Legislation

Needlestick and Prevention Act

The Needlestick and Prevention Act places the requirement on the healthcare employer to document that they have implemented safety-engineered sharp devices and needless systems. This documentation must be provided in the employer’s exposure control plan, with the goal of reducing employees’ occupational exposure to HIV, hepatitis C and other blood borne diseases.

In addition, the Needlestick and Prevention Act states that:

  • The employer’s exposure control plans must be reviewed and updated annually. Any changes in sharps safety technology that has occurred must be included.
  • There must be a sharps injury log maintained at every healthcare facility. Detailed information must be documented in the log, including:
    - The department where the injury occurred,
    - An explanation of how the injury occurred, and
    - The type and brand of the device involved in the injury.
  • Employers must ask for input from non-managerial, frontline healthcare workers when identifying, evaluating and selecting safety-engineered sharp devices. These actions must be documented in the employer’s exposure control plan.
  • The definition of “Engineering Controls” now includes devices with engineered sharps injury protection.

The Needlestick and Prevention Act also:

Sets forth in greater detail requirements for employers to identify, evaluate, and implement safety-engineered medical devices.

As of 2002, legislation is in full affect and all medical practices and facilities should be using safety devices whose safety feature is integral to the device.

The Act applies to all employers who have employees with reasonably anticipated occupational exposure to blood or other potentially infectious materials (OPIM), including hospitals, surgery centers, medical clinics, physician offices, nursing homes, and home care/home infusion.

The Bloodborne Pathogen Standard applies to all workplaces, regardless of size, as not only are the practicing physicians at risk of needlesticks, but also those employees working with them and downstream. The safety legislation still applies when the physician is both the employer and the employee.

Employers also must investigate availability of safety devices each year and document that fact in their Exposure Control Plan. The device must be implemented as soon as it becomes available and documented.

OSHA

The current Federal standard for addressing needlestick injuries among healthcare workers is the OSHA blood borne pathogens standard [29 CFR 1910.1030; 56 Fed. Reg.†† 64004 (1991)], which has been in effect since 1992.

The standard applies to all occupational exposures to blood or other potentially infectious materials. Notable elements of this standard require the following:

  • A written exposure control plan designed to eliminate or minimize worker exposure to blood borne pathogens.
  • Compliance with universal precautions (an infection control principle that treats all human blood and other potentially infectious materials as infectious).
  • Engineering controls and work practices to eliminate or minimize worker exposure.
  • Personal protective equipment (if engineering controls and work practices do not eliminate occupational exposures).
  • Prohibition of bending, recapping, or removing contaminated needles and other sharps unless such an act is required by a specific procedure or has no feasible alternative.
  • Prohibition of shearing or breaking contaminated needles (OSHA defines contaminated as the presence or the reasonably anticipated presence of blood or other potentially infectious materials on an item or surface).
  • Free hepatitis B vaccinations offered to workers with occupational exposure to blood borne pathogens.
  • Worker training in appropriate engineering controls and work practices.
  • Post-exposure evaluation and follow-up, including post-exposure prophylaxis when appropriate.

OSHA also intends to act to reduce the number of injuries that health care workers receive from needles and other sharp medical objects [OSHA 1999a].

First, the agency has revised the compliance directive (guidance to be used in the field) accompanying its 1992 blood borne pathogens standard [29 CFR 1910.1030] to reflect newer and safer technologies now available and to increase the employer’s responsibility to evaluate and use effective, safer technologies [OSHA 1999b].

Second, the agency has proposed a requirement in the revised recordkeeping rule that all injuries resulting from contaminated needles and sharps be recorded on OSHA logs used by employers to record injuries and illnesses.

Finally, OSHA will take steps to amend its blood borne pathogens standard by placing needle stick and sharps injuries on its regulatory agenda.

FDA

Under the regulations of the Food and Drug Administration (FDA) application clearance process [FDA 1995], the manufacturers of medical devices (including needles used in patient care) must meet requirements for appropriate registration and for listing, labeling, and good manufacturing practices for design and production.

The process for receiving clearance or approval to market a device requires device manufacturers to:

  1. Demonstrate that a new device is substantially equivalent to a legally marketed device or
  2. Document the safety and effectiveness of the new device for patient care through a more involved premarket approval process.

FDA has also released two advisories pertaining to sharps and the risk of blood borne pathogen transmission in the health care setting [FDA 1992; FDA et al. 1999].

State Regulations

As of the writing of the NIOSH Alert on Preventing Needlestick Injuries in Healthcare Settings, three states have adopted, and more than two dozen are considering, legislation requiring additional regulatory actions addressing blood borne pathogen exposures to health care workers.

The recent California standard [State of California 1998] has several requirements that go beyond those currently required by OSHA. These requirements include stronger language for the use of needle less systems for certain procedures or (where needle less systems are not available) the use of needles with engineered sharps injury protection for certain procedures.

California Law Effective September 1, 2008

SB 1305 – The Medical Waste Management Act

On September 1, 2008 a new law became effective in the state of California, SB 1305 – The medical Waste Management Act.

Currently between 8 and 9 million Americans are self-injecting medication at home. The majority of these used needles are being thrown into household trash receptacles.

Nearly 21 million Americans have diabetes. In a study conducted by diabetes educators, 93% of the individuals polled stated that they place their used needles in the trash.

Other conditions that require self-administered injections include osteoporosis, multiple sclerosis, HIV/AIDS, Hepatitis C, migraines, cancer and psoriasis. Patients also self-administer blood thinners, growth hormones, infertility treatments, vitamin b12 and allergy shots.

SB 1305 defines “home-generated sharps waste” as hypodermic needles, pen needles, intravenous needles, lancets and other devices that are used to penetrate the skin for the delivery of medications derived from a household, including a multifamily residence or household.

On or after September 1, 2008, home-generated sharps waste shall be transported only in sharps containers or other containers approved by the enforcement agency, and shall be managed at any of the following:

  • A household hazardous waste facility pursuant to Section 25218.13.
  • A “home-generated sharps consolidation point” as defined in subdivision (b) of section 117904.
  • A medical waste generator’s facility pursuant to Section 118147.
  • A facility through the use of a medical waste mail-back container approved by the department pursuant to subdivision (b) of Section 118245.

About Us

U.S. Medical Instruments is a technology-based medical device manufacturer located in San Diego, CA. Our mission is to develop, manufacture and market safety-enhanced medical instruments that are both cost-effective and user-friendly.

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Contact Us

Mailing address:
P.O. Box 928439
San Diego, CA 92192

Telephone: (619) 661-5500
Fax: (619) 661-0500

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