[House Hearing, 109 Congress]
[From the U.S. Government Publishing Office]




U.S. Department of Veterans Affairs Oversight on Patient Safety
Thursday, June 15, 2006
House of Representatives
Committee on Veterans' Affairs
Subcommittee on Oversight and Investigations
Washington, D.C.





The Subcommittee met, pursuant to notice, at 10:14 a.m., in 
Room 340, Cannon House Office Building, Hon. Mike Bilirakis 
[Chairman of the Subcommittee] presiding.
 

Present:  Representatives Bilirakis, Boozman, Bradley, Reyes.
 

Also Present: Representative Deal.
 

Mr. Bilirakis.  Good morning.  Thank you all for being here as we 
discuss an important aspect of health care, and that is patient 
safety.  Today we will discuss oversight of patient safety at 
Department of Veterans Affairs (VA) medical facilities.
 

This review of patient safety comes to us not only as part of the 
Subcommittee on Oversight and Investigations' agenda, but in the 
wake of problems identified at two VA facilities.  Surgeons at the 
James Haley VA Medical Center in Tampa, Florida implanted an 
unsterilized cranial plate in a patient in February 2006, and 
nearly duplicated the mistake a week later.  At another facility 
in Augusta, Maine, it was determined that a transrectal ultrasound 
transducer was improperly sterilized and cleaned, following medical
 procedures.  It is my understanding that this incident was not a 
one-time occurrence, but happened repeatedly, repeatedly over a 
number of years, and that unclear instructions contributed to the
 sterilization problems.
 

Thankfully, we are unaware of any patients that were harmed in 
these incidents.  These medical devices and other versions of them 
are used in VA facilities across the country.  The VA had great 
difficult identifying the extent of the veteran patient population 
that may have been exposed to these inadequately sterilized devices.
 

Furthermore, VA was less than expeditious in notifying this 
exposed population.  Since these medical devices are not unique to 
the VA health care system, we have asked the Food and Drug 
Administration (FDA) to share with us what it has done to notify 
the entire U.S. healthcare delivery system of these patient safety
 implications, and we very much appreciate those good people being 
here.
 

Not only will we discuss the safety of medical devices that assist 
in patient care, but we will hear about the proper screening, or 
maybe I should say improper screening, possibly, of VA medical 
center employees, to include physician credentialing and privileging.
  In addition, we will review VA's policy and safeguards on hiring 
convicted sex offenders to work in the VA, and examine the 
implications for patient safety in VA employees.
 

Today, we will hear testimony from Dr. James Bagian, Director for 
the VA National Center for Patient Safety, who is here to discuss 
the situation of properly handling medical devices in VHA 
facilities.  Dr. Bagian is accompanied by Dr. Lawrence Deyton, the 
Chief Public Health and Environmental Hazard Officer for the 
Veterans' Health Administration (VHA).  From the Office of 
Inspector General (IG), Dr. John Daigh, Assistant Inspector 
General for Healthcare Inspections is here to share the IG 
findings on the medical device situations and on other patient 
safety issues found at VA medical centers.  Additionally, 
Dr. Daniel Schultz, Director of the Center for Devices and 
Radiological Health at the FDA is here to share FDA procedures on 
approval of medical devices and how concerns are reported and 
handled.  Finally, we have Laurie Ekstrand, Director of Health 
Care for the U.S. Government Accountability Office (GAO) --  it 
probably should be Dr. Laurie Ekstrand; is that correct?
 

Dr. Ekstrand.  Yes sir.
 

Mr. Bilirakis.  I thought so -- to discuss the credentialing and 
privileging of medical professionals at VHA facilities.
 

I know we all look forward to hearing your testimony and answers 
to our questions, and I would now like to recognize my colleague, 
Mr. Reyes, for an opening statement.
 

[The statement of Mr. Bilirakis appears on p.  ]

*********INSERT**********
 

Mr. Reyes.  Thank you, Mr. Chairman, and I apologize for keeping
 you waiting.  We are here today reviewing patient safety issues in 
the VA, as a result of two recent problems that were observed and 
acted upon by watchful VA employees.  In each of these events, a 
non-sterile device or implant was used medically on a veteran.  
And in each case, a VA employee asked questions and elevated their 
concerns until the true extent of the problem became clear and 
internal procedures were subsequently changed.
 

We all shudder at the thought of nonsterile invasive medical 
contacts.  We all recognize that a host of complex medical 
procedures are performed by the VA on a daily basis, and that 
sometimes things will go wrong.  Our goal is to help the VA find 
ways to reduce both the frequency and the severity of such problems.  
The events that we are reviewing today did not result in physical 
harm to any veteran.  We, collectively, learned something from 
analysis of these events.  Had the VA observers remained silent, 
the problems might still exist, and might do harm to others.
 

As important as it is to analyze these problems, we must also assure 
that the oversight system that protects VHA patients remains vigilant 
and responsive.  We must assure that patients outside VA are informed 
of potential problems with devices or with procedures.  Where patient 
safety is involved, the pursuit of best practices will save many, 
many lives.
 

With that, Mr. Chairman, I yield back.
 

Mr. Bilirakis.  The Chair thanks the gentleman.  Mr. Boozman, for a 
brief opening statement?  Mr. Bradley?  All right, thank you.
 

It is only one panel, but this is a pretty darn hectic day for all 
of us.  We very much appreciate your being here.  I am going to 
figure on maybe giving you 10 minutes to present your statement if 
you would like.  Of course, you can cut it down if you would like 
and allow more time for questions.
 

I would introduce Dr. Bagian -- I think I messed up your name a 
moment ago --  he is the VHA Chief Patient Safety Officer and 
Director of the VA National Center for Patient Safety with the 
Department of Veterans Affairs.  Dr. Bagian, please proceed.


STATEMENT OF JAMES P. BAGIAN, M.D., PE, VHA CHIEF PATIENT SAFETY 
OFFICER AND DIRECTOR, VA NATIONAL CENTER FOR PATIENT SAFETY, U.S. 
DEPARTMENT OF VETERANS' AFFAIRS, ACCOMPANIED BY LAWRENCE R. DEYTON, 
MSPH, M.D., CHIEF PUBLIC HEALTH AND ENVIRONMENTAL HAZARDS OFFICER, 
VETERANS HEALTH ADMINISTRATION; JOHN D. DAIGH, JR., M.D., ASSISTANT 
INSPECTOR GENERAL FOR HEALTHCARE INSPECTIONS, DEPARTMENT OF VETERANS' 
AFFAIRS; DANIEL SCHULTZ, M.D., DIRECTOR, CENTER FOR DEVICES AND 
RADIOLOGICAL HEALTH, FOOD AND DRUG ADMINISTRATION, U.S. DEPARTMENT 
OF HEALTH AND HUMAN SERVICES; LAURIE EKSTRAND, DIRECTOR, HEALTH 
CARE, U.S. GOVERNMENT ACCOUNTABILITY OFFICE



STATEMENT OF JAMES P. BAGIAN 

 

Dr. Bagian.   Thank you, Mr. Chairman. It is a pleasure to be asked 
to talk to you today to explain what we do in the VA. As you know, I 
have been before you before, and your colleagues, and we have been 
working for quite some time to really bring a culture of safety into 
the VA, where it is not strictly rules; it is to understand how 
people are willing, as was pointed out in the opening comments, 
willing to raise their hand when a problem occurs so we can address 
it in a systematic and effective way.  That doesn't mean problems 
don't occur, but we are glad that we understand when they occur, 
because you can't fix what you don't know about.  And we are glad 
that people are willing to come forward when they could have easily 
turned the other cheek and never told anybody, and then we would 
still have patients in peril.
 

I was asked specifically to speak about the issue in Tampa with the 
implant, and then the transducer, so I will discuss those first.
 

The issue with the implant in Tampa, the time line was basically as 
follows: February 28th, during surgery on a veteran where he had 
sustained injury from an IED, in OIF, they had to put an implant.  It 
is a model of, like, a piece of the skull that they would put in 
place.  And during the operation, the specimen was brought up, they 
opened it, went to put it in place, and having nothing to do with 
the implant, the condition of the patient was such that it would 
not fit.  That was just because of swelling of the brain, something 
that can't be controlled.
 

They decided not to use the implant at that time, but in the process 
of doing this, one of the nurses who was alert became concerned.  She 
said she thought she remembered that one of the pieces of paper --  
and here is a replica of that --  that comes up with the implant is 
not sterile, and yet she found it on a back table.  That is not the 
table right next to the operating table, but back there, and she 
said, " I don't think that's right."
 

She called the rep from the factory, you know, the factory rep, and 
she said, "Is this sterile or not?"
 

He got back to her and said, "No, the paper isn't sterile but the 
device itself is."
 

Subsequently, that didn't make sense to them.  The following day on 
March 1st they said, " This doesn't really make sense that this could 
be that way,"  followed up more and found out that the representative 
from the company was in error, and in fact neither were sterile.
 

Now here is the thing I show you to understand how this happens.  
Here are two peel-back containers.  They are commonly used in the 
operating room.  If I asked you which one is a sterile and which one 
isn't, which one do you think is sterile?  I will tell you one is in 
one is not.  Which one would you say?
 

Mr. Reyes.  I haven't been to Vegas in a while.  I'd say the left 
one?
 

Dr. Bagian.  This one is the sterile one?  Okay.
 

Mr. Reyes.  I don't know if it is my left or your left, too.  You 
answer my question.
 

Dr. Bagian.  Well, okay, I will say it is my left. That is a good 
point.  You are making my point anyway, that is even better.
 

Now if I turn them around, and now I ask you which one is sterile, 
still think this one?
 

Mr. Reyes.  The white one.
 

Dr. Bagian.  Oh, now you are changing to this one. Okay.  So now, 
this one.  Okay, now it turns out this actually is the sterile one.  
However, they look identical. And the fact is --  
 

Mr. Bilirakis.  I would say to the gentleman that is the one that 
I picked.
 

Dr. Bagian.  So now -- and it is good that you are lucky, because 
this nonsterile one looks like a sterile one, and there is almost 
no difference except there would be a little hourglass with a date 
there if it were sterile.  That is the only difference.  Now, when 
you look at things that come up in the OR, they come in peel-back.  
Usually, anything that comes in a peel-back is sterile.  They handle 
thousands of times a day.  What happens when this comes up to the 
operating room, this, with this on top of it, is there, sort of like 
when you buy aspirin and you open the box, you know that there is a 
label, that --  what do you do with that? You read that?  You throw 
it away, right? Supposing this one you open today, in fine print it 
says, " If you take more than one, this particular new formulation, 
you will die."   You would be in trouble I guess, right?
 

