Frequently Asked Questions
- What is the Needlestick Safety and Prevention Act?
The Needlestick Safety and Prevention Act (the Act) (Pub. L. 106-430) was signed into law on November 6, 2000. Because occupational exposure to bloodborne pathogens from accidental sharps injuries in healthcare and other occupational settings continues to be a serious problem, Congress felt that a modification to OSHA's Bloodborne Pathogens Standard was appropriate (29 CFR 1910.1030) to set forth in greater detail (and make more specific) OSHA's requirement for employers to identify, evaluate, and implement safer medical devices. The Act also mandated additional requirements for maintaining a sharps injury log and for the involvement of non-managerial healthcare workers in evaluating and choosing devices.
- How does the "Needlestick Act" apply to OSHA's Bloodborne Pathogens Standard?
The Act directed OSHA to revise its Bloodborne Pathogens Standard (29 CFR 1910.1030). OSHA published the revised standard in the Federal Register on January 18, 2001; it took effect on April 18, 2001. The agency implemented a 90-day outreach and education effort for both OSHA staff and the regulated public before beginning enforcement of the new requirements. Accordingly, OSHA will not enforce the new provisions of the standard (requiring employers to maintain a sharps injury log and to involve non-managerial employees in selecting safer needle devices) until July 17, 2001. (The requirement to implement the use of engineering controls, which includes safer medical devices, has been in effect since 1992).
- How does the revision affect states that operate their own federally-approved occupational safety and health programs?
States and territories that operate their own OSHA-approved state programs must adopt the revisions to the bloodborne pathogens standard, or adopt a more stringent amendment to their existing standard, by Oct. 18, 2001. (NOTE: The original adoption date for state plan states was July 18, 2001 (or six months from the date the standard was published in the Federal Register). However, an additional three months was added which coincides with the Federal 90-day education campaign).
- Does the standard apply to public sector (State and local government) employees?
Federal OSHA standards do not apply to public sector employees, but the 24 states and two territories that operate OSHA-approved state plans are required to enforce an "at least as effective" standard in the public sector.
- Does the "Needlestick Act" apply to me?
OSHA's Bloodborne Pathogens Standard, including its 2001 revisions, applies to all employers who have employees with reasonably anticipated occupational exposure to blood or other potentially infectious materials (OPIM). These employers must implement the applicable requirements set forth in the standard. Some of the new and clarified provisions in the standard apply only to healthcare activities, but some of the provisions, particularly the requirements to update the Exposure Control Plan and to keep a sharps injury log, will apply to non-healthcare as well as healthcare activities.
- By what date do we have to implement safer medical devices?
The requirement to implement safer medical devices is not new. However, the revised standard further clarifies what is meant by "engineering controls" in the original 1991 Bloodborne Pathogens standard by adding language to the definition section of the standard that reflects the development and availability of new safer medical devices over the last decade. The 1991 standard states, "engineering and work practice controls shall be used to eliminate or minimize employee exposure." The revision defines Engineering Controls as "controls (e.g., sharps disposal containers, self-sheathing needles, safer medical devices, such as sharps with engineered sharps injury protections and needleless systems) that isolate or remove the bloodborne pathogens hazard from the workplace." Consequently, you should already have safer devices in place. If you have not already evaluated and implemented appropriate and available engineering controls, you must do so now. Also, employees with occupational exposure to blood and OPIM must be trained regarding the proper use of all engineering and work practice controls.
- What if I've never had an employee experience a needlestick, do I still need to use safer devices?
Yes. OSHA standards are intended to be implemented as a means to prevent occupational injuries and illnesses. In order to most effectively avoid percutaneous injuries from contaminated sharps, employees must use engineering controls, including safer medical devices.
- How many non-managerial employees do I need to include in the process of choosing safer medical devices?
Small medical offices may want to seek input from all employees when making their decisions. Larger facilities are not required to request input from all exposed employees; however, the employees selected should represent the range of exposure situations encountered in the workplace (e.g., pediatrics, emergency department, etc.). The solicitation of employees who have been involved in the input and evaluation process must be documented in the Exposure Control Plan.
- Does OSHA have a list of available safer medical devices?
No. OSHA does not approve or endorse any product. It is your responsibility as an employer to determine which engineering controls are appropriate for specific hazards, based on what is appropriate to the specific medical procedures being conducted, what is feasible, and what is commercially available.
- What if a safer option is not available for the medical device that I use?
A key element in choosing a safer medical device, other than its appropriateness to the procedure and effectiveness, is its availability on the market. If there is no safer option for a particular medical device used where there is exposure to blood or OPIM, you are not required to use something other than the device that is normally used. During your annual review of devices, you must inquire about new or prospective safer options and document this fact in your written Exposure Control Plan. With increasing medical technology, more devices are becoming available for different procedures. If no engineering control is available, work practice controls shall be used and, if occupational exposure still remains, personal protective equipment must also be used.
- What if the safer device that I choose is on back order?
Safety equipment must be available at all times. If for some reason an engineering control is not available (due to supply shortages, back orders, shipping delays, etc.), this must be documented in your Exposure Control Plan. You would then be responsible to implement the chosen control(s) as soon as it becomes available and adjust your exposure control plan to illustrate such. In the meantime, work practice controls must be used and, if occupational exposure still remains, personal protective equipment must also be used.
- Do I have to keep a sharps injury log? Does it have to be confidential?
If, as an employer, you are required to maintain a log of occupational injuries and illnesses under 29 CFR 1904, you must also establish and maintain a sharps injury log for recording percutaneous injuries from contaminated sharps. The Sharps Log must contain, at a minimum, information about the injury, the type and brand of device involved in the injury (if known), the department or work area where the exposure occurred, and an explanation of how the incident occurred. The log must be recorded and maintained in such a manner so as to protect the confidentiality of the injured employee (e.g., removal of personal identifiers).
- Does the revised Bloodborne Pathogens Standard apply to medical or dental offices that have fewer than 10 employees?
OSHA's Bloodborne Pathogens Standard applies to all employers with employees who have occupational exposure to blood or other potentially infectious materials (OPIM), regardless of how many workers are employed. However, workplaces with 10 or fewer employees are exempt from OSHA recordkeeping requirements and are also exempt from recording and maintaining a Sharps Injury Log. (See 29 CFR 1904 for applicability of recordkeeping requirements). All other applicable provisions of the Bloodborne Pathogens Standard still apply.
- What new information do I need to include in my written Exposure Control Plan? How often to I need to update it?
In addition to what is already required by the 1991 standard, the revised standard requires the documentation of (1) annual consideration and implementation of appropriate engineering controls, and (2) solicitation of non-managerial healthcare workers in evaluating and choosing devices. The plan must be reviewed and updated at least annually.
- Where can I get information about what is expected of me?
There are several resources available for employers and employees with regard to occupational exposures to blood and OPIM. First, of course, is the OSHA Bloodborne Pathogens Standard (29 CFR 1910.1030). Also available are "CPL 2-2.69 (November 2001). Enforcement Procedures for the Occupational Exposure to Bloodborne Pathogens, and many other related documents. You may access this information, as well as information from OSHA's Consultation and State Plan State Offices, via OSHA's website at http://www.osha.gov or by phone at 1-800-321-OSHA. The National Institute for Occupational Safety and Health (NIOSH) and the Centers for Disease Control and Prevention (CDC) also have several documents related to the prevention of occupational exposure to blood and OPIM.
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