Objectives:

Upon completion of this course the student will be familiar with the epidemiology of Needlestick Injuries, understand the occupational risks of Needlestick Injuries, understand the definition and efficacy of safer needle devices as well as how to evaluate and select safer needle devices and OSHA's Position on safer needle devices.

Acronyms and Abbreviations

Purpose of this Course

A. The purpose of this packet is to:

• Update OSHA staff's knowledge of current statistical data on exposure risk, prevalence, and incidence of human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) in health care workers.
• Provide technical assistance to OSHA staff in understanding the role of safer needle devices in preventing needlestick injuries.
• Give guidance on the process of selecting safer devices.

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:

• What are the current risks to health care workers who sustain a needlestick injury?
• What is the definition of a safer needle device?
• Why do we need safer needle devices?
• Does OSHA require us to use these devices?
• What features make a safer needle device an effective engineering control?
• How can a health care facility develop a program to implement safer needle devices?

Epidemiology of Needlestick Injuries

A. Five primary activities are associated with the majority of needlestick injuries. They are:

• Disposing of needles, including collection and disposal of materials used during patient care procedures
• Administering injections
• Drawing blood
• Recapping needles (not allowed under the Bloodborne Pathogens Standard)
• Handling trash and dirty linens (termed "downstream injuries", these usually affect the housekeeping department (Chiarello, 1992).

• Participating hospitals reported an overall rate for sharp-object injuries of 27.0 per 100 occupied beds per year.
• Most exposure incidents occurred in patient rooms (37%), the operating room (16%), the emergency department (7%) or the critical care units (6%). (Figure 1)
• Nurses report the most frequent exposures (49.7%), while physicians rank second at 12.6%. Nursing assistants and housekeeper/laundry workers account for 5.3% and 5.1% of exposures respectively. (Table 1)
• Hollow-bore needles are the cause of injury in 68.5% of cases. Hollow-bore needles (the type of needle used for giving injections or drawing blood) also are implicated as the devices most often associated with the transmission of bloodborne pathogen infections, because the blood remaining inside the bore of the needle after use contains a larger volume of virus than the relatively small amount of blood remaining on the outside of a solid core needle (e.g., a suture needle). The amount of blood the health care worker is exposed to during the exposure event is one of the risk factors assessed to determine the type of post-exposure prophylaxis needed. (Figure 2)

Figure 1 Locations Where Percutaneous Injuries and Mucocutaneous Blood Exposures Occurred, U.S. EPINet, 1995 63 hospitals, 3,552 total incidents

(Source: Ippolito, 1997)

Figure 2 Items Most Frequently Causing Sharp-Object Injuries, U.S. EPINet, 1995 63 hospitals, cases = 3,003

(Source: Ippolito, 1997)

