Safer Needle Devices:
|CDC||Centers for Disease Control and Prevention|
|CSHO||Compliance Safety and Health Officer|
|FDA||Food and Drug Administration|
|HBV||Hepatitis B Virus|
|HCV||Hepatitis C Virus|
|HIV||Human Immunodeficiency Virus|
|MMWR||Morbidity and Mortality Weekly Report|
|NCID||National Center for Infectious Diseases|
|OPIM||Other potentially infectious materials|
|OSHA||Occupational Safety and Health Administration|
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:
A. Five primary activities are associated with the majority of needlestick injuries. They are:
Locations Where Percutaneous Injuries and Mucocutaneous Blood Exposures Occurred,
U.S. EPINet, 1995
63 hospitals, 3,552 total incidents
|(Source: Ippolito, 1997)|
Health Care Workers Reporting Percutaneous and Mucocutaneous Blood Exposures, by Occupation, U.S. EPINet, 1995
(63 hospitals, 3,552 total exposures)
|Reported percutaneous and mucocutaneous blood exposures|
|Housekeeper/laundry worker/central supply||180||5.1%|
|Clinical lab worker (non-phlebotomist)||143||4.0%|
|Surgery attendant/surgical technician||132||3.7%|
|(Source: Ippolito, 1997)|
Items Most Frequently Causing Sharp-Object Injuries, U.S. EPINet, 1995
63 hospitals, cases = 3,003
|(Source: Ippolito, 1997)|
Safer Needle Devices:
Health Care Workers with Documented and Possible Occupationally Acquired AIDS/HIV Infection, by Occupation, Reported through December 1998, United States(1)
(Source: CDC, HIV/AIDS Surveillance Report, 1998; vol.10 (no.2), table 17)
|Occupation||Documented occupational transmission(2)||Possible occupational transmission(3)||Total|
|Laboratory technician, clinical||16||16||32|
|Emergency medical technician/paramedic||0||12||12|
|Dental worker, including dentist||0||6||6|
|Other health care occupations||0||4||4|
Health care workers are defined as those persons,
(including students and trainees), having worked in a
health care, clinical, or HIV lab setting at any time
(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.
Health Care Workers with Occupationally Acquired AIDS/HIV Infection Cumulative Cases, 1987 through 1996
|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).
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.
A. All needlestick injuries are not preventable, but research has shown that almost 83% of injuries from hollow-bore 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.
A. The Food and Drug Administration (FDA, 1992, 1995) has suggested that a safety feature designed to protect health care workers should:
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).
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:
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:
A. OSHA's position:
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.
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. "An 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/cons/105/105_intro.htm. 1997.
FDA SAFETY ALERT:
Needlestick and Other Risks from Hypodermic Needles
on Secondary LV. Administration Sets -
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 that 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 that 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:
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,
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;
3. Jagger J.
[Letter to James S. Benson, Director, Center for Devices
and Radiological Health, Food and Drug Administration].
February 14, 1992.
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,
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