Copyright 2000 Federal News Service, Inc.
Federal News Service
June 22, 2000, Thursday
SECTION: PREPARED TESTIMONY
LENGTH: 3895 words
HEADLINE:
PREPARED TESTIMONY OF LINDA ROSENSTOCK, M.D., M.P.H. DIRECTOR NATIONAL INSTITUTE
FOR OCCUPATIONAL SAFETY AND HEALTH CENTERS FOR DISEASE CONTROL AND PREVENTION
BEFORE THE HOUSE EDUCATION AND THE WORKFORCE
COMMITTEE SUBCOMMITTEE ON WORKFORCE PROTECTIONS
SUBJECT - "OSHA
COMPLIANCE DIRECTIVE ON ENFORCEMENT PROCEDURES FOR THE OCCUPATIONAL EXPOSURE TO
BLOODBORNE PATHOGENS"
BODY:
As the Director
of the National Institute for Occupational Safety and Health (NIOSH), I thank
you, Chairman Ballenger, and members of the Subcommittee, for the opportunity to
submit this statement, which discusses the science and public health issues that
pertain to needlestick injuries among health care workers.
NIOSH is a research institute within the Centers for Disease Control and
Prevention (CDC), a part of the Department of Health and Human Services. CDC,
through NIOSH, is the federal agency mandated to conduct research to identify
and prevent workplace safety and health hazards. In addressing
needlestick injuries, NIOSH works closely with the National
Centers for Infectious Disease (NCID), also part of CDC.
This statement
summarizes the scientific issues related to needlestick
injuries, including what we know about the number of workers affected, what can
happen to a worker's health as a result of such an injury, how these injuries
occur, and ways to prevent them. In addition, it describes what CDC is doing to
address this serious public health problem. First, it is important to provide
some context about health care workers in general. Over 10 million workers are
now employed in health care industries. They cover a range of occupations, from
nurses and doctors to pharmacists to laboratory technicians to dental
assistants. Health care services are growing at twice the rate of the overall
economy--rivaling the high-tech field--with over three million new jobs
projected by 2006.
The Number of Needlestick Injuries
We know that needlestick injuries are contributing to
the overall burden of health care worker injuries. Although we do not know
exactly how many work-related needlesticks occur each year
across the country, estimates indicate that 600,000 to 800,000 such injuries
occur annually, about half of which go unreported. A recent CDC study estimates
that an average of 385,000 needlestick injuries occur annually
in U.S. hospital settings. At an average hospital, workers incur approximately
30 reported needlestick injuries per 100 beds per year. Most
reported needlestick injuries involve nursing staff; but
laboratory staff, physicians, housekeepers, and other health care workers are
also injured. Health care workers outside the hospital setting are also at risk.
Others at clinics, private medical and dental offices, nursing homes,
correctional facilities, and in the community, such as emergency medical
response workers, are also at risk of exposure to contaminated blood.
Needlestick Injuries and the Risk of Disease
Fortunately, most needlestick injuries do not result in
exposure to an infectious disease, and of those that do, the majority do not
result in the transmission of infection. Nevertheless,
needlestick injuries may expose workers to bloodborne pathogens
such as human immunodeficiency virus (HIV), hepatitis B virus, and/or hepatitis
C virus. A health care worker's risk of infection depends on several factors,
such as the pathogen involved, the severity of the needlestick
injury, and the availability and use of pre-exposure vaccination and
post-exposure prophylaxis (i.e., protective treatment for the prevention of
disease once exposure has occurred).
HIV
HIV infection is a
complex disease that can be associated with many symptoms. The virus attacks
part of the body's immune system, eventually leading to severe infections and
other complications--a condition known as AIDS. Despite current therapies that
delay the progression of HIV disease, many individuals who become infected with
HIV are likely to develop AIDS.