Safer Needle Devices: Protecting Health Care Workers   Occupational Risk of Needlestick Injuries 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. Hospital-based health care workers experience some 800,000 needlestick injuries each year in the United States (Jagger,1990). About 2% or approximately 16,000 of these are likely to be contaminated by HIV (American Hospital Association, 1992). Needlestick injuries account for up to 80% of all accidental exposures to blood. (Jagger, 1988). Based on various studies, researchers have documented that needlestick injuries are under reported by health care workers and the number of exposures could potentially be much higher (Hamory, 1983). Chiarello (1992) cites several studies that found rates of under-reporting between 40.4% and 53% for nurses and 92% for laboratory personnel. Physicians under reported needlestick injuries by 70% to 95%. In well-documented studies, injuries from contaminated needles and other sharp devices used in the health care setting have been associated with transmission of bloodborne pathogens to health care workers. In fact, more than 20 pathogens have been transmitted through sharps or needlestick injuries (Chiarello, 1992). Of these, HIV, HBV and HCV pose the greatest risk to the health care worker (Ippolito et al., 1997). The risk of transmission of HBV and HCV through percutaneous injury is much higher than for HIV (CDC, 1991). Understanding the prevalence of these bloodborne diseases in the patient population gives a better picture of the risk health care workers face: A study of the Johns Hopkins Hospital emergency room determined the prevalence of the HCV, HBV and HIV in blood samples from 2523 patients. Of those patients: 18% were seropositive for HCV 5% were seropositive for HBV 6% were seropositive for HIV (Kalen et al, 1997). An estimated 1.25 million people in the U.S. are chronically infected with HBV and 6,000 die each year as a result of HBV-related liver disease (Moyer & Hodgson, 1996). In 1989, the CDC studied the prevalence of HIV in three inner-city hospitals and three suburban hospitals. In the three inner-city hospitals, seroprevalence of HIV ranged from 4.1 to 8.9 per 100 patients. The suburban hospitals' seroprevalence rates ranged from 0.2 to 6.1 per 100 patients. (Marcus et al., 1989) In 1997, the National Institutes of Health estimated that nearly 4 million people in the U.S. are infected with Hepatitis C (NIH, 1997). Of these, 85% develop chronic HCV infection and the potential for transmission of HCV to others (CDC, 1997). Occupational Risk of Hepatitis B 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). Hepatitis B is much more transmissible than HIV. Health care workers at greatest risk work in areas where they are directly exposed to blood ( in emergency rooms, clinical laboratories, operating rooms, hemodialysis units, etc.) (CDC, 1991). The risk of a health care worker contracting HBV from needlestick injuries ranges from 6% to 30% (CDC, 1991). In 1994, 1000 health care workers developed HBV infection, and each year 100 to 200 health care workers die from this disease (CDC, 1997). The Centers for Disease Control and Prevention (CDC) estimates that the annual number of new HBV infections in health care workers has steadily declined from 12,000 in 1985, due in part to the widespread adoption of universal precautions, vaccination against hepatitis B, and the implementation of OSHA's Bloodborne Pathogens Standard. (Moyer & Hodgson, 1996). Occupational Risk of Hepatitis C 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). Needlestick injuries are the most common cause of occupational HCV exposure (Hibberd, 1995). In 1995, an estimated 560 to 1,120 cases of HCV infection occurred among health care workers who were occupationally exposed to blood (Alter, 1993). No vaccine is available for hepatitis C and no effective post-exposure prophylaxis is known at this time (CDC, 1997). Screening tests for hepatitis C antibodies are commercially available, but interpretation of the results, especially in a post-exposure situation, is limited by several factors. A positive result does not distinguish between acute, chronic, or past infection, and a negative result does not indicate the absence of acute infection, only the absence of antibodies to HCV. False positives are common in populations with a low prevalence of HCV. The tests do not detect HCV antibodies in approximately 5% of people (CDC, 1997). As many as 85% of all HCV-infected persons develop chronic infection. Persons with chronic hepatitis are at increased risk for cirrhosis and primary hepatocellular carcinoma. Hepatitis C is now the leading reason for liver transplantation in the United States. (NIH, 1997). Occupational Risk of HIV 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. Exposures from needlesticks or cuts cause most infections. The average risk of HIV infection after a needlestick exposure to HIV-infected blood is 0.3% or 1 in 300. Even though the risk of seroconversion after needlestick is relatively rare, injured health care workers may suffer disabling physical side effects from post-exposure anti-viral medication as well as severe emotional trauma as they await their test results (CDC, 1991). The risk after exposure