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Expanded federal standards aim to better protect health-care workers from blood-borne pathogens transmitted by needlesticks, but they also pose potential problems for a pediatric practice.
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Expanded federal standards aim to better protect health-care workers from blood-borne pathogens transmitted by needlesticks, but they also pose potential problems for pediatric practice. Here's what you need to know.
In 1992, the Occupational Safety and Health Administration (OSHA) mandated nationwide implementation of its universal precautions standard to prevent the transmission of blood-borne pathogens. The standard required each health-care employer to safeguard employees by developing and implementing an exposure control plan, offering hepatitis B vaccine, keeping meticulous records, and making available safety equipmentincluding gowns, gloves, and face shieldsthat would reduce exposure to blood-borne diseases.1
In November 2000, Congress unanimously passed the Needlestick Safety and Prevention Act, which directed OSHA to revise the universal precautions standard to direct health-care employers to maintain a sharps injury log and, with employee input, to consider and introduce into practice safer medical devices, including safer needle devices. OSHA revised its standard to reflect these mandates in April 2001 and began to enforce the new provisions in July 2001 (see "Preventing transmission of blood-borne pathogens: The new OSHA standard").2 This article describes the new standard and discusses the latest information on how to protect yourself and your employees from needlesticks and resulting exposures to disease.
Infectious diseases that can be transmitted by needlestick accidents include not only hepatitis B virus (HBV) and human immunodeficiency virus (HIV) infection, but hepatitis A and C, malaria, cytomegalovirus infection, Rocky Mountain spotted fever, toxoplasmosis, syphilis, Epstein-Barr virus infection, and tuberculosis.3 Physicians and nurses who care for infants and children perform a variety of procedures that may result in needlestick injuries. In pediatricians' offices, emergency departments, and hospital wards, parenteral medications and vaccinations are administered to children with disposable syringes, phlebotomy is performed with butterfly needles or vacuum tube systems, and intravenous catheters are inserted to provide a route for administration of fluids and drugs. Lancet devices are often used to obtain fingerstick or heelstick samples of blood from infants and children.
Young patients are typically uncooperative when subjected to these procedures and may squirm or flinch when stuck with a needle. For this reason, pediatricians and office nurses may be at greater risk of needlestick injuries than their colleagues in adult medicine.
In 1983, the Centers for Disease Control and Prevention (CDC) recommended that health-care workers use "blood and body fluid precautions" with patients who had known or suspected infections believed to be transmitted by blood contamination.4 Hepatitis B was (and still is) the most commonly acquired occupational disease among health-care workers. The precautions were adopted because it was recognized that HBV could be transmitted from patient to medical personnel by exposure of nonintact skin or mucous membranes to the patient's blood or by needlestick injury, the most likely mechanism of exposure.
In the mid-1980s, the AIDS epidemic caused the CDC to re-examine its blood and body fluid precautions. It was increasingly apparent that HIV could be transmitted by needlestick injury, and that, as was often the case with HBV, patients capable of transmitting HIV could not always be identified by history and physical examination. In 1987, the CDC recommended that health- care workers implement universal precautionsthat is, use blood and body fluid precautions with all patients, regardless of what disease they had or whether their infectivity was known. This policy was later endorsed by OSHA as a way to protect against occupational exposure to HIV.1
Universal precautions apply not just to blood, but also to other body fluids containing visible blood and to semen, vaginal secretions, cerebral spinal fluid, synovial fluid, pleural fluid, peritoneal fluid, pericardial fluid, wound exudates, and amniotic fluid. Universal precautions do not apply to feces, nasal secretions, sputum, sweat, tears, urine, and vomitus, unless they contain visible blood. In recent years, the emergency medical services community has taken universal precautions one step farther, implementing body substance isolation (BSI) to prevent contact with blood, body fluids, and any body substance capable of transmitting disease, such as feces and nasal secretions.
