By Maxey H.B. No. 2535 77R6722 YDB-D A BILL TO BE ENTITLED 1-1 AN ACT 1-2 relating to the use of single-use surgical devices; providing a 1-3 penatly. 1-4 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: 1-5 SECTION 1. Chapter 431, Health and Safety Code, is amended by 1-6 adding Subchapter M to read as follows: 1-7 SUBCHAPTER M. SINGLE-USE SURGICAL DEVICES 1-8 Sec. 431.301. DEFINITION. In this subchapter, "single-use 1-9 surgical device" means a cardiac catheter, angioplasty balloon 1-10 catheter, arthroscopic knee surgery blade, or any other device 1-11 marketed or sold as a disposable or single-use device, as 1-12 determined by board rule, to be designed for use in a single 1-13 surgical procedure to avoid risk of infection from improper 1-14 sterilization or risk of mechanical failure posed by subsequent 1-15 use. 1-16 Sec. 431.302. PROHIBITED ACT. A person may not knowingly 1-17 reuse, recycle, refurbish for reuse, or provide for reuse a 1-18 single-use surgical device. 1-19 Sec. 431.303. EXEMPTION. This subchapter does not apply to a 1-20 person who reuses, recycles, refurbishes for reuse, or provides for 1-21 reuse a single-use surgical device reprocessed by an entity or 1-22 person registered with and regulated by the United States Food and 1-23 Drug Administration. 1-24 Sec. 431.304. CRIMINAL PENALTY. (a) A person commits an 2-1 offense if the person knowingly violates this subchapter. 2-2 (b) Except as provided by Subsection (c), an offense under 2-3 this section is a Class B misdemeanor. 2-4 (c) An offense under this section is a Class A misdemeanor 2-5 if the person has been previously convicted of an offense under 2-6 this section. 2-7 SECTION 2. This Act takes effect September 1, 2001, and 2-8 applies only to the use of a single-use surgical device on or after 2-9 that date.