LEGISLATION; HEALTH (GENERAL); AIDS;

AIDS;

Federal laws/regulations; Connecticut laws/regulations;

You asked for information on state and federal law on needle safety.

SUMMARY

As best as we can determine, 21 states have passed some sort of safe needle legislation. These laws range from merely an advisory or study commission to a detailed regulatory process. New Jersey appears to have the strongest law in the opinion of some observers. Roughly eight states (Alaska, Georgia, Massachusetts, New Jersey, New York, Ohio, Tennessee, and West Virginia) have written exceptions or waivers in their law that exclude the use of safe devices under certain conditions such as market availability and patient safety.

A federal law passed in 2000 directed the Occupational Health and Safety Administration (OHSA) to revise and strengthen its existing bloodborne pathogens rule concerning use of safe medical devices to eliminate or minimize occupational exposure to bloodborne pathogens through needlesticks and other exposure.

FEDERAL LAW

The federal Occupational and Health Safety Administration (OHSA) estimates that 5. 6 million workers in the health care industry and related occupations are at risk of occupational exposure to bloodborne pathogens, including human immunodeficiency virus (HIV), hepatitis B and C virus, and others. A National Institute for Occupational Safety and Health (NIOSH) alert in 1999 estimated that 600,000 to 800,000 needlestick injuries and other percutaneuous injuries occur annually among health care workers. The Centers for Disease Control (CDC) estimates that between 62 to 88% of sharps injuries can potentially be prevented by the use of safer medical devices.

The federal ”Needlestick Safety and Prevention Act of 2000”(PL 106-430) revised the Bloodborne Pathogens Standard (29 CFR Sec. 1910. 1030), a regulation in effect under the federal Occupational Safety and Health Act of 1970. This new law directed OHSA to revise and strengthen its existing bloodborne pathogens rule to require hospitals and other health care facilities to identify, evaluate, and implement the use of safer medical devices designed to eliminate or minimize occupational exposure to bloodborne pathogens through needlestick and other injuries. This act also mandated additional requirements for maintaining a sharps injury log and for the involvement of non-managerial health care workers in evaluating and choosing devices.

States that operate their own OSHA-approved state programs must adopt the revisions to the bloodborne pathogens standard or adopt a more stringent amendment to the existing standard. Federal OSHA standards do not apply to public sector employees, but the states that operate OSHA-approved state plans are required to enforce an “at least as effective” standard in the public sector.

The revision was published by OHSA in January 2001, and Congress mandated that it be implemented on April 18, 2001.

STATE LAWS

As best as we can determine, 21 states have passed some sort of needle safety legislation. Following is a summary of those states’ laws, based on a survey undertaken by the International Healthcare Worker Safety Center at the University of Virginia. (We have not summarized Connecticut’s law. )

California

California was the first state to pass needle safety legislation (AB 1208, 1998). It mandates that the state’s bloodborne pathogens standard (California has its own OHSA plan) be revised to require the use of safety devices. This revision took effect in July 1999.

Alaska

Alaska’s law was enacted in June 2000 (SB 261). Alaska has a state OSHA plan, and the law requires the Labor Department to revise the state’s bloodborne pathogens standard to mandate that needleless systems and sharps with engineered sharps injury protection (ESIP) be included as work practice controls. The law has an exemption for patient safety. It also requires that a sharps injury log be kept with detailed information on exposure incidents.

Arkansas

Arkansas’ law (HB 1356) was passed in 2001. It speeds up the process of implementing safer devices that OHSA’s revised standard requires. The law notes that since “considerable time” will elapse before the revised standard is fully implemented, hospitals should begin purchasing needleless systems or sharps injury protections or both for use in high risk areas with the goal of ensuring that within 18 months after the bill’s effective date all high risk areas shall be supplied exclusively with safer devices. “High risk areas” are defined as emergency departments, operating rooms, and intensive care units in acute care hospitals.

Georgia

Georgia’s law (HB 1448) took effect in 2000 and requires the state’s Human Resources Department to adopt a bloodborne pathogens standard to cover public employees that is “at least as prescriptive” as the federal OHSA. The standard includes a requirement that the most effective available needleless systems and sharps with ESIP be included as engineering and work practice controls in all facilities employing public employees.

Exceptions are included for lack of market availability and risk to patient safety.

Iowa

Iowa’s law took effect in 2000 (SB 2302). It requires the state Health Department, in cooperation with the Labor Commission, to study state and federal laws concerning protection of persons who may be at risk of needlestick injuries in their employment.

Maine

Maine’s law (HB 1532) was passed in 2000. It requires the state Labor Department to adopt the federal OHSA’s revised compliance directive for bloodborne pathogens as a state rule governing public sector workplaces. (Maine has a federal OSHA plan, and federal OHSA does not cover public sector employees. ) The law also requires the Labor and the Human Services departments to conduct a survey of public and private health care providers to determine if they are using safe needle devices and how they plan to comply with the federal directive.

