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Preventing
Needlestick Injuries in Health
Care Settings
November 1999
DHHS (NIOSH)
Publication No. 2000-108
Disclaimer
DHHS (NIOSH)
Publication No. 2000-108
November 1999
Preventing
Needlestick Injuries
in Health Care
Settings
WARNING!
Health
care workers who use or may be exposed to needles are at increased
risk of needlestick injury. Such injuries can lead to serious or
fatal infections with bloodborne pathogens such as hepatitis B
virus, hepatitis C virus, or human immunodeficiency virus (HIV).
Employers of health care workers should implement the use of
improved engineering controls to reduce needlestick injuries.
Eliminate the use of needles where safe and effective alternatives
are available. Implement the use of devices with safety features and
evaluate their use to determine which are most effective and
acceptable. Needlestick injuries can best be reduced when the use of
improved engineering controls is incorporated into a comprehensive
program involving workers. Employers should implement the following
program elements:
Analyze
needlestick and other sharps-related injuries in your workplace to
identify hazards and injury trends.
Set
priorities and strategies for prevention by examining local and
national information about risk factors for needlestick injuries and
successful intervention efforts.
Ensure that
health care workers are properly trained in the safe use and
disposal of needles.
Modify work
practices that pose a needlestick injury hazard to make them safer.
Promote
safety awareness in the work environment.
Establish
procedures for and encourage the reporting and timely followup of
all needlestick and other sharps-related injuries.
Evaluate
the effectiveness of prevention efforts and provide feedback on
performance.
Health care
workers should take the following steps to protect themselves and
their fellow workers from needlestick injuries:
Avoid the
use of needles where safe and effective alternatives are available.
Help your
employer select and evaluate devices with safety features.
Use devices
with safety features provided by your employer.
Avoid
recapping needles.
Plan for
safe handling and disposal before beginning any procedure using
needles.
Dispose of
used needles promptly in appropriate sharps disposal containers.
Report all
needlestick and other sharps-related injuries promptly to ensure
that you receive appropriate followup care.
Tell your
employer about hazards from needles that you observe in your work
environment.
Participate
in bloodborne pathogen training and follow recommended infection
prevention practices, including hepatitis B vaccination.
For additional information, see NIOSH Alert: Preventing Needlestick
Injuries in Health Care Settings [DHHS (NIOSH) Publication
2000-108]. Single copies of the Alert are available free from the
following:
NIOSH—Publications Dissemination
4676 Columbia Parkway
Cincinnati, OH 45226-1998
Telephone: 1-800-35-NIOSH
(1-800-356-4674)
Fax number: (513) 533-8573
Email: pubstaft@cdc.gov
Web site: www.cdc.gov/niosh
U.S. Department of Health and Human Services
Public Health Service
Centers for Disease Control and Prevention
National Institute for Occupational Safety and Health
Preventing Needlestick Injuries
in Health Care
Settings
WARNING!
Health
care workers who use or may be exposed to needles are at increased
risk of needlestick injury. Such injuries can lead to serious or
fatal infections with bloodborne pathogens such as hepatitis B
virus, hepatitis C virus, or human immunodeficiency virus (HIV).
The National
Institute for Occupational Safety and Health (NIOSH) requests
assistance in preventing needlestick injuries among health care
workers.* These injuries are caused by needles such as hypodermic
needles, blood collection needles, intravenous (IV) stylets, and
needles used to connect parts of IV delivery systems. These injuries
may cause a number of serious and potentially fatal infections with
bloodborne pathogens such as hepatitis B virus (HBV), hepatitis C
virus (Hepatitis C Virus), or human immunodeficiency virus (HIV)—the
virus that causes acquired immunodeficiency syndrome (AIDS).
*In this
document, the term health care worker includes all workers in the
health care setting who use or may be exposed to needles and other
sharp devices that may contain blood or other potentially infectious
materials. Health care workers include physicians, nurses,
laboratory and dental personnel, pre-hospital care providers, and
housekeeping, laundry, and maintenance workers.
These injuries
can be avoided by eliminating the unnecessary use of needles, using
devices with safety features, and promoting education and safe work
practices for handling needles and related systems. These measures
should be part of a comprehensive program to prevent the
transmission of bloodborne pathogens.
This Alert
provides current scientific information about the risk of
needlestick injury and the transmission of bloodborne pathogens to
health care workers. The document focuses on needlestick injuries as
a key element in a broader effort to prevent all sharps-related
injuries and associated bloodborne infections. The document
describes five cases of health care workers with needlestick-related
infections and presents intervention strategies for reducing these
risks. Because many needleless devices and safer needle devices have
been recently introduced and the field is rapidly evolving, the
Alert briefly describes an approach for evaluating these devices.
