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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.
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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).
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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).
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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).
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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.
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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.
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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 2-2.44D (November 1999), 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.