Maryland

Maryland’s law (HB 360; 2000) required that federal OHSA’s revised compliance directive for bloodborne pathogens standard be adopted as state regulation (Maryland has a state OHSA plan).

Massachusetts

Massachusetts passed a law in 2000 (HB 5794) that requires ‘the use, at all acute and non-acute hospitals of only such devices which minimize the risk of injury to health care workers from needlesticks and sharps. ” It also states “sharps injury prevention technology shall be included as engineering or work practice controls. ” The law includes an exception for “circumstances in which the technology does not promote employee or patient safety or interferes with a medical procedure. ”

Minnesota

Minnesota’s law (SB 1202; 2000) calls for exposure control plans to be reviewed at least annually and whenever necessary to reflect changes in technology that eliminates or reduce exposure to bloodborne pathogens. The law includes a three-year compliance period for manufacturers of prefilled syringes.

Missouri

Missouri’s law (SB 266; 2001) covers state and municipal health care facilities, which are not subject to federal OHSA standards. It requires the Health Department to adopt a bloodborne pathogens standard equivalent to OHSA’s for “occupational exposures of public employees to blood or infectious materials. ” It also provides that a requirement must be included that the most effective needleless systems be used in certain circumstances. The law also subjects any public employer violating these provisions to a loss or reduction of state funding.

New Hampshire

New Hampshire passed a law (HB 1244) in 2000 that requires the labor commissioner, in conjunction with the health commissioner, to adopt rules to protect health care workers in the public sector from occupational exposure to blood.

New Jersey

New Jersey’s 2000 law (A 3546) requires that within 12 months of its passage health care facilities use “only needles and other sharp devices with integrated safety features…cleared and approved…by the Food and Drug Administration…and commercially available for distribution. The law allows 36 months for manufacturers of prefilled syringes to comply; it also provides a waiver procedure allowing health care workers to use conventional (non-safety) devices if it can be shown that using a safety device would have a “negative impact” on patient safety or “the success of a specified medical procedure. ”

New York

New York law (A 7144; 2000) requires use of safer sharps and needles by health care facilities and in all health care settings. It directs the health commissioner to adopt regulations that prohibit the use of sharps that do not incorporate ESIP. The law includes exceptions to using safety devices for lack of market availability, risk to patient safety or effectiveness of a medical procedure, and lack of evidence showing that a safety device is more effective than a conventional device.

Ohio

Ohio’s law (SB 183; 2000) requires state and other public health care facilities to include, as part of the employer’s engineering and work practice controls, needleless systems, sharps with ESIP, and other devices that comply with OHSA’s bloodborne pathogens standard. The law provides exceptions to adoption of safer devices for market availability and patient safety reasons and allows five years for manufacturers of prefilled syringes to comply.

Oklahoma

Oklahoma requires that a needlestick injury prevention committee submit proposed rules for preventing needlestick injuries and implementing devices with ESIP. These rules must also requires that sharps prevention technology be included as engineering or work practice controls in high exposure areas.

Pennsylvania

Pennsylvania’s law (HB 454; 2001) requires the state Health Department to establish a bloodborne pathogens standard to cover public employees, with the same requirements as those for private sector employees. “Public employee” means an employee of the state or political subdivision employed in a health care facility, home health care organization, or other facility providing health-related services. The law includes a three-year exemption for prefilled syringes.

Rhode Island

Rhode Island has passed two laws (H 5906 and H 6311; both 2001). The laws are almost identical to that of the federal OHSA’s revised bloodborne pathogens standard. The purpose of the legislation appears to be to extend the standard to state and local employees.

Tennessee

Tennessee’s law (SB 1023; 1999) covers the public and private sectors. It calls for the state health and labor commissioners to review sharps injury prevention technology and determine those work settings where standards require that safety devices be implemented. Safety devices are not required where the employer can demonstrate that such technology is ‘medically contraindicated” or “is no more effective than alternative measures used by an employer to prevent exposure incidents. ”

Texas

Texas’ law (HB 2085; 1999) covers state or government-run health care facilities, which are not subject to federal OHSA standards. The law recommends that governmental units implement needleless systems and sharps with ESIP to protect employees at risk of bloodborne pathogen exposure.

West Virginia

West Virginia’s law (HB 4298; 2000) states that health care facilities must, as a part of their procedures for injury prevention, ensure the provision of services to individuals through the use of “hollow-bore needle devices or other technology known to minimize the risk of needlestick injury to health care workers. ” It allows for exceptions, including patient safety, interference with a medical procedure, and evidence that the technology is not more effective than alternative measures. It also allows three years for manufacturers of prefilled syringes to comply.

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