Both universal precautions and BSI involve using appropriate barriers (gloves, gowns, eye shields), frequent hand washing, and extreme care when using and disposing of needles. Needles should not be recapped by hand, removed from used disposable syringes by hand, or manipulated by hand. Used sharps should be placed in puncture-resistant containers located close to the area of use. Hands and exposed skin surfaces should be immediately and thoroughly washed following contamination with blood or other body fluids to which universal precautions apply.
Using gloves reduces the incidence of blood contamination during phlebotomy but does not prevent needlestick injury. Gloves should always be available to health-care workers who want to use them, and their use is recommended when:
It is estimated that some 5.6 million health-care workers routinely handle medical sharps. Information from the CDC, based largely on surveys from hospitals participating in the CDC National Surveillance System for Hospital Health Care Workers (NaSH), suggests that 600,000 to 800,000 percutaneous exposures occur each year, but, fortunately, only 2% of these episodes actually result in transmission of blood-borne pathogens.5 The CDC estimates that using safer medical devices could prevent from 62% to 88% of sharps injuries in hospitals.6 A health-care worker's risk of infection following a needlestick injury depends on many factors, including the severity of exposure, the worker's immune status, the pathogen involved, and the availability of postexposure prophylaxis.
The rate of HBV transmission to susceptible health-care workers ranges from 6% to 30%. Even among susceptible persons, postexposure prophylaxis (PEP) is more than 90% effective in preventing HBV infection.7
Hepatitis C seroconversion occurs at an average rate of 1.8% per injury. No hepatitis C vaccine is available, and postexposure prophylaxis with immunoglobulin and antivirals is not recommended for exposure to hepatitis Cinfected blood.8
Occupational transmission of HIV is thought to be extremely lowthe average risk of transmission as a result of an injury being three in 1,000.9 PEP has been shown to be effective.
It should also be noted that there is no federal or state requirement to report needlestick injuries to local health authorities. If the health-care worker contracts an illness as a result of the incident, however, that disease is reportable.
NaSH data indicate that approximately 62% of the estimated 384,000 needlestick injuries that occur in US hospitals each year are associated with hollow-bore needles (such as those used to administer vaccines), butterfly needles or phlebotomy needles, and IV needles. Half the injuries occur between completing the procedure and disposing of the device, and 20% are associated with disposal.
Injuries are often related to the design of the device, which is most hazardous if it requires disassembly. Such devices include IV tubing and needle assemblies, vacuum tube needle assemblies, and IV catheter stylet systems. Disposable syringe needles are less hazardous, but because they are used so often, they still account for the majority of reported needlestick injuries. The CDC estimates that using safer needle devices would prevent approximately 69,000 needlestick injuries each year in our nation's hospitals.
In addition to risks inherent in the devices themselves, needlestick injuries are associated with certain health-care behaviors such as recapping needles, transferring body fluids between containers, and attempting to dispose of used needles in puncture-resistant sharps containers. NaSH statistics reveal that 26% of needlesticks in hospitals occur during use of the needle; these injuries are not preventable with currently available technology other than needle-free injection systems.
Surveys of hospitals conducted by OSHA before updating its standard in 2001 indicated that, as a result of the initial 1992 mandate, more than 80% of hospitals had already adopted safer devices for IV line access, about 30% for IV line insertion, and 40% for phlebotomy. Fewer than 20% had adopted safer devices for intramuscular (IM) or subcutaneous injections, however. With the implementation of the 2001 revised standard, OSHA recommends that employers and employees evaluate new "safety devices" and acknowledge in the evaluation process that many available devices may have advantages as well as disadvantages compared to the new devices.2
Ideally, the safest device is one that has no needle, integrates safety features into the structure of the device (as opposed to add-on features such as needle sheaths), requires no user activation, and, if it does require activation, can be actuated with a single-hand technique that allows the worker's hands to remain behind the sharp. Additional desirable features enable the user to tell if the safety device is activated, do not permit it to become deactivated, and allow safe and effective patient care despite the safety feature.2
Equipment manufacturers have responded to the need for safer devices with a number of simple yet effective designs. Many heelstick and fingerstick devices incorporate an automated mechanism that hides the lancet point before and after use (Figure 1). It is likely that the majority of pediatric practices already have adopted safety lancets. Such devices are inexpensive, costing 10 to 25 cents each.
