That can be handled
either way that suits you.

I have at the moment seven names on the list, some of which signed up
ahead of time for that and I would take those in this order that you
signed up and after that it will be first come, first served when
everyone\'s had everything they wanted to say about that or we\'ve spent
an hour on it. We\'ll shift into the next part.

So the list that I have at the moment: David Lytle, Jim Shepherd, Steve
Rohring, William Benner, Dr. Sandra Read, Liz Coronado. If you don\'t
mind I\'ll go in that order. Then anyone else after that I see some of
you smiling. Did I misspeak somehow or another? What did I do wrong?
Lisa, sorry. Okay. David Lytle first. I think the original thought was
three or four minutes each. Does that work for you? If you need
something different than that, talk to me.

MR. LYTLE: It works for me. I\'m David Lytle. I\'m the Executive
Director of the International Laser Display Association. We\'re a little
different than everyone else here. Our members, their goal is to have
fun with radiation. They make laser light shows for artistic and
entertainment purposes.

And you all know that the responsibility of making fun is not easily
born.  We started doing shows in the mid 70s and the Bureau of
Radiological Health back then immediately enacted a series of
regulations to protect the public and they really stepped in. They saw a
need to control some of these exposures and enacted many regulations
that worked very well back then.

But now we\'re fast-forwarding 30 years in the future and we\'re so glad
to have this opportunity because many of those rules that worked then
don\'t work now. I\'ll give it in a nutshell. What our industry faces
that a lot of you may not face is a requirement not only to comply with
all the usual bells and whistles that all the laser products must comply
with but we have to submit a variance requirement if any of our lasers
are above 5 milliwatts and we have to submit a specific request to vary
from the standard to use this for an entertainment application and that
has to be approved by the CDRH before the product can be brought to
market.

The second step is if our customer wants to purchase this product which
has a variance, they cannot purchase the product. The customer then has
to submit a request to the CDRH to vary from the standard to simply buy
the product and they have to wait until that\'s approved before they can
take delivery of the product.

Then finally before they can use the product, they have a file a laser
light show report with the CDRH defining the proper use of the product
and that\'s because the CDRH defined a laser show as a product and they
actually control the use of the product in that regard. I\'ve just
learned that\'s a pretty unusual situation here. But that\'s the fact of
life of us.

In now 2005, the U.S. industry as changed in many ways, most of them for
the worst, the current regulations have built in a huge amount of
uncertainty because there\'s no guarantee of when or even if our
variances will be granted. The customer sees that and they\'re not
inclined to hop into a competitive marketplace when they don\'t even
know if they can get the product.

Manufacturers in turn have a big disincentive to product new products
especially if they\'re cutting edge or if they have a novel approach
because there is not guarantee when or if the CDRH will approve that
variance. That\'s not knock on the CDRH. It\'s a knock on the fact that
their resources are limited and we\'re perhaps low on their radar
screen. There are many other applications, but as a consequence, the
U.S. laser industry has suffered immensely. Our market share has
declined incredibly. It\'s to the point where our association will
probably not have another conference in the United State because it\'s
too difficult to stage laser shows here and most of our members too
difficult for them to bring their products to a trade show to just show
them to potential customers.

So it comes down to what we can do about this. We have a written
proposal we submitted to the CDRH which proposes to streamline some of
these reporting burdens. So that instead of doing a variance for every
single laser product, most of which are very similar and are no novel
uses, nothing different about it, to eliminate that requirement to focus
their resources only on the applications which pose the greatest risks.

That might be something which wants to change the exposure levels to the
audience or route the show in a whole unique way. Those will pose risks
and those deserve attention. But 99 percent of the shows done today in
the U.S. and for the last 25 years have a record where they don\'t need
to do that. So we\'re proposing to eliminate that reporting requirement.

We\'re also proposing since we want to get down to the use of the
product let\'s have a collaboration with the CDRH and produce training
materials, safety materials, to provide to that enduser that they can
know how to produce this show effectively and safely. So instead of
asking them to fill out a pile of paperwork which is dense to them,
it\'s practically grief, they have no idea really what it means, we\'ll
give them safety information, safety training opportunities saying this
is how you use the product, this is the proper method to use. We think
that will encourage more compliance and will enhance the overall safety
levels of the shows while at the same time making it easier for
companies to manufacture and sell the products and making it easier for
the CDRH to concentrate its resources on those that pose the greatest
risk.

So that\'s our hope and talking about collaboration, our view is we want
to work hand-in-hand with CDRH to develop these materials. We have no
problem with the current exposure levels of bells and whistles. It\'s a
matter of putting that into an effort which everyone can understand and
digest easily enough. That\'s what we\'re extending our hand to do and
we hope to do in the future. Thanks.

FACILITATOR LESLIE: Thank you. Jim Shepherd.

PARTICIPANT: They had to leave for an early flight. They can\'t deliver
their speech but they have written comments.

FACILITATOR LESLIE: Okay. And we\'ll get those.

PARTICIPANT: We have them.

FACILITATOR LESLIE: Got it. Okay. Steve Rohring. He has his coat off.
Must be expecting it to get warm in here.

MR. ROHRING: I hate to read in front of people but I\'m going to read
our written comments for the record and then probably make a few
comments of my own. In a sense, I\'ve approached the age of 50 plus.
I\'d better use some help.