NIOSH requests
that workers, employers, manufacturers, editors of professional
journals, safety and health officials, and labor unions implement
the recommendations in this Alert and bring them to the attention of
all health care workers who use or may be exposed to needles in the
workplace.
BACKGROUND
More than 8
million health care workers in the United States work in hospitals
and other health care settings. Precise national data are not
available on the annual number of needlestick and other percutaneous
injuries among health care workers; however, estimates indicate that
600,000 to 800,000 such injuries occur annually [Henry and Campbell
1995; EPINet 1999]. About half of these injuries go unreported [Roy
and Robillard 1995; EPINet 1999; CDC 1997a; Osborn et al. 1999].
Data from the EPINet system suggest that at an average hospital,
workers incur approximately 30 needlestick injuries per 100 beds per
year [EPINet 1999]. Most reported needlestick injuries involve
nursing staff; but laboratory staff, physicians, housekeepers, and
other health care workers are also injured. Some of these injuries
expose workers to bloodborne pathogens that can cause infection. The
most important of these pathogens are HBV, Hepatitis C Virus, and
HIV. Infections with each of these pathogens are potentially life
threatening—and preventable.
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 [Henry et al. 1990].
Other stress reactions requiring counseling have also been reported
[Armstrong et al. 1995]. Not knowing the infection status of the
source patient can accentuate the health care workers stress. In
addition to the exposed health care worker, colleagues and family
members may suffer emotionally.
HIV
Between 1985 and
June 1999, cumulative totals of 55 "documented"† cases and 136
"possible"‡ cases of occupational HIV transmission to U.S. health
care workers were reported to the Centers for Disease Control and
Prevention (CDC) [CDC 1998a]. Most involved nurses and laboratory
technicians. Percutaneous injury (e.g., needlestick) was associated
with 49 (89%) of the documented transmissions. Of these, 44 involved
hollow-bore needles, most of which were used for blood collection or
insertion of an IV catheter. †Health care workers who had
documented HIV after occupational exposure or had other laboratory
evidence of occupational HIV infection.
‡Health care
workers who were investigated and (1) had no identifiable behavioral
or transfusion risks, (2) reported having had percutaneous or
mucocutaneous occupational exposures to blood or body fluids or to
laboratory solutions containing HIV, but (3) had no documented HIV
seroconversion resulting from a specific occupational exposure.
HIV infection is
a complex disease that can be associated with many symptoms. The
virus attacks part of the bodys 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,
most health care workers who become infected with HIV are likely to
eventually develop AIDS and die.
HBV
Information from
national hepatitis surveillance is used to estimate the number of
HBV infections in health care workers. In1995, an estimated 800
health care workers became infected with HBV [CDC unpublished data].
This figure represented a 95% decline from the 17,000 new infections
estimated in 1983. The decline was largely due to the widespread
immunization of health care workers with the hepatitis B vaccine and
the use of universal precautions and other measures required by the
Occupational Safety and Health Administration (OSHA) bloodborne
pathogens standard [29 CFR§ 1910.1030].
§Code of Federal
Regulations. See CFR in references.
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 5% to 10% of patients develop chronic
infection with HBV that carries an estimated 20% lifetime risk of
dying from cirrhosis and 6% risk of dying from liver cancer [Shapiro
1995].
Hepatitis C
Virus
Hepatitis C
virus infection is the most common chronic bloodborne infection in
the United States, affecting approximately 4 million people [CDC
1998b]. Although the prevalence of Hepatitis C Virus infection among
health care workers is similar to that in the general population (1%
to 2%) [CDC 1998b], health care workers clearly have an increased
occupational risk for Hepatitis C Virus infection. In a study that
evaluated risk factors for infection, a history of unintentional
needlestick injury was independently associated with Hepatitis C
Virus infection [Polish et al. 1993]. The number of health care
workers who have acquired Hepatitis C Virus occupationally is not
known. However, of the total acute Hepatitis C Virus infections that
have occurred annually (ranging from 100,000 in 1991 to 36,000 in
1996), 2% to 4% have been in health care workers exposed to blood in
the workplace [Alter 1995, 1997; CDC unpublished data].
Hepatitis C
Virus infection often occurs with no symptoms or only mild symptoms.
But unlike HBV, chronic infection develops in 75% to 85% of
patients, with active liver disease developing in 70%. Of the
patients with active liver disease, 10% to 20% develop cirrhosis,
and 1% to 5% develop liver cancer [CDC 1998b].
RISK OF
INFECTION AFTER A NEEDLESTICK INJURY
After a
needlestick exposure to an infected patient, a health care worker's
risk of infection depends on the pathogen involved, the immune
status of the worker, the severity of the needlestick injury, and
the availability and use of appropriate post-exposure prophylaxis.