That is what this is like.  When you get to the third page on this, 
in the fine print at the bottom, it says, " This is not sterile,"  
when you get to this.  Now let me show you, other people missed this 
as well.  When you get this, the first thing it says about cleaning 
and sterilization, it says, " Do not autoclave."   That is steam- 
sterilize, says " Do not do that."   You know why?  Because it will 
melt.
 

But interestingly enough, in the FDA's testimony, it says it was 
simply error, it says you should have sterilized it by steam.  So 
they obviously had trouble reading this as well, preparing their 
testimony.  But they still don't understand how it is supposed to 
be done.  I guess other people can make errors, too.  So the fact 
is this is a problem with the way this is set up.  So even when the
 FDA got done, as you will see in their testimony, they say, " People 
should just read the directions."
 

That is not enough, because when you have a device that you supply 
thousands of times a day in this packaging, that is always sterile, 
and now send up one that is not, what do you expect people to do; 
to do what they have done thousands of times, or this one when it 
is in the throwaway paper that they get in every package?  That is 
what happened.
 

So, we looked at the root cause.  They did, too.  They immediately 
notified us, soon as they knew about it, that afternoon.  They found 
out, they put it in our safety system, and they called us as well.  
We talked to them, within literally hours, we had called Stryker, 
who is the manufacturer of this, and talked to their --  sorry, it 
is not the vice president, but he is the --  in charge of regulatory 
affairs and risk management --  and talked to them --  regulatory 
affairs and quality assurance, I am sorry --  talked to him. He 
talked to us and said, " Can we talk more?"  He came out and 
visited us.  He said, " What can we do?"  He said " There is a 
problem with this."
 

We said, "Why don't you label this on the thing itself, says, " not
 sterile"  since it is in --  if you are going to keep it in the
 same packaging, it is in packaging that is routinely sterile, put 
" not sterile, must be sterilized," and not steam sterilized, 
because that is what most people do.  It may not be steam 
sterilized.  Ethylene oxide only. You know, there is even stuff you 
can put on the device itself so you do not have to worry about the 
packaging so when it is sterilized it goes away, so you could write 
on them with a drawing of a skull and crossbones, " not sterile,"  
so that any surgeon who would get it would have it in front of them, 
and if it said " not sterile,"  they would know it.  If it is 
sterilized, it goes away, you know, it disappears.  We talked about 
it.  That's all the things we said.
 

Nothing has happened with that.  And as you can see, the recommendation 
from the FDA is, " Just follow the directions,"  which, while yes, it 
is written, but it is like reading the fine print in a contract; it is 
not really fair. We know in loan applications we don't allow people to 
do that.
 

So we went through that, and we are putting systems in place to get 
past that.  You know, I know Dr. Daigh is going to talk to you, and we 
agree with the IG's report.  We think the IG's report is accurate in 
virtually every respect.  The way it happened is consistent with our 
root cause and showed the same things.  We absolutely concur.  Did 
somebody miss that it said sterilize that way?  Absolutely, it is 
true.  But it is more than that.  You have to ask the second question, 
it is like Paul Harvey, " And now the rest of the story,"  that to have 
a better system is not just have systems in place, people, which can 
foul up, but make it easier for people not to foul up.  And label them 
clearly to begin with.
 

So that is basically the sum and substance.  As far as with the 
patients, we identified only two patients that had this happen, no 
others.  I must admit that the ones that they used before this, the 
same kind of implant was made by another manufacturer, in the same 
packaging, looks the same, except it was sterile, okay.  These are 
the first two times they ever used ones that were by this new 
manufacturer, labeled the same, except if you read the small print.
 

So that is kind of it for the Stryker.  We go ahead then, then in end 
of January this year, you know, on safety walk-arounds.  We encourage 
our safety managers to walk, you know, look around their facilities 
for things that could be a problem, not wait for a problem to occur 
and then react, but in fact to go out and see what is going on.  They 
were looking at scopes, and in the case of this transducer, it is a 
transducer that is introduced through the rectum to view the prostate, 
so you can do a biopsy just where you want to do it.
 

When they were there, they picked up one of the needle guides, it is 
a channel through which you put the needle that does the sampling, 
does the biopsy, and they held it up to the light and they couldn't 
see through it.  They tapped it on the table, and some stuff fell 
out.  Don't know what the stuff was, just some stuff.  Obviously, 
it shouldn't be that way.
 

They immediately suspended all biopsy procedures in that facility 
while they looked at that.  After they reviewed the situation and 
understood it, on February 13th, they instituted procedures again, 
and they notified us, and they said, " We think this is a generic 
problem with the way the instructions are written and carried out, 
and we think it could be a bigger problem."
 

So, we were notified on the 14th at 10:40.  By 11:01, we had already 
had four other staff looking at all literature, talking to the 
factory and manufacturer.  By a little bit later that day we had 
talked to Dr. Deyton, Dr. Roselle, we had talked to operations 
folks, we talked to our SPD, the people that do sterilization, those 
kind of things. That was all within hours of being known.  Within 
less than a day, we sent out a note to all our sterilization SPD 
folks in the field, that they should have everybody review the 
procedures for their various devices, to make sure they are really
 complying with them the best they can.  We sent a further 
clarifying message, to really point out about the brush, which was 
one of the issues, the following day.
 

So within less than 48 hours, we had gone out to all of our 
facilities.  We also had the manufacturer, B-K Device, come in and 
talk to us, and they admitted that the directions can be somewhat 
problematic.
 

Oh, I forgot to mention, on the previous thing, I should have said 
this.  On the previous device, Stryker, on March 6, after several 
days of knowing it, we filed with the FDA a Medwatch thing, a 
Medwatch report to the FDA reporting about the implant, and the 
recommendation was, they should be labeled, says " nonsterile"  
on the device itself, or on the packaging.  That was in our 
suggestion to the FDA, but obviously they didn't think that was
 worthwhile.
 

Going back to this, we looked at our manuals, and I have these 
cross-tabbed, because you can't look at one manual to figure out 
how to sterilize it.  It took over an hour and a half between 
three bioengineers, two of us who are also physicians, and a 
bioengineer that is just a bioengineer, to go through this to try 
to decipher what they really were telling us.
 

Now interestingly, I will tell you in November 2003 we found out 
that this occurred in Toronto in nine hospitals, as well.  And in 
the press, the open press, there are quotes from the medical officer 
there saying that the B-K device manuals are not clear.  And this 
is reported in ECRI, as well.
 

So we went and looked through this.  We worked with the company.  
The company actually was very good about working with us to make 
sure we could come up with a better, clearer procedure.  During this 
time, we contacted the FDA as well, and we asked them some questions.  
After some time, they responded to us, after a little prodding, and 
responded to us about our alert, if they had any concerns.  And they 
had some good questions that helped us clarify it further.
 

We then issued an alert on April 3rd to all VAs.  Now, this is just 
in the first 48 hours, giving instructions. Now we had tested the 
real response, as far as going out to our facilities, piled them to 
make sure it really works.  It is one thing to write a procedure; it 
is another thing to make sure it can be done appropriately.  And that 
takes an iterative process; you can't do it in a day.  We wanted to 
be thorough.
 

We did this.  We worked at length with the facilities, with the 
company, who verified everything we put down, said, " Yes, that is 
correct,"  and we followed that up.
 

We completed that on April 3rd.  That was completed, and since that 
time that has been out in the field.  And that is basically what we 
have done to address it.  We also, I should add, as with all our 
alerts virtually, we put them on the Web.  Not just the internal 
Internet for the VA hospitals, but we put them so everyone else can 
look at them outside the VA, because we know that both inside the 
U.S. and outside the U.S., people subscribe to our web site because 
we often turn up things that haven't been written up by anybody else 
with very clear instructions; not just " Be worried,"  but " Here is 
what you can do to make it safer."
 

[The statement of Dr. Bagian appears on p.  ]  

*********INSERT**********
 

Mr. Bilirakis.  Thank you, Doctor, I'm sure you weren't quite finished.
 

Dr. Bagian.  No, that is fine.
 

Mr. Bilirakis.  I did want to say that Chairman Nathan Deal, who 
chairs the Health Subcommittee on Energy and Commerce, which has 
full jurisdiction over FDA, has honored us by coming here today at 
my invitation.
 

Nathan, we should have notified you yesterday that we were going to 
have the FDA here, and I apologize for that. But --  
 

Mr. Deal.  Mr. Chairman, as you know, we have got a markup at 11:00.
 

Mr. Bilirakis.  I know.
 

Mr. Deal.  I am going to have to leave, Mr. Chairman, but I 
appreciate your inviting me here.  This is interesting testimony.
 

Mr. Bilirakis.  Well, and I want to skip Dr. Daigh if I may for a 
moment, and skip right over to Dr. Schultz, so that we can hear from 
FDA while hopefully you are still here.
 

I also have to be at that markup, so I am not sure how we are going 
to get all this worked out, but Dr. Schultz, I would appreciate your
 summarizing your statement, if you would.  You may have questions 
to ask, or points to make in rebuttal to what possibly Dr. Bagian 
said, I don't know.  You have got 10 minutes, go ahead, sir.
 

Dr. Schultz.  Thank you so much. 


STATEMENT OF DANIEL SCHULTZ 

 

Dr. Schultz.  I am Dan Schultz, Director of Center for devices and 
Radiological Health, at the Food and Drug Administration.  I 
appreciate the opportunity to talk to you today about device 
safety and sterility, an issue --  
 

Mr. Bilirakis.  Can everybody hear him all right? You might pull 
the mike a little closer, Doctor.
 

Dr. Schultz.  Sorry.  An issue that is of utmost importance to the 
agency.  I have submitted written testimony for the record.
 

For my opening statement, I will provide a brief overview of our 
regulatory authority regarding medical devices, following which I 
will provide a discussion of the specific cases that brought us 
here today.
 

As defined by federal law, the term "medical device"encompasses 
several thousand health products, from simple articles such as 
tongue oppressors and heating pads, to cutting-edge and complex 
devices such as pacemakers, lasers, and imaging technologies.
 

The medical device amendments of 1976 gave FDA specific authority 
to regulate the safety and effectiveness of medical devices.  The 
Federal Food, Drug, and Cosmetic Act prescribes a variety of 
mechanisms to achieve that goal.  These include general controls, 
such as listing, registration, quality system requirements, 
prohibition of adulterated devices, premarket notification, record 
keeping, et cetera.
 