Thank you for the opportunity to address the Food and Drug
Administration stakeholder meeting. My name is Steve Rohring. I\'m here
on behalf of the Federal Aviation Administration. I would like to thank
the FDA for their assistance over the past ten years in addressing the
impact of outdoor laser demonstrations on aviation.

When these shows began to proliferate in the mid 1990s, the FAA received
reports of pilots being impacted by the inadvertent illumination of
their cockpit by lasers. The FDA\'s Center for Devices and Radiologic
Health and their regulatory role with regard to lasers came to the aid
of the FAA by requiring operators of outdoor laser demonstrations
exceeding five milliwatts in power to notify the FAA in advance and
resolve any objections that the FAA may have.

Since that time, other applications for the use of outdoor lasers and
the number of uses of outdoor lasers has increased dramatically.  As a
result, the FAA now faces new threats to aviation safety and security
related to the use of outdoor lasers.

These threats predominantly fall into two major categories. First, the
outdoor use of high power, visible and nonvisible lasers for scientific
research and commercial purposes has and continues to dramatically
increase due to the emerging technology and the increased affordability
of lasers. These lasers are emitted from the ground or airborne
platforms and have the potential for devastating results on aviation.
Currently, there is no regulatory requirement for these operators to
notify the FAA of proposed outdoor laser operations. Some notify the FAA
voluntarily and many do not.

Second, over the past year, the FAA has received an alarming number of
reports of apparently intentional illumination of cockpits by a variety
of types of laser pointers hand-held and others. In fact, the FAA has
received over 200 such reports since November of 2004. Although the vast
majority of these incidents have not resulted in injury to pilots or
passengers, some injuries have been reported and the FAA believes that
the potential exists for even more devastating results.

We believe that this matter is crucial to aviation safety and security
and ask that the FDA explore any means possible for assisting the FAA
with this matter as long as the FAA remains willing to work with your
staff to identify, develop and implement any measures that may mitigate
the potentially harmful effects of the outdoor use of lasers.

We have had a lot of success in addressing outdoor laser light shows and
since the 1990s, when there were some incidents in Las Vegas, those
reports have literally dropped off with the variance process and with
the analysis the FAA has done when they\'re notified of laser
operations.

We are now hearing reports though that many operators do not contact the
FAA even for laser light shows. The laser light shows are only a part of
what we\'re concerned with because there is now a lot of other high
power outdoor lasers that are projected through the navigable airspace.
Many of these lasers far exceed the five milliwatts. In fact, they are
very powerful lasers and they\'re now not only shot straight up or
straight down but they\'re projected at angles over the horizon which
can affect a lot larger area of airspace.

So we\'re very much interested in some kind of a notification or control
process that we can be aware of what\'s happening and being able to
apply some standards to whether these would be safe and how we can
integrate these lasers safety into the national airspace system.

By the way, there is also, I just learned in the past week, a House
resolution that is reported out of committee approximately two weeks ago
that would actually levy a criminal fine for the use for laser pointer
against an aircraft. So we\'ll see what happens with that in the future.
Thank you.

FACILITATOR LESLIE: Great. Thank you. Mr. William Benner.

MR. BENNER: Both of these guys are going to be a hard act to follow. My
colleague, David Lytle, from International Laser Display Association
works within our realm of business and we\'ve actually worked with
SAEG-10 Committee on producing the document that light show people use
when they file reports. My partner, Patrick Murphy, wrote most of the
document that people use to file that.

My name is William Benner. I am President of Pangolin Laser Systems.
Pangolin is the Microsoft of the laser light show industry. We produce
software that people use to create their shows and like Microsoft, we
have about 90 percent market share. We\'ve been in business since 1986
and we have users in 60 countries. This position that we have gives us a
unique view of the laser light show industry in that we can see how
they\'re being used here in the U.S. and abroad.

What I\'m coming here to speak to you about is much like my colleague,
David Lytle, spoke to you about. We\'ve seen a tremendous decline in
laser light shows here in the United States. Currently we sell only
about eight percent of our software into the United States, not that
another company sells more. But 92 percent of our business comes from
Asia and Europe and Latin America. One reason for this decline in the
U.S. use of laser shows is because of the variance requirements and the
difficulty in conforming with current CDRH regulation.

Earlier today what we\'ve heard is that the CDRH regulates only
products, not the use of that product. Well, that\'s not exactly true
because in 1976 what CDRH did was they called laser light shows a
product and since that point in time, they require use to have a
variance to sell the laser equipment. They require the venue to have a
variance and they require a variance for the show itself.

Because as David Lytle said, we\'re kind of low on the totem pole, low
on the radar of CDRH\'s daily business, they\'re looking at CT, MR and
various exposure levels like that, as a result, the time it takes us to
have variance applications approved could be three months on the very
early end and my company and another company has a variance request in
that has been in for over a year and I think by law they have to approve
them in a year. That\'s what I heard. Maybe I\'m wrong.

So as you can see, it takes a very long time to get a variance approved
even for companies like Pangolin who are very active in the safety
community. We\'ve attended ILSC. Obviously, we\'re here.  We attended
almost every SAEG 10 meeting. We produced the document FAA uses now to
make sure that laser light shows are safe and yet here we go. Fourteen
months after we\'ve applied for a variance we still don\'t have it.