HIV
To estimate the
rate of HIV transmission, data were combined from more than 20
worldwide prospective studies of health care workers exposed to
HIV-infected blood through a percutanous injury. In all, 21
infections followed 6,498 exposures for an average transmission rate
of 0.3% per injury [Gerberding 1994; Ippolito et al. 1999]. A
retrospective case-control study of health care workers who had
percutaneous exposures to HIV found that the risk of HIV
transmission was increased when the worker was exposed to a larger
quantity of blood from the patient, as indicated by (1) a visibly
bloody device, (2) a procedure that involved placing a needle in a
patient's vein or artery, or (3) a deep injury [Cardo et al. 1997].
Preliminary data suggest that such high-risk needlestick injuries
may have a substantially greater risk of disease transmission per
injury [Bell 1997].
Post-exposure
prophylaxis for HIV is recommended for health care workers
occupationally exposed to HIV under certain circumstances [CDC
1998c]. Limited data suggest that such prophylaxis may considerably
reduce the chance of becoming infected with HIV [Cardo et al. 1997].
However, the drugs used for HIV post-exposure prophylaxis have many
adverse side effects [CDC 1998c]. Currently no vaccine exists to
prevent HIV infection, and no treatment exists to cure it [CDC
1998d].
HBV
The rate of HBV
transmission to susceptible health care workers ranges from 6% to
30% after a single needlestick exposure to an HBV-infected patient [CDC
1997b]. However, such exposures are a risk only for health care
workers who are not immune to HBV. Health care workers who have
antibodies to HBV either from pre-exposure vaccination or prior
infection are not at risk. In addition, if a susceptible worker is
exposed to HBV, post-exposure prophylaxis with hepatitis B immune
globulin and initiation of hepatitis B vaccine is more than 90%
effective in preventing HBV infection.
Hepatitis C
Virus
Prospective
studies of health care workers exposed to Hepatitis C Virus through
a needlestick or other percutaneous injury have found that the
incidence of anti-Hepatitis C Virus seroconversion (indicating
infection) averages 1.8% (range, 0% to 7%) per injury [Alter 1997;
CDC 1998b]. Currently no vaccine exists to prevent Hepatitis C Virus
infection, and neither immunoglobulin nor antiviral therapy is
recommended as post-exposure prophylaxis [CDC 1998b]. However,
recommendations for treatment of early infections are rapidly
evolving. Health care workers with known exposure should be
monitored for seroconversion and referred for medical follow-up if
seroconversion occurs.
Summary
Although
exposure to HBV poses a high risk for infection, administration of
pre-exposure vaccination or post-exposure prophylaxis to workers can
dramatically reduce this risk. Such is not the case with Hepatitis C
Virus and HIV. Preventing the needlestick injury 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.
HOW DO
NEEDLESTICK INJURIES OCCUR?
Devices
Associated with Needlestick Injuries
Health care
workers use many types of needles and other sharp devices to provide
patient care. However, data from hospitals participating in the CDC
National Surveillance System for Hospital Health Care Workers (NaSH)
and from hospitals included in the EPINet research database show
that only a few needles and other sharp devices are associated with
the majority of injuries [International Health Care Worker Safety
Center 1997; EPINet 1999; CDC unpublished data 1999]. Of nearly
5,000 percutaneous injuries reported by hospitals participating in
NaSH between June 1995 and July 1999, 62% were associated with
hollow-bore needles—primarily hypodermic needles attached to
disposable syringes (29%) and winged-steel (butterfly-type) needles
(13%). Figure 1 shows the extent to which these and other sharp
devices contributed to the burden of percutaneous injuries in NaSH
hospitals. Data from hospitals participating in EPINet show a
similar distribution of injuries by device type [EPINet 1999].
Activities
Associated with Needlestick Injuries
Whenever a
needle or other sharp device is exposed, injuries can occur. Data
from NaSH show that approximately 38% of percutaneous injuries occur
during use and 42% occur after use and before disposal. Causes of
percutaneous injuries with hollow-bore needles are shown in Figure
2.
The
circumstances leading to a needlestick injury depend partly on the
type and design of the device used. For example, needle devices that
must be taken apart or manipulated after use (e.g., prefilled
cartridge syringes and phlebotomy needle/vacuum tube assemblies) are
an obvious hazard and have been associated with increased injury
rates [Jagger et al.1988]. In addition, needles attached to a length
of flexible tubing (e.g., winged-steel needles and needles attached
to IV tubing) are sometimes difficult to place in sharps containers
and thus present another injury hazard. Injuries involving needles
attached to IV tubing may occur when a health care worker inserts or
withdraws a needle from an IV port or tries to temporarily remove
the needlestick hazard by inserting the needle into a drip chamber,
IV port or bag, or even bedding.
