Occupational Exposure to Bloodborne Pathogens: Request for Information

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-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