We\'ve come here with a couple of suggestions. One of them is to relax
the variance requirement, possibly substituting that for a reporting
requirement just like laser manufacturers themselves need to produce
what\'s called a Federal Laser Product Report about their system to make
sure that it meets the regulations. That sounds reasonable to me.
Instead of us submitting paperwork and waiting for CDRH to look at the
paperwork and then rubber-stamp it 14 months later, we could just submit
the report and start using the show immediately.

Another suggestion that we have is to harmonize with IEC as much as
possible.  There are currently two IEC documents which regulate and
control and describe how lasers are used safely, 60825-1 and -3. The -3
standard actually discusses how to do laser light shows safely. These
are being used outside the United States obviously and as David Lytle
says, laser light shows stem back as far as 30 years and we have an
excellent safety record even outside the United States.

So we believe that by relaxing the variance requirement, substituting it
for some sort of reporting measure and by adopting IEC we won\'t be
giving up anything in terms of the excellent safety record we have. But
instead what we\'ll have is a much more streamlined, much more uniform
approach just as taken all over the entire world and at the same time,
what we realize is that we burden CDRH. You should see the paperwork
that we submit to CDRH that somebody on the other end has to review.

We would like to take that and substitute it for some training as David
Lytle said and I\'m running out of gas here. But that\'s the gist of it.
I look forward to working with CDRH and as far as my colleague says here
\"Ask not what you can do for your country but what your country could
do for you.\" That\'s it.

Well, we\'re a software author. We write software all the time. If you
need software to help us to submit these reports to you, we\'ll write it
for nothing. We\'ll write it quickly. I\'m serious. What do you want us
to do? We\'ll do it. No problem. My partner, Patrick Murphy, spent a
year and a half of his life working on the document that FAA uses. We
are serious about laser safety because it\'s our business. If lasers
bring down planes, guess who that\'s bad for? Ultimately, it\'s bad for
us.  So we\'ve very serious about this. We look forward to these kind of
collaborations, training programs, whatever it takes. You tell us what
you want. We\'ll make it happen.

FACILITATOR LESLIE: Good. Thank you. Dr. Sandra Read. Hi.

DR. READ: Thank you. I\'m here to talk about a much more serious side of
this committee. We\'ve had so much fun listening to the laser talks. But
I\'m here to talk to you about the industry of the tanning industry. I
am a dermatologist and I\'m here to talk to you about the darker side of
tanning.

Thank you for allowing me to have the opportunity to be here today and
to speak to you about something that\'s of great importance to me and to
all of you and the FDA which is the continued and further regulation of
the indoor tanning equipment. My name is Dr. Sandra Read. I currently
serve as the President of the D.C. Dermalogic Society and I\'m speaking
on behalf of the American Academy of Dermatology Association.

I am here to ask you to partner with the Academy to protect our patients
and especially our children from skin cancer. We ask that you do not
decrease regulation and oversight of the indoor tanning industry. We ask
you to encourage the FDA to institute a national age limit to decrease
the exposure of minors to ultraviolet radiation by tanning salons.

The Academy of Dermatology strongly urges the FDA through its
Radiological Health Program not only to continue to focus on the
regulation of indoor tanning but the Academy would like to suggest that
you increase the regulation of these devices. It is our concern that the
reorganization plan that is being discussed today would actually divert
needed resources from this missions.

According to 2005 and 2010 plan, the program will focus resources on the
products and procedures with the highest risks to the public including
those that are affected by the greatest numbers of people or cause the
most severe problems. Indoor tanning equipment meets all of these
criteria.

HHS in 2002 declared broad spectrum ultraviolet radiation to be a known
carcinogen and declared that exposure to sun beds and sun lamps to known
to be a human carcinogen. It\'s based on sufficient evidence of
carcinogenicity from studies in humans. As we are all aware, indoor
tanning equipment emits broad spectrum ultraviolet radiation which again
as HHS has declared is a known carcinogen. HHS even goes further in its
tenth report on carcinogens to state that epidemiological studies have
shown that exposure to sun lamps and sun beds is associated with skin
cancer.

For the majority of users, indoor tanning equipment provides a cosmetic
service, however one that can sadly lead to serious side effects. The
long-term consequences of using indoor tanning equipment can lead to a
lifetime of damage to the skin and eyes and in some cases, even be
deadly.

Given our society\'s misplaced and destructive fascination with being
tan, the use of indoor tanning equipment continues to grow and has
become a multi-billion dollar a year industry which is putting more and
more people at risk for developing skin cancer, eye damage and premature
aging of the skin through photo damage. What is even more frightening is
the increasing numbers of preteens and teenage users of indoor tanning
equipment which seems to be a contributing factor in the increased
number of children and young adults that our members are treating for
skin cancers including the deadly melanoma.

As you are probably aware, melanoma is the most aggressive form of skin
cancer which will lead to death in one out of every five individuals
diagnosed. I have been in private practice in Washington D.C. for more
than 20 years and I\'ve watched with horror in the growing popularity of
the indoor tanning use especially among my younger patients. In my
practice, I have had teenagers and young adult patients with skin
cancers and melanoma. Some have died. Childhood melanoma is increasing.

