[Federal Register Volume 63, Number 174 (Wednesday, September 9, 1998)]
[Notices]
[Pages 48250-48252]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-24124]
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DEPARTMENT OF LABOR
Occupational Safety and Health Administration
[Docket No. H370A]
Occupational Exposure to Bloodborne Pathogens: Request for
Information
AGENCY: Occupational Safety and Health Administration (OSHA),
Department of Labor.
ACTION: Request for information.
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SUMMARY: OSHA requests information and comment on engineering and work
practice controls used to eliminate or minimize the risk of exposure to
bloodborne pathogens due to percutaneous injuries from contaminated
needles and other contaminated sharps in occupational environments.
Percutaneous injuries continue to be a concern in work settings where
employees are exposed to bloodborne pathogens. The Agency is
considering possible actions that it can undertake to assist in
addressing this issue. Consequently, OSHA is interested in strategies
for reducing percutaneous injury rates that have been successfully
implemented in the work environment, including work practices and, in
particular, the use of devices designed to limit the risk of such
injuries. The information received in response to this notice will be
carefully reviewed and will assist OSHA in determining effective
approaches to reducing percutaneous injury rates and what role the
Agency may have in these approaches.
DATES: Comments should be postmarked on or before December 8, 1998.
ADDRESSES: Comments should be submitted in quadruplicate or one
original (hardcopy) and one diskette (5\1/4\ or 3\1/2\ inch) in
WordPerfect 5.0, 5.1, 6.0, 6.1, 7.0, 8.0, or ASCII to the Docket
Officer, Docket No. H370A, Room N-2625, U.S. Department of Labor, 200
Constitution Avenue, NW, Washington, DC 20210. Telephone: (202) 219-
7894. Comments of 10 pages or fewer may be transmitted by fax to (202)
219-5046, provided the original and three copies are sent to the Docket
Office thereafter.
Comments may also be submitted electronically through OSHA's
Internet site at URL, http://www.osha-slc.gov/html/needle-form.html.
Please be aware that information such as studies, journal articles, and
so forth cannot be attached to the electronic response and must be
submitted in quadruplicate to the above address. Such attachments must
clearly identify the respondent's electronic submission by name, date
and subject, so that they can be attached to the correct response.
FOR FURTHER INFORMATION CONTACT: Bonnie Friedman, Director, OSHA Office
of Public Affairs, Room N-3647, U.S. Department of Labor, 200
Constitution Avenue, NW, Washington, DC 20210. Telephone: (202) 219-
8148.
SUPPLEMENTARY INFORMATION:
I. Background
Needlesticks and other sharps injuries are a recognized means of
transmitting infectious bloodborne diseases. Bloodborne pathogens shown
to be transmitted through percutaneous injuries include hepatitis B
virus (HBV), human immunodeficiency virus (HIV), and hepatitis C virus
(HCV). In recognition of the threat to the health of workers posed by
HBV, HIV, and other bloodborne pathogens, OSHA promulgated the
Bloodborne Pathogens standard (29 CFR 1910.1030) on December 6, 1991.
The Agency is interested in the progress in efforts to prevent
needlesticks and other percutaneous injuries in the years following
promulgation of the Bloodborne Pathogens standard and in assessing the
status of approaches to percutaneous injury prevention. Such approaches
include use of safer medical devices and safer work practices as well
as integrated percutaneous injury prevention programs. In using the
term ``safer medical device,'' the Agency is referring to the wide
variety of implements designed to reduce the risk of needlesticks and
other percutaneous injuries through such measures as substitution (as
in the use of a blunt cannula with a prepierced septum for intravenous
administration of medication), modification of the device to reduce the
hazard (as with a blunt suture needle), or incorporation of safety
features (as with a retractable-needle syringe). In addition, OSHA is
interested in integrated percutaneous injury prevention programs that
have been successfully implemented in the workplace. These programs may
include use of safer medical devices, safer work practices, elimination
of needles and other sharps in certain instances and procedures,
focused intervention in high injury areas, specialized training, and
other elements.