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.
Past studies of
needlestick injuries have shown that 10% to 25% occurred when
recapping a used needle [Ruben et al. 1983; Krasinski et al. 1987;
McCormick and Maki 1981; McCormick et al. 1991; Yassi and McGill
1991]. Although recapping by hand has been discouraged for some time
and is prohibited under the OSHA bloodborne pathogens standard [29
CFR 1910.1030] unless no alternative exists, 5% of needlestick
injuries in NaSH hospitals are still related to this practice
(Figure 2). Injury may occur when a health care worker attempts to
transfer blood or other body fluids from a syringe to a specimen
container (such as a vacuum tube) and misses the target. Also, if
used needles or other sharps are left in the work area or are
discarded in a sharps container that is not puncture resistant, a
needlestick injury may result.
OSHA
The current
Federal standard for addressing needlestick injuries among health
care workers is the OSHA bloodborne pathogens standard [29 CFR
1910.1030; 56 Fed. Reg.†† 64004 (1991)], which has been in effect
since 1992. The standard applies to all occupational exposures to
blood or other potentially infectious materials. Notable elements of
this standard require the following:
A written
exposure control plan designed to eliminate or minimize worker
exposure to bloodborne pathogens
Compliance with
universal precautions (an infection control principle that treats
all human blood and other potentially infectious materials as
infectious)
Engineering
controls and work practices to eliminate or minimize worker exposure
Personal
protective equipment (if engineering controls and work practices do
not eliminate occupational exposures)
Prohibition
of bending, recapping, or removing contaminated needles and other
sharps unless such an act is required by a specific procedure or has
no feasible alternative
Prohibition
of shearing or breaking contaminated needles (OSHA defines
contaminated as the presence or the reasonably anticipated presence
of blood or other potentially infectious materials on an item or
surface)
Free
hepatitis B vaccinations offered to workers with occupational
exposure to bloodborne pathogens
Worker
training in appropriate engineering controls and work practices
Post-exposure evaluation and followup, including post-exposure
prophylaxis when appropriate
**Because of
recent changes and pending legislation in the area of needlestick
injury prevention, readers are urged to check with current
Federal as well
as State regulations.
††Federal
Register. See Fed. Reg. in references.
OSHA also
intends to act to reduce the number of injuries that health care
workers receive from needles and other sharp medical objects [OSHA
1999a]. First, the agency has revised the compliance directive
(guidance to be used in the field) accompanying its 1992 bloodborne
pathogens standard [29 CFR 1910.1030] to reflect newer and safer
technologies now available and to increase the employer's
responsibility to evaluate and use effective, safer technologies [OSHA
1999b]. Second, the agency has proposed a requirement in the revised
recordkeeping rule that all injuries resulting from contaminated
needles and sharps be recorded on OSHA logs used by employers to
record injuries and illnesses. Finally, OSHA will take steps to
amend its bloodborne pathogens standard by placing needlestick and
sharps injuries on its regulatory agenda.
FDA
Under the
regulations of the Food and Drug Administration (FDA) application
clearance process [FDA 1995], the manufacturers of medical devices
(including needles used in patient care) must meet requirements for
appropriate registration and for listing, labeling, and good
manufacturing practices for design and production. The process for
receiving clearance or approval to market a device requires device
manufacturers to (1) demonstrate that a new device is substantially
equivalent to a legally marketed device or (2) document the safety
and effectiveness of the new device for patient care through a more
involved premarket approval process. FDA has also released two
advisories pertaining to sharps and the risk of bloodborne pathogen
transmission in the health care setting [FDA 1992; FDA et al. 1999].
State
Regulations
Currently, three
States have adopted and more than two dozen are considering
legislation to require additional regulatory actions addressing
bloodborne pathogen exposures to health care workers. The recent
California standard [State of California 1998] has several
requirements that go beyond those currently required by OSHA. These
requirements include stronger language for the use of needleless
systems for certain procedures or (where needleless systems are not
available) the use of needles with engineered sharps injury
protection for certain procedures.
CASE REPORTS
The following
case reports briefly describe the experiences of five health care
workers who developed serious infections after occupational
exposures to bloodborne pathogens. Their cases illustrate a number
of the preventable hazardous conditions and practices that can lead
to needlestick injuries.
Case 1
A hospitalized
patient with AIDS became agitated and tried to remove the
intravenous (IV) catheters in his arm. Several hospital staff
members struggled to restrain the patient. During the struggle, an
IV infusion line was pulled, exposing the connector needle that was
inserted into the access port of the IV catheter. A nurse at the
scene recovered the connector needle at the end of the IV line and
was attempting to reinsert it when the patient kicked her arm,
pushing the needle into the hand of a second nurse. The nurse who
sustained the needlestick injury tested negative for HIV that day,
but she tested HIV positive several months later [American Health
Consultants 1992a].