CDRH developed a medical device postmarket transformation initiative, 
which encompasses taking steps to increase its ability to identify, 
analyze, and act on postmarket information.
 

In 2005, the Center conducted a comprehensive inventory of its post 
market safety programs, including recalls, MDR reports, medical 
device safety network of about 350 hospitals and other facilities 
trained to recognize and report device-related adverse events.
 

We have prepared a report in ensuring the safety of marketed medical 
devices, CDRH's medical devices postmarket safety program, which 
documents the postmarket inventory, and discusses CDRH postmarket 
program.
 

A separate synopsis and recommendations document provides a list of 
initial action steps the center will take to strengthen the 
effectiveness of our postmarket programs, and I would like to submit 
these for the record.
 

Mr. Bilirakis.  Without objection.
 

[The attachment appears on p.  ]  

*********Committee INSERT**********
 

Dr. Schultz.   Thank you.  As you know, FDA is in the process of 
addressing issues raised by the Department of Veterans' Affairs 
regarding the sterility of medical devices.  We take these events 
very seriously, as they represent a serious breach in patient safety.
 

In the first case, the VA reported to FDA's Medwatch system an 
incident involving the potential implantation of a nonsterile 
cranial prosthesis into a patient at the James A. Haley Department 
of Veterans' Affairs Medical Center in Tampa, Florida.
 

A cranial implant, or cranioplasty device, is a device that is 
implanted into the skull to repair head injuries. Our manufacturer 
and user device experience database containing two reports from 
the device manufacturer, Stryker, one of which was linked to the 
VA report.  The second report from Stryker described an incident 
apparently at the same VA facility, where a nonsterile cranioplasty 
device was actually implanted into a patient.
 

The manufacturer -- and I want to emphasize this -- the manufacturer
 characterized both of these adverse events as use error --  and I 
would like to talk a little bit about the difference between user 
error and use error, because we think that while the words are 
similar, there is a very important distinction and maybe I can get
 back to that later --  did not indicate that follow-up was 
warranted. Again, this was the manufacturer.
 

A search of the FDA adverse events database did not turn up any other 
reports of this nature for this type of device.  There is no 
information in the adverse event database to indicate that the rate 
of infection associated with this type of device is abnormal, or is 
trending upward. And I would say that we look at about 180,000 
adverse event reports per year, and one of the things that we try to 
do is not only look at the individual reports, but look at how those 
report fit together, and whether there are trends that would lead us 
in one direction or another.  And again, I will get back to that later.
 

FDA conducted a report of the marketing application for this product 
and found that the device is nonsterile when shipped, consistent with 
industry practice for certain types of orthopedic and neurosurgical 
devices.  The labeling states that the device should not be 
sterilized by steam sterilization, autoclaving, prior to use, and 
I will certainly go back and verify that because I understand that 
there is some question about the exact method that should be used 
for sterilizing this product.
 

But I think the bottom line is that this was a device for 
implantation, and I fully understand that there is some overlap in 
the sense that some of these devices are provided sterile, where you 
just take it out of the package and it's ready for implantation, and 
some of these devices are provided nonsterile for the user to be able 
to manipulate, examine, do what they need to do with the device prior 
to implantation.
 

FDA concluded that the events were most likely attributed to use 
error --  and again I want to emphasize that word --  and that the 
adverse event database should be actively monitored for serious 
similar events.  As with all reports of use error, FDA is looking for
 ways to reduce the likelihood that similar errors will occur.
 

In the other case, the VA informed CDRH staff that it had determined 
some of its hospitals were improperly cleaning and sterilizing 
reusable transrectal ultrasound transducer devices manufactured by 
B-K medical systems.  The lumen of the needle guide was found to be 
soiled.  Upon investigation, again, it was discovered that brushes 
were not being used to clean the lumen of the needle guide.
 

Transrectal ultrasound transducers are used to perform prostate 
biopsies.  And I would emphasize that these types of devices are 
being used more and more, and it is because of these devices that 
patients with early prostate cancer can be identified, and can 
receive appropriate treatment. So when we talk about patient safety, 
which we obviously all believe is of paramount importance, we also 
have to talk about the availability of these life-saving diagnostic 
and therapeutic products.
 

FDA provided comments on the VA's draft patient safety alert, which 
VA subsequently issued April 3rd, 2006.  FDA and the VA have been 
working together to ensure that users have clear and accurate 
instructions for cleaning and sterilizing the device.
 

In addition, FDA assembled a Post Market Action Team, what we 
abbreviate as a PMI action team, to investigate this matter and 
continues to work with the VA.  The PMI action team is preparing a 
public-health notification to further reinforce for the user 
community recommendations of safe practices in reprocessing 
invasive ultrasound devices.  The notification will focus on a broad 
range of reusable ultrasound transducers used for biopsy procedures.  
It will remind users of the importance of property cleaning and 
disinfecting these devices between uses, and reiterate how critical 
it is to comply with individual manufacturers' instructions for 
reprocessing the transducer assemblies. Because each brand and model 
of device may require different cleaning and sterilization procedures.
  The notification will automatically be forwarded to over 45,000 
subscribers on our listserv, including health-care providers and 
hospitals.
 

For the incidents involving the cranioplasty devices, FDA has 
determined the events were attributable to use error, and the 
devices are labeled appropriately by the manufacturer.  Thus, the
 Office of Surveillance and Biometrics will monitor the adverse 
event database for any further reports, and if safety concerns 
arise, we will respond accordingly.
 

In addition, FDA is working on revising our labeling guidance for
 manufacturers, and will consider including recommendations that 
implantable devices supplied as nonsterile are clearly labeled as 
nonsterile.
 

With respect to the transrectal ultrasound transducer devices, the 
agency's actions will depend on the results of the investigation of 
the PMI action team.  In addition, FDA will collaborate with the VA 
health care system to ensure delivery of safe and optimal health care.
 

We applaud the Veterans' Administration's proactive stance and their 
efforts to prevent further incidents involving these devices.  We 
also appreciate the good work of the VA's office of Inspector 
General who investigated the nonsterile cranial prosthesis event, 
and whose conclusions and recommendations provide value for all of 
us.  We will continue to work with the VA on both of these issues 
and take whatever corrective actions may be necessary to ensure the 
safety of medical devices.
 

And I just want to add, if I have two seconds left, we look at these 
kinds of reports as a critical piece of our postmarket surveillance 
process.  We can't go out and actively survey all the uses of all the 
medical devices in this country.  Systems, safety systems like the 
one at the VA, and other systems like our Medsun hospitals, provide 
us with these kinds of signals that allow us to look at these events, 
decide how widespread they are, how much they may indicate a wider 
problem, a wider concern, and take appropriate action.  So we see 
this as a way of accessing information and being able to take 
appropriate action.  And this is something that is critical to our 
process.
 

Thank you for your time, and I am happy to answer any questions you 
might have.
 

[The statement of Dr. Schultz appears on p.  ]  

*********INSERT**********
 

Mr. Bilirakis.  Thank you very much, Dr. Schultz.
 

I am going to use the Chairman's prerogative here, and I have also 
gotten the approval of Mr. Reyes, to ask Mr. Deal to inquire, if you 
would like, Nathan.  You know, the concern that I have and I think 
it is probably pretty obvious, first of all are the two departments 
or the two agencies coordinating adequately?  But obviously the 
bottom line is also about patient safety.  You have received a copy
 of this article in a Toronto newspaper back in 2003.  861 men were 
exposed to unsterilized equipment which was used in their particular 
case.
 

Well, go ahead, sir.  Take all the time that you wish.
 

Mr. Deal.  Thank you, Mr. Chairman, and thank you, Mr. Reyes, for 
affording me this opportunity, and I do appreciate the invitation, 
and I think it is important that Committees such as ours work 
together, because we have mutual interest and mutual concerns, and 
I appreciate your reaching out in that regard.
 

I would just make first of all an observation.  It appears to me that 
in the instance of the bandage that has been referred to here, it
 simply comes down to primarily a question of labeling of warnings.  
Now, that does not seem to be that complicated to me as an outside 
observer that there should be some standardization of warnings on 
the face of materials, such as has been suggested by Mr. Bagian, 
especially on materials such as this that are going into very 
sensitive portions of the body, the brain in particular.
 

And I guess that would be my first observation, is that why is there
 not some overarching requirement of labeling that is clear and 
unequivocal in these kinds of things? I don't think it is reasonable, 
even if the device is in the hands of a medical doctor, to expect them 
to wade through the minutia of a multipage small print instruction 
device. Why is that not an appropriate approach to solving that kind
 of problem?
 

Dr. Schultz.  I think it is a fair question.  All I can say is at 
this point, there is no specific requirement that a label be placed 
on a device clearly stating that it is a sterile or nonsterile, and 
I think this is something that we need to look at.
 

Mr. Deal.  Does your agency have authority to put that in by 
regulation?
 

Dr. Schultz.  Well, that is a good question. Actually, we have gone 
back and looked at our labeling regulation, and we may need some 
additional wording in the labeling regulation for medical devices 
that addresses that issue.  And that is something that we will get 
back to --  
 

Mr. Deal.  I would appreciate if you would follow back up to both 
this Committee and my Subcommittee as well on the issue.
 

Dr. Schultz.  You bet.
 

Mr. Bilirakis.  Will you do that within what kind of period of time 
here?  I would like to put a time line on that.  What is reasonable?
 

Dr. Schultz.  In terms of following up on -- 
 

Mr. Bilirakis.  In terms of following up, communicating with the 
manufacturer, determining whether the regulations are adequate, 
whether that has to be changed, whether you need legislation or 
what the situation is there.
 

Dr. Schultz.  The need for legislation may take a little bit of 
time.  Could we say two weeks? Is that fair?
 

Mr. Bilirakis.  Two weeks you will notify us, as well as the Health
 Subcommittee on Energy and Commerce, thank you very much.  Go 
ahead, sir.
 

Mr. Deal.  Could I ask one other -- or make one other observation, 
followed by a question.
 

