INTRODUCTION OF THE NEEDLESTICK SAFETY AND PREVENTION ACT -- HON. CASS BALLENGER (Extensions of Remarks - September 18, 2000)

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HON. CASS BALLENGER OF NORTH CAROLINA IN THE HOUSE OF REPRESENTATIVES Monday, September 18, 2000

Mr. BALLENGER. Mr. Speaker, I am joined by my colleague and ranking member of the Subcommittee on Workforce Protections, the Honorable MAJOR R. OWENS, in the introduction of the Needlestick Safety and Prevention Act. This bipartisan legislation will address an important public health issue confronting our nation's health care workers.

The Needlestick Safety and Prevention Act derives from the convergence of two critical circumstances that have a profound effect on the safety of health care workers. The first circumstance is the increased concern over accidental needlestick injuries suffered by health care workers each year in health care settings. ``Needlesticks'' is a term used broadly, as health care workers can suffer injuries from a broad array of ``sharps'' used in health care settings, from needles to IV catheters to lancets. The second circumstance is the technological advancements made over the past decade in the many types of ``safer medical devices'' that can be used in health care settings to help protect health care workers against sharps injuries.

The Needlestick Safety and Prevention Act would modify the Bloodborne Pathogens Standard (29 CFR 1910.1030), one of the leading health and safety standards promulgated by the Department of Labor's Occupational Safety and Health Administration (OSHA). The legislation builds on the most recent action taken by OSHA related to the Bloodbome Pathogens Standard--the November 1999 revision of OSHA's Compliance Directive on Enforcement Procedures for the Occupational Exposure to Bloodborne Pathogens.

The concern about accidental injuries to health care workers from contaminated sharps first entered the public consciousness in the mid-1980's as concern over the AIDS epidemic grew, along with concern about the spread of hepatitis B. By the end of the decade, there were a number of documented cases of health care workers contracting the HIV virus by accidentally getting stuck with a needle when treating a patient. In 1991, responding to many of those concerns, OSHA issued the Bloodborne Pathogens Standard, which specified workplace safety requirements to protect against occupational exposure to bloodborne pathogens.

Since that time, numerous studies have demonstrated the continuing serious risk to health care workers of percutaneous injuries from contaminated sharps. In March of this year, the Centers for Disease Control and Prevention estimated that more than 380,000 percutaneous injuries from contaminated sharps occur annually among health care workers in United States hospital settings. Estimates for all health care settings are that 600,000 to 800,000 needlestick and other percutaneous injuries occur among health care workers annually. At an average hospital, workers incur approximately 30 reported needlestick injuries per 100 beds per year. While most reported needlestick injuries involve nursing staff--laboratory staff, physicians, housekeepers, and other health care workers are also injured.

At a Subcommittee on Workforce Protections hearing in June, Mr. Charles Jeffress, the Assistant Secretary of OSHA, testified about the most recent federal action to address this issue--OSHA's revised Compliance Directive on Enforcement Procedures for Occupational Exposure to Bloodborne Pathogens. While the goals of the Bloodborne Pathogens Standard are clearly stated, many aspects of the standard give employers considerable flexibility in choosing the methods most feasible for accomplishing those goals. Thus, the standard directs employers to use engineering controls and work practices to eliminate or minimize employee exposure to bloodborne pathogens, but it does not list or specify particular engineering controls (such as which medical devices) that employers must use. This approach allows the rule to take into account the continual progress of medical research and technology and the diversity of workplaces and workplace operations and processes, and allows the employer to detennine what engineering controls will provide the best protection.

A highlight of the revised Compliance Directive, and indeed one of the main reasons for its revision, is the emphasis on the need for employers to identify, evaluate, and make use of effective commercially available engineering controls, including ``safer medical devices'' to reduce or minimize the risks of occupational exposure to bloodborne pathogens. These devices are also referred to as ``safety devices'' or ``safe-needle devices,'' but their common element is that they have a built-in safety mechanism that reduces or eliminates exposure to the needle or sharp. Neither the Compliance Directive, nor the current bloodborne
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pathogens standard advocates the use of one particular device over another.