Several companies make syringes with a retraction mechanism that enables the user to draw vaccine or IM drugs into the syringe, administer the injection, and then retract the needle into the barrel of the syringe by depressing the plunger against a collar at the base of the syringe (Figure 2). They usually cost 50 cents per syringe, five times as much as a typical disposable syringe. Other safe syringes incorporate a sheathing mechanism that requires the user to push a locking barrel over the needle (Figure 3) or flip a cover over the needle (Figure 4). Such syringes cost about 10 cents more than standard disposable syringes.
Bioject Corporation manufactures a needle-free injection system, the Biojector, that can give either subcutaneous or IM injections. The device uses disposable carbon dioxide cartridges and disposable ampules filled with either vaccine or medication. After prepping the patient's skin with an alcohol wipe, the person giving the injection presses the Biojector against the skin and pushes a button to initiate the jet injection. The injection is accompanied by a loud popping sound and leaves a puncture about one third the size of the puncture made by a needle syringe. The unit costs about $700; each disposable ampule costs 85 cents.
Vacuum phlebotomy systems are particularly hazardous because the needle, the only part of the assembly that requires disposal, is typically unscrewed from a reusable holder before discard. Several devices are now available to make these systems safer (Figure 5). PUNCTUR-GUARD, manufactured by Bioplexus, features an internal blunting mechanism that is activated before the needle is withdrawn from the vein. The blunted phlebotomy needle cannot puncture skin and can be safely removed from the holder with a gloved hand. Bioplexus also markets an inexpensive, easy-to-use system for phlebotomy that includes a PUNCTUR-GUARD needle attached to a PUNCTUR-GUARD Revolution quick-release safety needle holder. A twist of the needle holder activates the blunting mechanism, and a push of a button then releases the needle for disposal in a needle bin.
Butterfly needles, often used for sampling blood from infants and children, are useful devices but pose a tremendous hazard to both patient and phlebotomist because an exposed needle dangles free on long, flexible tubing after use. Several companies now manufacture butterfly systems that incorporate a needle sheath that is advanced over the needle when phlebotomy is completed.
Many injuries result from using piggyback IV setups in which needles are introduced and removed from needle ports in IV tubing. Safety devices incorporate valve systems that allow drug administration, pump infusions, and fluid aspiration through the IV tubing without using a needle. Becton Dickinson's Interlink access system replaces needles with a plastic cannula that provides an interface with an injection cap, allowing either intermittent or continuous access to IV tubing.
Many experienced pediatric nurses will tell you that inserting an IV catheter in a small infant or child requires skill and luck. These devices are dangerous because, during catheter insertion, the sharp stylet is removed from the catheter and can inflict injury while the IV tubing is attached to the catheter hub. The Protectiv IV catheter system from Ethicon Endo-Surgery allows the stylet to be withdrawn into a protective plastic chamber, rendering it harmless, as the catheter is advanced into the lumen of a vein. Nurses must learn a slightly different technique to use the device effectively, but most tell me it is easy to operate. A newer version employs an internal blunting mechanism.
Because every health-care workplace is unique, OSHA recommends that each practice or health-care institution convene a team of employers and employees to develop, implement, and evaluate a plan to reduce needlestick injuries and assess needle devices with safety features. The team must document that it has thoroughly evaluated new devices and their applicability to the workplace and put in place a plan to introduce safer devices into practice if the team concludes a new device is indicated.
OSHA acknowledges that cost considerations may figure prominently in this decision. As previously noted, for example, a syringe with a retractable needle costs five times as much as a standard syringe. A syringe with a needle-protecting sheath may cost twice as much as a syringe that does not provide this protection.