On the second issue, and that is the device that was not properly 
cleaned, sterilized, et cetera; my observation as a commonsense 
approach to that is, there are obviously some rather standardized 
disinfection devices, solutions, et cetera, that are commonly used 
for other devices, a variety of devices in a hospital setting.  And 
I realize that every device may have its own peculiarities, such as 
the brush that has been referred to, et cetera.  But can't there be 
some standardization of devices capable of being disinfected, for 
example, with the most common disinfectant solutions, procedures, 
et cetera, and not being allowed to be put on the market if they 
have some deviation from what would be a normal standard?  Because 
I can just envision that if you are dealing with multiple devices, 
if it is like most of us, we can't remember what they said yesterday 
about this when you are putting another one in and it is different, 
and you have got all these little things taped to the wall, you 
know, about this device, you know, " Read this particular part of 
the instruction."
 

There seems to me, as a commonsense outside observer, that we ought 
to be approaching some kind of standardization of disinfection as a 
part and component of the approval of the device itself.  Is that 
an unreasonable observation?
 

Dr. Schultz.  I don't think it is unreasonable to try to achieve
 standardization in those areas that can be standardized.  Again, 
the whole area of disinfection, it is not simply disinfecting, it is 
a matter of cleaning and making sure that all the gross material is 
not there, and then following up with either an appropriate 
sterilization or disinfection procedure.  One of the things that we 
have noticed, and again, in looking at this incident, when we have 
gone back and looked at similar devices, and this is something that 
we have in fact recognized before, is that increasingly, as procedures 
go from being open, large procedures, to these minimally invasive 
procedures, which are in fact a good thing for patients, allow for 
diagnoses with minimal trauma; one of the, sort of, the byproduct of 
that is that companies are creating smaller devices that can be fit 
into smaller channels, which are more and more difficult to clean.
 

And I think again, what this points out, what this incident points 
out, is the need to pay more and more attention to those channels, 
and see if there is a way that we can in fact provide widespread 
standardized instructions on how to deal with those channels.  So 
I think it is a fair comment.
 

Mr. Deal.  Well, I am all in favor of small invasions.
 

Dr. Schultz.  I understand.  We all are.
 

Dr. Schultz.  We are all getting to that age.
 

Mr. Deal.  I would just like for us to try to make sure that we 
don't have these kind of complications, and it appears that maybe in 
light of the information that has now come forward on this issue, 
this might be a good springboard for looking at that approach.  And 
I would be interested in hearing what conclusions you might reach in 
moving in that direction.
 

Dr. Schultz.  Thank you.
 

Mr. Deal.  And with that, Mr. Chairman, I will yield back the time 
you have so generously allowed me to have, and proceed to our hearing, 
and I will explain your absence or at least your delay.
 

Mr. Bilirakis. Well, on community health centers, I would love to be 
there on that particular portion, as you know.
 

Mr. Deal.  I understand.
 

Mr. Bilirakis.  So we will see.  I was going to call on Dr. Ekstrand 
possibly while you are still here.  I don't know, maybe you might 
have another five minutes or so?
 

Dr. Ekstrand, would you maybe proceed with your -- your written 
statement obviously is a part of the record, so if you would 
summarize, more than anything else. 


STATEMENT OF LAURIE E. EKSTRAND

 

Ms. Ekstrand.  Yes, sir, I have a brief summary.
 

I would like to thank you for inviting GAO to testify today concerning 
efforts by the Department of Veterans' Affairs to ensure that its 
health-care practitioners provide safe care to veterans.  
Specifically I would like to discuss findings related to patient 
safety in two reports that we are releasing today, and let me 
discuss the major findings of these two reports in turn.
 

First, more than two years ago we made four recommendations that were 
intended to close gaps in VA practitioner screening requirements for a 
wide range of employees that come into contact with veterans when they 
are provided health care.  Today, we are reporting that although 
progress has been made in relation to all four areas, none of these
 recommendations have been completely implemented. For example, 
while VA has implemented procedures to verify that licenses and 
certificates held by those that VA intends to hire are completely 
verified, they have not extended this verification to include all 
licenses for those who are already employed with VA.
 

This means that a currently employed nurse, for example, could
 present a license to VA that is without restrictions, yet they 
have one or more additional licenses that are in fact restricted.
 

Mr. Bilirakis.  Doctor, forgive me.  I know that I am being rude.  
While Mr. Deal is here, and take into consideration the jurisdiction 
over FDA, and I appreciate the fact that properly your report is 
regarding the VA Committee and the VA, here.
 

Ms. Ekstrand.  Yes, sir.
 

Mr. Bilirakis.  Do you have, before you go into the rest of your --  
do you have any comments regarding FDA, the relationship that exists 
or should exist between FDA and the Veterans' Administration, things 
of that nature that might be not only helpful to this Committee, but 
also helpful to the energy and commerce Committee?
 

Ms. Ekstrand.  We have no specific work that addresses that, only 
commonsense.
 

Mr. Bilirakis.  Well, can we hear some of that commonsense.
 

Ms. Ekstrand.   Common sense is that they should be talking to each 
other.  But we have nothing specific --  
 

Mr. Bilirakis.  Are they talking to each other?
 

Ms. Ekstrand.  We have not done any work that would provide us any 
evidence one way or another, sir.
 

Mr. Bilirakis.  I see.  Okay, well, all right, please continue.  
Apparently, she has no comments regarding the FDA.  I wanted to let 
you go in case --  thank you, Doctor. Please continue, and again I 
apologize.
 

Ms. Ekstrand. Sure, no problem.
 

This review further documented that for the seven facilities we 
visited, compliance was poor with four of five screening 
requirements that we reviewed.  Very briefly, in our report, we 
have a table that arrays seven facilities across the top, and five 
screening requirements down the side; thus we have a 35 cell table, 
and in each cell we either have a dark circle to signify compliance, 
or a light circle to show lack of compliance.  Of the 35 cells, 
just 10 are dark to show compliance.
 

In our other report that we are releasing today, we have a somewhat 
more positive message concerning credentialing and privileging of 
physicians.  Indeed, VA complied with all four credentialing and 
four of five privileging requirements that we reviewed.  Let me 
outline our concern about the fifth privileging requirement --
 

To use information on physicians' performance in making privileging
 decisions --  that is the fifth requirement --  compliance with 
this requirement was problematic at six facilities because 
officials used information from their facilities' quality 
assurance program for privileging decision-making.  Using this 
source of information is prohibited by VA policy, so as to 
preserve the confidentiality of quality assurance information.
 

We also raised concerns in this report about delays at three of 
seven facilities in submitting medical malpractice claim information 
to VA's office up medical legal affairs. This office reviews the 
information provided to make a determination as to whether 
substandard care has been provided.  Delays in providing this 
information could lead to privileging decisions being made 
without the benefits of this information.
 

And finally, we report the need for internal controls to ensure 
that privileging information is accurate.  In both of these 
reports I have talked about today we have made recommendations for 
further actions by VA, and VA has concurred with them.  We believe 
that implementation of these recommendations is vital for patient 
safety.
 

Mr. Chairman, this closes my oral statement, and of course we would 
be happy to answer any questions you may ask.
 

[The statement of Ms. Ekstrand appears on p. ]  

*********INSERT**********
 

Mr. Bilirakis.  Thank you.  Thank you very much, Doctor.
 

Dr. John Daigh is the Assistant Inspector General for Health Care 
Inspections for VA.  Dr. Daigh, you are on, sir. 


STATEMENT OF JOHN D. DAIGH, JR. 

 

Dr. Daigh.  Thank you, sir, for the opportunity to testify this 
morning.  I think I will just make a couple of comments in light of 
what has already been said.
 

First, I think that with respect to the issue at Tampa, and with the 
use of the medical devices at Togus, Maine and other places, I think 
that we, or my office, will work to try to seek standardization of 
the complex process by which supplies, equipment, and devices are 
procured and then work their way through the SBD system, up to the 
operating room. I think that is one level at which a VA can act 
relatively quickly to try to limit the chance that patients will 
be injured.
 

And then of course, the second level, as you have identified, is to 
work with agencies outside the VA, so that a prosthetic supply clerk 
doesn't have to make the decision at 150 different sites as to 
whether or not this particular bag is sterile or not sterile by 
just looking at the bag.  It will be easier to arrive at the 
correct conclusions.
 

So I agree with the recommendations that the SPD to patient process 
needs to be reviewed.  To the extent that we can require product 
design features to require standard sterilization procedures, safety 
will be improved.  And as Dr. Bagian pointed out, big, bright visual 
cues to let you know whether a product is sterile or not would be 
important.
 

So I would have no further comment at this time, unless you have 
questions.
 

[The statement of Dr. Daigh appears on p. ]  

*********INSERT**********
 

Mr. Bilirakis.  Thank you, Doctor.  Let me ask you first, Dr. Daigh, 
background checks.  I know that there is only so much time here, and 
these other subjects, patient safety or directly related to patient 
safety is very significant.  But what can you tell us about the 
background checks that the VA conducts?
 

Dr. Daigh.  Well, sir, that is a little out of my area of expertise, 
but I will indicate that the IG's office has decided to not rely on 
the VA for background checks because they take so long to procure.  
So we, I believe, are investigating other methods outside the VA's 
current system to get background checks done.  So there is 
dissatisfaction with the speed at which they occur.  I am not able 
to comment more fully on that.
 

Mr. Bilirakis.  You have determined apparently, your office has 
determined that they take an unduly long period of time and 
therefore you have tried to come up with a different way to do it.
 

Dr. Daigh.  That is correct, sir.
 

Mr. Bilirakis.  Why should that be? I mean, that is just as natural 
as anything can be.  Shouldn't it be that we run background checks 
on people who are going to be servicing our veterans?
 

Dr. Daigh.  Well, sir, I would have to respond to you in writing.  I 
just am not an expert on background checks.
 

Mr. Bilirakis.  Do you have anything to add to that, Dr. Ekstrand?
 

Ms. Ekstrand.  Yes, sir.  We are reporting actually on page 11 of 
our testimony, we have a small table that indicates that in only one 
of the seven facilities we visited did we find that background checks 
were documented in employees' records to the extent that 90 percent 
of the ones we look at had the background checks in the records. It 
is difficult to tell from the records whether they were never 
completed, but we know that they were not recorded in the records.
 

Mr. Bilirakis.  Dr. Bagian, what impact would an inadequate background 
check have on patient safety?  I know that has to concern you.
 

Dr. Bagian.  Well, one, I would say, you know, we don't run the 
background checks, and really I wasn't tasked to come forward and 
talk about that, so I really can't say much.
 

