SLIDE 2: (Opening slide) Good Morning (Afternoon, Evening). Thank you for inviting me to speak to you today about safer needle devices.

Transcription

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2 SLIDE 2: (Opening slide) Good Morning (Afternoon, Evening). Thank you for inviting me to speak to you today about safer needle devices. 2

3 SLIDE 3: (Purpose) Since the Bloodborne Pathogens Standard was issued in 1992, many changes designed to protect the health care worker from occupational exposure to bloodborne pathogens have occurred in the health care workplace. We have seen many procedures changed so that exposure risks are reduced or even eliminated. The rapid evolution of technology in this area makes keeping up with current information a difficult task. The purpose of my (our) presentation today is to update your information in this area. I will talk about three different parts of this topic. First, we will review the current statistics on exposure risk and prevalence and incidence of HIV, HBV, and HCV in health care workers. Next, we will define safer needle devices and discuss their role in preventing needlestick injuries. Finally, we will examine OSHA s position on the use of safer needle devices. 3

4 SLIDE 4: (The pattern of needlestick injuries) First, let s take a look at the risk of exposure among health care workers. In order to evaluate exposure risk, we first look at the pattern that the majority of needlestick injuries follow. We ll answer the following questions: 1. Who is injured most frequently? 2. What types of devices are most commonly involved in needlestick injuries? 3. Where do most needlestick injuries occur? 4. Which tasks involve the most injuries? Many studies have been done to answer these questions. The data presented here comes from research done at the University of Virginia by Dr. Janine Jagger and the International Health Care Worker Safety Center and from research done by the CDC. 4

5 SLIDE 5: (800,000) It may surprise you to learn that there are an estimated 800,000 needlestick injuries each year in the U.S... 5

6 SLIDE 6: (Needlestick costs) This slide lists some of the costs of needlesticks. 6

7 SLIDE 7: (Question) The first question is: Which group of health care workers is injured most frequently? Research indicates that.. 7

8 SLIDE 8: (Needlestick injuries among health care workers..)...nurses are the most frequently injured in hospitals. Nurses reported almost 50% of the 3,552 exposures. The reasons for this high percentage include the larger number of nurses employed in the hospital setting as compared to other groups, the higher rate of reporting compliance, and the high proportion of nursing tasks which involve needles. Physicians rank second in number of exposures at 12.6%. Nursing assistants and housekeepers/laundry workers report 5.3% and 5.1% of the exposures respectively. The large other category in this pie chart includes students, respiratory therapists, dental workers, emergency personnel, IV teams, dialysis workers, and other others. 8

9 SLIDE 9: (Under-reporting) Based on various studies, researchers have documented that needlestick injuries are underreported by health care workers and the number of exposures could potentially be much higher (Hamory, 1983). Underreporting rates range between 40.4% and 53% for nurses, 92% for laboratory personnel, and 70% to 95% for physicians. 9

10 SLIDE 10: (Under-reporting reasons) The main reason for underreporting is a lack of time, but the perceived response of the employer and the health care worker=s concern about the HIV status of the source also influence reporting rates (Hibberd, 1995). Employers with more complete or extensive post-exposure follow-up procedures have more complete reporting of injuries (Ippolito, et al., 1997). 10

11 SLIDE 11: (Question) The second question is: What types of devices are most commonly involved in needlestick injuries? 11

12 SLIDE 12: (Hollow-bore needles) According to the research data, 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 (i.e., 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. 12

13 SLIDE 13: (Items most frequently causing) It is important to note the number of injuries caused by blood-filled vs. non-bloodfilled devices. This graph shows that the number of injuries caused by syringes is quite high. However, most of those injuries did not involve needles which were filled with blood because most of these injuries occurred during administration of some type of intramuscular or subcutaneous injection. While these injuries still carry a risk for transmission of bloodborne pathogens, the risk is not as high as with a blood-filled needle. Most of the injuries caused by blood gas syringes, IV catheter stylets, butterfly needles, and phlebotomy needles were high risk because the needles were filled with blood. 13

14 SLIDE 14: (Question) Where do most needlestick injuries occur? 14

15 SLIDE 15: (Location where puncture injuries occur) Most injuries occur, as you would probably suspect, in areas where patient care occurs. Injuries occur most frequently in patient rooms, in the operating room, the emergency room, or the critical care units. 15