Recent statistics show significant increases and this raises a red flag
to dermatologists and all the medical profession and so it should with
the FDA. Dr. John Strauss, a pediatric oncologist at Johns Hopkins
University, coauthored a July 2005 article in the *Journal of Clinical
Oncology*, stating that statistics gleaned from the NCI CyRE data show a
dramatic rise in the rate of melanoma among children. The variable of
greater exposure to UV radiation was listed as a factor in this
increase.

Non melanoma skin cancer is also on the rise in our young patients. This
was reported in *JAMA* August 10, 2005 by Dr. Christiansen et al. Dr.
Christiansen is a dermatologic surgeon at the Mayo Clinic who treats the
most advanced and the difficult of the skin cancer cases. In an
interview, Dr. Christiansen also expressed concern over the causative
association between intentional, intense, intermittent exposure which
occurs in the tanning salon use.

That is why we are all here today to protect our patients who are not
able to protect themselves. Much like restrictions on cigarette and
alcohol consumption and access to firearms, our culture places great
importance on protecting children from harmful products. The Academy has
encouraged the FDA for many years to increase its oversight of indoor
tanning equipment and has specifically requested a revision of the
current warning label to state an explicit link between UV radiation and
skin cancer.

Now is not the time for the FDA to lessen its vigilance especially as
medical science and data is revealing more and more about the adverse
effects of ultraviolet exposure. Now is the time for the FDA to make
protecting citizens from the dangers of indoor tanning a priority. It is
a shame that our patients and particularly our children are dying to be
beautiful.

For these reasons, the Academy strongly urges the FDA to make indoor
tanning regulation a top priority of its radiological health program. I
thank you for your time and attention.

FACILITATOR LESLIE: Thank you. Lisa Coronado.

MS. CORONADO: I think I\'ll follow her lead. Good afternoon. My name is
Lisa Coronado. I\'m a Senior Health Physicist at the National Institute
of Health, Bethesda, Maryland. Today I\'m speaking on behalf of the
Health Physics Society. We\'re about 6,000 members strong and we are
health physicists who are specializing in the field of radiation safety
in minimizing dose to be as low as reasonably achievable, also known as
ALARA. My children say I\'m Dose Buster because our job is to bust the
dose as low as we can go.

We are grateful to have this opportunity to interface with the FDA and
with other members of the community who are interested in the same goals
as we are. We feel that it\'s important for the CDRH to maintain a core
group of health physicists. We feel that the CDRH ought to be involved
in or concerned about the supply of qualified radiation safety
professionals to support the use of radiation devices.

HBS efforts in Congress and federal agencies over the past six years
have been concentrated on raising awareness of the human capital crisis
in health physics. FDA once was a major player through a public health
service fellowship program in supporting academic university programs
for health physics. It\'s not clear whether the PHS currently recognizes
health physics as a discipline for officers in the public health
service.

A few years ago, the PHS might have dropped it as a recognized allied
health discipline due to lack of accreditation of academic programs. At
the NIH when I started back in 1986, our staff of 25 health physicists,
13 were commission core officers. Today there are zero. We have no more
commission core health physicists at the NIH.

We recognize and appreciate the CDRH stated intent to focus on the
product use such as multi-slice CT scanners as opposed to just product
development. We agree that the current concern has shifted from quality
of product development to the varied product use.

In terms of partnership, in terms of the education arena, the HPS feels
that we could best dovetail our efforts in this department. Most of the
health physicists are out in the field and we interact with all segments
of society being the schools, the teachers, the public, the patients,
the physicians, the researchers, all segments, all aspects. And we\'ve
established ourselves as educators in the field of radiation safety.

One of our most popular features and services on our HPS website is
\"Ask the Expert\" where members of the general public, students,
patients will send questions in about how many x-rays can I have before
I glow in the dark and if I stand by the microwave when I\'m nuking a
sandwich, how bad is that and what if I\'m at elbow length. So they
could be from very innocent to very serious questions to I\'ve been
diagnosed with this type of cancer. My physician recommends I get A, B
and C. What do you think?

So we have a canned array of professional in health physics who
diligently answer these questions and research and farm them out to
other allied health care professionals if we\'re not equipped to answer
those. We think that we should be able to bridge that resource and that
knowledge and a lot of people know that that venue exists today that we
would bridge that with the FDA, CDRH and their terms of public outreach
and getting information out there to the community. Thank you very much.

FACILITATOR LESLIE: Thank you. That exhausts the list I have written
down up here. I guess the question now is are there others of you who
would like to make a comment. Going once. Twice. Okay. We\'ll call the
public comment period closed. All right.

Before this, I said I wanted to raise the question of collaboration and
it goes all the way back to the first piece this morning. Somebody said
what do you mean by and I think it was monitoring. But in this case, as
this plan looks forward, maybe it\'s a decade long plan, I don\'t know,
but as this plan looks forward and says here\'s some things that need to
be done in the future and you don\'t ever see a government agency or
actually any agency these days that does not talk about partnering, that
doesn\'t talk about collaborating with a variety of stakeholders.

Here\'s no exceptions. For you in your various roles in your various
organizations, my question, and I would love to have people get up here
to the microphone and have your opinion about that, what is
collaboration? Where should the bar be set? What constitutes
satisfactory collaboration?