Mr. Bilirakis.  All right, but you can tell us your -- 
 

Dr. Bagian.  Certainly we would like to make sure we have people who 
are appropriately, you know, of right moral character, et cetera, 
et cetera, and that is why we do background checks.  As to what the 
length of time is, I don't know how it is done, but I think it is not 
just done by us, there are other agencies that supply that service in 
the federal government.  And I really don't know enough about it to 
comment about it effectively.
 

Mr. Bilirakis.  All right, but I have talked with you earlier and, 
you have testified before us previously.  My feeling is that you are 
a very conscientious doctor here, and you care about patient safety 
and whatnot.  So shouldn't it bother you that maybe there aren't 
adequate background checks taking place?
 

Dr. Bagian.  Well, certainly.  I mean we would want to make sure 
that people have the appropriate checks as quickly as possible.  But 
I guess I would also point out, as you do that there is always a risk 
assessment, you know, that I would say, that is how we look at all 
the safety things.  You have to look at what the probability of a 
problem it is, and the severity of the outcome.  You know, for 
example, hypothetically, suppose it takes five months to get a 
background check done.  I think it is longer than that sometimes, 
depending on the level of background check that is required, and 
that depends on the position or the responsibilities of the individual 
involved.  Suppose you need a cardiologist.  You have no reason to 
believe through licensure and all of those things that was already 
mentioned, like in our VetPro, we know that they are licensed and all 
that, but the background check isn't complete, and our choice is, 
would you like to have a cardiologist care for you, or nobody care 
for you, on the off chance that there is some mass murderer that you 
don't know about.
 

I mean, I think you have to make that judgment.  And I think you 
really need to talk about the people that are running that program.  
And I really don't know enough to comment more than that.  I think 
you have to look at what is the system demand versus the risk to 
the patient, and play that off against how fast you can get them 
qualified, and I really can't say more than that.
 

Mr. Bilirakis.  You know that we did have a mass murderer in the VA.
 

Dr. Bagian.  That was a long time ago, and that was before the VetPro, 
and that's why VetPro was put in, and I think which is what was, I'm 
not sure, but Dr. Ekstrand's comment about the licensure and that 
sort of thing.  VetPro was put in place, which allows us to make sure 
that people have appropriate, you know, they are licensed, they really 
are licensed, that those source documents have been verified, that 
they really do have a doctor of medicine that is not from, you know, 
a cereal box or something like that.
 

So we have done that, which I would say there is virtually no other 
organization in this country that does that.  And part of that was out 
of response of that one, and that particular mass murderer that you 
are talking about, I would point out that the VA is the one that 
discovered that one, and he had operated outside of the VA, where he 
had been responsible for the deaths of patients outside of VA. It was 
the VA that detected it.  So while it is not a good thing, sir, you 
know, you only can do what you can do.  And I agree we should do the 
best we can.
 

Mr. Bilirakis.  I should think that you would raise holy hell if you 
have the impression that proper background checks are not taking 
place in a timely fashion.
 

Dr. Bagian.  Well, I really haven't -- unfortunately, I haven't had 
a chance to review --  
 

Mr. Bilirakis.  You can raise holy hell, I know that.  That is why --  
 

Dr. Bagian.  Well, that is true.  I guess the first thing I would say 
is it is hard for me a comment in an intelligent way, because I have 
not had the opportunity to read Dr. Ekstrand's report.  So I am not 
sure what is in it, to say if I should be.  And when I read it, if 
there is reason, I certainly would do that.
 

Mr. Bilirakis.  If you need any help from this Committee and this 
Congress, you just let us know.
 

Dr. Bagian.  I am not bashful, you know that.
 

Dr. Bagian.  You are not bashful, right.  Okay.  We probably will go 
through a brief second round, but I just want to go ahead with 
Mr. Reyes at this point.
 

Mr. Reyes.  Thank you, Mr. Chairman.  And thank you all for your 
testimony.  I was curious, is there an industry standard in terms of 
checking into the credentials and the licenses, and all of those 
things?  I mean, we have a government standard.  Is there an industry 
standard by the American Medical Association, by the American Hospital 
Association?
 

Dr. Daigh.  I don't think so, sir.  We work by the VA policies, so 
there would be directives in policy that VA has, and when the 
Inspector General's office goes out, we look to see that that policy 
is reasonable, and that it is being complied with.  I think the issue 
here is that the policy requires background checks, and they are not 
being done. And we consider that an important issue that needs to be 
addressed.


Mr. Reyes.   Well, but in being able to make recommendations, isn't it 
a good idea to know what the civilian sector does, or how they, you 
know, because the potential for somebody either coming in with a false 
license, or somebody that has been --  I don't know, in the legal 
profession it is " disbarred,"  I don't know what it is called in the 
medical profession, but --  revocation of license, or whatever?  
Isn't that a good idea to --  
 

Ms. Ekstrand.  Sir, if I could add to this.
 

When a new employee is considered for being hired at the VA, there is 
a form that is filled out to determine what kind of background check 
might be appropriate for that employee.  At minimum, there is a 
fingerprint-only background check, which means that the prospective 
employee's fingerprint is compared to the criminal history databases 
to determine whether there is basically a hit for this particular 
individual.
 

If it does in fact turn up something from the criminal history 
database, then it is up to the facility administration to determine 
whether this type of offense record is something that would not allow 
this person to work at VA.
 

But at minimum, there should be this fingerprint check. Some facilities 
were still installing the machinery to put this in place, but they 
seemed to be very close at the time we were finishing our work to 
having this functional, at all of the facilities.
 

Mr. Reyes.  Dr. Bagian, given these concerns that have been raised, are 
you contemplating, or are you in a position to perhaps reevaluate, or 
make recommendations about what should be done, or what needs to be 
done in this area?
 

Dr. Bagian.  Well, I guess what I would do first is I would want to 
read the report and know what it says. Certainly after I read it, if 
it was showing material weaknesses, which I must assume that there are 
some material weaknesses there, certainly I will then ask, you know, 
the deputy undersecretary or the undersecretary, and say " It appears 
that there are weaknesses here.  Why is that, and what does it take 
to make it right?"  I mean, that would be my question.  But that is 
about the most I can say without having the opportunity to have read 
it.
 

Mr. Reyes.  And I would give you a recent example, because a number of 
us on the Committee have been raising issues and concerns about the IT 
capabilities of the VA, funding studies and all that.  The recent 
example of the release of 26 and a half million veterans' records is a 
very good example of these concerns not being taken seriously. Mine 
were compromised along with 26 million other veterans.
 

So I think it is vitally important that these concerns and these issues 
be taken seriously, and be given some kind of a deadline to be able to 
come back to the Committee and say, " Look, I have read the report.  
This is what the report says, this is where we are in terms of the 
issues raised by the report, and here is how we are going to get to 
where the report recommends that we be."   Can I get your commitment 
to do that, in this area?
 

Dr. Bagian.  Well, I mean -- this, you know, the only commitment I can 
give you is within my scope of responsibility, and that is certainly I 
will read this report as pertains to safety and in general.  I will 
make whatever comments seem appropriate after I read it to the principal 
deputy undersecretary, and the undersecretary, who is who I report 
immediately to.  I guess that is all I can say.
 

I guess I would also point out, since you brought up the IT security 
thing, you know, the 26.5 million, 19 million, et cetera, I think one 
thing I would point out was, it wasn't a criminal act by one of our 
employees that caused that.  It was the fact --  
 

Mr. Reyes.  Doctor, with all due respect, I mean, the results are the 
same regardless of whether it was willful intent, whether there was 
criminal --  
 

Dr. Bagian.  Oh, there are problems, to be sure.  And I assure you 
that the VA is taking that extremely seriously. I can't tell you, I 
cannot even begin to describe to you the efforts and time that has 
been spent as we have been I would say going back to basics on these 
security things, how much time is being consumed with that to make 
sure it is buttoned down.  And I think that is appropriate, I do not 
disagree with that one little bit.
 

But I think the other thing we have to keep in the back of our minds, 
as we do this in a reasoned way, the goal is we don't want these 
things to happen, that is the goal.  The goal is that we don't want 
to have somebody who is a criminal that is undetected or whatever, 
is of improper background to be delivering care.  That is the goal,
and the question is how do we get there?  But I would still point out 
that that doesn't mean that there is no risk.  You can have somebody 
that comes into the hospital that has all the background checks, and 
that day, they decide to do something weird, and --  
 

Mr. Reyes.  That is something I certainly would understand.  But the 
reason I mentioned that breach was because for at least three to five 
years, and I have been on this Committee for 10 years, we have been 
raising the issue of IT concerns and security to the Veterans' 
Administration funding a study, Mr. Chairman, if you recall, a study 
that largely was discounted by the VA, and they went off and did their 
own thing, and now we are seeing these kinds of consequences.  So that 
is why I mentioned it.
 

And I think everybody on the Committee fully understands that we don't 
expect guarantees, but we do expect due diligence, especially in an 
area that is so vital to the health of our veterans, and the facilities 
that we operate.
 

Dr. Bagian.  Well, all I can say is I certainly don't disagree that we 
need to provide due diligence.  I guess the other thing I would point 
out is everybody is working hard on the IT thing right now.  I think 
there is no doubt if you talked to anybody, I don't care if they are 
at my level or if they are sweeping the floor, if they touch a computer 
they know there is something going on, there is no question.
 

I think the other thing I would point out is that where the problem 
occurred was not in the health system, it was not with medical records 
or anything like that, because our systems are a little bit better than 
were used on the other side.  I mean just to be quite honest, you know, 
I am on the health side and they are different.  We take it very 
seriously because we think patient records just by themselves are a 
huge responsibility, and we take it seriously.  But that doesn't mean 
we shouldn't re-look at it, and we are.
 

Mr. Reyes.  Thank you, Mr. Chairman.
 

Mr. Bilirakis. The Chair thanks the gentleman, Dr. Boozman.
 

Mr. Boozman. Yes, thank you.  We appreciate all of you being here.  
This really is an important topic.
 

Dr. Schultz, I think I would agree with Mr. Deal in the sense that it 
does make sense, these type of prostheses or devices that are put in 
really any place in the body, but certainly critical places, that it 
does make sense to make very clear if it is sterilized versus 
non-sterilized.  That seems like it is common sense, and yet I 
understand in dealing with the agency, it is not as simple as it 
appears.  And in order for you all to get things done, sometimes it 
is difficult.  If we can be helpful in that regard, I think that 
would be an improvement.
 

On the other hand, Doctor -- Dr. Bagian -- 
 

Dr. Bagian.  That is all right.  Bagian.
 