At the Subcommittee hearing, a consensus among all of the witnesses was that choosing and using a safer medical device is a complicated process for many reasons, not the least of which is that most health care settings, particularly hospitals, are enormously complex work environments. While no one type of intervention in the workplace will completely eliminate the risk of exposure, numerous studies have demonstrated that the use of safer-medical devices, when they are part of an overall bloodborne pathogens risk-reduction program, can be extremely effective in reducing accidental sharps injuries.

Witnesses also stressed the importance of including health care workers in the selection and evaluation of newer devices. This is particularly so because there are many types of safer medical devices available on the market and using them may involve some adjustment in technique on the part of the health care worker. It is also important for facilities to have some type of surveillance system, such as a sharps injury log, in place to monitor the sharps injuries. This type of system is useful both for helping a facility track its high risk areas and for evaluating which types of devices are most effective.

While the revised OSHA Compliance Directive emphasizes ``safer medical devices,'' the Bloodborne Pathogens Standard does not include safer medical devices in its examples of engineering controls. And so, this legislation would include that language in the Bloodborne Pathogens Standard.

The bill requires that the Bloodborne Pathogens Standard explicitly state that employers must document in their Exposure Control Plans the consideration and implementation of appropriate commercially available and effective engineering controls, such as safer medical devices. This legislation does not advocate the use of one particular device over another and it would not change the flexible-performance-oriented nature of the Bloodborne Pathogens Standard.

In addition, the bill would add two new sections to the Bloodborne Pathogens Standard. The first section adds a new part to the Standard's recordkeeping section, specifying that employers maintain a ``sharps injury log'' for the recording of percutaneous injuries from contaminated sharps. Through the use of this log, employers would be able to better monitor sharps injuries and by doing so, better evaluate high risk areas and the types of engineering controls and devices that are most effective in reducing or minimizing the risk of exposure. Employers may decide what information is useful and the information must be recorded in such a manner as to protect the confidentiality of the injured employee. The log would record the type of device used, an explanation of the incident and where it occurred. Employers who are exempt from maintaining OSHA 200 logs, such as employers with 10 or fewer employees, would likewise be exempt from maintaining a sharps injury log.

A second section would be added to the Bloodborne Pathogens Standard to specify that employers solicit input from frontline health care workers (non-managerial employees responsible for direct patient care) in the identification, evaluation and selection of effective engineering and work practice controls and to document that solicitation in the Exposure Control Plan.

Sixteen states have already passed some type of safe needle legislation over the past two years and many other states are considering similar legislation. These state actions result in coverage of state public health care facilities and state public employees both of which are not reached by federal OSHA, except in those states which are OSHA state plan states. I hope that our action on the federal level will encourage more states to take similar action--as it is well within their prerogatives to do--and adopt the same standards as those we are putting forward today for inclusion in the federal Bloodborne Pathogens Standard.

I also want to point out that many of the state bills that have passed and been signed into law during the past two years, beginning in California, have included a number of explicitly stated exceptions to the requirement for the use of safer medical devices. The lack of explicitly stated exceptions in this legislation may cause some concern for those upon first review. I emphasize there should be no cause for concern. The current Bloodborne Pathogens Standard, which we are revising through this legislation, does not contain explicitly stated exceptions. Therefore, all of the traditional defenses, including affirmative defenses available to an employer related to the use of engineering controls under the current Bloodborne Pathogens Standard, remain in effect even as to the use of safer medical devices. I would point out also that the requirement in this legislation for the consideration and implementation of safer medical devices is hinged upon the ``appropriateness'' and the ``commercial availability'' of such devices. Finally, while this may be stating the obvious, it is not the intent of this legislation, nor for that matter of the current Bloodborne Pathogens Standard, for employers to implement use of any engineering control, including a safer medical device, in any situation where it may jeopardize a patient's safety, an employee's safety or where it may be medically contraindicated.

Finally, I would like to commend the many groups who have worked so diligently on this issue over the past few years and worked so hard to reduce sharps injuries for health care workers. The broad consensus we have reached on this issue is due in no small part to the work of the American Nurses Association, the American Hospital Association, manufacturers and many others who represent health care workers. I especially want to thank Karen Daley, who testified at the hearing in June about her personal experience on behalf of the American Nurses Association.

More than 8 million health care workers in the United States work in hospitals and other health care settings. I urge my colleagues to support the Needlestick Safety and Prevention Act, which is designed to make their work places safer.
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