It\'s not sufficient in my view to simply say CDRH, you provide the
money and I\'ll show up and that\'s collaboration. So you all have a
stake in this in some form or another and I guess when you think of your
interaction with CDRH on the one hand, others of you in the room on the
other, what should we strive for in terms of collaboration that
acknowledges accountability where it belongs because somebody spoke to
accountability? Was it you, Ellen? Somebody spoke to that and I\'m not
suggesting that accountability get move around and misplaced.

But I think there is a working together that comes with the concept of
collaboration and I would very much like to have those of you in the
room have a quite vocal say about that. I\'d like to hear what you think
about that. Fair question? Because we\'re going to get into it tomorrow
to say what are the opportunities for collaboration. This whole plan is
built on the notion that nobody can do it all by themselves. We actually
have to help each other to get it done.

So my question is what in your view is satisfactory collaboration. What
should we strive for in that regard? Please come. We need for the
transcriber to get this. So have at it.

MR. BALTER: Steve Balter again.  I\'m going to say this personally
rather than response to an organization. I think the first part of
collaboration as we saw in several of the talks is communicate,
communicate, communicate. If we all know what each other is doing, a lot
of the rest will work out. Budgets, authority are less flexible. We have
to know rather than worrying with some of the things. A good
collaboration, call them up and ask what they think.

FACILITATOR LESLIE: Good. Thank you. Others? Ellen, come. While Ellen is
walking up here, one of those points I would say is a question for the
subject and I think it may even have been you that says that I have a
workforce that\'s aging. They\'re going to retire. Do I just look at you
and say good to you or is there something else? Please.

MS. HAARS: Ellen Haars from State of Washington. Let me give you an
example of what I call collaboration and let\'s use training. FDA has
this basic radiological health training and I think the state has a
role.  They should pay for the per diem and travel expenses of the
student, probably pay some tuition but then FDA would get the
instructor, get the setting. So it\'s two-sided. We\'re equal partners.
It doesn\'t come down from Washington D.C. this is the way it is. They
work together.

FACILITATOR LESLIE: Good. Thank you. Others? Please.

MR. BRITAIN: Bob Britain with NEMA. Collaboration is sort of an
interesting issue when you have the regulator and the regulatee.
Obviously manufacturers would like to collaborate on issues with the
government and medical associations if the result of that collaboration
will or might impact the design of the equipment, standards associated
with the equipment and this is not an easy issue because of the arms
length situation between regulators and industry but it\'s something
that has to be worked through.

I\'ll give you a good example and that is in many cases we work very
closely with the American College of Radiology. But with their
accreditation program, it was a real arms length situation and we were
set aside as far as being invited in to help them with their
accreditation program which could impact equipment and the way it\'s
measured. So that\'s a good example.

We worked through a couple of situations with MRI where we were able to
get in after the fact and do some improvements. Anyway, I just wanted to
throw that on the table that collaboration isn\'t always easy although
we really want it.

FACILITATOR LESLIE: Cool. Thank you. William.

MR. BENNER: You know one of the ideas when I hear the word collaboration
within our industry what it means to me is that we would participate in
helping CDRH accomplish their goals. Like for example if CDRH said we
would trade this for some increase in training, training is something
that we do on a regular basis. It\'s something we\'re set up to do. We
could do very easily putting together a training program, things like
that.

One of the things I\'m thinking about is as I heard problems with the CT
machines and dosage and dosage measurement and there was a word that I
don\'t really understand but it conjured up in my mind this dummy human
that you throw into the machine and you kind of somehow get some kind of
measurements off of this thing.

One of the things that\'s going through my mind as I hear each one of
you and as I hear the CDRH reaching out for collaboration is that
industry itself, the Siemens, the GEs, the people who are making these
machines could participate in helping CDRH to accomplish their goals and
also helping people who have reduced staffs. One of the things, I\'m not
sure if I\'m the only one thinking along these lines, but as these
staffers which are going to be retiring soon and you\'re wondering where
you\'re going to come up with these new staffers, that\'s going through
my mind is are there alternative ways of accomplishing the same things
such as coming up with another way of testing, some sort of a more
advanced dummy human that you throw into the machine.

Think about this. This may sound wacky but this is possible. My company
accomplishes impossible things all the time. Think about this. This
FedEx box comes. It\'s this dummy human. You throw in the x-ray machine.
It gets x-rayed. Then you FedEx it back. Then somebody analyzes the data
that was experienced by the dummy human to figure out is it too high or
too low. This is really possible. It may sound stupid or wacky or
whatever but really this is the kind of really base level, easy to
accomplish stuff that could be happening and the industry itself could
be helping out with.

I bet if you asked Siemens what\'s the best way to test your x-ray
machine. In addition to coming up with the machine, come up with the
tester too. Yes, they can and they\'ll more than happy to help you guys
do that. So I think that\'s the answer is industry participation.
Sometimes it\'s really just figuring out what the question is and you
never come up with the good idea until you ask the question.

A while back, HP had a saying which I love which they\'ve dropped and
we\'ve adopted. It said \"We never stop asking what if.\" So I think we
all need to start asking \"what if.\" What if there was a FedEx dummy
thing? It could happen.

FACILITATOR LESLIE: Good.  Thank you. John.

MR. VILLFORTH: Sure glad I\'m retired. I don\'t think I could deal with
all this. I just want to again compliment the folks in the back of the
room from CDRH (1) for being here. Could I ask for a show of hands of
those of you who are from FDA other than ORA or CDRH? The senior people
in FDA. Who\'s the most senior person in CDRH here? Is the Center
director here? Deputy director? Does that tell you something?