In September 2001, the American Academy of Pediatrics (AAP) requested that OSHA ease the new standards for immunization injections. The request points out that no currently available safety syringe will necessarily prevent needlesticks when a child flinches or struggles during vaccine administration. Even safety syringes with retractable needles activate the retraction mechanism after the injection has been given. The AAP, fearing that the OSHA requirement would add $14 million a year to the cost of immunizing infants during the first year of life, has asked OSHA to consider five alternatives:
In December 2001, the AAP received a letter from Richard E. Fairfax, Director, Directorate of Compliance Programs at OSHA, summarily denying all the proposed alternatives. (The letter is posted in its entirety at www.aap.org .) Of note is the response to the second alternative, which includes the following:
"Nonmanagerial employees responsible for direct patient care must have input in employer decisions about which engineering controls to adopt, not whether or not to adopt them. The standard does not give the employer the option to forgo appropriate, commercially available and effective engineering controls. If the employer determines through device evaluation that no available devices are appropriate for a specific procedure, that decision must be documented in the Exposure Control Plan. . . ."
". . . Please keep in mind that the Blood-borne Pathogen Standard and several other new OSHA standards are written in performance-oriented language, giving the employer the opportunity to implement the controls which best suit the safety of his or her employees. . . ."
In response to the denials, Joe Sanders, MD, executive director of the AAP, wrote a letter on January 10, 2002 (also posted on the AAP Web site) to the Assistant Secretary of Labor for Occupational Safety and Health, requesting reconsideration of the academy's requests and suggesting that a legislative solution may be necessary to resolve the issue. (See "Are those safety devices mandatory?".)
The OSHA standards require employers to offer voluntary hepatitis B vaccination to any employee at risk of occupational exposure. They also require that employers prescribe appropriate medical evaluation, treatment, and counseling following an exposureall at no cost to the employee. All types of needlestick injuries, including those involving clean needles, should be treated with appropriate wound care (see "Ouch! What do you do after a needlestick?").
Tables 1 and 2 outline recommendations for postexposure evaluation and treatment of health workers exposed to blood from patients with hepatitis B or who are positive for HIV. PEP with hepatitis B immune globulin and hepatitis B vaccine should be considered for occupational exposures to HBV after evaluating the hepatitis B surface antigen status of the source and the vaccination and vaccine-response status of the exposed person.
|Vaccination and antibody response status of exposed worker*||Treatment|
|Source is HBsAG||Source is HBsAG negative||Source is unknown or not available for testing|
|Unvaccinated||HBIG||Initiate HB vaccine series||Initiate HB vaccine series|
|Previously vaccinated||No treatment||No treatment||No treatment|
Known responder (adequate levels of serum antibody to HBsAG: anti-HBs 10 mIU/mL)
Known nonresponder (inadequate response to vaccination: serum anti-HBs <10 mIU/mL)
|HBIG x 1 and initiate revaccination or HBIG x 2 (the option of giving 1 dose of HBIG and reinitiating the vaccine series is preferred for nonresponders who have not completed a second 3-dose vaccine series; for persons who previously completed a second vaccine series but failed to respond, 2 doses of HBIG are preferred)||If known high-risk source, treat as if source were HBsAGpositive|
|Antibody response unknown||Test exposed person for antiHBs||No treatment||Test exposed person for antiHBs If adequate, no treatment is necessary|
|Exposure type||Infection status of source|
|HIVpositive Class 1*||HIVpositive Class 2*||HIV status unknown||Unknown source||HIVnegative|
|Less severe (e.g., solid needle or superficial injury)||Recommend basic two-drug postexposure prophylaxis (PEP)||Recommend expanded three-drug PEP||Generally, no PEP warranted; however, consider basic two-drug PEP** for source with HIV risk factors||Generally, no PEP warranted; however, consider basic two-drug PEP** in settings where exposure to HIVinfected persons is likely||No PEP warranted|
|More severe (e.g., large-bore, hollow needle; deep puncture, visible blood on device; needle used in patients artery or vein)||Recommend expanded three-drug PEP||Recommend expanded three-drug PEP||Generally, no PEP warranted; however, consider basic two-drug PEP** for source with HIV risk factors||Generally, no PEP warranted; however, consider basic two-drug PEP** in settings where exposure to HIVinfected persons is likelyNo PEP warranted||No PEP warranted|
Recommendations for HIV PEP include a basic four-week, two-drug regimen of zidovudine (ZDV) and lamivudine (3TC); 3TC and stavudine (d4T); or didanosine (ddI) and d4T for most HIV exposures. An expanded regimen that includes the addition of a third drug is recommended for HIV exposures that pose an increased risk of transmission. Unfortunately, patients receiving PEP for HIV exposure often experience nausea and diarrhea and may experience toxic effects, including hematuria and hemolytic anemia, from the drugs.