As of December 1999, CDC received
reports of 56 "documented" cases and 136 "possible" cases of occupationally
acquired HIV infection in the U.S. Most involved nurses and laboratory
technicians. Percutaneous injury-such as needlesticks-was
associated with 89% of the documented occupationally acquired infections.
Studies that followed health care workers with occupational HIV exposures
indicate that the risk of transmission from a single percutaneous exposure, such
as a needlestick or a cut with a sharp object, to HIV-infected
blood is approximately 0.3%. To say this another way, three of every 1,000
health care workers stuck with a needle contaminated with HIV-positive blood
will become infected with HIV.
An epidemiologic study of health care
Workers who had percutaneous exposures to HIV found that the risk of HIV
transmission was increased in certain circumstances: when the worker was exposed
to a larger quantity of blood from the patient, a procedure that involved
placing a needle in a patient's vein or artery, a deep injury, or when the
patient was in a phase of the illness associated with higher viral levels.
Hepatitis B Virus
Hepatitis B virus (HBV) infection is another
risk associated with needlestick injuries. About one-third to
one-half of persons with acute HBV infection develop symptoms of hepatitis such
as jaundice, fever, nausea, and abdominal pain. Most acute infections resolve,
but 2% to 6% of patients develop chronic infection with HBV that carries an
estimated 15% lifetime risk of dying from cirrhosis of the liver or from liver
cancer.
CDC national hepatitis surveillance indicates that, in 1997, an
estimated 500 health care workers became infected with HBV. This figure
represents a greater than 95% decline from the 17,000 new infections estimated
in 1983, largely due to the widespread immunization of health care workers with
the hepatitis B vaccine and the use of universal precautions.
Most
health care workers are immune to HBV due to pre-exposure vaccination. However,
studies done before the availability of hepatitis B vaccine showed rates of HBV
transmission ranging from 6% to 30% after a single needlestick
exposure to an HBV-infected patient.
Hepatitis C Virus
Health
care workers with needlestick injuries are also at risk for
infection with the Hepatitis C virus (HCV). The precise number of health care
workers who have acquired HCV occupationally is not known. However,
epidemiologic studies of health care workers exposed to HCV through a
needlestick or other percutaneous injury have found that the
incidence of infection averages 1.8% per injury. Of the total new HCV infections
that have occurred annually (declining from 112,000 in 1991 to 38,000 in 1997),
2% to 4% have been in health care workers exposed to blood in the workplace.
HCV infection often occurs with no symptoms or only mild symptoms. But
unlike HBV, with only 2% to 6% of adults developing chronic infection, with HCV
chronic infection develops in 75% to 85% of patients. Seventy percent of those
with chronic HCV develop active liver disease, with 10% to 20% of patients then
developing cirrhosis and 1% to 5% developing liver cancer over a period of 20 to
30 years.
Prophylaxis and Post-Exposure Treatments
Postexposure
prophylaxis is available for hepatitis B and HIV exposures but not for hepatitis
C. However, preventing the needlestick injury in the first
place is the best approach to preventing these diseases in health care workers,
and it is an important part of any bloodborne pathogen prevention program in the
workplace.
Emotional Impact
Another serious effect of
needlestick injuries is the emotional toll on health care
workers. With each needlestick incident, workers .face the
possibility of having been exposed to a bloodborne pathogen, in which case they
face difficult decisions about undergoing medical treatment with both short-term
and long-term side effects. In addition, the worker is advised to use barrier
contraception and to postpone decisions on childbearing.
Studies have
shown that the emotional impact of a needlestick injury can be
severe and long lasting, even when a serious infection is not transmitted. This
impact is particularly severe when the injury involves exposure to HIV. In one
study of 20 health care workers with an HIV exposure, 11 reported acute severe
distress, 7 had persistent moderate distress, and 6 quit their jobs as a result
of the exposure. Other stress reactions requiring counseling have also been
reported. Not knowing the infection status of the source patient can accentuate
the health care worker's stress. In addition to the exposed health care worker,
colleagues and family members may suffer emotionally.