Okay. This is such a big issue and I think the Center must be
complimented for taking the time and putting this together and making
this step in the right direction.

I think this is where collaboration starts. It starts with the fact that
the juices flow as you hear all of these different organizations, all of
you, and I thought it was very exciting to hear the attempts to say hey
we want to work together and that\'s wonderful. But we\'re down here to
do two things, this and leadership. This is going to be hard to come by.
I\'ll let the other speak for itself.

I don\'t have an answer other than going back to the basic Radiation
Control for Health and Safety Act. There\'s a lot in here if you ever go
back and read it. It\'s great reading. I think it\'s one of the \--
Seriously, for those of you in the medical device area and with Bob
Britain aborting and going over to medical device program in the early
days, we used to talk about the fact that the Medical Device Regulation
which was initiated by Congressman Paul Rogers as was this Radiation
Control for Health and Safety Act, this is \`68 and one is \`76, the
Device Act, the Device Act starts out by saying that all medical devices
will be divided into three parts: Class 1, Class 2 and Class 3. If you
fall in one of those three classes, here\'s the sequence of events that
you must do.

The Radiation Control for Health and Safety Act I think is one of the
most beautiful pieces of legislation because it says our job is to
protect the public from unnecessary radiation exposure and there\'s a
whole bunch of tools in here that suggest how that might be done. As I
said earlier, the main tool is performance standards. That\'s the basis
of which it was said. But there are other important tools like I said,
the defect, the recall provisions and so forth.

But there\'s a big section here about what could be called collaboration
and working with other federal agencies, consult and maintain liaison
with the Secretary of Commerce and the Secretary of Defense and
Secretary of Labor, AEC and blah, blah and working together. There\'s
also a comment in here about professional organizations and other
scientific organizations which is another word I guess of saying
collaboration.  So there\'s good stuff in here. A lot of it\'s
discretionary and a lot of it because of this and because of that have
gotten lost. So I hope we can reinstate it. I hope what we\'re seeing
here today with the leadership of John and the folks in the back of the
room that you\'re going to start in the proper direction.

I played around with some numbers here. You were talking about training
and education just to let you see how things have gone down the tubes. I
wanted to share that with you. In the Heddie (PH) days starting after
1961, this is really ancient history, the training grants to
institutions that came out of what was then the Bureau of Radiological
Health, and I had nothing to do with this, amounted to about 30 to 35
training grants to academic institutions at the graduate level and about
seven at the undergraduate level and many of you and many of the people
you work with are probably the fruits of some of those programs that
were funded.

Those abruptly ended in 1975 when they went back to zero. So there is no
money coming out of this department, Health and Human Services, through
CDRH to support any kind of graduate training program or technician
training program. In addition to that, of course, there were research
grants which went into universities which helped in a way to support
research assistantships for various projects related. So that helped
amplify things.

With regard to the short-term training programs, I don\'t have the
actual numbers but I remember the statistics. Back in 1969 when I first
had the opportunity to be the Director of the Bureau of Radiological
Health that year we conducted 99 class weeks of training in all of the
facilities. Training was done at Rockville. It was done at Montgomery,
Alabama, Las Vegas and Winchester, Massachusetts. Not all of that was
the type of radiation we\'re talking about here. A lot had to do with
environmental radiation. But 99 weeks. Classes were going on
continuously in those programs.

Those I guess are down except for what\'s being done in MQSA essentially
zero.  I don\'t know whether EPA is doing any thing in this. They\'re
not. Okay. But that\'s the problem you have to face where again we\'re
talking about money, recognition and so forth because I think the
concern of the Health Physics Society is real and very clear. I don\'t
know the solution to it. I just know that this kind of a discussion, the
fact that there will be a written record and an opportunity for
everybody to make their points known is going to be a real step in the
right direction and I appreciate what leadership you\'ve expressed here.

FACILITATOR LESLIE: Great. Thank you, John. One word in here in between.
I would offer to you. John said something really important in the sense
that the leadership piece here is a critical one and I\'m reminded.

To illustrate let me do this. Last week I was actually doing a similar
sort of activity for the President\'s Cancer Panel and at one point in
that meeting, one of the panel participants asked Dr. Margaret Kripke
from M.D. Anderson who was one of the panel members, we were discussing
this recommendation that said the NCI was supposed to create this task
force and this panel member said to Dr. Kripke who is this task force.
And she looked around the panel who like you was a selected group of
people who cared very much about the subject and she said, \"It is
you.\"

That is true in this room. You all are the ones who care. You are the
ones who saw fit to come and be here and be part of this. I think you
with John and his staff share the leadership responsibility, John, that
you so correctly point to to make this move forward because I think it
is you all that will do that. So please.

DR. READ: Thank you. Dr. Sandra Read for the American Academy of
Dermatology. The FDA and the AAD have participated and cooperated in the
past in scientific consensus conference on issues of mutual interest
such as skin cancer, Vitamin D levels, tanning salon and regulation and
we are very grateful for that association in the past. I think that is
the best form of collaboration is to continue to share our experts and
our scientific knowledge and we look forward to a future working with
this committee. Thank you.