16 SLIDE 16: (Question) Finally, which tasks involve the most injuries? 16

17 SLIDE 17: (The majority of needlesticks occur when) The five activities listed here are associated with the majority of needlestick injuries. When health care workers dispose of needles, administer injections, draw blood, recap needles, or handle trash and dirty linens, they are at greater risk for needlestick injuries. This may be the result of a combination of poorly designed devices and unsafe work practices. 17

18 SLIDE 18: (When do needlesticks happen?) About 20% of injuries occur before or during use. These injuries usually involve clean needles and present a lower risk to employees. Up to 70% of needlesticks occur after the needle has been used (is contaminated) and before disposal. The remaining ten percent of injuries occur during or after disposal. Three activities included in this 10 % are cleaning up after a procedure has been completed, carrying out trash, and washing dirty linens. These downstream injuries are particularly threatening to the worker because the source of the needle is generally unknown. 18

19 SLIDE 19: (Question) How serious a threat are needlestick injuries to health care workers? 19

20 SLIDE 20: (800,000) As we mentioned earlier, it is estimated that health care workers experience some 800,000 needlestick injuries each year in the United States. [American Hospital Association, 1992] 20

21 SLIDE 21: (16,000 of thesey) Two percent or approximately 16,000 of these are likely to be contaminated by HIV. 21

22 SLIDE 22: (80%) Needlestick injuries account for up to 80% of all accidental exposures to blood. 22

23 SLIDE 23: (More than 20 pathogens) 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). 23

24 SLIDE 24: (HBV and HCVY..) The risk of transmission of HBV and HCV through percutaneous injury is much higher than for HIV (CDC, 1991) for several reasons. First, Hepatitis B and C live longer than HIV once the virus is exposed to air. In fact, Hepatitis B can survive for at least a week in a drop of dried blood, while the AIDS virus will survive only 24 hours. Second, the concentration of virus in a single drop of blood is generally much higher in HCV and HBV than in HIV. Finally, the prevalence of HCV, in particular, is higher in the general population than HIV. Understanding the prevalence of these bloodborne diseases in the patient population gives a better picture of the risk health care workers face. 24

25 SLIDE 25: (Prevalence) A study done in the Johns Hopkins Hospital emergency room determined the prevalence of the HCV, HBV and HIV in blood samples from approximately 2500 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). 25

26 SLIDE 26: ( Occupational risk of HBVY) What occupational risk does Hepatitis B pose to the health care worker? For more than 50 years, HBV infection, a well-documented and recognized occupational risk for health care workers, has been and continues to be one of the most dangerous bloodborne pathogens to health care and laboratory personnel (Moyer & Hodgson, 1996). Hepatitis B is much more transmissible than HIV. Health care workers at greatest risk work in areas such as emergency rooms, clinical laboratories, operating rooms, and hemodialysis units, where they are directly exposed to blood (CDC, 1991). The chances of infection from a single contaminated needlestick is 2% to 40% (American Liver Foundation, 1995). In 1994, 1000 health care workers developed HBV infection, and each year approximately 200 health care workers die from this disease (CDC, 1997). 26

27 SLIDE 27:( Estimated incidencey) This slide shows the decline in HBV infection in the US between 1978 and Mirroring the decline in the general population, 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 to 1000 in 1994, 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). 27

28 SLIDE 28: (Occupational risk of HCV) What occupational risk does Hepatitis C pose to the health care worker? 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). Some facts about Hepatitis C: Needlestick injuries are the most common cause of occupational HCV exposure (Hibberd, 1995). In 1995, an estimated 560 to 1120 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). [continued on next page] 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 28

29 the leading reason for liver transplantation in the United States (NIH, 1997). 28

30 SLIDE 29: (Occupational risk of HIV) What occupational risk does HIV pose for the health care worker? 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 postexposure 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 1000 (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). 29

31 SLIDE 30: (HCWs with HIV/AIDS) As of December 1998, CDC had received reports of 54 documented cases and 34 possible cases of occupationally acquired HIV among health care workers in the United States. Of the 54 documented cases of occupationally acquired HIV infection, 46 were caused by needle sticks or cuts (CDC HIV/AIDS Surveillance Report, 1998). 30

32 SLIDE 31: (Graph) As shown by this graph, the total number of health care workers with occupationally acquired HIV infections is increasing each year. 31

33 SLIDE 32:(PPE alone) Personal protective equipment provides a barrier to protect skin and mucous membranes from contact with blood and other potentially infectious materials (OPIM), but most personal protective equipment is easily penetrated by needles. 32

