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Prepared by the Occupational Safety and Health Administration
Acknowledgment: This document was
developed by the Office of Occupational Health Nursing, with significant
contributions from Susan Elliott, ARNP, MSN, MPH, OSHA Nurse Intern, and
Digna Walker, RN, B.S.N., OSHA Nurse Intern. Contents Acronyms and
Abbreviations Purpose of this Packet Epidemiology of
Needlestick Injuries Occupational Risk of
Needlestick Injuries Definition of a Safer
Needle Device Efficacy of Safer Needle
Devices Characteristics of Safer
Needle Devices Evaluation and Selection
of Safer Needle Devices OSHA's Position on Safer
Needle Devices References Appendix A Appendix B Appendix C List of Illustrations Figure 1 - Locations
Where Percutaneous Injuries and Mucocutaneous Blood Exposures Occurred, U.S.
EPINet, 1995 Figure 2 - Items Most
Frequently Causing Sharp-Object Injuries, U.S. EPINet, 1995 Figure 3 - Health Care
Workers with Occupationally Acquired AIDS/HIV Infection, Cumulative Cases,
1987 through 1996 Table 1 - Health Care
Workers Reporting Percutaneous and Mucocutaneous Blood Exposures, by
Occupation, U.S. EPINet, 1995 Table 2 - Health care
workers with documented and possible occupationally acquired AIDS/HIV
infection, by occupation, reported through December 1998, United States
Q What
is the purpose of this packet? A The purpose of this packet is to:
Q What are some questions that
may be asked about safer needle devices and needlestick prevention programs? A Although OSHA does not review,
approve, license, or endorse products, OSHA staff may receive questions about
safer needle devices and therefore have an excellent opportunity to educate
the public about the role of these devices in preventing needlestick
injuries. Questions that may be asked include:
This guide will provide
answers to these questions. Q What
is the epidemiology of needlestick injuries? A Five primary activities are
associated with the majority of needlestick injuries. They are:
Since 1992, the
International Health Care Worker Safety Center has gathered data on
needlestick injuries from 63 cooperating hospitals around the country. The
results of the data analysis provide us with a useful picture of the pattern
of needlestick injuries leading to occupational exposure to bloodborne
pathogens.
(Source: Ippolito, 1997)
(Source: Ippolito, 1997)
(Source: Ippolito, 1997) Q How
serious is the occupational risk of needlestick injuries to health care
workers?
A One of the most critical control
components of health care worker protection against bloodborne pathogens must
be the reduction of sharps-related incidents. The statistics cited below
provide a picture of the seriousness of the problem.
Q What
occupational risk does Hepatitis B pose to the health care worker? A For more than 50 years, HBV
infection, a well-documented and recognized occupational hazard, has been and
continues to be one of the most common bloodborne pathogens among
health care workers. Studies conducted prior to implementation of
recommendations to prevent bloodborne pathogen transmission (1976-1985) show
that health care workers had a prevalence of HBV infection three to
five times higher than the general U.S. population (Moyer &
Hodgson, 1996).
Q What
occupational risk does Hepatitis C pose to the health care worker? A Hepatitis C virus infection
is a major cause of chronic liver disease in the United States and worldwide.
The virus, because of its similarity to HBV, presents an occupational
risk to persons whose work activities involve handling human blood
and body fluids (CDC, 1997).
Q What occupational risk does HIV pose for the health care worker? A HIV infection has been reported
after occupational exposures to HIV-infected blood through needlesticks
or cuts; splashes in the eyes, nose, or mouth; and skin contact.
Table 2:
2
Health care workers who had a documented HIV seroconversion after
occupational exposure or had other laboratory evidence of occupational
infection: 46 had percutaneous exposures, 5 had mucocutaneous exposures, 2
had both percutaneous and mucocutaneous exposures, and 1 had an unknown route
of exposure. Forty-nine exposures were to blood from an HIV-infected person,
1 to visibly bloody fluid, 1 to an unspecified fluid, and 3 to concentrated
virus in a laboratory. Twenty-four of these health care workers developed
AIDS. 3
Health care workers in this category have been investigated and are without
identifiable behavioral or transfusion risks; each reported percutaneous or
mucocutaneous occupational exposures to blood or body fluids, or laboratory
solutions containing HIV, but HIV seroconversion specifically resulting from
an occupational exposure was not documented. 4
Technician/therapist-other than respiratory therapists, dialysis technicians,
and surgical technicians.
