Healthcare worker safety and needlestick injuries : hearing before the Subcommittee on Regulation, Business Opportunities, and Energy of the Committee on Small Business, House of Representatives, One Hundred Second Congress, second session, Washington, DC

580 Pages·1992·19.8 MB·English

by  United States. Congress. House. Committee on Small Business. Subcommittee on Regulation, Business Opportunities, and Energy

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HEALTHCARE WORKER SAFETY AND NEEDLESTICK
INJURIES
HEARING
BEFORE THE
SUBCOMMITTEE ON REGULATION, BUSINESS
OPPORTUNITIES, AND ENERGY
OF THE
COMMITTEE ON SMALL BUSINESS
HOUSE OF REPRESENTATIVES
ONE HUNDRED SECOND CONGRESS
SECOND SESSION
WASHINGTON, DC, FEBRUARY 7, 1992
Printed for the use of the Committee on Small Business
Serial No. 102-60
U.S. GOVERNMENT PRINTING OFFICE
52-372s=» WASHINGTON : 1992
For sale by the U.S. Government Printing Office
Superintendent of Documents, Congressional Sales Office, Washington, DC 20402
ISBN 0-16-039065-6
COMMITTEE ON SMALL BUSINESS
JOHN J. LaFALCE, New York, Chairman
ANDY IRELAND, Florida
NEAL SMITH, Iowa
JOSEPH M. McDADE, Pennsylvania
IKE SKELTON, Missouri
ROMANO L. MAZZOLI, Kentucky WM. S. BROOMFIELD, Michigan
NICHOLAS MAVROULES, Massachusetts JAN MEYERS, Kansas
LARRY COMBEST, Texas
CHARLES HATCHER, Georgia
RICHARD H. BAKER, Louisiana
RON WYDEN, Oregon
JOEL HEFLEY, Colorado
DENNIS E. ECKART, Ohio
MEL HANCOCK, Missouri
GUS SAVAGE, Illinois
NORMAN SISISKY, VirginiaPESTEBAN RONALD K. MACHTLEY, Rhode Island
EDWARD TORRES, California JIM RAMSTAD, Minnesota
DAVE CAMP, Michigan
JIM OLIN, Virginia
GARY A. FRANKS, Connecticut
RICHARD RAY, Georgia
WAYNE ALLARD, Colorado
JOHN CONYERS, Jr., Michigan
JAMES H. BILBRAY, Nevada JOHN A. BOEHNER, Ohio
KWEISI MFUME, Maryland SAM JOHNSON, Texas
FLOYD H. FLAKE, New York WILLIAM H. ZELIFF, Jr., New Hampshire
H. MARTIN LANCASTER, North Carolina GEORGE ALLEN, Virginia
BILL SARPALIUS, Texas
RICHARD E. NEAL, Massachusetts
GLENN POSHARD, Illinois
JOSE E. SERRANO, New York
ROBERT E. ANDREWS, New Jersey
THOMAS H. ANDREWS, Maine
BILL ORTON, Utah
ED PASTOR, Arizona
Donald F. Terry, Staff Director
Stephen P. Lynch, Minority Staff Director
Subcommittee on Regulation, Business Opportunities, and Energy
RON WYDEN, Oregon, Chairman
RICHARD E. NEAL, Massachusetts JAN MEYERS, Kansas
FLOYD H. FLAKE, New York WM. S. BROOMFIELD, Michigan
ROBERT E. ANDREWS, New Jersey DAVE CAMP, Michigan
H. MARTIN LANCASTER, North Carolina MEL HANCOCK, Missouri
Steve Jenning, Subcommittee Staff Director
Jenifer Loon, Minority Subcommittee Professional Staff Member
(II)
CONTENTS
Page
Hearing held on February 7, 1992. 1
WITNESSES
Friday, February 7, 1992
Adkins, Charles E., Director of Health Standards, Occupational Safety and
Health Administration, U.S. Department of Labor, and Susan Harwood,
Director, Office of Risk Assessment. 48
Arrowsmith-Lowe, Thomas, Deputy Director, Office of Health Affairs and
AIDS Coordinator, Food and Drug Administration, Public Health Service,
Department of Health and Human Services, accompanied by David West,
Deputy Director, Office of Device Evaluation, Center for Devices and Radio¬
logical Health. 46
Bell, David M., Chief, HIV Infections Branch, Hospital Infections Program,
National Center for Infectious Diseases, Public Health Service, U.S. Depart¬
ment of Health and Human Services, accompanied by Robert J. Mullan,
medical officer, HIV Activity, National Institute for Occupational Safety
and Health, Centers for Disease Control. 44
Chiarello, Linda, registered nurse, New York State Department of Health. 27
Christensen, Janet, registered nurse. 7
Gianakos, Arthur, president and CEO, North American Medical Products. 30
Jagger, Janine, associate professor of neurosurgery, University of Virginia. 12
Johnson, William H., CEO, University of New Mexico Hospital, on behalf of
American Hospital Association [AHA]. 37