Hepatitis B infection in health care workers has been estimated to
have declined following promulgation of the Bloodborne Pathogens
standard, from 5,000 new cases in 1991 to 800 new cases in 1995
(Exhibit 1-5). The HBV infection incidence rate for health care workers
is now lower than the incidence rate for the general U.S. population
(Exhibit 1-4). However, needlesticks and other percutaneous injuries
continue to be of occupational health concern due to the frequency of
their occurrence and the severity of the health effects that can be
associated with them. In the occupational environment, percutaneous
injuries have been estimated to occur approximately 600,000 times
annually (Exhibit 1-2).
HBV has long been recognized as a pathogen capable of causing
serious illness and death. Approximately 60-70% of acute HBV infections
are asymptomatic; the remaining cases result in symptoms and signs
which may include jaundice, fatigue, abdominal pain, loss of appetite,
[[Page 48251]]
nausea, and vomiting. Severe acute infections may require
hospitalization, and can result in death. Most HBV infections result in
complete recovery and immunity from future infection; in 5-10% of adult
cases, however, inability to clear the virus from liver cells results
in chronic HBV infection. Chronic HBV infection has been linked to
increased risk of cirrhosis and liver cancer; approximately 15%-25% of
chronically infected persons are expected to die prematurely from these
causes.
In 1981, the first cases were reported in the United States of what
was to become known as Acquired Immunodeficiency Syndrome (AIDS); AIDS
is caused by HIV. By killing or impairing cells of the immune system,
HIV progressively destroys the body's ability to fight infections and
certain cancers. Two to four weeks after exposure to the virus, up to
70 percent of HIV-infected persons suffer flu-like signs and symptoms,
which may include fever, headache, malaise and enlarged lymph nodes.
These signs and symptoms usually disappear within a week to a month.
More persistent or severe signs and symptoms may not surface for a
decade or more after HIV first enters the body. During the asymptomatic
period, however, HIV is actively infecting and killing cells of the
immune system, and the virus is transmissible to others through sexual
contact with an infected person, percutaneous injury with infected
blood or other infectious materials, injection of infected blood
(transfusions, IV drug abuse), exposure to infected blood or other
infectious materials through mucous membranes or non-intact skin, and
perinatal exposure. As the immune system deteriorates, a variety of
complications begin to surface. Enlarged lymph nodes, fatigue, and
fever may again be evident; weight loss, persistent skin rashes, and
short-term memory loss have also been associated with HIV infection.
The term AIDS applies to the most advanced stages of HIV infection.
Opportunistic infections common in people with AIDS can cause coughing,
shortness of breath, seizures, dementia, severe and persistent
diarrhea, vision loss, severe headaches, extreme fatigue, nausea,
vomiting, lack of coordination, coma, abdominal cramps, and difficult
or painful swallowing. People with AIDS are particularly prone to
developing various cancers such as Kaposi's sarcoma or lymphomas.
Persons who become acutely infected with the Hepatitis C virus
(HCV) may develop illness evidenced by jaundice, fatigue, abdominal
pain, loss of appetite, nausea, and vomiting. Nearly all acute
infections are persistent; chronic liver disease develops in about 67%
of those who become infected, placing these individuals at increased
risk of developing cirrhosis and liver cancer.
In the U.S., between one and 1.25 million persons are estimated to
suffer from chronic HBV infection (Exhibits 1-6, 1-10, 1-11); 650,000
to 900,000 individuals are estimated to be infected with HIV (Exhibit
1-3), and nearly four million persons are estimated to be chronically
infected with HCV (Exhibits 1-8, 1-12, 1-13). Percutaneous injury
resulting in exposure to blood or certain other body fluids from any of
these individuals places health care workers at risk of contracting
disease. In addition to the risk of disease transmission, workers may
suffer from the side effects of drugs used for post-exposure
prophylaxis and from psychological stress due to the threat of
infection after an exposure occurs.