Sources: Morbidity and
Mortality Weekly Report (1987-1988) and the HIV/AIDS Surveillance Report
(1992-1995), Centers for Disease Control and Prevention. Note: The CDC did not publish
statistics on occupationally acquired HIV in health care workers in the years
1989, 1990, and 1991. The CDC began publishing statistics on health care
workers with possible occupationally acquired HIV in 1992. Q Why are universal precautions
and personal protective equipment not adequate to protect the health care
worker against needlestick injuries? A Using universal precautions,
along with personal protective equipment, engineering controls and other work
practice controls, reduces employee exposure to bloodborne pathogens. Personal
protective equipment provides a barrier to protect skin and mucous membranes
from contact with blood and other potentially infectious material (OPIM), but
most personal protective equipment is easily penetrated by needles. Needlestick
injuries are caused by unsafe needle devices rather than careless use by
health care workers. (Jagger, 1988). Safer needle devices have been shown to
significantly reduce the incidence of accidental needlesticks and exposure to
potentially fatal bloodborne illnesses (CDC, 1997). Q What is a safer needle device? A A safer needle device
incorporates engineering controls to prevent needlestick injuries
before, during, or after use through built-in safety features. The term, "safer
needle device," is broad and includes many different types of
devices from those that have a protective shield over the needle to those
that do not use needles at all. The common feature of effective safer
needle devices is that they reduce the risk of needlestick injuries for
health care workers. Q Can
safer needle devices prevent needlestick injuries? A All needlestick injuries are not
preventable, but research has shown that almost 83% of injuries from
hollowbore needles can be prevented (Ippolito et al, 1997). Many of these
needlesticks can be prevented by using devices that have needles with safety
features or eliminate the use of needles altogether (e.g., needleless IV
connectors, self re-sheathing needles, and blunted surgical needles). Most current research is
hospital based and studies have indicated that a significant portion of
needlestick injuries occur when manipulating IV lines or administering IV and
IM injections (Jagger, 1988). In 1992 the FDA published a safety alert
warning of the risk of needlestick injuries from the use of hypodermic
needles as a connection between two pieces of IV equipment. This alert was
based on research that demonstrated that secondary IV tubing with connector
needles was associated with the highest risk of needlestick injury. The use
of needleless IV systems or systems with recessed needles to connect
adjoining equipment was strongly encouraged in this alert (See Appendix A). Two new studies indicate
that the use of safer needle designs can reduce the risk of needlestick
injuries among health care workers. The National Center for Infectious
Diseases (NCID) Hospital Infections Program conducted the studies in collaboration
with eight hospitals in three U.S. cities. The results appear in the January
17, 1997 issue of MMWR. (See References) The first study describes
the use of blunt suture needles during gynecologic surgery, and indicates
that blunt suture needles may reduce the likelihood of a needlestick during
surgery by as much as 86%. The second study examined the use of safer needles
for drawing blood and found that safer needles for drawing blood may reduce
needlesticks to health care workers by 27% to 76%. The investigations also
found that the use of safer needles did not lessen the quality of patient
care. Further, the safer needles were generally accepted by health care
workers. Some devices have not
been well-accepted in the clinical setting nor associated with a significant
decrease in injury rate. These results may be explained by lack of training
or lack of support for change in the clinical setting (Chiarello, 1992). Although all major
medical device manufacturers market devices with safety features, no standard
criteria exist for evaluating the safety claims of these features. Employers
implementing needlestick prevention programs should evaluate the
effectiveness of various devices in their specific settings. Q What
are the design features of a safer needle device? A The Food and Drug Administration
(FDA, 1992, 1995) has suggested that a safety feature designed to protect
health care workers should:
Features designed to
protect the health care worker should not "have a negative impact on the
delivery of patient care. As an example, there are a few reports of increased
bloodstream infections with the use of needleless IV systems"
(Chiarello, 1997). Q What are some of the types
of safety features used in safer needle devices? A The types of safety features used
in safer needle devices can be categorized according to certain aspects of
the safety feature, i.e., whether the feature is active or passive and
whether the engineering control is part of the device (Chiarello, 1995).