Lashof, Joyce, Dean Emerita, University of California at Berkeley, and presi¬
dent, the American Public Health Association. 24
Moore, Bob, president, Local 1199-E/DC, Service Employees International
Union, AFL-CIO, CLC. 11
Roe, Jean, certified nursing assistant. 4
Russell, Barbara, chair, American Nurses Association [ANA], Task Force on
AIDS. 15
Seifert, Kevin, director of marketing, Bioplexus. 34
Spruill, Gwyen, medical laundry transport worker. 9
APPENDIX
Prepared statements:
Adkins, Charles E., with attachment. 222
Arrowsmith-Lowe, Thomas. 216
Bell, David M., with attachments. 192
Chiarello, Linda. 166
Christensen, Janet, with attachments. 83
Gianakos, Arthur. 170
Jagger, Janine. 143
Johnson, William H. 185
Lashof, Joyce. 161
Moore, Bob. 138
Roe, Jean. 78
Russell, Barbara, with attachments. 146
Seifert, Kevin, with attachment. 174
Spruill, Gwyen, with attachments. 121
Response to request of Chairman Wyden for information before hearing:
U.S. Department of Health and Human Services. 374
liiil
(iv)
Page
Response to request of Chairman Wyden for information before hearing—
Continued
U.S. Department of Labor........ 369
Response to request of Chairman Wyden for additional information during
hearing:
American Hospital Association... 248
Department of Health and Human Services, Food and Drug Administra¬
tion ..... 280
Department of Health and Human Services, Centers for Disease Control... 300
Recommendations for Preventing Transmission of HIV and Hepatitis
B virus to Patients During Exposure-Prone Invasive Procedures. 303
Guidelines for Prevention of Transmission of HIV and Hepatitis B
virus to Health-Care and Public-Safety Workers. 311
U.S. Department of Labor. 362
University of Virginia Sciences Center, letter to James S. Benson from
Janine Jagger, associate professor of neurosurgery. 364
Wyden, Hon. Ron:
Opening statement. 62
Subcommittee staff memo. 65
ADDITIONAL MATERIAL SUBMITTED FOR THE RECORD
Miscellaneous submissions:
Health Devices, Special Report and Product Review. 495
HIV-AIDS Surveillance Report, Table 3., AIDS cases by age group, expo¬
sure category, and sex, reported in 1990 and 1991... 522
Becton Dickinson, sharps safety system brochure. 523
Photograph. 528
Sharp-Trap, Inc., Rick Sawaya, M.D., medical disposal device. 529
Sterimatic Safety Needle, brochure. 567
Statements and letters:
American Association of Nurse Anesthetists. 383
American Society of Anesthesiologists. 405
Baxter, Cheryl L. Moraca, group marketing manager. 407
Becton Dickinson and Co., Ted Juraschek, director, Government Rela¬
tions. 409
Critikon, a Johnson & Johnson company, David R. Murray. 417
Engel-Arieli, Susan L. M.D. 420
Federation of Nurses and Health Professionals, Candice Owley, vice presi¬
dent, American Federation of Teachers, and chair, Health Care Divi¬
sion . 439
International Medication Systems, Limited, Randall J. Wall, president
and CEO. 455
National Phlebotomy Association, Inc., Diane C. Crawford, CEO. 460
North American Medical Products, Inc. 466
Pascall Medical Corp., William R. Tarello, VP, operation. 468
Ryan Medical, Inc., Henry H. Kuehn, chairman and CEO. 472
Safe Tech Medical Products, Inc., Re-Trak, Michael Haining. 475
Sherwood Medical, David A. Low, president. 485
Sterimatic Medical Systems, Ltd., John S. Parry, managing director. 488
Sterling Winthrop, Kathleen M. Whyte, vice president. 492
Tri-State Hospital Supply Corp., Don Propp, new product development 493
HEALTHCARE WORKER SAFETY AND
NEEDLESTICK INJURIES
FRIDAY, FEBRUARY 7, 1992
House of Representatives,
Subcommittee on Regulation, Business
Opportunities, and Energy,
Committee on Small Business,
Washington, DC.
The subcommittee met, pursuant to notice, at 10:15 a.m., in room
2359-A, Rayburn House Office Building, Hon. Ron Wyden (chair¬
man of the subcommittee) presiding.
Chairman Wyden. The subcommittee will come to order.