FACILITATOR LESLIE: Cool. Thank you. Anybody else? Please. The point you
keep making is you have to get in the room and talk to each other. If
you don\'t do that, not much else happens. You\'re on.

MR. CYRE: Jim Cyre from Phillips Lighting Company. I\'ve been listening
and at the risk of going back to something elementary I keep hearing
something that harkens maybe to Quality 101 which many times gets
screwed up in the implementation as well. But really what constitutes
collaboration is (1) total trust by the community of stakeholders. The
willingness to listen and accept breaking or shifting of paradigms, the
interesting example of the FedEx box, I don\'t know but is there other
ways of doing it?

I\'ve heard a lot today about consensus standards. Anybody here ever
been involved in the development of a so-called consensus standard that
they didn\'t feel good about. Well, the same deal here. I have two. But
it comes back to it\'s not taking a vote and the majority wins. It\'s
finding solutions that meet the requirements of all of the stakeholders
and that really I think is the challenge here today.

FACILITATOR LESLIE: Cool. Thank you. Anybody else want a crack?

MR. McCORMICK: Luke McCormick with Customs and Border Protection again
and I have a little bit different view on this because I\'m not really
regulated by you guys. I\'m an enduser and I think maybe a little of the
collaboration the way we can get into it is the way I collaborate with
our manufacturers.

I don\'t know. I\'m sure some of the manufacturers out there saw the
paper today and realize that we have a couple hundred million dollars
budgeted for non intrusive inspection equipment this year. I have a lot
of our manufacturers who will very willingly fly out to see us and take
our suggestions for the radiation safety that we want input into the
systems that we\'re going to buy. It\'s that bottom line that somehow
makes people collaborate much more effectively.

FACILITATOR LESLIE: Doesn\'t it though?

MR. McCORMICK: I think maybe that\'s one thing we can do is look at the
end users, the medical community, the laser users. Get them involved in
the collaboration because I have certain needs in my non intrusive
imaging. I would hate to have your regulations only reflect my needs.
DoD has the need for this type of imaging as well and they have some
needs that I don\'t think I need. So your regulation is going to have to
be from a bunch of different users of the same type of equipment and
unfortunately in NII there aren\'t a lot of us that use this.

FACILITATOR LESLIE: Great. Thank you. anybody else?  You know it\'s that
old business of finding the solution that you can all support even
though it might not be your first choice. But it gets to the point of if
we can find a way where we can move it forward without winding up it\'s
either my way or your way and we\'ll let the lawyers work it out. Okay.
Any other comments? John, do you want to say anything about the topic I
raised here before I talk about tomorrow? Apparently yes.

DEPUTY DIRECTOR McCROHAN: When invited, I almost always speak. I wanted
to in particular thank John for his comments and the woman from NIH
representing the Health Physics Society. There you are. Okay. I can\'t
keep track of time anymore. I\'m getting too old for that. But it was
two, three years ago that I finished my 30 years career in the Public
Health Service as a commissioned officer and I came to the Public Health
Service in part through the PHS training fellowships which incidentally
funded by graduate career at the University of Washington in Seattle. So
lot of little connections here.

I also wanted to react to a comment that was made about, I think it was
by Bob Britain, the situation in which we sometimes find ourselves where
we\'re held at arm\'s length from certain developments and just reflect
on the fact that back before the advent of MQSA, back at the time when
notwithstanding I was part of FDA, a regulatory agency, I didn\'t know
how to spell that word and when I was more in an educational mode and
where collaboration was what you did every day, there were a number of
organizations with whom I had what I at least considered to be a very
productive relationship. CRCPD was certainly one. ACR was another.

Then MQSA passed and then ACR applied to the accrediting body and then
they were being regulated by us in that respect. I think it\'s fair to
say that that had for me a somewhat sort of chilling effect and I think
that\'s too bad. I don\'t know that there was a way to avoid that. But I
think Bob has a good point in terms of particularly the manufacturers in
collaboration with the regulatory agency and so on. I think that is
difficult.

On the other hand, I think FDA in this context is worth looking at if I
can put it this way in a somewhat schizophrenic fashion. We are
certainly a regulatory agency. We have that relationship with a number
of our stakeholders. But there\'s a sense in which we\'re another kind
of an agency. We\'re a public health agency and the public health is I
think what we\'re primarily about. That\'s why we engage in regulation
but it\'s also why we do other things.

And I think to the extent that there are opportunities to collaborate on
things which are not of a regulatory nature, we shouldn\'t let our
nature as a regulatory agency get in the way of that. I say that in
particular because to the extent that we see the public health problems
that we are faced with as being problems of use with the sole exception
of mammography, we don\'t have a regulatory role. We don\'t have the
authority, the responsibility, to regulate the endusers and yet I think
we have the public health responsibility to try to do what we can to
provide those endusers with the appropriate information, to what we can
to educate, to motivate, to challenge those people to do the best job
that they can and I think that\'s a mission that we share with lots of
you folks and I wouldn\'t want to see our regulatory role get in the way
of the potential for collaboration in those areas.

For our friends in the states who do have the authority to regulate use,
I would say what I\'ve said more than once over our 30 year association
and that is there are certain programs that we have that are
nonregulatory like NEXT for example which is the basis for reference
levels or expected values of exposure for certain examinations that we
think ought to be applied in a nonregulatory fashion.