Immune globulin and antiviral agents are not recommended for PEP of persons exposed to hepatitis C virus. The HCV status of the source and the exposed person determine management. For health-care workers exposed to an HCVpositive source, follow-up HCV testing should be performed to determine if infection develops.
1. US Department of Labor, Occupational Safety and Health Administration: Occupational exposure to blood-borne pathogens; needlesticks and other sharps injuries (29 CFR, Part 1910). Federal Register 1991;56:64004
2. US Department of Labor, Occupational Safety and Health Administration: Occupational exposure to blood-borne pathogens; needlesticks and other sharps injuries (29 CFR, Part 1910). Federal Register 2001;66:5318
3. Collins CH, Kennedy DA: Microbiological hazards of occupational needlestick and "sharps" injuries. J Appl Bacteriol 1987;62:385
4. Garner JS, Simmons BP: Guidelines for isolation precautions in hospitals. Infect Control 1983;4 (suppl):245
5. International Health Care Worker Safety Center: Uniform needlestick and sharp-object injury report 1996, 65 hospitals. Advances in Exposure Prevention 1997; 3(2):15
6. Centers for Disease Control and Prevention: Evaluation of safety devices for preventing percutaneous injuries among health-care workers during phlebotomy procedures 19931995. MMWR Morb Mortal Wkly Rep 1997;46:21
7. Centers for Disease Control and Prevention: Immunization of health-care workers: Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the Hospital Infection Control Practices Advisory Committee (HICPAC). MMWR Morb Mortal Wkly Rep 1997;46:1
8. Centers for Disease Control and Prevention: Recommendations for prevention and control of hepatitis C virus (HCV) infection and HCVrelated chronic disease. MMWR Morb Mortal Wkly Rep 1998; 47(RR19):1
9. Centers for Disease Control and Prevention: Public Health Service guidelines for the management of health-care worker exposures to HIV and recommendations for postexposture prophylaxis. MMWR Morb Mortal Wkly Rep 1998;47(RR7):1
The OSHA standard for universal precautions against transmission of blood-borne pathogens, published in 1992, required medical facilities with 10 or more employees to:
In addition to these requirements, the 2001 revised standard:
When I contacted OSHA to clarify whether incorporating safer sharps into pediatric office practice is "mandatory" to demonstrate compliance with the 2001 revised OSHA standard to prevent transmission of blood-borne pathogens, a couple of points became clear. First, and most important, no clinical data are available concerning the number and nature of needlestick injuries that occur in office-based pediatric practice. Projections from hospital-derived statistics may or may not apply to the pediatric office. As noted elsewhere in this article, hospital data indicate that 26% of injuries involving needles occur during use and would not be prevented by using safer devices. It is reasonable to assume that, given the nature of pediatric practice, a higher percentage of needlestick injuries in the pediatric office occur during use of the needle, before a safety feature can be activatedwhen a child flinches, for examplethan occur after use, when safety devices prevent injury.
Second, OSHA officials indicate that if a pediatric practice documents that the evaluating team believes that safety devices will not prevent needlestick injuries, then the office does not have to introduce safety devices. The evaluating team must re-evaluate the situation as new devices become available, however. OSHA officials also wish to remind physicians that safety devices prevent injuries that occur after use or during the disposal process.