How
Needlestick Injuries Occur: Devices and Activities
Health care workers use many types of needles and other sharp devices to
provide patient care.
Whenever one of these "sharps" is exposed in the
work environment there is an opportunity for injury. Data from two surveillance
programs, the CDC National Surveillance System for Healthcare Personnel (NaSH)
and EPINet, a project developed by Dr. Janine Jagger at the University of
Virginia, provide descriptive epidemiological evidence of how such injuries
occur, including under what circumstances, with what devices and during what
types of procedures. The picture that emerges reflects a continuum of risk
opportunities throughout the life-cycle of sharp device use involving
interactions among patients, workers, devices and the environment. Approximately
38% of percutaneous injuries occur during use, when a needle or other sharp
being manipulated in a patient becomes accidentally dislodged. Other injuries
occur after use during cleanup, or in association with the disposal of a sharp
device.
The circumstances leading to a needlestick
injury depend partly on the type and design of the device used. In addition to
risks related to device characteristics, needlestick injuries
have been related to certain work practices such as recapping, transferring a
body fluid between containers, and failing to properly dispose of used needles
in puncture-resistant "sharps" containers.
Preventing
Needlestick Injuries
Based on a review of the science,
CDC recommends a hierarchical approach for implementing strategic measures to
prevent needlestick injuries. Among these measures is
eliminating the use of needles wherever possible through changes in how
medications are delivered or specimens obtained, and by using engineered
technologies, such as non- needle connectors for intravenous delivery systems.
If safe and effective alternatives to needles are not available, devices with
engineered sharps injury prevention features such as shields and sheaths should
be used. In addition to the changes in the use of medical devices, other factors
that must be addressed in the prevention of needlestick
injuries include modification of hazardous work practices, administrative
changes to address needle hazards in the environment (e.g., prompt removal of
filled sharps disposal boxes), safety education and awareness, feedback on
safety improvements, and action taken on continuing problems. Each health care
setting should have its own carefully tailored program, developed with front
line worker input and review.
Effectiveness of Medical Devices with
Safety Features
Research has shown that devices with safety features,
especially when used as part of a comprehensive prevention program are effective
in preventing needlestick injuries.
For example, some
studies have shown that needleless or protected- needle IV systems decreased
needlestick injuries related to IV connectors by 62% to 88%. In
a CDC study, phlebotomy injuries (i.e., those involving the letting of blood)
were reduced by 76% with a self- blunting needle, 66% with a hinged needle
shield, and 23% with a sliding-shield, winged-steel (butterfly-type) needle.
Another study concluded that phlebotomy injuries were reduced by 82% with a
needle shield, but a recapping device had minimal impact. Other research
concluded that safer IV catheters that encase the needle alter use reduced
needlestick injuries related to IV insertion by 83% in three
hospitals.
A number of sources have identified the desirable
characteristics of safety devices, which can be used as a guideline for device
design and selection. These are included, along with a description of their
limitations, in CDC's Alert, Preventing Needlestick Injuries in
Health Care Settings (November 1999) (at pp. 10-11), attached to this testimony.
Comprehensive Safety Programs
Although medical safety devices
are key in the prevention of needlestick injuries, as already
mentioned, they are most effective when used in the context of a comprehensive
safety program that considers all aspects of the work environment and that has
employee involvement and management commitment. Several studies document
substantial reductions in needlestick injuries with the proper
use of needleless systems or newer safety needle devices used in a comprehensive
program to prevent needlestick injuries.
CDC believes
that a comprehensive strategy to prevent percutaneous injuries is necessary and
should include the following: occupational injury and disease surveillance to
identify procedures, devices and injury mechanisms for targeting prevention
efforts; development and implementation of a prevention plan that includes 1)
elimination of unnecessary use of needles, 2) implementation of devices with
safety features, 3) modification of procedures and work practices, 4) health
care worker education, and 5) safety promotion in the work environment; and
outcome evaluation
The critical role of appropriate training has been
emphasized by several recent reports of increased patient bloodstream infections
associated with improper care of needleless IV systems, primarily in the home
health care setting. These data emphasize the need for patient safety
surveillance and thorough training as well as occupational injury surveillance
when implementing the use of a new medical device.