By this notice, OSHA solicits public input on approaches to
percutaneous injury prevention. In order to assist the Agency in
evaluating the issue of prevention of percutaneous injuries and
possible actions that could promote implementation of prevention
strategies, OSHA encourages responses to include any pertinent data
that could be helpful in performing this evaluation, including
information on systems used for the collection and assessment of data
on needlestick and other percutaneous injuries; intervention measures,
including specific types of safer medical devices and safer work
practices currently in use and the effect these devices and work
practices have had on injury rates; and the costs and savings
associated with particular approaches. The Agency's actions are
independent of the current activities in California relative to this
issue. Further information on California's deliberations can be
obtained by contacting the OSHA-approved State Plan Agency: California
Department of Industrial Relations, Division of Occupational Safety and
Health, at (415) 972-8500.
Executive Order 12866 and the President's memorandum of June 1,
1998, require each agency to write in plain language. For the purpose
of improving future requests for information, we invite your comments
on how successful this notice is in meeting this goal. For example:
--Is the material organized to suit your needs?
--Is the Agency's intent and meaning of the questions understood?
--Would a different format (grouping and order of sections, use of
headings, paragraphs) have made the notice easier to understand?
--Would more (but shorter) questions be better?
--Does the request for information contain technical language or jargon
that isn't clear?
--Could something have been done to make the request for information
easier to understand?
If you are submitting your comments via the electronic form,
responses to the above questions can be placed in the box labeled
``Additional Comments or Questions.''
II. Key Issues on which Comment is Requested
OSHA includes these questions to provide a basis for response to
this general request for information. However, commentors are
encouraged to address any aspect of percutaneous injury prevention
strategies that they feel is pertinent to the issue.
1. What is the type, size, and employment of your facility or work
setting? OSHA solicits information on the type and size of your
facility or work setting (e.g., 200-bed tertiary care hospital, 10-bed
nursing home), the total number of employees, how many of these
employees have the potential to sustain a needlestick or other
percutaneous injury during performance of their job duties and, if
possible, the job classification(s) of these employees.
2. Does your facility have a surveillance system to track
needlesticks and other percutaneous injuries? If yes, please state if
your system includes tracking of needlesticks and other percutaneous
injuries other than those that must be recorded on the OSHA 200 log.
OSHA solicits information on systems being used to track needlesticks
and other percutaneous injuries, if and how the gathered information is
used, and any factors affecting the successful implementation of such
systems.
3. What is the total number of potentially contaminated
needlesticks and other percutaneous injuries that have occurred in your
facility in the past year and in previous years? OSHA solicits
information on how many of these needlesticks and other percutaneous
injuries were recordable on the OSHA 200 log and how many were non-
recordable.
4. What is the rate of injuries from potentially contaminated
needles and other sharps in your workplace in the past year and in
previous years? If possible, please express your response in terms of
Injuries per 100 Workers according to the following formula:
* Base for 100 equivalent full-time workers, working 40 hours per
week, 50 weeks per year.
[[Page 48252]]
[GRAPHIC] [TIFF OMITTED] TN09SE98.004
** Includes hours worked by all full time, part time, or temporary
workers covered by your bloodborne pathogens exposure control plan.
OSHA seeks information and comment on needlestick and other
percutaneous injury rates and/or patterns associated with particular
employee groups, work locations, procedures, or devices.
5. What methods and criteria are used in your workplace to evaluate
the effectiveness of existing exposure controls? If a system is used in
your workplace for periodic review of the feasibility of instituting
more effective engineering controls, please describe the system
including the type of information obtained, how this information is
applied, and how the appropriate individuals in your workplace become
aware of the availability of new controls.
6. Has any type of integrated percutaneous injury prevention
program, as discussed above, been established in your workplace to
reduce the incidence of needlesticks and other percutaneous injuries?
