[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