Case 2
A physician was
drawing blood from a patient in an examination room of an HIV
clinic. Because the room had no sharps disposal container, she
recapped the needle using the one-handed technique. While the
physician was sorting waste materials from lab materials, the cap
fell off the phlebotomy needle, which subsequently penetrated her
right index finger. The physician's baseline HIV test was negative.
She began post-exposure prophylaxis with zidovudine but discontinued
it after 10 days because of adverse side effects. Approximately 2
weeks after the needlestick, the physician developed flu-like
symptoms consistent with HIV infection. She was found to be
seropositive for HIV when tested 3 months after the needlestick
exposure [American Health Consultants 1992b].
Case 3
After performing
phlebotomy on a patient with AIDS, a health care worker sustained a
deep needlestick injury with the used phlebotomy needle. Blood from
the collection tube also spilled into the space between the wrist
and cuff of the health care worker's gloves, contaminating her
chapped hands. The health care worker removed the gloves and washed
her hands immediately. She had a negative baseline HIV test and
refused zidovudine prophylaxis. Because her patient was not known to
have Hepatitis C Virus infection and did not have clinical evidence
of liver disease, the health care worker did not receive baseline
testing for exposure to Hepatitis C Virus. Eight months after the
incident, the health care worker was hospitalized with acute
hepatitis. She was found to be seropositive for HIV 9 months after
the incident. Sixteen months after the incident, she tested positive
for anti-Hepatitis C Virus antibodies and was diagnosed with chronic
Hepatitis C Virus infection. Her clinical condition continued to
deteriorate, and she died 28 months after the needlestick injury [Ridzon
et al. 1997].
Case 4
During
bronchoscopy to determine the cause of shortness of breath in a
patient infected with HBV, a health care worker sustained a
percutaneous injury with a 25-gauge needle while extracting tissue
from biopsy forceps. The worker did not receive post-exposure
prophylaxis with hepatitis B immune globulin or hepatitis B vaccine.
Approximately 15 weeks after the needlestick injury, the worker
noted fatigue, malaise, and jaundice. Later, he was found to have
abnormal liver enzymes and a positive test for hepatitis B surface
antigen, consistent with acute hepatitis B infection. The patient
who underwent bronchoscopy was diagnosed with Pneumocystis carinii
pneumonia and died 8 months later after he was diagnosed with
disseminated Kaposi's sarcoma and overwhelming opportunistic
infection. The injured worker had an uncomplicated medical course,
and his liver enzymes and his health eventually returned to normal.
He later tested negative for hepatitis B surface antigen and
positive for hepatitis B surface antibody, indicating recovery from
his HBV infection. On followup 15 months after the needlestick
injury, the worker also tested HIV negative; serum from the deceased
patient was not available for antibody testing [Gerberding et al
1985].
Case 5
In 1972, a nurse
sustained a needlestick injury to her finger while removing a
hypodermic needle from a patient's arm. At the time of the injury,
the source patient had apparent acute non-A, non-B hepatitis. The
nurse developed hepatitis 6 weeks after the needlestick injury. Her
liver enzymes remained elevated for nearly a year. Later examination
of serum samples from the nurse and the source patient showed that
both persons were infected with Hepatitis C Virus. The initial serum
sample from the nurse in 1972 was negative for anti-Hepatitis C
Virus antibody, but the sample obtained 6 weeks after the
needlestick injury was seropositive. Although the nurse was
clinically well at the time of the report, she remained seropositive
for Hepatitis C Virus [Seeff 1991].
USE OF
IMPROVED ENGINEERING CONTROLS IN A PREVENTION STRATEGY
Comprehensive
Programs to Prevent Needlestick Injuries
Safety and
health issues can best be addressed in the setting of a
comprehensive prevention program that considers all aspects of the
work environment and that has employee involvement as well as
management commitment. Implementing the use of improved engineering
controls is one component of such a comprehensive program. Since
many devices with needlestick prevention features are new, this
section primarily addresses their use, including desirable
characteristics, examples, and data supporting their effectiveness.
However, other prevention strategy factors that must be addressed
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. Several authors have noted the importance of a
comprehensive approach [Krasinski et al. 1987; Hanrahan and Reutter
1997; DeJoy et al. 1995; Ramos-Gomez et al. 1997; Gershon et al.
1995]. 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 [Cookson et al. 1998;
Danzig et al. 1995; Do et al. 1999; Kellerman et al. 1996]. 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.