of the eye, nose, or mouth to HIV-infected blood is estimated to be, on the average, 0.1% or 1 in 1,000 (CDC, 1987). The risk after exposure of the skin to HIV-infected blood is estimated to be less then 0.1%. The risk may be higher if the skin is broken or if the contact involves a large area of skin or is prolonged (CDC, 1987). As of December 1998, CDC had received reports of 54 documented cases and 134 "possible" cases (i.e., documentation was unclear) of occupationally acquired HIV among health care workers in the United States. Of the 54 documented cases of occupationally acquired HIV infection, 46 resulted from needle sticks or cuts (CDC HIV/AIDS Surveillance Report, 1998) (Table 2). The total number of occupationally acquired HIV infections in health care workers is increasing each year (Figure 3).   Table 2 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 Nurse 22 33 55 Laboratory technician, clinical 16 16 32 Physician, nonsurgical 6 12 18 Health aide/attendant 1 14 15 Housekeeper/maintenance worker 1 12 13 Emergency medical technician/paramedic 0 12 12 Technician/therapist4 0 10 10 Dental worker, including dentist 0 6 6 Physician, surgical 0 6 6 Technician/dialysis 1 3 4 Technician/surgical 2 2 4 Embalmer/morgue technician 1 2 3 Technician/laboratory, nonclinical 3 0 3 Respiratory Therapist 1 2 3 Other health care occupations 0 4 4 TOTAL: 54 134 188 (1) 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 since 1978. (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.   Figure 3 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). Definition of a Safer Needle Device 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. Safer Needle Devices: Protecting Health Care Workers Efficacy of Safer Needle Devices 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 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. Characteristics of Safer Needle Devices 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: Provide a barrier between the hands and the needle after use; The safety feature should allow or require the worker's hands to remain behind the needle at all times; Be an integral part of the device and not an accessory; Be in effect before disassembly and remain in effect after disposal to protect downstream workers; and Be simple and self evident to operate and require little or no training to use effectively. 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). Passive safety features remain in effect before, during and after use; health care workers do not have to activate them. Passive features enhance the safety design and are more likely to have a greater impact on prevention. Active devices require the health care worker to activate the safety mechanism. Failure to do so leaves the worker unprotected. Proper use by health care workers is the primary factor in the effectiveness of these devices. An integrated safety design means that the safety feature is built in as an integral part of the device and cannot be removed. This design feature is preferred. An accessory safety device is a safety feature that is external to the device and must be carried to or temporarily or permanently fixed to the point of use. This design also is dependent on employee compliance and according to some researchers, is not desirable. (See Appendix B for examples of ways these engineering features can be designed into needle devices.) Evaluation and Selection of Safer 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: Clinically effective, Acceptable to users, and Most effective in reducing needlestick injuries in that particular setting (Chiarello, 1995). 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: The needs of the primary users. The need of the patients who must continue to receive safe, efficient, and comfortable care. Health care workers are likely to reject products that they think will interfere with patient care in any way. Chiarello (1995) suggests that a comprehensive needlestick prevention program might include the following: Creating of a multi-disciplinary team. Defining prevention priorities on the basis of collection and analysis of an institution's injury data. Developing design and performance criteria for product selection according to needs for patient care and health care worker safety. Planning and implementing an evaluation of products in clinical settings. Analyzing product performance and cost-effectiveness to choose the product. OSHA's Position on Safer Needle Devices Q. What is OSHA's position on safer needle devices? A. OSHA's position: Section (d)(2)(i) of the Bloodborne Pathogen Standard requires the use of engineering and work practice controls to eliminate or minimize employee exposure. CPL-2.44C states that "Section (d)(2) shall be cited for failure to use engineering/work practice controls." CPL 2-2.44C also states that: "Most preferable is the use of devices which offer an alternative to needles being used to perform the procedure. Examples of such devices include stopcocks (on-off switch), needle-protected systems or needleless systems which can be used in place of open needles to connect intravenous lines. Other devices which are integral to the syringe, such as self-sheathing needles, allow both hands to remain behind the needle and require very little manipulation to isolate the needle safely." In addition, "While employers do not automatically have to institute the most sophisticated engineering controls ( e.g., needleless IV connectors, self-sheathing needles), it is the employer's responsibility to evaluate the effectiveness of existing controls and to review the feasibility of instituting more advanced engineering controls." Health care workers in settings where safer needle devices have not been implemented may be at higher risk of sustaining a needlestick injury. Therefore, failure to use engineering and work practice controls could result in a citation. 