I think at the same time there are things which can be done by states as
regulators of the endusers particularly for example in medical
facilities such as requiring medical facilities using x-ray systems to
have a quality assurance/quality control program to maintain some form
of oversight, to have a medical physicist alla MQSA come in on an annual
basis and do an assessment of not just the machine but how the facility
is maintaining not just the machine but it\'s whole quality control
program and assuring that the exposures to their patients are
reasonable. And I think sort of oversight would be very helpful but I
think again there\'s this issue of balance and how do we do that without
creating a barrier that may not need to exist amongst those of us who
would otherwise be able to collaborate given the regulatory nature as
Bob was saying of some of our responsibilities.

I think in the training arena we\'ll talk about this certainly tomorrow
there\'s a real opportunity I think here to have some effective
collaboration. The days unfortunately, John, are long past when HHS or
whoever we were at the time can mount 99 weeks worth of training in a
year much less support the institutions of higher education where I got
my advanced degree. Thank you very much.

But I think that there are in the audience any number of people who have
access to information which would be useful in a training environment,
have actual training programs and courses and so on and so forth. I
think what\'s called for is bringing that to bear on the training if you
want to think of it in those terms of the public, of endusers and
regulators because I think it\'s in the bottom-line vested interest of
the regulated community to see to it that the regulators know what
they\'re doing.

If you have a regulator come into your facility, into your manufacturing
plant, who is not well versed in the topical area that they have to deal
with, I think you\'ll find that they\'re going to do a lot more harm
than good. So I think that it is in everyone\'s interest that we be as
smart as we can be. I think that the states would agree and I\'ll leave
it at that until tomorrow.

FACILITATOR LESLIE: Okay. Let me talk a little bit about tomorrow and
then we\'ll get out of here. On your name tag, you will see a number.
That number is to be the starting group you\'ll go to tomorrow once we
launch out of there. The intention of tomorrow is take the three new
areas of intent in this CDRH plan of standards, monitoring and
education, set up essentially round-robin groups and allow each of you
the opportunity to go to each one of those for about an hour and have
your say.

Now when we originally conceived this meeting, I must say we truthfully
envisioned that probably 50 people would find this interesting. So we
were envisioning the groups would be a little smaller than we\'re
turning to be. So there will be a little bit of cooperating with each
other tomorrow so that everybody gets to have their say.

But what we\'re really wanting you to do is in each of those areas with
our folks in the room talk to the pieces that are these. What are the
issues looking ahead that have to be solved with regard to standards,
monitoring, education? What should be the priorities over the next
couple of years? You know it\'s this limited money and energy thing. I
only got X amount of folks. I only got X amount of money. And I can\'t
do it all. What should we put real muscle behind knowing that that meant
something else didn\'t get quite as much?  Your view of what those
priorities ought to be will be very important and very interesting to
hear.

Then the third piece is the thing that we\'ve just been talking about.
What are the opportunities to collaborate that you see? I\'m hoping you
actually see some rather specific things so that you can say \"Hey, you
and me. Let\'s get together and work up a piece of X and do this with
it.\" I\'m hoping some things come out of that like that. But bottom
line, it\'s what are the things that have to get solved going forward to
make this thing move, to head in the direction to benefit the public
health, the thing that you\'ll in this room for. And then the priorities
and then the opportunities to collaborate.

So what we\'re wanting to do tomorrow is cycle through giving you an
opportunity to be in each of those groups and then come back in here,
hear what the themes out of those groups were before you leave because
those will be we have facilitators for each of those groups. We\'ll
having somebody working a laptop to try to make some sense out of all
that and out each of those, I\'m expecting you to see five, ten, fifteen
item list that says these are the things said most often. These are the
themes that came out of the days\' discussions on standards, on
monitoring, on education. It may surprise all of us what comes back out
of that because you\'ll see it as you go around.

There is a piece on the schedule tomorrow afternoon that\'s 3:15 p.m.
which I think John and I\'ll be up here in front of room and it\'s
called open discussion and it\'s for this. We\'re asking you to spend
most of the day focusing on those three areas. There may be some other
things you think we ought to be talking about. There may be some other
things you think are important and that will be the opportunity to get
that on the table because if it\'s not be said and it needs to be said,
we want to hear it because it will then provide the basis, all of this
provide the basis, so how do we move this thing forward.

Deals will get make later. Plans will get made and talked about later
and work structured because what\'s that old line about ultimately it
all evolves into hard work. All of this conversation is terrific but
sooner or later somebody had better do something or it\'s just been a
nice talk. We have to get to that but that\'s a little down the road.

What I\'m envisioning is we\'ll come in here tomorrow morning. We\'ll
bang the gavel at 8:30 a.m. I think the coffee is ready at 7:45 a.m.
earlier. Coffee and the continental breakfast will be there as this
morning. We\'ll get going and I\'ll get you launched out of here into
these groups fairly quickly and we\'ll spend the day doing that. I think
you\'ll find tomorrow different than today and I\'ll hope you\'ll find
it a very good day.

Anything before we draw it to a close and hopefully adjourn in here and
have a glass of iced tea, a cup of coffee or something else? Anything?
Cool. See you in the morning and if you can have a drink of something,
please do. Thank you for a good day.

(Whereupon, at 4:13 p.m., the above-entitled matter concluded.)