Code Section Group

Health and Safety Code - HSC


  ( Division 103 added by Stats. 1995, Ch. 415, Sec. 5. )


  ( Part 5 added by Stats. 1995, Ch. 415, Sec. 5. )

CHAPTER 6. Safer Medical Devices [105325 - 105340]
  ( Chapter 6 added by Stats. 1995, Ch. 415, Sec. 5. )


The Legislature hereby finds and declares all of the following:

(a)  In California, more than 700,000 health care workers and professionals, such as nurses, physicians and surgeons and housekeeping staff, are at risk of infection from bloodborne diseases, including Hepatitis B, Hepatitis C, and Human Immunodeficiency Virus, the causative agent of Acquired Immunodeficiency Syndrome.

(b)  Contaminated needlestick and other sharp instrument injuries threaten the well-being of health care workers and cost health care providers millions of dollars annually.

(c)  While health care employers have implemented rigorous, universal infection control procedures, requiring gloving and other protective equipment, exposure to bloodborne diseases continues to be a risk for health care workers.

(d)  Medical devices, such as needles, are reviewed by the federal Food and Drug Administration for patient safety and efficacy but are not reviewed by any state or federal agency for worker safety.

Improved product design of medical devices, such as needles, syringes, connectors for intravenous tubes, and vacuum blood collection systems, could reduce the number of sharps injuries.

(e)  Mechanisms for the collection and dissemination of information will allow health facilities to better evaluate safer devices and permit better comparisons across institutions.

(f)  Improvements in device and procedure-specific injury surveillance and information dissemination may increase market pressure to further improve medical device product design and enhance product evaluation.

(g)  Potential savings to the health care system from preventing exposure to bloodborne pathogens include reduced cost of followup procedures which occur following a sharps injury, such as source and employee testing, counseling, and prophylactic treatment. In addition, costs related to lost work time, personnel, insurance, possible legal problems, and workers compensation could be diminished.

(h)  It is the intent of the Legislature in enacting this chapter to reduce exposure of health care workers to bloodborne diseases by encouraging the development and use of medical devices that are designed to assure worker safety, the safety of patients, and the efficacy of the device.

(Amended by Stats. 1996, Ch. 683, Sec. 1. Effective January 1, 1997.)


(a)  The documentation of sharps injuries, as required by Section 5193 of Title 8 of the California Code of Regulations, shall also include the type and brand of device involved in the incident, unless this information is unknown by the health care worker.

(b)  Documentation, as required by Section 5193 of Title 8 of the California Code of Regulations, shall be referred to in this section as the “Sharps Injury Log”.

(c)  In consultation with the program on occupational health and occupational disease prevention, the department’s Environment Management Branch, Medical Waste Program, and local enforcement agencies may verify that each hospital, skilled nursing facility, and home health agency is in compliance with this chapter through its current medical waste program or through the establishment of a self-audit program.

(Repealed and added by Stats. 1996, Ch. 683, Sec. 3. Effective January 1, 1997.)


The Department of Health Services shall maintain a Sharps Injury Control program that shall do all of the following:

(a)  Maintain a continuously updated list of existing needleless systems and needles with engineered sharps injury protection, which shall be made available to assist facilities as provided by Section 144.7 of the Labor Code.

(b)  Solicit voluntary submission of data by health care institutions regarding the effectiveness of needleless systems and needles with engineered sharps injury protection.

(c)  Provide assistance to industry and the Division of Occupational Safety and Health to further compliance with occupational safety and health standards related to the use of needleless systems and needles with engineered sharps injury protection.

(Added by Stats. 2001, Ch. 370, Sec. 1. Effective January 1, 2002.)

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