By: Wentworth S.B. No. 1193
 
 
A BILL TO BE ENTITLED
 
AN ACT
  relating to the maintenance and service of certain medical devices
  in health care facilities; providing a criminal penalty.
         BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
         SECTION 1.  Subdivision (13), Section 431.002, Health and
  Safety Code, is amended to read as follows:
               (13)  "Device," except when used in Sections 431.003,
  431.021(l), 431.0215, 431.082(g), 431.112(c), and 431.142(c),
  means an instrument, apparatus, implement, machine, contrivance,
  implant, in vitro reagent, or other similar or related article,
  including any component, part, or accessory, that is:
                     (A)  recognized in the official United States
  Pharmacopoeia National Formulary or any supplement to it;
                     (B)  intended for use in the diagnosis of disease
  or other conditions, or in the cure, mitigation, treatment, or
  prevention of disease in man or other animals; or
                     (C)  intended to affect the structure or any
  function of the body of man or other animals and that does not
  achieve any of its principal intended purposes through chemical
  action within or on the body of man or other animals and is not
  dependent on metabolization for the achievement of any of its
  principal intended purposes.
         SECTION 2.  Subchapter B, Chapter 431, Health and Safety
  Code, is amended by adding Section 431.0215 to read as follows:
         Sec. 431.0215.  ADDITIONAL PROHIBITED ACTS; CRIMINAL
  PENALTY. (a)  In this section:
               (1)  "Electronic direct care medical device" means a
  device used in the treatment, monitoring, or diagnosis of a
  patient.
               (2)  "Facility" means an ambulatory surgical center,
  physician's office, or medical clinic, other than an ambulatory
  surgical center, physician's office, or medical clinic owned or
  operated by a hospital, that is authorized under the laws of this
  state to provide health care in this state.
         (b)  Except as provided by Subsection (c), a person may not
  calibrate, repair, or perform preventive maintenance on or
  otherwise service an electronic direct care medical device in a
  facility unless the person:
               (1)  holds at least an associate of applied science
  degree issued by an accredited college or university in engineering
  as a biomedical equipment technician or medical imaging specialist
  or holds a similar degree focused on the service, maintenance, or
  service and maintenance of medical devices;
               (2)  holds satisfactory evidence of completion of a
  program of service or maintenance of medical devices issued by the
  United States military;
               (3)  for at least two of the preceding four years has
  been actively engaged in and holds documented evidence of
  proficient performance of electronic direct care medical device
  service or maintenance apprenticeship or training, including
  experience under Subdivision (4);
               (4)  holds at least an associate's degree in an
  electronics field or an information management field from an
  accredited college, university, or vocational school, or is
  actively pursuing such a degree or pursuing an associate's degree
  described in Subdivision (1), and is servicing or maintaining
  electronic direct care medical devices under the supervision of an
  individual who meets the requirements of Subdivision (1) or (2);
               (5)  holds satisfactory evidence of successful
  completion of service or maintenance training from an electronic
  direct care medical device manufacturer or designated trainer,
  provided the person only provides service or maintenance for
  devices made by that manufacturer and specifically covered by the
  training; or
               (6)  holds a certification issued by the International
  Certification Commission as a certified biomedical equipment
  technician, certified laboratory equipment specialist, or
  certified radiology equipment specialist, provided the person only
  provides service or maintenance for the type of electronic direct
  care medical devices covered by the certification.
         (c)  Subsection (b) does not apply to:
               (1)  the calibration, repair, maintenance, or service
  of a class II or class III medical device that is used only for
  teaching and research purposes;
               (2)  in-service or software upgrades of a medical
  device performed by an employee or authorized sales representative
  of a medical device manufacturer; or
               (3)  routine evaluations specified by the medical
  device manufacturer performed by the owner or person designated by
  the owner of the medical device.
         (d)  A person commits an offense if the person violates
  Subsection (b). An offense under this subsection is a Class C
  misdemeanor.
         SECTION 3.  (a)  Except as provided by Subsection (b) of
  this section, this Act takes effect September 1, 2010.
         (b)  Subsection (d), Section 431.0215, Health and Safety
  Code, as added by this Act, takes effect September 1, 2011.