Mr. Boozman.  Bagian.  I am Boozman, Boseman, whatever.
 

Dr. Bagian.  I am the same way.
 

Mr. Boozman.  If in fact some devices are shipped sterile, some aren't 
shipped sterile, it is the responsibility of the surgeon and his team 
to make sure that it is, regardless of the fine print or whatever, 
that is the bottom line.
 

Dr. Bagian. Absolutely.  Sure.
 

Mr. Boozman.  And the other thing that I would say is that if you are 
having trouble with this particular product, I guess the question is 
why continue to use it?  Why not use one that is stamped like you would 
like it? 
 

Dr. Bagian.  Well, we took action.  I mean, as soon as we found out 
about it, we took action.  It was within hours.  So I mean, we found 
out it happened, we found out the one before that happened, they were 
within seven days of each other, that was how we found it out, and 
then we stopped it, then.  Not three hours later, we stopped it then.  
So we did do that, and I think your recommendation is exactly 
appropriate.
 

Mr. Boozman.  Right.  On the other device that was used that wasn't 
sterile as we would like, was that at a hospital, or was that 
systemwide in the VA, or --  
 

Dr. Bagian.  It is used in many places in the VA, but not the 
majority, but it is quite commonly used.  That device is used in about 
20 of --  it was used in 60 facilities of about 150 that could use 
it.  Sixty used that device, and we represent, what was it, like 10 
percent of the number of facilities in the United States --  not in 
the VA, but in the United States --  so we are just the tip of the 
iceberg that were --  
 

Mr. Boozman.  And those 10 percent that were using it were all of them 
doing it wrong?
 

Dr. Bagian.  About a third, right? About a third. Twenty-one of about 
60 were not doing it exactly as they should.
 

Mr. Boozman.  How about in private practice?  What is the --  
 

Dr. Bagian.  Well, I guess by talking to different people, I mean I 
have talked to people on the outside, and they said, " Oh, yeah, we
have had those problems."   So yeah, I know anecdotally from talking 
to directors in other hospital systems, and then as was pointed out, 
in a Sunnybrook in Toronto --  
 

Mr. Boozman.  I read the article.  Yes, sir.
 

Dr. Bagian.  You know, it was at nine hospitals there, and I talked 
to their medical director there about that as soon as we turned it 
up, and he explained, " Oh yeah, we looked around."   Every hospital 
that they had talked to in the Toronto area, nine hospitals, all had 
numerous patients that had that happen.
 

Mr. Boozman.  I guess I would be curious, is that kind of what you 
are seeing, Dr. Schultz, also?  I guess I would be concerned that if 
we had this problem in the VA and we weren't having it in 
Fayetteville, Arkansas in my local hospital and in Rogers, Arkansas,
then I would have real problems with why the VA is lagging behind on 
this.  If we were having problems throughout the country then that is 
another thing.
 

Go ahead, Dr. Schultz, if you would.
 

Dr. Schultz.  I just wanted to say that I think that, you know, one of 
the concerns that has been raised is in terms of the time line in our
response to this issue.  And again, I think what you are raising is 
really sort of a critical issue to us, which is to figure out sort of 
what the root cause of the problem is, and is it a particular facility, 
is it a particular product, or is it really something more generic?
 

And I think what we are all saying today is that in fact it is something 
more generic, that involves not a particular user or a particular 
product, but a range of products, and a new type of technology where we 
are starting to understand some of the unintended consequences of what 
is in fact a major advance in technology.  This is not unusual. We have 
seen this problem in many other areas, going from infusion pumps to 
pacemakers, to a whole range of technologies, where as the technology 
changes, problems arise.
 

And again, the goal is to try to be able to understand what the problem 
is, and to try to be able to deal with it both thoughtfully as well as 
timely.  And hopefully, our goal is to have a response out within the 
next few days that won't simply deal with this individual event, but 
will deal with the larger issue.
 

Mr. Boozman.  Our patients that perhaps because of the sterilization 
technique wasn't as good as we would like, how are we doing as far as 
contacting them?
 

Dr. Bagian.  Let me refer that to Dr. Deyton, because he is running 
that whole part of the operation.
 

Dr. Deyton.  Sure.  Thank you for the question, sir. As Dr. Bagian 
said, of the 60 VA facilities that identified that they had ever used 
this particular set of equipment, 21 of them identified that the 
instructions for the way that they were reprocessing that equipment was 
not in the way that we later defined would be perfect.  Those 21 
facilities went back and looked at all of their records for when that 
device was used, and identified 22,122 patients who needed to be 
notified.  And so we initiated a systemwide patient notification and 
look-back program to identify, those 22,000 patients, notify them and 
then tell them about the situation.
 

As of my last update of that patient notification program, 96 percent 
of those patients had been notified by their facilities.  I am also 
pleased to report that there has been a vigorous response by those 
veterans to get more information about this.  And 50 percent of those 
veterans who had been notified have already contacted their VA or the 
closest VA to get more information.
 

Mr. Boozman.  Okay, good.  Just one further comment, Mr. Chairman.  It 
is good that the FDA and VA are here.  It seems like with the VA being 
a closed system, the FDA in many cases, with certain areas, it looks 
like it would be good to talk to them, because I think with some things 
that you are wondering about, it does seem like with it being a closed 
system, a government agency, that it would be a good partner in dealing 
with some of these things.  Does that make sense?
 

Dr. Schultz.  I think it makes perfect sense, and in fact I think a lot 
of that communication does occur at the staff level.  At least that is 
my understanding of what occurs on a daily basis.  I am not convinced 
that it occurs on an upper management level, but it certainly does 
occur on the staff level, and there have been a number of interactions 
on a number of different products with our staff and the VA staff.
 

Mr. Boozman.  Okay.  Thank you, Mr. Chairman.
 

Mr. Bilirakis.  The Chair thanks the gentleman.
 

Dr. Schultz, you may know that prior to this Congress, I chaired the 
Subcommittee that Mr. Deal chairs, I did that for 10 years.  So I have 
spent a lot of time with the FDA, had the complete jurisdiction over it.
 

Well, I am an engineer, as well as a lawyer.  I am more proud of the 
fact that I am an engineer.  But I guess what I am saying is that, you 
know, it is important to get down to the bottom line on things.  
Mr. Reyes has talked, as did Mr. Boozman, about the privacy problems, 
and the mistake that was made, and we spent time on that.  For years, 
we have talked about IT.  We have had a roundtable in the other room 
with the VA, and nothing has --  nothing really has taken place so far 
as I can see.  And they were warned by the IG, and by the General 
Accounting Office that there was inadequate security regarding IT in 
the VA, and just nothing of any consequence took place, and look at 
the problem that has developed.
 

Dr. Bagian, I do not want to put you in a difficult position here.  
But you heard Dr. Schultz testify, you have heard Dr. Daigh, 
Dr. Ekstrand comment.  Do you have any comments regarding the 
relationship with FDA? You know, this Committee does not have any 
direct jurisdiction over FDA, I appreciate that and that is why I 
really am very appreciative of Dr. Schultz deciding to come here.  I 
am not trying to put him or FDA in a difficult position, but I think 
it is important, indeed critical, that the problems that you all run 
into be coordinated with them, and that they pick up on it, because 
it involves incidents like unsterilized equipment used on 861 men 
for blood tests, which took place in Toronto.  As a result, 861 men 
who received biopsies at the Toronto hospital between December in 
1999 and August, 2003, have been told to get a blood test for 
hepatitis B or C, and HIV.  I know there is something in here, that 
there are other hospitals who were using that same equipment, things 
of that nature.  I would like to know, did VA pick up on this to see 
if the same problem had developed elsewhere in the VA?  Did they pick 
up that they were going to try to do something about it?  Has FDA 
picked up on that?  Do you know, Dr. Schultz? This goes back maybe 
before your time, I don't know.
 

Dr. Schultz.  I don't.  I don't, but I will certainly look into that.
 

Mr. Bilirakis.  Don't you think that is important?  I mean, isn't that 
the sort of thing that should concern FDA?
 

Dr. Schultz.  Absolutely.  I don't think there is anyone who would say 
that that shouldn't concern FDA.  Yes.
 

Mr. Bilirakis.  So you don't really know what steps may have been 
taken by FDA at that time?
 

Dr. Schultz.  I don't.  I don't, but I will certainly find out.
 

Dr. Bagian.  I can answer that because I talked to the --  or whatever 
it is called.
 

Mr. Bilirakis.  Okay.
 

Dr. Bagian.  First, to answer your overall question: we have worked 
with the FDA ever since I have been --  I mean, I was the first director 
of patient safety in the VA, so I can tell you since the beginning we 
have often worked with FDA, especially at the staff level.  And in 
general, the working relationship with the staff level people is 
generally very good.
 

Where we have had more problems, and I think this will be worked out.  In 
fact, I want to point out right now that on the 27th of this month, from 
2:00 to 4:00, there is going to be a meeting with the undersecretary, 
with Dr. Von Eschenbach, and I don't know who else he is going to bring 
from the FDA, to explore ways we can more productively interact, because 
we are concerned, as a result of this one right now, where I think it was 
this Committee, you sent a letter to the FDA, and we were copied, and 
also my boss, the undersecretary, sent a letter to Dr. Von Eschenbach as 
well, and we received no response for weeks.  Even when I called 
Dr. Von Eschenbach's office, we received no response.  And I was 
concerned because we wanted to work together and avoid a problem here, 
and we had problems with that.  When we talked to them about this 
particular thing, you talked to the newspaper articles, we asked them 
about, do they look at ECRI, which is like the " consumer reports,"  
and they said, " We don't usually monitor that,"  which we were kind of 
astounded at, that we even look at that, and this is reported in the 
ECRI in December of 2003, and they told us not just that they didn't 
know about it, but they don't see a reason to monitor ECRI, and that 
is what their expert team said, which we were kind of flabbergasted at.
 

We were the ones that approached FDA, not the other way around, that is 
the way it has historically been, including with this case and many 
others.  In many cases, recently, when we have, we have received 
responses that, " Well, why don't you send us your alert when it comes 
out, but that is not really for us to worry about."
 

And that concerns us because we look at the goal a little differently 
maybe, as our responsibility is to make sure that the best thing 
happens for the patients.  And my own opinion is that if the 
regulations or laws aren't right, you need to come forward and get 
them changed so they are right for the patient.  And you know, the 
fact is that they might be a limitation today, but if you don't say 
anything about it, it doesn't get fixed.  And that has been our concern 
all along.
 