(See Appendix B for
examples of ways these engineering features can be designed into needle
devices.) Q How can health care employers evaluate and select safer needle
devices?
A OSHA's Bloodborne Pathogens
Standard requires that "Each employer having an employee(s) with
occupational exposure ... shall establish a written Exposure Control Plan
designed to eliminate or minimize employee exposure" [29 CFR
1910.1030(c)(1)(ii)(B)]. A variety of safer needle devices is now widely
available. Manufacturers have responded to the need for safer devices and as
a result, a wave of safer medical products have flooded the marketplace. One
thousand U.S. patents for safer medical devices have been issued since 1984
(Ippolito,1997). Employers are faced with the tremendous task of selecting
and evaluating products from the vast array of devices available. Although OSHA does not
require employers to institute the most sophisticated engineering controls,
it does require the employer to evaluate the effectiveness of existing
controls and to review the feasibility of instituting more advanced
engineering controls (CPL 2-2.44C). OSHA staff should encourage an employer
to implement a needlestick prevention program. Research to date has shown
that no single safer needle device will work equally well in every
facility so employers must develop their own programs to select the most
appropriate devices. The goal is to choose devices that are:
To evaluate and select
appropriate safer needle devices, health care employers should review
available needlestick injury data including the personnel involved, the
devices used, and the circumstances and frequency of needlestick events. This
information can assist the employer in determining how employees can
maximally benefit from a product change to safer needle devices. Although not
required by OSHA, collection and evaluation of complete needlestick injury
data by hospitals are key to identifying injury patterns and then
implementing an effective abatement plan (Chiarello, 1995). Q What are the steps a health
care employer should consider in developing a comprehensive needlestick prevention
program and implementing safer needle devices? A Chiarello (1995) describes a
framework to aid health care employers in establishing a comprehensive
program to select and evaluate safer medical devices in a systematic manner. The
product choice should ideally be based on:
Chiarello (1995) suggests
that a comprehensive needlestick prevention program might include the
following:
Q What is OSHA's position on safer needle devices? A
Q What are some resources one
can use to update their knowledge of safer needle devices, needlestick
prevention programs, and current statistics about bloodborne pathogens? A The face of the bloodborne
diseases is changing rapidly as new treatments are developed and new ways of
preventing disease are introduced. Manufacturers continue to introduce new
products with more efficient and less costly safety features. A variety of
resources are available on this subject. Appendix C contains a partial list
of helpful resources as well as the reference material that is provided on
the following pages. Q What conclusions can be
drawn from this information? A Safer needle devices can
protect employees from occupational exposure to blood and other potentially
infectious materials. When the first case of occupationally transmitted
HIV through needlestick was reported in 1984, a new awareness about the
occupational hazards faced by health care workers emerged. Employers adopted
aggressive prevention strategies in response to increased awareness of risk to
workers from HIV and other bloodborne pathogens, but the health care worker's
risk of acquiring a potentially lethal infection through needlestick injury
remains very real. Safer needle devices can protect health care workers
from exposure to life-threatening diseases by preventing needlestick
injuries. Alter, M.J.. "The
Detection, Transmission, and Outcome of Hepatitis C Virus Infection." Infectious
Agents and Disease. 2(8): 155-166, 1993. American Hospital
Association. Implementing Safer Needle Devices. December, 1992. Centers for Disease
Control and Prevention. "Recommendations for Preventing Transmission of
Human Immunodeficiency Virus and Hepatitis B Virus to Patients During
Exposure-Prone Invasive Procedures." MMWR Recommendations and
Reports. 40(RR-8): 1-9, 1991. Centers for Disease
Control and Prevention. "Evaluation of Safety Devices for Preventing
Percutaneous Injuries Among Health care Workers During Phlebotomy Procedures
- Minneapolis, St. Paul, New York City, and San Francisco, 1993-1995." MMWR.