Case Study of a
Successful Comprehensive Prevention Program
The value of a
comprehensive approach is illustrated by its success in a recent
report by Dale et al. [1998]. Between 1993 and 1996, the phlebotomy
service at a major institution decreased the needlestick injury rate
among its 200 full-time phlebotomists from 1.5 to 0.2 per 10,000
venipunctures performed. In comparison, a national survey from 1990
to 1992 found a median needlestick injury rate of about 0.94 per
10,000 venipunctures [Howanitz and Schifman 1994]. A retrospective
review of the events contributing to the success of the phlebotomy
service 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 OSHA bloodborne pathogens
standard were associated with the observed steady decline in the
injury rate. The authors noted that an important factor contributing
to this success was a thorough understanding of the injuries that
occurred among their staff.
Desirable
Characteristics of Devices with Safety Features
Improved
engineering controls are often among the most effective approaches
to reducing occupational hazards and therefore are an important
element of a needlestick prevention program. Such controls include
eliminating the unnecessary use of needles and implementing devices
with safety features. A number of sources have identified the
desirable characteristics of safety devices [OSHA 1999c; FDA 1992;
Jagger et al. 1988; Chiarello 1995; Quebbeman and Short 1995;
Pugliese 1998; Fisher 1999; ECRI 1999]. These characteristics
include the following:
The device
is needleless.
The safety
feature is an integral part of the device.
The device
preferably works passively (i.e., it requires no activation by the
user). If user activation is necessary, the safety feature can be
engaged with a single-handed technique and allows the worker's hands
to remain behind the exposed sharp.
The user
can easily tell whether the safety feature is activated.
The safety
feature cannot be deactivated and remains protective through
disposal.
The device
performs reliably.
The device
is easy to use and practical.
The device
is safe and effective for patient care.
Although each of
these characteristics is desirable, some are not feasible,
applicable or available for certain health care situations. For
example, needles will always be necessary where alternatives for
skin penetration are not available. Also, a safety feature that
requires activation by the user might be preferable to one that is
passive in some cases. Each device must be considered on its own
merit and ultimately on its ability to reduce workplace injuries.
The desirable characteristics listed here should thus serve only as
a guideline for device design and selection.
Evidence of
Effectiveness
Accumulating
evidence indicates that devices with safety features reduce
needlestick injuries:
Needleless
or protected-needle IV systems decreased needlestick injuries
related to IV connectors by 62% to 88% [Gartner 1992; Yassi et al.
1995; Lawrence et al. 1997].
Phlebotomy
injuries 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 [CDC 1997a].
Phlebotomy
injuries were reduced by 82% with a needle shield, but a recapping
device had minimal impact [Billiet et al. 1991].
Safer IV
catheters that encase the needle after use reduced needlestick
injuries related to IV insertion by 83% in three hospitals [Jagger
1996].
Other studies
also 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 [NCCC
and DVA 1997; Zafar et al. 1997]. Although the focus in this section
is on needle devices with safety features, sharps disposal
containers are also important engineering controls to consider in a
comprehensive needlestick injury prevention program. NIOSH [1998]
recently reviewed the proper location, use, and benefits of sharps
disposal containers.
As illustrated
by the examples listed here, many devices with safety features
decrease the frequency of needlestick injuries, but for many reasons
they do not completely eliminate the risk. In some cases, the safety
feature cannot be activated until after the needle is removed from
the patient. Or the needle may be inadvertently dislodged during a
procedure, thereby exposing the unprotected sharp. Some health care
workers fail to activate the safety feature, or the safety feature
may fail. With some devices, users can bypass safety features. For
example, even with some needleless IV delivery systems, a needle can
be used to connect parts of the system. Understanding the factors
that influence the safety of a device and promoting practices that
will maximize prevention effectiveness are therefore important
components in prevention planning.
CONCLUSIONS
Needlestick
injuries are an important and continuing cause of exposure to
serious and fatal diseases among health care workers. Greater
collaborative efforts by all stakeholders are needed to prevent
needlestick injuries and the tragic 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 are the elimination of
needle-bearing devices where safe and effective alternatives are
available and the development, evaluation, and use of needle devices
with safety features.
RECOMMENDATIONS
Selecting and
Evaluating Needle Devices with Safety Features
An increasing
number and variety of needle devices with safety features are now
available, but many of these devices have had only limited use in
the workplace. Thus health care organizations and workers may find
it difficult to select appropriate devices. Although these devices
are designed to enhance the safety of health care workers, they
should be evaluated to ensure that
—the safety
feature works effectively and reliably,
—the device
is acceptable to the health care worker, and
—the device
does not adversely affect patient care.
