Revision to OSHA's Bloodborne
Pathogens Standard
Technical Background and
Summary
April 2001
Background
The Occupational Safety and Health Administration
published the Occupational Exposure to Bloodborne Pathogens standard in
1991 because of a significant health risk associated with exposure to
viruses and other microorganisms that cause bloodborne diseases. Of
primary concern are the human immunodeficiency virus (HIV) and the
hepatitis B and hepatitis C viruses.
The standard sets forth requirements for employers with workers exposed
to blood or other potentially infectious materials. In order to reduce or
eliminate the hazards of occupational exposure, an employer must implement
an exposure control plan for the worksite with details on employee
protection measures. The plan must also describe how an employer will use
a combination of engineering and work practice controls, ensure the use of
personal protective clothing and equipment, provide training , medical
surveillance, hepatitis B vaccinations, and signs and labels, among other
provisions. Engineering controls are the primary means of eliminating or
minimizing employee exposure and include the use of safer medical devices,
such as needleless devices, shielded needle devices, and plastic capillary
tubes.
Nearly 10 years have passed since the bloodborne pathogens standard was
published. Since then, many different medical devices have been developed
to reduce the risk of needlesticks and other sharps injuries. These
devices replace sharps with non-needle devices or incorporate safety
features designed to reduce injury. Despite these advances in technology,
needlesticks and other sharps injuries continue to be of concern due to
the high frequency of their occurrence and the severity of the health
effects.
The Centers for Disease Control and Prevention estimate that healthcare
workers sustain nearly 600,000 percutaneous injuries annually involving
contaminated sharps. In response to both the continued concern over such
exposures and the technological developments which can increase employee
protection, Congress passed the Needlestick Safety and
Prevention Act directing OSHA to revise the bloodborne pathogens
standard to establish in greater detail requirements that employers
identify and make use of effective and safer medical devices. That
revision was published on Jan. 18, 2001, and became effective April 18,
2001.
Summary
The revision to OSHA's bloodborne pathogens standard
added new requirements for employers, including additions to the exposure
control plan and keeping a sharps injury log. It does not impose
new requirements for employers to protect workers from sharps injuries;
the original standard already required employers to adopt engineering and
work practice controls that would eliminate or minimize employee exposure
from hazards associated with bloodborne pathogens.
The revision does, however, specify in greater detail the engineering
controls, such as safer medical devices, which must be used to reduce or
eliminate worker exposure.
Exposure Control Plan
The revision includes new requirements
regarding the employer's Exposure Control Plan, including an annual review
and update to reflect changes in technology that eliminate or reduce
exposure to bloodborne pathogens. The employer must:
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document consideration and use of appropriate,
commercially-available, and effective safer devices (e.g., describe the
devices identified as candidates for use, the method(s) used to evaluate
those devices, and justification for the eventual
selection).
No one medical device is considered appropriate or effective for all
circumstances. Employers must select devices that, based on reasonable
judgment:
- will not jeopardize patient or employee safety or be medically
inadvisable; and
- will make an exposure incident involving a contaminated sharp less
likely to occur.
Employee Input
Employers must solicit input from
non-managerial employees responsible for direct patient care regarding the
identification, evaluation, and selection of effective engineering
controls, including safer medical devices. Employees selected should
represent the range of exposure situations encountered in the workplace,
such as those in geriatric, pediatric, or nuclear medicine, and others
involved in direct care of patients.
OSHA will check for compliance with this provision during inspections
by questioning a representative number of employees to determine if and
how their input was requested.
Documentation of employee
input
Employers are required to document, in the Exposure
Control Plan, how they received input from employees. This obligation can
be met by:
- Listing the employees involved and describing the process by which
input was requested; or
- Presenting other documentation, including references to the minutes
of meetings, copies of documents used to request employee participation,
or records of responses received from employees.
Recordkeeping
Employers who have employees who are
occupationally exposed to blood or other potentially infectious materials,
and who are required to maintain a log of occupational injuries and
illnesses under existing recordkeeping rules, must also maintain a sharps
injury log. That log will be maintained in a manner that protects the
privacy of employees. At a minimum, the log will contain the
following:
- the type and brand of device involved in the incident;
- location of the incident (e.g., department or work area); and
- description of the incident
The sharps injury log may include additional information as long as an
employee's privacy is protected. The format of the log can be determined
by the employer.
Modification of Definitions
The revision to the bloodborne
pathogens standard includes modification of definitions relating to
engineering controls. Two terms have been added to the standard, while the
description of an existing term has been amended.
Engineering Controls
Engineering
Controls include all control measures that isolate or remove a hazard from
the workplace, such as sharps disposal containers and self-sheathing
needles. The original bloodborne pathogens standard was not specific
regarding the applicability of various engineering controls (other than
the above examples) in the healthcare setting. The revision now specifies
that "safer medical devices, such as sharps with engineered sharps injury
protections and needleless systems" constitute an effective engineering
control, and must be used where feasible.
Sharps with Engineered Sharps Injury
Protections
This is a new term which includes nonneedle sharps
or needle devices containing built-in safety features that are used for
collecting fluids or administering medications or other fluids, or other
procedures involving the risk of sharps injury. This description covers a
broad array of devices, including:
- syringes with a sliding sheath that shields the attached needle
after use;
- needles that retract into a syringe after use;
- shielded or retracting catheters
- intravenous medication (IV) delivery systems that use a catheter
port with a needle housed in a protective covering.
Needleless Systems
This is a new term
defined as devices which provide an alternative to needles for various
procedures to reduce the risk of injury involving contaminated sharps.
Examples include:
- IV medication systems which administer medication or fluids through
a catheter port using non-needle connections; and
- jet injection systems which deliver liquid medication beneath the
skin or through a muscle.
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