34 SLIDE 33: (Unsafe needle devicesy) 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). 33

35 SLIDE #33: (Safer needle devices) A safer needle device uses 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 including those that have a protective shield over the needle and 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 to health care workers. 34

36 SLIDE 35: (Do safer needle devices prevent injury?) 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 which have needles with safety features or eliminate the use of needles altogether (e.g., needleless IV systems, self re-sheathing needles, blunted phlebotomy 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 regarding the use of hypodermic needles as a connection between two pieces of IV equipment. The FDA said 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. 35

37 SLIDE 36: (Current research) Two new studies indicate that the use of safer needle designs can reduce the risk of needlestick injuries among health care workers. The two studies were conducted by the CDC, in collaboration with eight hospitals across the U.S. (MMWR, 1997). The first study showed that blunt suture needles may reduce the likelihood of a needlestick during surgery by as much as 86%. The second study 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, and that the safer needles were generally accepted by health care workers. Some devices, however, have not been well-accepted in the clinical setting or have not been associated with a significant decrease in injury rate. These results may be explained by lack of training, lack of support for change in the clinical setting (Chiarello, 1992), or by inadequate design of the device. While 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 setting. 36

38 SLIDE 37: (Steps to choose products) 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 of complete needlestick injury data is key to identifying injury patterns, implementing an abatement plan (including engineering controls) and evaluating its effectiveness. Chiarello (1995) suggests that a comprehensive needlestick prevention program might include the following: Create a multi-disciplinary team. Define prevention priorities on the basis of collection and analysis of an institution s injury data. Develop design and performance criteria for product selection according to needs for patient care and health care worker safety. Plan and implement an evaluation of products in clinical settings. Analyze product performance and cost-effectiveness to choose the product. 37

39 SLIDE 38: (Blocks) The goal is to choose devices that are: Clinically effective, Acceptable to users, Most effective in reducing needlestick injuries in that particular setting, and which also serve the needs of the patients and of the primary users of the devices. 38

40 SLIDE 39: (Evaluating and selecting) Manufacturers have responded to the need for safer devices and as a result, a wave of safer medical products has 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 selection and evaluation of products among the vast array of devices available. The Bloodborne Pathogens Standard requires that each employer having an employee(s) with occupational exposure (as defined by paragraph (b) of this section) shall establish a written Exposure Control Plan designed to eliminate or minimize employee exposure. [29CFR (c)(1)(ii)(B)] While OSHA does not require employers to institute the most sophisticated engineering controls, OSHA does require the employer to evaluate the effectiveness of existing controls and to review the feasibility of instituting more advanced engineering controls (CPL C). Implementing a comprehensive needlestick prevention program may be evidence that the employer meets this requirement. 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. 39

41 SLIDE: 40: (Design features) What are the design features of a safer needle device? The Food and Drug Administration (FDA) 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. Be simple and self evident to operate and require little or no training to use effectively. Have safety mechanisms with a visual or audible cue to assure the user of activation that cannot be accidentally or intentionally disengaged or bypassed (FDA, 1992 and 1995). 40

42 SLIDE 41: (Types of safety features) What are some of the types of safety features used in safer needle devices? 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 or not 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 less desirable. 41

43 SLIDE 42: (Puzzle pieces) Some needle devices that incorporate safety features include: Needleless IV systems that eliminate the need for a needle. Recessed needles located inside a plastic housing can be used for connecting a second IV (secondary set). There is a Y- shaped connector with a rubber septum into which the recessed needle fits. These needles can also be used for giving additional IV medications into the IV line. Needle guards on syringes which are an alternative to recapping an exposed needle. Miscellaneous devices (e.g., blunted suture needles, phlebotomy needles which are blunted prior to withdrawal from the vein, retractable lancets). 42

44 SLIDE 43: (OSHA s position) Section (d)(2)(i) of the Bloodborne Pathogens Standard requires the use of engineering and work practice controls to eliminate or minimize employee exposure. CPL C states that Section (d)(2) shall be cited for failure to use engineering/work practice controls. CPL C 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. Therefore, failure to use engineering and work practice controls could result in a citation. 43

45 SLIDE 44:(Safer needle devices) Safer needle devices are effective engineering controls and a variety of these devices are widely available. Health care workers in settings where safer needle devices have not been implemented may be at higher risk of sustaining a needlestick injury. 44

46 SLIDE 45: (Conclusion) 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. However, 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. Thank you for your attention. Any questions? 45

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