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A BILL TO BE ENTITLED
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AN ACT
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relating to the maintenance and service of certain medical devices |
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in health care facilities; providing a criminal penalty. |
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BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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SECTION 1. Subdivision (13), Section 431.002, Health and |
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Safety Code, is amended to read as follows: |
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(13) "Device," except when used in Sections 431.003, |
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431.021(l), 431.0215, 431.082(g), 431.112(c), and 431.142(c), |
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means an instrument, apparatus, implement, machine, contrivance, |
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implant, in vitro reagent, or other similar or related article, |
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including any component, part, or accessory, that is: |
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(A) recognized in the official United States |
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Pharmacopoeia National Formulary or any supplement to it; |
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(B) intended for use in the diagnosis of disease |
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or other conditions, or in the cure, mitigation, treatment, or |
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prevention of disease in man or other animals; or |
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(C) intended to affect the structure or any |
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function of the body of man or other animals and that does not |
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achieve any of its principal intended purposes through chemical |
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action within or on the body of man or other animals and is not |
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dependent on metabolization for the achievement of any of its |
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principal intended purposes. |
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SECTION 2. Subchapter B, Chapter 431, Health and Safety |
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Code, is amended by adding Section 431.0215 to read as follows: |
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Sec. 431.0215. ADDITIONAL PROHIBITED ACTS; CRIMINAL |
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PENALTY. (a) In this section: |
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(1) "Electronic direct care medical device" means a |
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device used in the treatment, monitoring, or diagnosis of a |
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patient. |
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(2) "Facility" means an ambulatory surgical center, |
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physician's office, or medical clinic, other than an ambulatory |
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surgical center, physician's office, or medical clinic owned or |
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operated by a hospital, that is authorized under the laws of this |
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state to provide health care in this state. |
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(b) Except as provided by Subsection (c), a person may not |
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calibrate, repair, or perform preventive maintenance on or |
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otherwise service an electronic direct care medical device in a |
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facility unless the person: |
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(1) holds at least an associate of applied science |
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degree issued by an accredited college or university in engineering |
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as a biomedical equipment technician or medical imaging specialist |
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or holds a similar degree focused on the service, maintenance, or |
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service and maintenance of medical devices; |
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(2) holds satisfactory evidence of completion of a |
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program of service or maintenance of medical devices issued by the |
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United States military; |
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(3) for at least two of the preceding four years has |
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been actively engaged in and holds documented evidence of |
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proficient performance of electronic direct care medical device |
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service or maintenance apprenticeship or training, including |
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experience under Subdivision (4); |
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(4) holds at least an associate's degree in an |
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electronics field or an information management field from an |
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accredited college, university, or vocational school, or is |
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actively pursuing such a degree or pursuing an associate's degree |
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described in Subdivision (1), and is servicing or maintaining |
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electronic direct care medical devices under the supervision of an |
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individual who meets the requirements of Subdivision (1) or (2); |
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(5) holds satisfactory evidence of successful |
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completion of service or maintenance training from an electronic |
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direct care medical device manufacturer or designated trainer, |
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provided the person only provides service or maintenance for |
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devices made by that manufacturer and specifically covered by the |
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training; or |
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(6) holds a certification issued by the International |
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Certification Commission as a certified biomedical equipment |
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technician, certified laboratory equipment specialist, or |
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certified radiology equipment specialist, provided the person only |
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provides service or maintenance for the type of electronic direct |
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care medical devices covered by the certification. |
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(c) Subsection (b) does not apply to: |
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(1) the calibration, repair, maintenance, or service |
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of a class II or class III medical device that is used only for |
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teaching and research purposes; |
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(2) in-service or software upgrades of a medical |
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device performed by an employee or authorized sales representative |
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of a medical device manufacturer; or |
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(3) routine evaluations specified by the medical |
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device manufacturer performed by the owner or person designated by |
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the owner of the medical device. |
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(d) A person commits an offense if the person violates |
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Subsection (b). An offense under this subsection is a Class C |
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misdemeanor. |
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SECTION 3. (a) Except as provided by Subsection (b) of |
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this section, this Act takes effect September 1, 2010. |
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(b) Subsection (d), Section 431.0215, Health and Safety |
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Code, as added by this Act, takes effect September 1, 2011. |