26:2H-5.12 Integrated safety features required on needles, etc.; dentists, exempt, certain circumstances.
3. a. No later than 12 months after the date of enactment of this act, the commissioner shall require that a health care facility licensed pursuant to P.L.1971, c.136 (C.26:2H-1 et seq.) use only needles and other sharp devices with integrated safety features, which needles and other sharp devices have been cleared or approved for marketing by the federal Food and Drug Administration and are commercially available for distribution.
b. By a date established by the commissioner by regulation, but no later than 36 months after the date of enactment of this act, the requirements of subsection a. of this section shall also apply to pre-filled syringes, as that term is defined by the commissioner by regulation pursuant to this act.
c. No later than six months after the date of enactment of this act, the commissioner shall develop evaluation criteria for use by an evaluation committee established pursuant to subsection a. of section 4 of this act in selecting needles and other sharp devices for use by a health care facility.
d. In the event that there is no cleared or approved for marketing product with integrated safety features for a specific patient use, the licensed health care facility shall continue to use the appropriate needle or other sharp device that is available, including any needle or other sharp device with non-integrated, add-on safety features, until such time as a product with integrated safety features is cleared or approved for marketing and is commercially available for that specific patient use.
e. No later than six months after the date of enactment of this act, the commissioner shall develop and make available to health care facilities a standardized form that shall be used by health care professionals and the health care facility's evaluation committee for applying for a waiver and in reviewing a request for a waiver, respectively, and for reporting the use of a needle or other sharp device without integrated safety features in an emergency situation by a health care professional, pursuant to the provisions of subsection d. of section 4 of this act.
f. Notwithstanding the provisions of this section to the contrary, a dentist who determines that use of a needle or other sharp device with integrated safety features potentially may have a negative impact on patient safety or the success of a specific medical procedure may use a needle or other sharp device without integrated safety features, without obtaining a waiver from the evaluation committee and without providing notification to the evaluation committee pursuant to section 4 of P.L.1999, c.311 (C.26:2H-5.13).
L.1999,c.311,s.3; amended 2005, c.278.