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.