Today, the Subcommittee on Regulation, Business Opportunities,
and Energy continues an inquiry begun almost 5 years ago into the
U.S. health industry’s efforts to control the AIDS-HIV epidemic.
Our focus is whether American healthcare workers are adequately
protected in the workplace from exposure to the HIV virus and
other bloodborne diseases like hepatitis B. After careful examina¬
tion, we can only conclude that much remains to be done.
More than 5 million healthcare workers are exposed daily to the
deadly infectious disease. When the safety of these workers is in
question, their patients will continue to doubt the ability of the
healthcare delivery system to protect the public health. If you
reduce accidental needlestick injuries, you break the first critical
chain link in the transmission of infectious disease.
At issue today is the problem of infection control among those
who are on the front lines fighting the disease—the doctors, the
nurses, the trained technicians, and support workers who staff the
hospitals, clinics, physicians’ offices, and other parts of our health
system.
What we have seen are three pictures. One is of great profession¬
al heroism—individuals who take unavoidable risks daily to treat
people whose contagion could cause serious illness or death for the
healer. The second picture is one of a system in failure. Many
healthcare providers are moving at a snail’s pace in acquiring and
using new, safer technologies that are now readily available to pro¬
tect healthcare workers from the accidental spread of disease.
The third and most frustrating picture is of a lack of Federal
leadership. After 6 years of bureaucratic wrestling to devise a
bloodborne disease standard for occupational safety in this very
high risk area, the Government next month will implement a
safety rule that is full of holes. Specifically, the Chair is concerned
that this standard does not go beyond the use of high-strength
(l)
2
gloves and masks in surgery. No standard has been written to
demand use of safer needles, connective devices, and IV lines, the
source of real disease risk to workers.
The Chair is going to take a minute for the subcommittee to take
a look at one of the safer blood collection devices. For the sake of
those whose vision is as squinty as mine, there is a blowup of the
needle for the committee as well.
Over one billion blood collection devices are used each year in
the American hospital system, but the vast majority are not like
this one. The difference here is that this needle is safely retracted
in a plastic sheath. In effect, if I stick myself several times with
this, there is no puncture. The sharp end of this innovative device
only emerges when you press down on the end of the tube collector,
in effect, using it like a plunger. When you relieve that pressure,
the sharp retracts back into the plastic sheath. It is virtually im¬
possible to receive an accidental stick with this kind of medical
device.
It is important that the committee understands the cost differen¬
tial. The cost differential for a needle device like this is only 8
cents, and it is my view that the kind of investment we are talking
about for this safer device—only pennies—is a good investment to
make when it takes only one stick from a contaminated sharp to
cause the HIV virus, hepatitis B, or any one of a number of other
bloodborne diseases that can cause serious illness.
The subcommittee has found that there are an estimated 1 mil¬
lion plus accidental needlesticks per year sustained by public
health workers from surgeons to laborers in the laundry room.
These accidents have resulted in thousands of cases of hepatitis B,
a disease which claims the lives of approximately 300 health serv¬
ice workers each year.
In addition, there is solid documentation of the increasing
number of AIDS-HIV transmission cases among healthcare work¬
ers from these accidental sticks. The Centers for Disease Control
has readily admitted to the subcommittee that the number of docu¬
mented cases probably is far outnumbered by the number of unre¬
ported and undocumented instances of transmission.
The cost of these injuries is staggering. Accidents from needles
cost the U.S. health system $750 million a year just to test the
workers who report the sticks.
It is not just HIV and hepatitis B that is involved here. Health
workers also face measurable risks of contracting from contaminat¬
ed needles diseases such as Delta hepatitis, syphilis, and even ma¬
laria.
The subcommittee has found that by utilizing new technologies,
including syringes, IV tubes, and connective devices, up to one-half
of the accidental sticks could be prevented each year.
The question we are especially interested in is what is keeping
this state-of-the-art, new technology from being fully deployed? The
devices are marketed today by several companies. They do have
Food and Drug Administration approval. Medical providers who
use them report good results.
As we shall hear firsthand from workers today, infections from
these accidents have had a devastating impact on many lives.
3
So, why aren’t healthcare providers purchasing these safer de¬
vices? The reasons seem to be twofold. First, as I mentioned earlier,
the devices are slightly more expensive than older, less safe needles
and connective hardware. As one device manufacturer told the sub¬
committee, virtually every hospital purchasing agent in the coun¬
try is taking a wait-and-see approach to newer, safer devices.
But this seems short-sighted. The subcommittee has documented
both short- and long-term savings for medical providers. Use of
safer devices will save money in reducing mandated post-stick test¬
ing all by itself. Add in the treatment costs for those who actually
come down with infectious diseases as a result of these needles-
ticks, and it is very clear that safety pays.