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.   References 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. "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. Appendix A: FDA Safety Alert FDA SAFETY ALERT: Needlestick and Other Risks from Hypodermic Needles on Secondary LV. Administration Sets - Piggyback and Intermittent I.V. 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:   A fixed safety feature to provide a barrier between the hands and the needle after use; the safety feature should allow or require the worker's hands to remain behind the needle at all times. The safety feature as an integral part of the device, and not an accessory. The safety feature in effect before disassembly and remaining in effect after disposal, to protect users and trash handlers, and for environmental safety. The safety feature as simple as possible, and requiring little or no training to use effectively. 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. FDA is interested in information concerning the role of medical devices in the transmission of bloodborne pathogens including HIV. We encourage you to report potential hazards for patients and/or health care professionals to the Product Problem Reporting Program at 1-800-638-6725. 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. Sincerely yours, James S. Benson Director Center for Devices and Radiological Health 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. Appendix B: 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) Trauma Foundation Building 1, Room 300 San Francisco General Hospital 1001 Potrero Avenue San Francisco, CA 94110 For further information or criteria sheets for other types of devices call: (415) 431-4336   DRAFT Safety Syringes Safety Feature Evaluation Form Date:__________ Department:___________________ Occupation:________________ Product evaluating:______________________________ Number of times used:________   Please circle the most appropriate answer for each question. Not applicable (N/A) may be used if the question does not apply to this product.     DURING USE: agree..............disagree 1. The safety feature can be activated using a one-handed technique 1 2 3 4 5 N/A 2. The safety feature does not interfere with normal use of this product 1 2 3 4 5 N/A 3. Use of this product requires you to use the safety feature 1 2 3 4 5 N/A 4. This product does not require more time to use than a non-safety device 1 2 3 4 5 N/A 5. The safety feature works well with a wide variety of hand sizes 1 2 3 4 5 N/A AFTER USE:   6. There is a clear and unmistakable change (either audible or visible) that occurs when the safety feature is activated 1 2 3 4 5 N/A 7. The safety feature operates reliably 1 2 3 4 5 N/A 8. The exposed sharp is blunted or covered after use and prior to disposal 1 2 3 4 5 N/A TRAINING:   9. The product does not need extensive training to be operated correctly 1 2 3 4 5 N/A   Of the above questions, which three are the most important to your safety when using this product? Are there other questions which you feel should be asked regarding the safety/utility of this product?   © Training for Development of Innovative Control Technology Project June Fisher, M.D. August 1992 Appendix C: 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   Call 1-800-AHA-2626 to order copies of "Implementing Safer Needle Devices" (Item No. 196310). The AHA published this report in December, 1992. EPINet Program   EPINet includes manuals and software, data collection tools, and tracking and reporting systems for surveillance of bloodborne exposures, tracking device specific injuries, and evaluating the efficacy of safer needle devices. To order: Call EPINet Program 1-800-528-9803. ECRI Health Devices Journal   ECRI's Health Devices journal features a comprehensive evaluation on safer needle devices. To order: Call ECRI circulation department at 215-825-6000. SEIU Guide to Preventing Needlestick Injuries   Developed by Service Employees International Union (SEIU) this 36 page booklet includes a listing of safer needle devices, checklist for compliance with OSHA's bloodborne pathogen standard, safe device feature evaluation checklist, and guide for post-needlestick exposure follow-up. Produced in October 1998, it is available for $5.00 (must be prepaid) by sending a check with your name and mailing address to: SEIU Mailroom, 1313 L Street, NW, Washington, DC 20005. Only single copies are available at this time. This document was provided by the Occupational Safety & Health Administration (OSHA). MEDCEU Continuing Education Courses CEU for Nurses and Healthcare Professional  Home Page