As employers
implement the use of needle devices with safety features, they can
use several guidelines to select and evaluate these products. These
guidelines are derived partly from publications and other resources
offering plans, evaluation forms, and related information in this
new area [Chiarello 1995; Fisher 1999; SEIU 1998; EPINet 1999;
Pugliese and Salahuddin 1999]. While health care settings are
implementing the use of needle devices with safety features, they
should seek help from the appropriate professional organizations,
trade groups, and manufacturers in obtaining information about
devices and procedures suitable for specific settings (e.g. dental
offices). Other information sources are listed in later sections of
the Alert (see References, Additional Information, and Suggested
Readings). In addition, OSHA received nearly 400 responses to its
recent public request for information about preventing occupational
exposure to bloodborne pathogens from percutaneous injuries [63 Fed.
Reg. 48250 (1998); OSHA 1999c]. This information includes numerous
reports about the successful implementation of needlestick injury
prevention programs, and it may be useful to medical institutions as
they establish injury tracking systems, prevention approaches, and
the use of safer devices.
The major
elements of a process for selecting and evaluating needle devices
with safety features are listed here briefly:
1.Form a
multidisciplinary team that includes workers to (1) develop,
implement, and evaluate a plan to reduce needlestick injuries in the
institution and (2) evaluate needle devices with safety features.
2.Identify
priorities based on assessments of how needlestick injuries are
occurring, patterns of device use in the institution, and local and
national data on injury and disease transmission trends. Give the
highest priority to needle devices with safety features that will
have the greatest impact on preventing occupational infection (e.g.,
hollow-bore needles used in veins and arteries).
3.When
selecting a safer device, identify its intended scope of use in the
health care facility and any special technique or design factors
that will influence its safety, efficiency, and user acceptability.
Seek published, Internet, or other sources of data on the safety and
overall performance of the device.
4.Conduct a
product evaluation, making sure that the participants represent the
scope of eventual product users. The following steps will contribute
to a successful product evaluation:
Train
health care workers in the correct use of the new device.
Establish clear criteria and measures to evaluate the device with
regard to both health care worker safety and patient care. (Safety
feature evaluation forms are available from the references cited
earlier.)
Conduct onsite followup to obtain informal feedback, identify
problems, and provide additional guidance.
5.Monitor the
use of a new device after it is implemented to determine the need
for additional training, solicit informal feedback on health care
worker experience with the device (e.g., using a suggestion box),
and identify possible adverse effects of the device on patient care.
Ongoing review
of current devices and options will be necessary. As with any
evolving technology, the process will be dynamic, and with
experience, improved devices with safety features will emerge.
Recommendations
for Employers
To protect
health care workers from needlestick injuries, employers must
provide a safe working environment that includes safer needle
devices and effective safety programs. Many types of needle devices
are associated with needlestick injuries, and these injuries can
occur in many ways. Thus a combination of prevention strategies must
be considered. Employers should take the following steps to
implement a program for reducing needlestick injuries and to involve
workers in this effort.
1.Employers
of health care workers should implement the use of improved
engineering controls to reduce needlestick injuries:
Eliminate the use of needle devices where safe and effective
alternatives are available. The most obvious example of unnecessary
needle use is the use of exposed needles to access or connect parts
of an IV delivery system. For nearly a decade, needleless IV
delivery systems and protected needles have been available to remove
or isolate this hazard. Examine information about your own
institution to identify other unnecessary needle use.
Implement the use of needle devices with safety features and
evaluate their use to determine which are most effective and
acceptable. Many devices are now available with safety features that
isolate an exposed needle after use. An evaluation approach and
references are provided in this document.
2.Needlestick
injury reduction can best be accomplished when the use of improved
engineering controls is incorporated into a comprehensive program
involving workers:
Analyze needlestick and other sharps-related injuries in your
workplace to identify hazards and injury trends. Data from injury
reporting should be compiled and assessed to identify (1) where,
how, with what devices, and when injuries are occurring and (2) the
groups of health care workers being injured.
Set
priorities and prevention strategies by examining local and national
information about risk factors for needlestick injuries and
successful intervention efforts. Procedures and devices that have
contributed to disease transmission (e.g., devices used to access a
vein or artery) should receive the highest priority
for intervention. Look to local and national resources for
information about the types of devices and work practices that have
been successful in reducing injuries.
Ensure
that health care workers are properly trained in the safe use and
disposal of needles. Health care workers and students in the health
professions should be trained to use needle devices properly and to
maximize their personal protection throughout the handling of these
devices. As safer devices are introduced, worker training is
essential to ensure proper use [Ihrig et al. 1997].