46(2): 21-29, 1997. Centers for Disease
Control and Prevention. A Evaluation of Blunt Suture Needles in Preventing
Percutaneous Injuries Among Health Care Workers During Gynecological Surgical
Procedures - New York City, March 1993-June 1994". MMWR. 46(2):
29-33,1997. Centers for Disease
Control and Prevention. HIV/AIDS Surveillance Report. Atlanta, GA:
Division of HIV/AIDS Prevention, National Center for HIV, STD, and TB
Prevention, Centers for Disease Control and Prevention. Vol. 8. No. 2. 1996. Centers for Disease
Control and Prevention. HIV/AIDS Surveillance Report. Atlanta, Ga:
Division of HIV/AIDS Prevention, National Center for HIV, STD, and TB
Prevention, Centers for Disease Control and Prevention. 9 (1), 1997. Centers for Disease
Control and Prevention. "Recommendations for Prevention of HIV
Transmission in Health care Settings". MMWR. 35 ( 2S): 1W-18S,
1987. Centers for Disease
Control and Prevention. Draft Guideline for Infection Control in Health
Care Personnel, 1997. Washington, D. C.: GPO, 1997. Chiarello, L.A. "Selection of Safer Needle Devices: A Conceptual Framework for Approaching Product Evaluation". American Journal of Infection Control. 23( 6):386- 395, 1995. Chiarello, L.A.. Written
private communication, to Susan Elliott, September, 1997. FDA. "Needlestick
and Other Risks From Hypodermic Needles on Secondary I.V. Administration
Sets-Piggyback and Intermittent I.V." FDA Safety Alert. April 16,
1992. FDA. Supplementary
Guidance on the Content of Premarket Notification (510K) Submissions for
Medical Devices with Sharps Injury Prevention Features (Draft). Rockville,
MD: General Hospital Devices Branch, Pilot Device Evaluation Division, Office
of Device Evaluation, 1995. Hamory, B.H. "Under
Reporting of Needlestick Injuries in a University Hospital." American
Journal of Infection Control. 11(5): 174-177, 1983. Hibberd, P.L.
"Patients, Needles, and Health care Workers: Understanding the
Epidemiology, Pathophysiology, and Transmission of the Human Immunodeficiency
Virus, Hepatitis B and C, and Cytomegalovirus." Journal of
Intravenous Nursing. 18 ( 6S): S22-S31, 1995. Ippolito, G., Puro, V.,
Petrosillo, N., Pugliese, G., Wispelwey, B., Tereskerz, P. M., Bentley, M.,
& Jagger, J. Prevention, Management, and Chemoprophylaxis of
Occupational Exposure to HIV. Charlottesville, VA: Advances in Exposure
Prevention, International Health Care Worker Safety Center, 1997. Jagger, J. "Rates of
Needlestick Injury Caused by Various Devices in a University Hospital". N
England J Med. 319(5): 284-8, 1988. Jagger, J. (1990). Preventing HIV transmission in health care workers with safer needle devices. Sixth International Conference on AIDS. June 22, 1990: San Francisco, CA. Kelen, G.D., Green, G.B., Purcell, R.H., Chan, D.W., Qaqish, B.F.,
Sivertson, K.T., Quinn, T.C. "Hepatitis B and Hepatitis C in Emergency
Department Patients." N
Engl J Med.
326(21):1399-1404, 1992. Kroc, K., Pugliese, G. Implementing
safer needle devices. Chicago: American Hospital Association, December,
1992. Marcus, R., Culver, D.
H., Bell, D.M., Srivastave, P., Mendelson, M., Zalenski, R., Farber, B.,
Flinger, D. Hassett, J., Quinn, T., Schable, C.A., Sloan, E. P., Tsui, P.,
Kelen, G.D. "Risk of Human Immunodeficiency Virus Infection at Sentinel
Hospitals in the U.S". American Journal of Medicine. 94(4):
363-370, 1993. Moyer, L., Hodgson, W.
"Hepatitis B Vaccine and Healthcare Workers." Advances in
Exposure Prevention. 2 (7):1-10, 1996. National Institutes of Health. Consensus Development Statement:
Management of Hepatitis C. Available online at http://odp.od.nih.gov/consensus/statements/cons/105/105_intro.htm.
1997.