Any needlestick injury that occurs in a health-care environment requires wound care, an occupational exposure report, and determination of the need for postexposure prophylaxis (PEP) and follow-up.
Wound care. This consists of simply cleaning the wound with soap and water.
Occupational exposure report. According to the new OSHA requirements, a log must be kept of the incident. It should include:
PEP. The need for PEP is determined by:
Testing procedures to help determine the need for PEP are as follows:
Tables 1 and 2 outline recommended PEP for HBV and HIV exposures.
Follow-up. Perform follow-up testing and provide counseling. Advise exposed persons to seek medical evaluation for any acute illness that occurs during follow-up.
For persons exposed to HBV who receive hepatitis B vaccine, perform follow-up testing for hepatitis B antibodies one to two months after the last dose of vaccine. Hepatitis B antibody response to vaccine cannot be ascertained if the patient has received hepatitis B immune globulin in the previous three or four months.
For persons exposed to HCV, perform baseline and follow-up testing for hepatitis C antibodies and alanine aminotransferase four to six months after the exposure. If an earlier diagnosis of HCV is desired, perform hepatitis C RNA testing at four to six weeks after the exposure. Confirm repeatedly reactive hepatitis C antibody enzyme immunoassays with supplemental tests.
For HIV exposure, perform HIV antibody testing for at least six months postexposure (at baseline, six weeks, three months, and six months, for example) and if illness compatible with an acute retroviral syndrome occurs. Advise exposed persons to use precautions to prevent secondary transmission during the follow-up period. Evaluate exposed persons taking PEP within 72 hours after exposure, and monitor for drug toxicity for at least two weeks.
An excellent resource for postexposure questions is the National Clinicians' Postexposure Prophylaxis Hotline (PEPline), which is run by the University of California, San Francisco and the staff of San Francisco General Hospital and supported by the Health Resources and Services Administration Ryan White CARE Act, HIV/AIDS Bureau, AIDS Education and Training Centers, and the Centers for Disease Control and Prevention. Phone: 888-448-4911; Internet: www.ucsf.edu/hivcntr .
Source: Health Service guidelines for the management of occupational exposures to HBV, HCV, and HIV and recommendations for postexposure prophylaxis. MMWR Morbid Mortal Wkly Rep 2001;50(RR-11):1
Lancet devices, Tenderfoot, and Tenderlett
International Technidyne Corp. (ITC)
8 Olsen Ave.
Edison, NJ 08820
Elite Safety Syringe
Medi-Hut Co., Inc.
1935 Swarthmore Ave.
Lakewood, NJ 08701
NMT Safety Syringe
New Medical Technology, Inc.
1500 W. Oak St., Suite 200
P.O. Box 317
Zionsville, IN 46077
Safety 1st Safety Syringe
Safety 1st Medical, Inc.
30100 Town Center Dr.
Laguna Niguel, CA 92677
Futura Safety Syringe
Futura Medical Corp.
380 Stevens Ave., Suite 212
Solana Beach, CA 92075
Vanish Point Syringe
Retractable Technologies, Inc.
622 South Mill St.
Lewisville, TX 75057
Shielded syringes, needle shielding devices,
winged butterfly needles, Interlink access system
One Becton Dr.
Franklin Lakes, NJ 07417
Jet injection system
7620 SW Bridgeport Rd.
Portland, OR 97224
Blunted vacuum tube needles and collection systems
129 Reservoir Rd.
Vernon, CT 06066
Safety IV catheters
Ethicon Endo-Surgery Div.
Johnson & Johnson Medical, Inc.
4545 Creed Rd.
Cincinnati, OH 45242
Tel. 800-USE-ENDO (800-873-3636)
Safeguarding yourself and your employees against needlestick injury
Andrew Schuman. Update: Preventing needlesticks and their nasty consequences.