U.S. Department of Veterans Affairs

Oversight on Patient Safety

Hearing

before the

Committee on 

Veterans’ Affairs

House of Representatives

Subcommittee on 

OVERSIGHT AND INVESTIGATIONS

one hundred ninth congress

second session

June 15, 2006

Printed for the use of the Committee on Veterans’ Affairs

Serial No. 109-52

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28-128.PDF
Committee on Veterans’ Affairs

Steve Buyer, Indiana, Chairman

Michael Bilirakis, Florida Lane Evans, Illinois, Ranking

Terry Everett, Alabama Bob Filner, California

Cliff Stearns, Florida Luis V. Gutierrez, Illinois

dan burton, Indiana Corrine Brown, Florida

Jerry Moran, Kansas Vic Snyder, Arkansas

richard H. baker, Louisiana Michael H. Michaud, Maine

Henry E. Brown, Jr., South Carolina Stephanie Herseth, South 

Jeff Miller, Florida Dakota

John Boozman, Arkansas Ted Strickland, Ohio

Jeb Bradley, New Hampshire Darlene Hooley, Oregon

Ginny Brown-Waite, Florida Silvestre Reyes, Texas

Michael R. Turner, Ohio ShellEy Berkley, Nevada

John Campbell, California Tom Udall, New Mexico

 John T. Salazar, Colorado

James M. Lariviere, Staff Director

Subcommittee on oversight and investigations

michael bilirakis Florida, Chairman Ted Strickland, Ohio, Ranking

Terry Everett, Alabama, Vice Chairman Silvestre Reyes, Texas

John Boozman, Arkansas John T. Salazar, Colorado

Jeb Bradley, New Hampshire

 

 

arthur k. wu, Subcommittee Staff Director

(II)
CONTENTS

June 15, 2006

 Page

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36

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37

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44

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55

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64

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86

U.S. Department of Veterans Affairs Oversight on Patient 

 Safety ......................................................................................

OPENING STATEMENTS

Chairman Bilirakis ....................................................................

Prepared statement of Chairman Bilirakis ..............................

Hon. Silvestre Reyes. .................................................................

Prepared statement of Congressman Reyes .............................

Witnesses

Bagian, James P, M.D., PE, Chief Patient Safety Officer,

Director of National Center for Patient Safety, Veterans

 Health, U.S. Department of Veterans Affairs ....................... 

Prepared statement of Dr. Bagian. ............................................

Schultz, Daniel, M.D., Director, Center for Devices and

Radiological Health, Food and Drug Administration, U.S.

Department of Health and Human Services ........................

Prepared statement of Dr. Schultz ...........................................

Daigh, John, D., Jr., M.D., Assistant Inspector General for

Healthcare Inspections, Office of the Inspector General,

 U.S. Department of Veterans Affairs ....................................

Prepared statement of Dr. Daign ..............................................

Ekstrand, Laurie E, Director, Health Care, U.S. Government

Accountability Office ...............................................................

Prepared statement of Ms. Ekstrand .......................................

MATERIAL SUBMITTED FOR THE RECORD

FDA Public Health Notification: Reprocessing of Reusable

Ultrasound Transducer Assemblies for Biopsy Procedures,

Issued June 19, 2006, submitted by Dr. Schultz.....................

Copies of Striker Label and Transducer Assembly Model 

8551, as referred to and submitted by Congressman Reyes..

(III)
 

 88

90

91

92

93

POST-HEARING QUESTIONS FOR THE RECORD

Congressman Bilirakis to Dr. James Bagian, U.S. Department of Veterans Affairs ..........................................................

 Congressman Bilirakis to Dr. John D. Daigh, U.S. Department of Veterans Affiars...........................................................

Congressman Bilirakis to Dr. Daniel Schultz, Food and Drug

 Administration, U.S. Department of Health and Human

Services......................................................................................

Congressman Bilirakis to Laurie Ekstrand, U.S. Government

Accountability Office.................................................................

Letter to Congressman Bilirakis from David W. Boyer,

 Assistant Commissioner for Legislation, U.S. Department

of Health and Human Services................................................ 

(IV)
(1)

U.S. Department of Veterans Affairs

Oversight on Patient Safety

Thursday, June 15, 2006

U.S. House of Representatives, 

Subcommittee on Oversight and Investigations,

Committee on Veterans’ Affairs,

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 Nathan 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 
2

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. 36.]

 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 
3

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.

[The statement of Mr. Reyes appears on p. 37.]

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, CHIEF

 PATIENT SAFETY OFFICER, DIRECTOR OF NATION-

 AL CENTER FOR PATIENT SAFETY, VETERANS

 HEALTH ADMINISTRATION, 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, OFFICE OF THE INSPECTOR GENERAL,

U.S. DEPARTMENT OF VETERANS AFFAIRS; DANEL

SCHULTZ, M.D., DIRECTOR, CENTER FOR DEVICES

 AND RADIOLOGICAL HEALTH, FOOD AND DRUG

 ADMINISTRATION, U.S. DEPARTMENT OF HEALTH

 AND HUMAN SERVICES; AND LAURIE E.

 EKSTRAND, DIRECTOR, HEALTH CARE, U.S. GOVERN-

 MENT ACCOUNTABILITY OFFICE

STATEMENT OF DR. 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 
4

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.
5

 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 
6

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 
7

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 
8

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. 38.] 

 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 
9

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 DR. 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 
10

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. 52.] 

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 
11

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 
12

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. 44.] 

 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 
13

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 ap-
14

proach 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.
15

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?
16

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.
17

[The statement of Ms. Ekstrand appears on p. 64.] 

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 DR. 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. 55.]

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.
18

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 
19

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 
20

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 
21

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 
22

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 
23

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 
24

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 
25

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.
26

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 atten-
27

tion 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 
28

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, 
29

“ 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 
30

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 
31

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 in-
32

struction, 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, 
33

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 with 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 exhibits appear on p. 86. ] 

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, be-
34

cause 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 
35

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.]
(36)

APPENDIX

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