Modify
work practices that pose a needlestick injury hazard to make them
safer. Hazards that can be eliminated by modifying work practices
include injuries due to recapping, failing to dispose of a needle
device properly, passing or transferring such a device, and
transferring blood or body fluids from a device into a specimen
container. Also, specimen collection can be coordinated to reduce
the number of times needles are used on a patient, thereby reducing
both worker risk and patient discomfort. In some cases, the use of
devices with safety features will reduce or eliminate these risks.
In all cases, involving health care workers will help identify and
resolve safety issues. Employers should thus review current
procedures for reporting and addressing hazards related to needles
and other sharps.
Promote safety awareness in the work environment. Many needlestick
injuries result from unexpected circumstances such as sudden
movement by a patient or collision with a coworker or needle device.
Health care workers should be trained to be constantly alert to the
injury potential when an exposed needle or other sharp device is
being used. A number of job-related factors influence the adoption
of safety behaviors by health care workers [Dejoy et al. 1995;
Murphy et al. 1996; Gershon et al. 1995]. These workers often place
patient needs before their personal safety. They are less likely to
perform a safety measure they perceive to interfere with patient
care or to require added steps. Therefore, employers must address
both the hazards that contribute to needlestick injuries and the
institutional barriers and attitudes that affect safe work practices
[Hanrahan and Reutter 1997].
Establish procedures for and encourage the reporting and timely
followup of all needlestick and other sharps-related injuries.
Reporting of needlestick injuries is essential to (1) ensure that
all health care workers receive appropriate post-exposure medical
management and (2) provide a record for assessing needlestick
hazards in the work environment.
Evaluate the effectiveness of prevention efforts and provide
feedback on performance. Employers need to ensure that health care
workers are adopting the recommended prevention strategies and that
the changes they make have the desired effect. Thus they should
provide a forum to assess worker perceptions, evaluate compliance,
and identify problems.
Recommendations
for Workers
To protect
themselves and their coworkers, health care workers should be aware
of the hazards posed by needlestick injuries and should use safety
devices and improved work practices as follows:
1.Avoid the
use of needles where safe and effective alternatives are available.
2.Help your
employer select and evaluate devices with safety features.
3.Use devices
with safety features provided by your employer.
4.Avoid
recapping needles.
5.Plan safe
handling and disposal before beginning any procedure using needles.
6.Dispose of
used needle devices promptly in appropriate sharps disposal
containers.
7.Report all
needlestick and other sharps-related injuries promptly to ensure
that you receive appropriate followup care.
8.Tell your
employer about hazards from needles that you observe in your work
environment.
9.Participate
in bloodborne pathogen training and follow recommended infection
prevention practices, including hepatitis
B
vaccination.
ADDITIONAL
INFORMATION
For additional
information about needlestick injuries, call 1-800-35-NIOSH
(1-800-356-4674); or visit the NIOSH Web site at www.cdc.gov/niosh.
The following
Web sites provide additional information about needlestick injuries
and safer needle devices:
University
of Virginia's International Health Care Workers Safety Center and
its EPINet needlestick injury data collection system:
www.med.virginia.edu/~epinet (or call 804-982-0702)
San
Francisco General Hospital's Trauma Foundation, Training for
Development of Innovative Control Technology (TDICT) Project:
www.tdict.org (or call 415-821-8209)
OSHA Web
page: www.osha.gov; for needlestick information, www.osha-slc.gov/SLTC/
needlestick/index.html (or call the OSHA Publications Office at
202-693-1888)
CDC Web
page: www.cdc.gov; for hepatitis information, www.cdc.gov/ ncidod/diseases/hepatitis/
index.htm; for hospital infections, www.cdc.gov/ncidod/hip/
default.htm; and for HIV information, www.cdc.gov/nchstp/hiv_aids/dhap.htm
FDA medical device safety alerts: www.fda.gov/cdrh/safety.html
ACKNOWLEDGMENTS
Principal
contributors to this Alert were Thomas K. Hodous, M.D.; Linda A.
Chiarello, R.N., M.S.; Scott D. Deitchman,
M.D., M.P.H; Ann
N. Do, M.D.; Anne C. Hamilton; Janice M. Huy, M.S.; E. Lynn Jenkins,
M.A.; Andrew M. Maxfield,
Ph.D.; Edward L.
Petsonk, M.D.; Raymond C. Sinclair, Ph.D.; and Angela M. Weber, M.S.
Please direct
comments, questions, or requests for additional information to the
following:
Director,
Division of Safety Research
National
Institute for Occupational Safety
and Health
1095 Willowdale
Road
Morgantown, WV
26505
Telephone,
304-285-5894; or call
1-800-35-NIOSH
(1-800-356-4674).
We greatly
appreciate your assistance in protecting the health of U.S. workers.
Linda Rosenstock,
M.D., M.P.H.
Director,
National Institute for
Occupational
Safety and Health
Centers for
Disease Control
and Prevention
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