So I think this is actually going to be a positive thing, what has 
happened today, because I think this is focusing everybody's attention 
on it, and I said before this hearing was rescheduled --  I mean, we 
had it back on the 25th, but before it was --  we actually had it 
canceled, you know, was three weeks ago, there was already the motion 
had been put in place that Dr. Perlin, the Undersecretary for Health, 
had already talked to Dr. Von Eschenbach about us having a meeting 
together to really improve the way we can help FDA really identify 
problems, and be more proactive.  So we are all for that, and we look 
forward to the meeting at the end of the month, and in a couple weeks, 
that that will happen.  So I think we are headed in the right direction.
 

Mr. Bilirakis.  All right.  Before Dr. Schultz responds, I am reminded 
by staff that CDC published information last year stating that the 
ultrasound urology transducers can cause infection when not cleaned 
properly. FDA as I understand it did not know about that until we, 
meaning the Committee staff, told them.  Comment, Dr. Schultz?
 

Dr. Schultz.  I can't comment on that, but I will certainly find out 
about it.
 

Mr. Bilirakis.  Well, we are not getting very much information, here, 
and the reason I invited Mr. Deal here was because I don't know, I see 
a lack of cooperation here. You know, Dr. Schultz, I don't mean to put 
you on the spot and whatnot, but you are here representing FDA, and we 
are not getting answers.  Mr. Reyes?
 

Mr. Reyes.   Mr. Chairman, I was just notified that we expect a vote at 
11:30, so maybe that will resolve the issue we were talking about.
 

But anyone that drives a car today, in their rearview mirrors, the one 
on the driver's side is a mirror that gives you the information as to 
what is coming up behind you without any reduction.  On the right side, 
the mirror says on the bottom, " vehicles may be closer than shown,"  
or I forget what the actual language is.
 

I was wondering, Dr. Schultz, when an issue like we discuss in terms of 
the sterile package and cleaning the instrument, when it comes up, first 
of all, do you have the authority, or what authority would you need to 
put out an immediate alert, and direct the manufacturer to put a notice, 
some kind of a transparent sticky notice on there, caution or alert, " 
Item not sterilized,"  or, " Refer to alert number such and such 
regarding the utilization of this instrument,"  something of an 
immediate nature that would preclude further hospitals or doctors from 
making the same mistake because the notice is on the third page, and 
very fine print, as Dr. Bagian notified; do you have that kind of 
authority, and would you be able to do that, to require the 
manufacturers to put out an immediate alert?
 

Dr. Schultz. We, if it were indicated, both we would have the authority 
to have the manufacturer do it, or we could do it ourselves.  Again, I 
think the first thing that we do is try to understand the nature of the 
problem and the extent of the problem.  I think one thing --  and I 
don't disagree that when you have a package that looks similar for an 
unsterile and sterile product, that that is a concern, and it is 
something that we need to look at.
 

I would point out that in many of these cases, as far as I know, this 
particular item is somewhat unique in the sense that this particular 
company provides both a sterile and nonsterile model of the same product.  
As I said before, and as we talked about, there are many products that 
are provided nonsterile for sterilization by the user, and I think in 
most cases it is understood, and it is pretty apparent to the user that 
those products need to be then be sterilized at the user facility.  
There are other products that are uniformly provided sterile by the 
manufacturer, that don't require that kind of processing at the user 
facility.  I do think that at least as far as I have been told, and as 
far as I know right now, it is unusual to have the same product 
provided both ways, which is probably why we have not seen this 
particular problem occur more extensively.
 

As I mentioned in my testimony this is certainly something that we 
want to look at, and if there is a particular issue with products --  
again, you know, we want to provide the right size brush.  If it is a 
narrow brush, to deal with particular products, we want to make sure 
we are doing that.  If it is a broader brush, like the other item that 
we talked about, we want to make sure that we are doing that.  And we 
will do that.
 

Mr. Reyes.  Dr. Bagian, did you -- 
 

Dr. Bagian.  Well, I think, you know, certainly it is always a 
challenging thing if one looks like another.  And I think the big issue 
here is understanding how prevalent the problem is, which I think is 
what Dr. Schultz was saying, and I think that is the issue, because 
the FDA is by reports, or self-reports.  And self-reports are 
inherently inaccurate to give you the extent of the problem.  Most 
things aren't reported at all; right?  Wouldn't you agree, most things 
don't get reported?  We know that statistically by observational 
tests, so the fact that you only have a couple doesn't mean that only 
a couple occurred.
 

For instance, in this particular case, had it not been for the 
diligence of the circulating nurse, that when she got an answer, even 
when she asked the factory rep and they said, " No, it is okay,"  and 
she looked at it and said, " That doesn't make sense then.  Why would 
this piece of paper be nonsterile?"  Didn't make sense, and she pursued 
it, and then not only  pursued it, found out it wasn't true, and then 
had the courage --  and I think also, because of the culture that we 
created --  that she raised her hand and said, " You know, I think we 
screwed up."
 

You know, most places would not have asked the question, they would not 
have pursued it, and then when they found out they wouldn't have said, 
" we are going to tell the world,"  which is what we did, right, 
because they wouldn't want to come here.  And we say, " If that is 
what it is, we will stand up and take our hit because we are trying 
to help not just us, but anybody."
 

And I think that is one of the issues, when we say our reporting 
systems are not counting exercises, because you can't count.  We say 
what they do is they identify a vulnerability, and it is for us to go 
out and see what is going on and say " What is the likelihood?"  And if 
we know that is the case, we go and do something about it.  And I think 
that is one of the differences in approach that needs to be used with 
these.  And if you don't and only rely on self-reports to count, that 
you are missing the boat.  You know, you won't know.
 

And we have shown many other cases where we have worked with the FDA, 
for instance with MRIs as a good example.  MRI rooms, you know, where 
they do MRI, there are really strong magnets.  And there are numerous 
cases where materials fly around the MR room, like whole IV pumps go 
catapulting across and hit the thing.  We have pictures of floor 
buffers, IV poles --  not in the VA --  floor buffers, IV poles, 
shares, that are stuck in magnets.  And yet, if you look at the 
reports, there are virtually none, very few, and yet they happen all 
the time.
 

And next time one of you goes to the MR room, if you happen to have an 
MRI, I just did a few weeks ago for a ruptured disc, I asked the tech, 
" Do many things fly around here?"  because I noticed some of the marks 
on the gantry. And he goes, " Oh yeah, about once a month we have some 
things fly through here."   And yet there is none reported because the 
techs just say, " that is just what happens."  Whereas, we looked at it 
and said it, " That is a dangerous thing because people can be killed."  
As you might remember, a few years ago a boy was killed, a 10-year-old 
boy was killed in New York --  not in a VA hospital --  where an oxygen 
tank hit him in the head.  And we said there is things you can do to 
design your system to do it.
 

It takes that proactive approach to understand where the risk is, and 
mitigate it before you have bodies stacking up like cordwood, and I 
think that is the kind of thing we look forward to collaborating with 
the FDA about, to try to share some of these ways to really identify 
problems before there is huge human suffering.
 

Mr. Reyes.  Thanks.  The other question that I had, Dr. Schultz, when 
you approve the product, do you also approve the literature that goes 
with it? For instance, the multipage document that gives the directions 
and cautions and all those, do you approve both?
 

Dr. Schultz.  I wish I could give you a simple answer to that question. 
Unfortunately, it is not simple.  As I mentioned in my opening statement, 
we have devices at various different risk levels and various different 
regulatory oversight levels, depending on risk.  And there are certain 
devices that we look at extremely carefully, like a new heart valve, or a 
drug-coated stent, or some of the more novel high-risk devices, where we 
actually do go over the labeling and every aspect of the testing, 
essentially 
word for word, and dot the " I's"  and cross the " T's."
 

In the area of the products that are being discussed here, which are 
class two devices, one level below that highest level, we do look at 
labeling, but we don't look at it in the same way that we do for those 
higher risk devices. We look at it more generically to make sure that 
it meets, that it provides certain key aspects and meets certain 
standards, in terms of the kind of information that is provided.
 

So for instance, in the case of a device that requires sterilization
by the user, a reusable device or an implant that would require 
sterilization, we would look at that product and look at the labeling, 
to make sure that it did in fact have instructions about how that 
device needed to be sterilized.  But would we go back and forth and 
try to fine- tune it to the extent that we could ensure that every 
single user would understand that particular label?  I think the fair 
answer that question is " no."  And we depend on, again --  I 
apologize.  I will stop.
 

Mr. Reyes.  Well, the point I wanted to make is that there should be 
a threshold of reasonableness here.
 

Dr. Schultz.  Right.
 

Mr. Reyes.  To have the warning on the third page and in very fine 
print that, " Oh, by the way, this instrument is not sterile,"  is 
not --  I mean, I'm not asking that we guarantee that the instructions 
or the warnings be at a minimum third grade level or sixth grade level 
or whatever so that we minimize the understanding part of it.  I think 
there is a greater concern, and this is predicated based on my own 
experience.
 

I had knee surgery in February.  One of the forms that I signed was 
that I understood that an infection, a staph infection or some other 
type of infection could occur because of the surgery.  And my daughter 
and my wife were with me, and my daughter asked the doctor, says, " 
Well, you know, we know that there is a possibility of infection even 
when you cut yourself, but why is this form particularly important?"
 

And I thought the doctor's answer was pretty germane, given what we 
are talking about here, is because there may be some instances where 
the instruments or some of the things that they use inadvertently 
may not be --  and I forget what the word that he used was, my 
daughter asked him, " Well, what does that mean?"
 

He says, "Well, something couldn't be sterilized, or even though we 
break it out of the sealed container, there could be some defect or 
something."   Which, you know, I am willing to accept that as --  and 
I think the doctor said, " It is one in 10 million that it would ever 
happen, but we are required for liability purposes to do this."
 

So I would understand that.  But I don't understand, knowing that this 
instrument is going to be --  I mean, what other use could possibly be 
put this instrument, other than implantation in a human being?  So it 
seems to me like the assumption is sterilization is pretty darned 
important.  And we shouldn't require the warning, or we shouldn't 
expect for the warning to be way down the third page, in fine print. 
It should be prominently displayed so that people understand, " You are 
going to cut a human being open, you are going to clean out whatever 
is in there, you are going to insert this instrument, please make sure 
that this instrument is sterilized."
 