Needlestick and Other Risks from Hypodermic
Needles April 16, 1992 To Hospital
Administrators, Directors of Nursing, Risk Managers, and Infection Control
Directors: This is to alert you to
the risk of needlestick injuries from the use of hypodermic needles as a
connection between two pieces of intravenous (I.V.) equipment.1, 2, 3 The use of exposed hypodermic
needles on I.V. administration sets or the use of syringes to access I.V.
administration set ports or injection sites are unnecessary and should be
avoided. Hypodermic needles should only be used in situations where there is
a need to penetrate the skin. The terms
"piggyback" or "intermittent I.V." are commonly
associated with this equipment configuration. In these procedures, a
hypodermic needle is inserted either into a connecting "Y" site on
a primary I.V. line ("piggybacking"), or directly into the I.V.
access port ("intermittent I.V."). Research shows that I.V.
tubing-needle assemblies have a higher risk of needlestick injury than any
other needle devices; needlestick rates more than six times as high as those
from disposable syringes have been documented.2 Although the risk is low, such
needlestick injuries have the potential for transmitting bloodborne pathogens
such as HIV, hepatitis B virus, and hepatitis C virus. Additionally, health
care workers (HCWs) sustain needlesticks from exposed needles dangling from
unintentionally disconnected secondary medication sets and from needles which
protrude from disposal containers. FDA's Device Experience Network has
received at least 24 reports describing hypodermic needles which have broken
off inside I.V. administration set ports. Injuries to patients may be
incurred if these needles travel directly into the patient's bloodstream. Although FDA can not
recommend use of specific products, we strongly urge that needleless systems
or recessed needle systems replace hypodermic needles for accessing I.V.
lines. There is
no evidence that patient bloodstream infection rates have increased with the
implementation of needleless systems which have been cleared for marketing. Patient
infection rates, however, should be monitored to ensure appropriate use of
these products as well as minimize risks to patients. For recessed needle
systems, we agree with researchers who have stated that devices with the
following characteristics have the potential to reduce the risk of
needlestick injuries:
Products with these
characteristics are currently available on the market. During 1991, some of
these products were evaluated as part of a pilot study by the State of New
York. Preliminary analysis of these data from hospitals which used a safer
technology for I.V. delivery (i.e., recessed needle or needleless systems),
alone or in combination with other safety devices, showed a dramatic decline
in sharps-related injuries and reductions of up to 93 percent in I.V.-related
injuries.4 On December 6, 1991, the
Occupational Safety and Health Administration (OSHA) promulgated a final rule
which is intended to minimize or eliminate the occupational exposure to
bloodborne pathogens. In promulgating the standard, which became effective on
March 6, 1992, OSHA concluded that exposures can be minimized or eliminated
using provisions which include engineering controls (e.g., use of
self-sheathing needles), work practices (e.g., universal precautions), and
personal protective clothing and equipment. I would appreciate your
sharing this Safety Alert with those on your staff who might find it useful,
including I.V. teams, nurses, ward supervisors, employee health programs, and
product evaluation committees. If you have questions,
please contact: Thomas Arrowsmith-Lowe, DDS, MPH, Deputy Director, Office of
Health Affairs, Center for Devices and Radiological Health, FDA at
301-427-1060.
1. Jagger J. Testimony on preventable needlesticks, preventable HIV
infections, preventable deaths among health care workers. Presented before
U.S. Congress Committee on Small Business, Subcommittee on Regulation,
Business Opportunities, and Energy. Washington D.C., February 7, 1992. 2. Jagger J, Hunt EH, Brand-Elnaggar
J, Pearson RD. Rates of needlestick injury caused by various devices in a
university hospital. New Engl J Med 1988; 319:284-288. 3. Jagger J. [Letter to James S.
Benson, Director, Center for Devices and Radiological Health, Food and Drug
Administration]. February 14, 1992. 4. Chiarello L. Testimony on needlestick
prevention technology. Presented before U.S. Congress Committee on Small
Business, Subcommittee on Regulation, Business Opportunities, and Energy. Washington
D.C., February 7, 1992.
Sample Evaluation Form The attached form is a sample of a form employers may use to evaluate
safer syringes. This form was developed by: Training for Development of Innovative Control Technology (TDICT) For further information or criteria sheets for other types of devices
call: DRAFT Safety Syringes
Please circle
the most appropriate answer for each question.
Of the above questions,
which three are the most important to your safety
when using this product?
Additional Resources Additional resources to
assist employers in the areas of needlestick injury analysis, selection of
safer needle devices, and in the development of a comprehensive needlestick
prevention program are listed below. American
Hospital Association
American Nurses
Association
EPINet Program
ECRI Health
Devices Journal
Internet Websites
SEIU Guide to
Preventing Needlestick Injuries
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