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.

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.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, 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.

Rate =	(Number of Injuries from question #3) x 200,000*
	Hours Worked **

** 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