One recent study
tracked phlebotomy services at a major institution and found that from 1993 to
1996, the needlestick injury rate among its 200 full-tune
phlebotomists decreased almost 90% (from 1.5 to 0.2 per 10,000 venipunctures
performed). The low rate achieved is almost 80% below an estimate of the
national rate (0.94 per 10,000 venipunctures). The actions contributing to the
success of the phlebotomy services included changes in worker education and work
practices, the implementation of devices with safety features, and encouragement
of injury reporting. These interventions as well as the implementation of CDC
published guidelines and the Occupational Safety and Health Administration's
(OSHA) bloodborne pathogens standard were associated with the observed steady
decline in the injury rate. The authors also noted that an important factor
contributing to this success was a thorough understanding among the
institution's staff of the injuries that had occurred.
Another recently
published study, funded by CDC, examined needlestick injuries
in an acute-care community hospital in Greater Washington, D.C., from 1990 to
1998. The study found that implementation of a multi-faceted intervention
program led to a significant and sustained decrease in the overall rate of
sharps injuries. Annual sharps injury incidence rates decreased from 82 sharps
injuries/I,000 full-tune workers to 24 sharps injuries/I,000 full-time workers,
representing a 70% decline in incidence rate overall.
The hospital's
interventions included an intensive training effort, expanded employee health
programs, and an expedited injury reporting process with a focus on
confidentiality issues, an anti-needlesticks and sharps task
force, and the implementation of new work practices, as well as the use of
medical safety devices.
CDC Efforts to Address
Needlestick Injuries
CDC has had a long-standing
interest and involvement in the prevention of needlestick
exposures dating back to its 1987 guidelines for universal precautions that
included recommendations for the safe handling of sharp devices, including
proper disposal. In a 1998 report, CDC reviewed the proper location, use, and
benefits of sharps disposal containers, which play a key role in
needlestick injuries. Last November, after reviewing the
available scientific research, CDC--with a broad range of review from diverse
stakeholders--published a national Alert on Preventing
Needlestick Injuries in Health Care Settings (mentioned
previously herein and attached hereto), which was distributed to every hospital
in the country. The Alert contains public health recommendations for preventing
needlestick injuries, as reflected in my previous comments. CDC
is now conducting an evaluation of the impact of the Alert.
CDC is
currently funding and conducting a wide variety of extramural and intramural
projects aimed at reducing the occurrence of needlestick
injuries and exposure to bloodborne pathogens. Current research on exposure
prevention is focused on the following: - evaluating safer blood collection
devices; developing evaluation criteria for selecting medical devices;
developing benchmarks for needlestick exposure frequencies that
could be used for local prevention efforts to protect health care personnel;
funding hospitals to demonstrate the use of data-driven strategies for the
prevention of needlestick injuries; and developing a workbook
on the prevention of needlestick injuries to guide health care
organizations in developing, implementing, and evaluating a prevention plan.
An extramural project beginning later this year will work to provide new
data on health care workers who work outside of hospitals, reflecting the
changing environment of health care delivery. CDC has also worked on a number of
projects with universities to examine safety climate and work organization
factors that have an impact on needlestick injuries and to
evaluate training programs for health care workers.
In terms of
postexposure management, CDC is monitoring the use and side effects of
postexposure prophylaxis after occupational exposures, assessing immune
responses of health care personnel, and assessing factors that influence
selection of postexposure measures. CDC has also joined the Health Resources and
Services Administration in funding the PEPline, an 800 number that provides
treatment advice to clinicians treating workers who have been occupationally
exposed to blood.