If yes, OSHA solicits information and comment on the structure and
content of this program (e.g., safer work practices, safer medical
devices, training), the results achieved, and any specific problems
and/or successes that have been encountered in the implementation and
operation of the program.
7. To what extent have devices designed to reduce the incidence of
needlesticks and other percutaneous injuries been adopted in your
workplace? Please provide any workplace- or industry-specific data you
have available indicating the degree to which devices incorporating
safety features have replaced standard devices, with specific
information on the types (e.g., needleless IV connector, blunt suture
needle) and brand or description of devices used; where such devices
are used (i.e., specific locations, procedures, or employee groups);
and any historical data indicating the rate at which your workplace has
implemented safer medical devices over the years.
8. On what basis are decisions made in your workplace concerning
selection of safer medical devices? OSHA solicits information and
comment on design and/or performance criteria being used to select
safer medical devices and the basis for using the particular criteria;
if and how percutaneous injury data are used in making selection
decisions; if and how the opinions of the primary users of needles and
other sharps are considered in selection decisions; how costs are
considered in the selection process; and any other factors that
influence selection decisions.
9. Have new safer medical devices been readily accepted and
correctly used when provided? OSHA seeks information and comment on
factors influencing successful implementation of safer medical devices
in the workplace.
10. What provisions are made to ensure adequate training and
education in the use of safer medical devices and/or safer work
practices in your workplace? OSHA solicits information and comment on
the effectiveness of training and education in reducing needlesticks
and other percutaneous injuries, both relative to and in conjunction
with the implementation of safer medical devices and/or safer work
practices. Specific information is desired regarding program elements,
successful and/or unsuccessful measures undertaken, and the method(s)
by which results were measured.
11. How effective are safer medical devices and/or safer work
practices in reducing percutaneous injury rates? OSHA seeks information
and comment on the efficacy of safer medical devices and/or safer work
practices in reducing injuries from needles and other sharps, including
any data available that will aid in quantifying these results in total
and/or for specific employee groups, work locations, procedures,
devices or work practices; and the method(s) by which these data were
obtained. OSHA is particularly interested in data regarding the
percutaneous injury rates prior to implementing the device(s) and/or
work practice(s), steps used in selecting and implementing the
device(s) and/or work practice(s) in the work setting, and the
percutaneous injury rates after implementation.
12. Has use of safer medical devices and/or safer work practices in
any way affected the delivery of patient care? If yes, please describe
the effects and any data quantifying these effects.
13. Based on observations in your workplace and your knowledge from
other sources, please describe any obstacles that may be encountered
relative to the selection, purchase, and effective implementation of
currently available and new safer medical devices in the workplace,
along with any specific information and comment you can provide
detailing successful and/or unsuccessful methods of overcoming these
obstacles.
14. OSHA solicits information on the costs associated with the
implementation of safer medical devices and any savings resulting from
their use. Please provide specific information on the methods used to
calculate these costs and savings.
15. Please describe any problems associated with sharps disposal
containers in your workplace, as well as successful and/or unsuccessful
measures that have been undertaken to correct these problems.
16. Based on experience in your workplace and your knowledge from
other sources, what are the most effective means of preventing
needlesticks and other percutaneous injuries? Please explain the basis
for your opinion on this matter and provide any supporting evidence.
Authority and Signature
This document was prepared under the direction of Charles N.
Jeffress, Assistant Secretary for Occupational Safety and Health, U.S.
Department of Labor, 200 Constitution Avenue, NW, Washington, DC 20210.
It is issued pursuant to section 6(b) of the Occupational Safety and
Health Act of 1970 (84 Stat. 1593: 29 U.S.C. 655).
Signed at Washington, DC, this 3rd day of September 1998.
Charles N. Jeffress,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 98-24124 Filed 9-8-98; 8:45 am]
BILLING CODE 4510-26-P