Beyond these cost issues, these new technologies ought to be
standard equipment simply because it is right. The Federal agen¬
cies charged by Congress with protection of healthcare workers
have failed to demand that safer needles become the industry
standard. The Occupational Safety and Health bloodborne disease
standard, which is targeted at curbing transmission of infectious
disease in the workplace, is certainly a beginning, but the standard
doesn’t go beyond masks, gloves, and other such shields. Safer nee¬
dles need to be required.
More importantly, serious questions remain as to OSHA’s ability
to enforce their modest standard. The Chair wants to note that
there are only 140 Federal inspectors for more than 6,000 U.S. hos¬
pitals. The Centers for Disease Control’s statistical tracking of in¬
fectious disease is a system that often misses the boat. They can’t
say with assurance how many healthcare workers are at risk or
what kind of accidents they experience.
We are going to hear testimony today from a healthcare worker
who contracted the HIV virus from a needlestick injury, but you
would not find her from the statistics kept by CDC because CDC
has no specific plan that is relative to the numbers of infected
healthcare workers and the way in which they were infected.
Critical information in battling the disease remains unknown
today. This is not acceptable, and clearly, the CDC needs a tracking
system that monitors healthcare workers like our witness with
HIV.
The Bush administration has rightfully declared war on AIDS,
but it seems, when joining the fight with new technologies, agen¬
cies like the Food and Drug Administration are still in their bar¬
racks. After initially approving many of the safer devices, the FDA
and other Federal agencies have done little to promote their use.
The bottom line is that all of us—caregivers, hospitals, the Gov¬
ernment—must do more to break that critical first link in the
chain of infectious disease transmission. State-of-the-art protection
can significantly reduce the spread of bloodborne disease among
healthcare workers, and all Americans would be safer as a result.
[Chairman Wyden’s statement may be found in the appendix.]
Chairman Wyden. We are very pleased to have a distinguished
panel of witnesses. On our first panel we have Ms. Jean Roe, a cer¬
tified nurses assistant, San Francisco, California; Ms. Janet Chris¬
tensen, R.N., San Francisco General Hospital; Mr. Gwyen Spruill,
Local 79, United Care Central Laundry; Mr. Robert Moore, Service
Employees International Union; Ms. Barbara Russell, American
4
Nurses Association; and Dr. Janine Jagger of the University of Vir¬
ginia School of Medicine.
If all of you would come forward, we are going to swear you in.
I would like to ask the press and all photographers, because of
the need for confidentiality for Ms. Jean Roe of San Francisco, to
take no pictures of Ms. Roe throughout her appearance today.
If all the rest of you will come forward, we have certain formali¬
ties that we have to take care of. For purposes of swearing the wit¬
nesses, if you would just raise your right hand where you are
seated now, that would be satisfactory.
Do any of you have any objection to being sworn as a witness?
[Witnesses sworn.]
Chairman Wyden. We welcome all of you. Please be seated.
The subcommittee has always afforded witnesses the right to be
represented by counsel. Do any of you desire to be represented by
counsel today?
We thank all of you for your patience and cooperation that you
have shown. The committee realizes the sensitivity of some of these
situations.
Ms. Roe, I read your testimony last night, and my heart goes out
to you. I appreciate your being here. We are going to protect your
confidentiality.
I want to thank all our other witnesses who come and express
my appreciation for your outstanding advocacy. We are going to
make your prepared statements a part of the hearing record in
their entirety, so if you could take about 5 minutes and address the
principal concerns that you have, that would be helpful to us.
Chairman Wyden. Why don’t we begin, with you, Ms. Roe. Wel¬
come.
TESTIMONY OF JEAN ROE, CERTIFIED NURSING ASSISTANT
Ms. Roe. Good morning, Chairman Wyden and members of the
committee.
I am honored to be here today to tell you about a hazard that I
and other healthcare workers-
Chairman Wyden. Ms. Roe, we do have a problem with the infer¬
nal microphones here. If you could just boom it up a little bit more
and speak into it, that would be great.
Ms. Roe. I am honored to be here today to tell you about the haz¬
ards that I and other healthcare workers face every day we go to
work—the danger of needlestick injuries caused by unprotected, ex¬
posed needles.
Regrettably, I cannot face you in person because I must protect
my confidentiality, both to preserve my privacy and to protect
myself from discrimination.
I use the name Jean Roe. I am a member of SEIU Local 250. I
have been a certified nursing assistant since 1969. I work at a
major private hospital in San Francisco. I continue to work there
today. I am a healthcare worker who is now HIV infected from a
needlestick injury. This is a documented occupational transmission.
If my HIV disease progresses, and I acquire full-blown AIDS,
only then will the Centers for Disease Control classify me in their