§ 7–2851. Definitions.
For the purposes of this chapter, the term:
(1) “Department of Health” means the District of Columbia Department of Health.
(2) “Engineered sharps injury protection” means a physical attribute built into a sharp that effectively reduces the risk of an exposure incident by a mechanism such as a barrier creation, blunting, encapsulation, withdrawal, retraction, destruction, or other effective mechanisms.
(3) “Exposure incident” means contact with blood or other potentially infectious materials that results from a sharp injury.
(4) “Person” means any individual, corporation, or other such entity that sells, distributes, uses, or possesses sharps.
(5) “Sharp” means any medical device that is or contains a needle.
(6) “Sharps injury” means any injury caused by a sharp, including cuts, abrasions, or needlesticks.
§ 7–2852. Prohibition.
(a) No sharp shall be sold, distributed, used, or possessed within the District of Columbia (“District”) unless its premarket notification for medical devises with engineered sharps injury protections has been approved by the United States Food and Drug Administration, pursuant to section 510(k) of the Federal Food, Drug, and Cosmetic Act, approved October 10, 1962 (76 Stat. 794; 21 U.S.C. § 360(k)).
(b) The Director of the Department of Health (“Director”) may provide a waiver of the prohibition in subsection (a) of this section to any person that can establish through objective data that:
(1) The use of sharps without engineered sharps injury protections is essential to the performance of a specific medical procedure;
(2) Sharps with engineered sharps injury protections are not presently available for use in that medical procedure; and
(3) In the case of a manufacturer, the manufacturer is currently developing, and will continue to develop:
(A) Sharps with engineered injury protections; or
(B) Medical devices that do not incorporate a needle into their design that are suitable for the specific medical procedure.
(c) For a period of one year following the implementation of the prohibition pursuant to subsection (a) of this section and § 7-2858, a waiver of the prohibition shall be granted to all persons for use of syringes that are pre-filled with medications by a pharmaceutical company.
(d) This chapter shall not apply to the sale, distribution, use, or possession of sharps used in the practice of dentistry or in the self-administration of drugs, medicines, or other treatments.
§ 7–2853. Reporting.
Any person involved in an exposure incident within the District shall report the incident to the Director within 90 days of its occurrence. The report shall include the date and time of the exposure, the type and brand of sharp involved in the exposure incident, and a description of the exposure incident. The Director shall compile an annual report of all exposure incidents within the District and make the report available to the public upon request.
§ 7–2854. Penalties.
(a) Any person who violates the provisions of this chapter shall be subject to a civil penalty not to exceed $1,000. The Corporation Counsel of the District of Columbia may bring an action to restrain violations of the provisions of this chapter.
(b) Any person who willfully and intentionally violates the provisions of this chapter shall be guilty of a misdemeanor and, upon conviction, shall be subject to the following:
(1) On a first offense, a fine of not more than $5,000 or imprisonment for not more than 30 days, or both; and
(2) On a second or subsequent offense, a fine of not more than $10,000 or imprisonment for not more than 90 days, or both.
§ 7–2855. Rules.
The Director, pursuant to subchapter I of Chapter 5 of Title 2, shall issue rules to implement the provisions of this chapter.
§ 7–2856. Appropriations. [Repealed]
§ 7–2857. Nonseverability.
If any provision of this chapter or its application to any person or circumstances is held to be unconstitutional, beyond the statutory authority of the Council of the District of Columbia, or otherwise invalid, then all provisions of this chapter shall be deemed invalid.
§ 7–2858. Applicability.
This chapter shall apply 12 months after April 4, 2001.
This section is referenced in § 7-2852.