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.