The other thing that concerns me is the issue of one of you says that 
whatever is boiling or steaming, I forget what the term was, is the way 
to sterilize it; but the other one says, " No, it is not the way"  --  
 

Dr. Bagian.  It is absolutely not.  I mean, we -- 
 

Mr. Reyes.  But either way it is a concern, because we have got two 
doctors that have a different opinion on something that should be a 
foregone conclusion.
 

Dr. Bagian.  Well, it is a Stryker label and I have it right here.
 

Dr. Schultz.  I am not saying I have a different opinion.  What I need 
to do is go back and look at the instructions.  I am not saying that I 
have a --  that I am arguing about whether it should be sterilized this 
way or that way.  I would have to go back and look at the instructions.
 

Mr. Reyes.  Well, somebody should have vetted your testimony and said, " 
Oh, by the way, Dr. Schultz, this is"  --  
 

Dr. Schultz. Fair statement.
 

Dr. Bagian.  May I say something -- 
 

Mr. Reyes.  That concerns me.
 

Dr. Bagian.  If I may say, I think this is just emblematic, I think it 
makes a great point that smart people looked at this.  You know they 
didn't take it lightly preparing the testimony.  But because this is 
so unusual, it is so unusual to say, " Don't autoclave,"  because that 
is how we usually sterilize everything, especially for implantation, 
but not with this device.  And most are already sterilized, but not 
with this particular manufacturer's device.  When they read it, the 
first thing that it says, " Don't autoclave,"  which is the same as 
steam sterilization, " Don't autoclave,"  because the thing melts. It 
basically shrinks and doesn't fit.  It is only the third bullet that 
says, you know, you have to use ethylene oxide.
 

And when somebody read it, because it is what they call confirmation 
bias in human factors engineering; you see what you expect to see.  That 
is how magicians work, right, the way a magician works is by, you see 
what you expected to see while they are doing something else.  So here,
very smart, very diligent people looked at that, and they put the exact 
wrong thing in.  And if somebody followed that and they were putting 
the implant in my brain, they would get to do it, and they would say, " 
Wait a minute, it is 40 percent too small now, it doesn't work."
 

That would be, like, a bad thing.
 

But my point is, that is why just relying on reading that little 
instruction, even if they read it, is not the way to do it, and this 
just, like, proves the point that here, even the FDA doing it, didn't 
get it right.  And that could happen to anybody else.  And had I not 
been looking at this because of the problem, the way we did, I very 
likely would have read it just the way they did.  And that is my 
point.  It is not that they are not smart, it is not that they are 
not dedicated, that is not the issue at all.  It is that they are 
human, just like we are human, just like the people down there are 
human, just like the representative for Stryker get it wrong 
initially, because it was so atypical.
 

I mean, I was -- shall we do the experiment, and show you what that 
means?  I mean, let me just show you what this means.  If I ask you 
right now if you want to try a little experiment to show you what
this is about, if you put your hand on the table, if you want to play 
with me here.  And every time I say " up,"  I want you to raise your 
palm and put it down as fast as you can.  So I am going to go " up,"  
and you are going to do that.  Would you play with me here for, like, 
10 seconds?  You ready?
 

Mr. Reyes.  You too, Chairman.
 

Dr. Bagian.  Ready? Just try this, anybody here try it, it will be an 
interesting experiment.  Ready?  Up.  Up. Up.
 

Wait a minute, guys, I didn't say "up."  My instruction was when I
say " up."  Was that so hard?
 

The point is, we could do that all day, and now you, knowing what I 
am going to do, and you still can't stop it. And if we put an EMG, a 
thing that measures when your muscles are going to contract, it still 
would spike because the way we are made is, when we associate pairs 
of things together, at all time, and when the exception occurs your 
brain can't handle it, because it is already wired for it. And that 
is what happened here.
 

Mr. Reyes.  But Doctor, why, in another industry, there is a very 
simple rule.  The Carpenter says, " Measure twice, cut once."   And 
they are not dealing with human beings, they are not dealing with 
staph infections, all these other things.  I mean, it seems to me 
like in the medical profession, we ought to have at least the 
minimum standards that a carpenter has.
 

Dr. Bagian.  Well, I think things are progressing.  I mean, you 
know, I am an engineer originally, who happens to be a physician.  
And I think in engineering, or if you are a carpenter, these things 
make sense.  But we don't train physicians or most health-care 
professionals in systems engineering practices and human factors 
engineering, and I think we now, only since 1999 or so, have we been 
progressing to talk about how systems are designed to do those very 
things.
 

And I think we are at the beginning, I think health care is advancing 
much more rapidly than aviation did, as an example, over time, 
because we are building on what has been learned by the carpenter, 
by engineers, by others that say there are certain things you can do 
to systematize it, rather than be, " I am just smart enough to do 
it."   It is not that you are smart enough, it has nothing to do w
ith how smart you are.  It has to do with good practice, and I 
think we are building those in, and I think that is what the FDA is 
working on, as well.
 

Mr. Reyes.   Mr. Chairman, if I could ask one last thing.  Could we 
enter into the record the Stryker label and all of the issues that we 
have been discussing here?
 

Mr. Bilirakis.  By all means.  Without objection, that will be okay.
 

[The attachment appears on p.  ]  

*********Committee INSERT**********
 

Mr. Bilirakis.  Dr. Schultz, and then I am going to go to you, John,  
in a minute, are you in a position to carry back some of the results 
of this hearing, and to see that something is done about it?
 

Dr. Schultz.  I certainly am.
 

Mr. Bilirakis.  You are going to do that for us, are you?
 

Dr. Schultz.  Yes.
 

Mr. Bilirakis.  Dr. Boozman to inquire.
 

Mr. Boozman.  I thank you all for coming.  I guess the purpose of this 
is to make sure that we are doing the procedural things right.  It is 
not surprising that the government --  I don't think it is surprising 
that the government has some illegal immigrants working for them 
someplace.  It is surprising that they are working in very sensitive 
positions.
 

And so if that is the case, then I would just encourage you to really 
look at your personnel.  That is something that I think that 
illustrates that we really do have to be very, very diligent with our 
personnel.  And I think probably some of the systems that we have 
relied on in the past and had good faith in evidently are not working, 
as illustrated by that.  But again, I appreciate all of your all's 
hard work, I really mean that.  Thank you.
 

Mr. Bilirakis.  Dr. Daigh, are you familiar with the --  I will call it 
a problem, because it is a problem --  the Bay Pines in St. Petersburg, 
the sex offender situation? I am talking about a lack of background 
checks.
 

Dr. Daigh.  Sir, that is mostly being handled by investigations, so I am 
aware that that is an issue, but I don't have any particular insight 
into that.
 

Mr. Bilirakis.  Somehow the reporter found out about it regarding one 
sex offender, and then I think the hospital admitted to two, and now 
there are three there, and so we know that there are three.
 

So you can't comment any further on that?  Dr. Bagian, you can't 
comment on that? Dr. Ekstrand, can you comment on that?
 

Ms. Ekstrand.  No, sir, we haven't done any work related to that.
 

Mr. Bilirakis.  Does the VA keep a list of sex offenders? Anybody know?
 

Ms. Ekstrand.  Not as far as I know, and I think it is unlikely, because 
the individual records about background checks are kept in the 
individual facilities in the files of the employee.
 

Mr. Bilirakis.  The employee only?
 

Ms. Ekstrand. So it is not in a major database.
 

Mr. Bilirakis.  Wow.  Should it be? Doesn't it make sense that it should 
be?
 

Ms. Ekstrand.  I think it is hard to say.  Perhaps there should be some 
record when they get a hit, you know, that is when they identify someone 
who has a criminal history that needs to be considered before someone 
gets hired.  Most of the employees that are screened, no doubt, are not 
hits on these databases.  So keeping a record of all of it might be
more than is needed.
 

Mr. Bilirakis.  Well, but we understand, you know, depends on your source 
and whatnot, that anywhere up to half of sex offenders re-offend after 
treatment.  Taking that into consideration, accepting it if you will, you 
would think that there would be a list kept.  Again, we are talking about
a lack of adequate background checks and that sort of thing, so it is --  
 

You know, Mr. Reyes really went into it on IT.  He has been a member of 
this Committee for 10 years I believe he said.  I have been a member of 
it for 24 years.  The frustrations that we have with the VA, the 
inefficiencies, and the lack of paying attention to good advice from 
their IGs, and from the GAO, and from, well, sometimes I like to think 
even the Congress partake some good advice.  But it has just been 
terribly, terribly frustrating.
 

You know, and all of the legislation in the world, first of all, it 
can't cover everything, shouldn't cover everything.  Second of all, the 
regulations are drawn up, and by the agencies and by the departments, 
and quite often any similarity between those relations and the intent 
of the legislation is purely coincidental.
 

I am greatly concerned.  I feel a little better about it here today, but 
you know, I am greatly concerned.  FDA should be cooperating with the 
VA, and I hope that they are, and I will be probably personally talking 
to Dr. Von Eschenbach not too long from now, and plan to bring it up 
to him.
 

Dr. Schultz, we depend upon you an awful lot, to a large degree here, 
and we have an awful lot of questions in writing that will be submitted 
to you, and we are requesting that you submit responses to those.  
Again, use this Committee, if there are things that you feel need to 
be done, and your particular department or your particular agency is 
just not looking into it adequately.  Use this Committee.
 

Dr. Boozman has this one last question, and then we have about nine 
minutes left to make this vote. Go ahead, sir.
 

Mr. Boozman.  I know we need to go, Mr. Chairman.  I would like to 
know, though, and again you can send this over because we do need to 
go, but on the application form, I am sure we ask people if they have 
been convicted of a felony. I guess I would like to know if these 
individuals wrote down that they had been convicted and then we hired 
them regardless, as them being sex offenders.
 

Mr. Bilirakis.  Can you get that information to us?
 

Mr. Boozman.  And then also, if they hadn't, if they wrote down " no,"  
then I guess my question then is why are we not firing them because 
they lied on the application?
 

Mr. Bilirakis.  Can you all respond to that, please?
 

Dr. Bagian.  Yes.
 

Mr. Bilirakis.  Thank you very much.  I am not sure that we have 
gotten as much information as we had hoped to acquire at this hearing, 
but then of course time has been a factor, too.  You have been helpful,
there is no question about it, and again, we appreciate your taking 
time and trouble to be here.  You are busy people.  We depend upon 
you for so very much.  Thank you.
 

This hearing is adjourned.
 

[Whereupon, at 11:44 a.m. the Subcommittee was adjourned.]
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