Also of note, coordinated national efforts to address
needlestick injuries are occurring through Healthy People 2010,
the Department of Health and Human Service's national health promotion and
disease prevention initiative (Objective 20-10, Reduce occupational
needlestick injuries among health care workers to 420,000
annual needlestick exposures) and the National Occupational
Research Agenda, or NORATM, a national research framework created and
implemented by a broad group of stakeholders. Several of NORA's 21 priority
research areas, including Infectious Diseases and Intervention Effectiveness
Research, are addressing needlestick injury issues.
Areas for Further Research
As with any emerging public health
problem, there are several important areas in which our knowledge about
needlestick injuries and their prevention can be improved.
Because most of the medical devices are in the first generation stage, ongoing
review of current devices and options will be necessary. Research will continue
to improve the safety features of devices. Evaluation studies to provide
improved information on what does and does not work will similarly continue to
improve the effectiveness of comprehensive safety programs. Because training for
employers and health care workers is a vital part of a comprehensive prevention
program, especially as new and safer devices are introduced, model training
curriculums need to be developed and evaluated at regular intervals.There is a
need to improve national surveillance and to build institutional capacity for
measuring the impact of prevention efforts. The two existing systems in the U.S.
that collect information on needlestick injuries have certain
limitations. CDC's NaSH surveillance system, mentioned earlier, is comprised of
60 hospitals around the country that voluntarily report blood exposures to the
CDC. The EPINet system, also mentioned previously, counts
needlestick injuries at 84 hospitals. Neither system surveys a
random selection of hospitals, and the participating hospitals may not be
representative of all hospitals across the U.S. Also, we do not have data
available to tell us whether the problem of needlestick
injuries is occurring uniformly across the country, or if there are pockets
where the situation is worse.
In addition, there is no system in place
to track the millions of health care workers employed outside of hospitals, or
exposed workers who are not health care workers. Needlestick
injuries at public health sector facilities are also not counted by current
reporting requirements. Moreover, from observational studies, we estimate that
approximately half of all needlestick injuries are never
reported by employees.
Accurately tracking needlestick
injuries is critical. Tracking-or public health surveillance-involves a
continuous and systematic process of collecting, analyzing, interpreting, and
disseminating descriptive information to monitor health problems. Surveillance
is used to guide disease prevention and control activities and provides a basis
for public health policy. Some have called surveillance the eyes and ears of
public health. Without surveillance, we don't know how big a problem is, whether
it's getting bigger or smaller, where it is, or whether our attempts at
prevention are effective.
Improved surveillance could be used to
identify potential risk factors associated with needlestick
injuries, such as high-risk occupations, settings, or procedures, and detect the
emergence of new problems. We could also use enhanced surveillance systems to
track whether interventions put into place significantly help reduce injuries;
for example, whether changes in staffing ratios or the use of newer medical
safety devices has an impact on these injuries. Individual facilities could use
surveillance to identify problem areas and solutions within their own
organization and could use the national data as a benchmark for comparison with
their own data. Any enhanced surveillance systems would include appropriate
privacy and confidentiality protections for those being monitored.
Conclusion
While the science base on
needlestick injuries continues to grow, completed research
indicates that such injuries are an important and continuing cause of exposure
to serious and sometimes fatal infections among health care workers. Greater
collaborative efforts by all stakeholders are needed to prevent
needlestick injuries and the consequences that can result. Such
efforts are best accomplished through a comprehensive program that addresses
institutional, behavioral, and device-related factors that contribute to the
occurrence of needlestick injuries in health care workers.
Critical to this effort is the elimination of needle use where safe and
effective alternatives are available and the continuing development, evaluation,
and use of needle devices with safety features. All such approaches must include
serious initial and ongoing training efforts. Monitoring systems are also needed
to provide accurate information on the magnitude of needlestick
injuries and trends over time, potential risk factors, emerging new problems,
and the effectiveness of interventions in all health care settings.
END
LOAD-DATE: June 23, 2000